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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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