to allow for the exclusion, with respect to a breakthrough device furnished to an individual by a provider or supplier under an alternative payment model, of any quality measure designed to reflect the results of care furnished to such individual by such provider or supplier (commonly known as a clinical outcome measure) from a determination described in such subparagraph. . (b) Study on limit of 510( k ) breakthrough devices (1) Study The Secretary of Health and Human Services shall conduct a study on the effect of the limit (under section 1899C(a)(2) of the Social Security Act, as added by subsection (a)) on the number of devices cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) ) that are breakthrough devices for purposes of such section 1899C. (2) Matters examined In conducting the study described in paragraph (1), the Secretary shall— (A) determine the number of medical devices cleared under such section 510(k) during the 5-year period beginning on the date of the enactment of this Act