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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

The Modular Hybrid Glenoid is intended to be inserted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

The Modular Hybrid Glenoid consists of a base and optional pegs. The polyethylene base has a concave articulating surface. The back side of the base has three outer polyethylene pegs for cement fixation and a central threaded titanium insert for the attachment of a central peg. The device may be used with or without a central peg.

The polyethylene peg has circumferential flanges. A titanium rod is molded within the peg to provide a threaded connection with the base.

The porous titanium peg provides the surgeon with an option for potential tissue ingrowth fixation. The peg is circular in design and tiered. Similar to the polvethylene peg, the porous titanium peg has a central titanium rod to provide a threaded connection.

The provided document is a 510(k) summary for the Biomet Orthopedics, Inc. Modular Hybrid Glenoid device. It describes the device, its indications for use, and a comparison to predicate devices, but does not contain information about studies proving the device meets acceptance criteria in the way a diagnostic AI/ML device would be evaluated.

This document pertains to a medical device, not an AI/ML diagnostic algorithm. Therefore, the specific criteria for evaluating AI/ML algorithms (such as sensitivity, specificity, AUC, sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not relevant to this submission.

Instead, the acceptance criteria for this type of medical device are generally based on non-clinical mechanical testing and establishing substantial equivalence to existing legally marketed devices.

Here's how the provided information relates to acceptance criteria for this specific medical device:

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

Since this is a mechanical orthopedic implant, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the document states:

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 for Test Set: Not applicable. The "testing" here refers to mechanical engineering tests of the device itself, not a clinical study on patients or an evaluation of an algorithm on a dataset.
• Data Provenance: Not applicable for clinical data. The mechanical tests would have been performed in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. "Ground truth" in the context of an AI/ML algorithm evaluation (e.g., radiologist diagnoses) is not relevant for this device's mechanical testing. The "ground truth" for mechanical testing is established by engineering standards and measurement techniques.

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

• Not applicable. This refers to consensus methods for interpreting medical images or data, which is not relevant for mechanical device 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. This type of study is specifically for evaluating diagnostic AI/ML algorithms used in conjunction with human readers. This document explicitly states: "Clinical Testing: None provided."

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

• Not applicable. This refers to the performance of an AI/ML algorithm by itself.

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

• Not applicable in the context of clinical "ground truth." For mechanical tests, the "ground truth" is derived from established engineering principles, material science, and testing methodology to ensure the device meets specified strength, fatigue, and other performance parameters.

8. The sample size for the training set:

• Not applicable. The concept of a "training set" is for AI/ML models. This is a physical medical device.

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

• Not applicable. (See #8)

Summary regarding AI/ML evaluation:

The provided document details a 510(k) submission for an orthopedic implant. It specifically states "Clinical Testing: None provided." The acceptance criteria and "study" are based on non-clinical mechanical testing and a demonstration of substantial equivalence to predicate devices, which is a different regulatory pathway and set of evaluation criteria than those used for AI/ML diagnostic devices.

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