Search Results

The BUECHEL-PAPPAS™ Humeral Head Resurfacing Shoulder Component is intended for the reconstruction of painful and/or severely disabled shoulder joints resulting from osteoarthritis and rheumatoid arthritis. For proper function of this device, the humeral head and neck must be of sufficient bone stock to support the loads on it. Also, the presence of an intact or reconstructable rotator cuff is important for proper functioning and dislocation resistance. Biocoat® porous coated components are intended for cemented use only.

Not Found

Based on the provided document, the device in question is the Buechel-Pappas™ Humeral Head Resurfacing Component. This document is a 510(k) clearance letter from the FDA, meaning it primarily focuses on establishing "substantial equivalence" to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device.

Therefore, the information requested in your prompt regarding acceptance criteria, performance tables, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance for an AI-powered device cannot be extracted from this document. This is a pre-AI era medical device clearance.

The document 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..."

Essentially, this document describes a traditional medical device (a humeral head resurfacing component) and its clearance based on substantial equivalence, not an AI/ML device requiring the specific types of studies you've outlined.

Ask a specific question about this device