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General indications: The LINK Embrace Shoulder System - Reverse Configuration is intended for reverse total shoulder arthroplasty.

Indications: Primary, fracture, or revision total shoulder arthroplasty in a grossly rotator cuff deficient joint with severe arthropathy. A functional deltoid muscle is necessary, and the patient's joint must be anatomically suited to receive the implants.

The Reverse Glenoid Baseplate component is intended for cementless fixation with the addition of bone screws.

The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.

The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cementless fixation.

The Humeral Fracture Stems and Proximal Bodies are intended for cementless fixation.

The Modular Stems 75mm are intended for cemented or cementless fixation.

The Modular Stems, fully corundum blasted, are intended for cementless fixation.

The Modular Stems, fully polished, are intended for cemented fixation.

This system adds modular humeral stem components to the LINK Embrace Shoulder System – Reverse Configuration, comprised of Proximal Bodies and Modular Stems. The modular Proximal Bodies (Ti6A4V) are available in several sizes and heights. The Proximal Bodies feature a spiked surface, and m-l and a-p holes for suture fixation. The Proximal Bodies feature a proximal modular taper connection for assembly to the existing Reverse Tray components. The Proximal Bodies feature a distal modular taper connection for assembly to a modular stem.

The modular stems (Ti6Al4V) are available in different diameters and lengths as well as different surface options for cemented or cementless fixation.

The provided text is a 510(k) summary for the LINK® Embrace Shoulder System - Reverse Configuration. This document describes a medical device, specifically a shoulder prosthesis, and its substantial equivalence to previously cleared devices. It does not contain information about an AI/ML (Artificial Intelligence/Machine Learning) device or any study that proves such a device meets acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them, as this information is not present in the provided text.

The document focuses on:

• Device Description: A shoulder joint replacement system, specifically an update adding modular humeral stem components.
• Indications for Use: When and for whom the device is intended.
• Comparison to Predicate Devices: Demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices, primarily by comparing materials,
  sterilization, packaging, and general design principles.
• Performance Testing: Mentioning non-clinical performance tests (Range of Motion analysis, Fatigue testing with Fretting/Corrosion assessment, and post-fatigue disassembly tests)
  to show mechanical safety and performance, but these are for the physical implant, not an AI component.
• No Clinical Testing: Explicitly states that clinical performance testing was not required to demonstrate substantial equivalence for this device.

In summary, the provided text describes a conventional physical medical implant, not an AI/ML-driven device.

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