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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The purpose of this submission is to gain clearance for the new Medacta Shoulder System: Threaded Glenoid Baseplate (also referred to as Threaded Glenoid Baseplate) which is part of the Medacta Shoulder System: Reverse; a modular system intended to be used for Reverse Shoulder Arthroplasties (RSA). The Medacta Shoulder System: Threaded Glenoid Baseplate is an alternative option to the pegged glenoid baseplate that is part of reference device Medacta Shoulder System (K170452). The Medacta Shoulder System: Threaded Glenoid Baseplate is made of titanium alloy.

The Threaded Glenoid Baseplate is intended to replace only the glenoid side of the glenohumeral joint. The Threaded Glenoid Baseplate is intended to be used in the reverse configuration only. The Threaded Glenoid Baseplate is designed to be fixed on the glenoid bone by means of a central threaded post and the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with a Glenoid Baseplate by means of a taper Morse connection and secured by a central securing screw. The Threaded Glenoid Baseplate directly couples with the Glenoid Polyaxial Locking Screws and Glenoidsphere as part of the Medacta Shoulder System (K170452).

The provided text describes a 510(k) premarket notification for a medical device (Medacta Shoulder System: Threaded Glenoid Baseplate), not an AI/ML powered device. Therefore, the information requested in the prompt, such as acceptance criteria for AI performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical performance testing for a physical implant. The relevant "acceptance criteria" in this context refer to the successful completion and passing of these mechanical and material tests based on established standards.

Here's the information that can be extracted or inferred from the provided text, framed within the spirit of the request as much as possible for a non-AI device:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not specified as individual units. For mechanical testing, samples are typically tested until the standard's criteria are met or failure modes are understood. The text states "testing was conducted."
• Data provenance: The tests were non-clinical (laboratory/mechanical testing). The device manufacturer is Medacta International SA, located in Switzerland. The testing was conducted in support of an FDA 510(k) submission in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a physical implant, not an AI model that requires expert-established ground truth from medical images or data. The "ground truth" here is the physical and mechanical performance of the device against engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not an AI/ML clinical study. Adjudication methods are relevant for resolving discrepancies in human expert evaluations, which is not pertinent to mechanical testing.

5. 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

• No. The document explicitly states: "No clinical studies were conducted." This relates to a physical implant, not an AI device, so MRMC studies examining reader performance with or without AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is defined by established engineering and material science standards (e.g., ASTM F1378-12, ASTM F2028-14, European Pharmacopoeia, USP chapters). Compliance with these standards demonstrates the physical and mechanical integrity and biocompatibility of the implant.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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