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

The Shoe Cover is a device intended to be worn by hospital personnel from transfer of procedures to protect both the patient and the hospital personnel from transfer of materials.

Device Description

Shoe Cover

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a "Shoe Cover" device. As such, it is not a study report or clinical trial. Therefore, it does not contain information regarding detailed acceptance criteria, device performance metrics (such as sensitivity, specificity, AUC), sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as typically found in reports for devices utilizing AI or complex algorithms.

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)."

The core of this FDA clearance is substantial equivalence to a predicate device, not a demonstration of specific performance metrics against pre-defined acceptance criteria through a quantitative study with the details requested. Such an extensive study as described in the prompt is generally not required for Class I devices cleared under the substantial equivalence pathway, especially not for a device like a shoe cover.

Given this context, I cannot provide the requested information from the provided document. The document describes a regulatory clearance process, not a performance study.

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K Number

K955833

Device Name

NIOMED SURGICAL CAPS

Manufacturer

AMERASIA CORP.

Date Cleared

1996-03-15

(80 days)

Product Code