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Anatomic Applications

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.

Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the Implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Comprehensive Convertible Glenoid Baseplate components are Intended for cementless applications with the addition of screw fixation.

Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive Convertible Glenoid Baseplate is round, truncated on the anterior and posterior sides. The baseplate features a medial boss through which a Central Screw is placed to hold the component in place. The back surface of the component is porous coated. There are two peripheral screw holes through the baseplate. Screws are available in both locking and non-locking styles. When used with a polyethylene liner, the construct is designed to articulate with a metallic humeral head attached to a humeral stem in a traditional, anatomic total shoulder configuration. Should revision to a reverse shoulder construct be desirable, the polyethylene liner can be removed without removal of the baseplate and replaced with a glenosphere component.

The provided text does not describe acceptance criteria for a device's performance in the context of an AI/ML-driven medical device, nor does it detail a study that proves a device meets such criteria.

Instead, this document is a 510(k) summary for a medical device called "Comprehensive® Convertible Glenoid," which is a shoulder joint prosthesis. The information presented is for the regulatory approval of this orthopedic implant.

Here's a breakdown of why this document doesn't contain the requested information about AI/ML device performance:

• Device Type: The device is a glenoid prosthesis, a physical implant for shoulder replacement surgery. It is not an AI/ML-driven device that analyzes data or images.
• Performance Data: The "Performance Data" section lists non-clinical tests typically performed on mechanical implants (e.g., range of motion, axial separation of tapers, shear load to failure, FEA stress simulation). These are engineering performance tests for mechanical integrity and function, not diagnostic or predictive performance metrics for an algorithm.
• Clinical Data: The document explicitly states, "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence." This means there was no clinical study conducted or required for this particular regulatory submission to assess device efficacy or safety in patients, let alone the performance of an AI.
• Ground Truth, Experts, Sample Sizes (for AI): Since this is not an AI/ML device, there are no mentions of test sets, training sets, data provenance, ground truth established by experts, or adjudication methods, which are all specific to the evaluation of AI/ML systems.
• MRMC Study: An MRMC comparative effectiveness study is used to assess the impact of an AI on human reader performance. This is irrelevant for a physical orthopedic implant.

In summary, the provided text does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets those criteria. The document pertains to a traditional medical device (a shoulder prosthesis) and its regulatory submission based on mechanical and material performance testing, not AI/ML algorithm evaluation.

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