FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided document is a 510(k) clearance letter from the FDA for a hospital bed. This type of document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/ML devices. Therefore, I cannot provide the requested information based on the input document.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

"This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market."

This indicates that the device (a hospital bed) was cleared based on substantial equivalence to an existing predicate device, not on clinical performance studies or specific acceptance criteria for an AI/ML component. The information requested pertains to the evaluation of AI/ML software, which is not applicable to a physical medical device like a hospital bed under a 510(k) clearance in 1997.

Ask a Question

Ask a specific question about this device

K Number

K964515

Device Name

ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002

Manufacturer

M.C. HEALTHCARE PRODUCTS, INC.

Date Cleared

1996-12-31

(76 days)

Product Code