DEPUY GLOBAL AP CTA HUMERAL HEAD by DEPUY ORTHOPAEDICS, INC.

A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

Ununited humeral head fractures.
Avascular necrosis of the humeral head.
Rotator cuff tear arthropathy.
Deformity and/or limited motion.

Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoat® are indicated for cemented or cementless use.

Device Description

The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use in hemi-shoulder arthroplasty.

AI/ML Overview

The provided document is a 510(k) summary for the DePuy Global AP CTA Humeral Head, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance criteria through a study in the same way a new drug or novel medical device might. Therefore, the information you're requesting regarding acceptance criteria and a study proving those criteria are met is not typically found or required in a 510(k) submission for a device of this nature.

510(k) clearances, especially for devices like orthopedic implants that are often based on existing designs and materials, focus on comparing the new device to a predicate device in terms of:

Intended Use and Indications: Ensuring they are the same or similar.
Design and Materials: Verifying similar principles, materials, and construction.
Performance (Bench Testing): Often involves mechanical and material testing to ensure safety and function equivalent to the predicate, rather than clinical efficacy studies.
Manufacturing and Sterilization: Demonstrating processes are consistent and appropriate.

Based on the provided document, here's what can be extracted/inferred regarding your questions:

A table of acceptance criteria and the reported device performance:
- Not Applicable (N/A). The 510(k) emphasizes substantial equivalence to the predicate device (DePuy Global Advantage Extended Head, K000575) based on similarities in intended use, indications for use, materials, design, method of manufacture, sterilization, and packaging. There are no specific "acceptance criteria" and "reported device performance" in the clinical or AI-assisted sense found in this document. Any performance testing would be standard mechanical/material testing for orthopedic implants, demonstrating equivalence to the predicate, rather than clinical efficacy metrics.
Sample size used for the test set and the data provenance:
- N/A. This document does not describe a "test set" in the context of a clinical study or AI model evaluation. It's a regulatory submission for a physical medical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Not relevant for this type of medical device submission. Ground truth establishment is not part of this 510(k) process.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is not an AI-powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI-powered device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. There isn't a "ground truth" in the context of clinical endpoints for the humeral head device as presented here. Substantial equivalence relies on comparison to a predicate, not establishing novel clinical efficacy against a "ground truth."
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- N/A. Not applicable.

Summary of what the document does address for proving device safety and effectiveness (via substantial equivalence):

The device is considered substantially equivalent to the DePuy Global Advantage Extended Head (K000575) because they share:

Intended Use: Hemi-shoulder arthroplasty.
Indications for Use: (listed in detail in the document, covering various conditions like osteoarthritis, fractures, avascular necrosis, etc.).
Materials: Implied to be similar to the predicate.
Design: Implied to be similar to the predicate.
Method of Manufacture: Implied to be similar.
Sterilization and Packaging Methods: Implied to be similar.

In essence, for this type of medical device 510(k), the "study that proves the device meets the acceptance criteria" is the comprehensive comparison demonstrating its equivalence to a device already legally on the market. Clinical trials demonstrating novel safety and efficacy are generally reserved for PMA (Pre-Market Approval) devices or devices with novel technology where substantial equivalence cannot be established.

Summary

Regulation Number and Section

§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.