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The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Anatomic Shoulder Prosthesis is a modular system intended to be used for anatomical shoulder arthroplasty.

The Medacta Anatomic Shoulder Prosthesis is composed of the following components:

• Standard Humeral Diaphysis - Cementless (sizes 6 to 16)
• Standard Humeral Diaphysis Cemented (sizes 6 to 16)
• Humeral Anatomical Metaphysis Cementless (128°, 135° and 142° inclinations, sizes 6 to 16)
• Humeral Anatomical Metaphysis Cemented (128°, 135° and 142° inclinations, sizes 6 to 16)
• Double Eccenter
• Cobalt-Chromium Humeral Head (10 sizes, Ø 40 mm to Ø 58 mm)
• Highcross PE Pegged Glenoid (10 sizes, Ø 40 mm to Ø 58 mm)
• Humeral Stem Screw

The Standard Humeral Diaphysis and the Humeral Anatomical Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Humeral Stem Screw. The Double Eccenter is also connected to the Humeral Anatomical Metaphysis by means of a press-fit cylinder and a securing screw. The Cobalt-Chromium Humeral Head is coupled to a Double Eccenter by means of a taper Morse connection.

The Glenoid Anatomical Implant is composed of the Highcross PE Pegged Glenoid only, which is cemented into the glenoid bone.

The Medacta Anatomic Shoulder Prosthesis components are single-use only, are provided sterile via gamma irradiation or ethylene oxide, and are packaged individually.

The standard humeral diaphysis, humeral anatomical metaphysis, double eccenter, and humeral stem screw are manufactured from titanium alloy. The humeral head is manufactured from CoCr, and the highcross glenoid is manufactured from polyethylene.

The provided text describes the "Medacta Anatomic Shoulder Prosthesis" and its regulatory clearance. However, it does not contain information about acceptance criteria for device performance related to a diagnostic or AI-driven system, nor does it detail a study proving such criteria are met.

This document is a 510(k) summary for a medical device (a shoulder prosthesis), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The performance data presented focuses on the mechanical, material, and sterilization aspects of the physical implant, NOT on the performance of an AI or diagnostic system.

Therefore, I cannot provide the requested information in the format specified because the input document does not contain the relevant data for an AI/diagnostic device.

To answer your request, the input document would need to describe a study evaluating the performance of an AI or diagnostic device, including its acceptance criteria and the results of that evaluation.

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