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The Comprehensive® Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Revision where other devices or treatments have failed.
• 3. Correction of functional deformity.
• 4. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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 suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The provided text describes a medical device, the "Comprehensive Segmental Revision System (SRS)," and its 510(k) premarket notification to the FDA. This document is a regulatory submission for a medical device and thus does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered diagnostic or predictive system.

The text does mention:

• Non-Clinical Tests/Justification: Coating Characterization, Fatigue Strength Report Flanges, Fatigue Strength Analysis Humeral Stems, Shot Peen Testing Summary, and MRI. These are engineering and material science tests relevant to the physical implant's safety and performance, not a study of an AI system's diagnostic accuracy.
• Clinical Tests: "None provided." This explicitly states that no clinical studies were performed for this specific submission to expand the indications of the device, as substantial equivalence was demonstrated through other means (comparison to predicates, engineering tests).

Therefore, based on the provided text, I cannot answer questions 1 through 9 as they relate to the performance evaluation of an AI device. The document is about a mechanical orthopedic implant, not an AI system.

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Biomet Comprehensive Vault Reconstruction System Components are 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 suited to receive the implants and a functional deltoid muscle is necessary.

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

The Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

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

The Comprehensive Vault Reconstruction System is a glenoid baseplate for reverse shoulder arthroplasty designed to match the natural geometry of an individual patient.

The provided text is a 510(k) summary for the Biomet Manufacturing Corp.'s Comprehensive Vault Reconstruction System. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it details the device description, indications for use, comparison to predicate devices, and a summary of technological characteristics and non-clinical tests to support substantial equivalence.

Therefore, I cannot extract the requested information based on the provided text. The document states "Clinical Tests: o None", which further confirms the absence of clinical study data to establish acceptance criteria or device performance in a clinical setting.

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

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

This regulatory submission for the "Alliance Glenoid" device (K191814) does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of an AI/ML medical device.

The document describes a medical device, specifically shoulder glenoid components for total shoulder replacement. The "Summary of Performance Data" section lists various non-clinical tests performed (e.g., accelerated corrosion, fatigue, glenoid loosening, range of motion, wear analysis, porous structure characterization, MR Evaluation). It explicitly states "Clinical Tests: None provided."

Therefore, I cannot fulfill your request as the provided text does not describe an AI/ML device or its associated performance study with acceptance criteria.

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