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

The Comprehensive Vault Reconstruction System 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 intents 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 intented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive Vault Reconstruction System (VRS) is a glenoid baseplate for reverse shoulder arthroplasty designed to match the anatomy of an individual patient.

The provided text describes the regulatory clearance (K152754) for the Biomet Comprehensive Vault Reconstruction System (VRS). However, it does not include detailed acceptance criteria or a study proving performance against such criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data with specific acceptance criteria.

Key takeaway: The document explicitly states, "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence." Therefore, it does not contain the information requested regarding acceptance criteria and performance studies.

Despite the absence of the requested information, here's a breakdown of what can be inferred or directly stated from the provided text, addressing the points where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific quantitative performance metrics comparing the device to such criteria. The performance data section only lists the types of non-clinical tests conducted.

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 for any of the listed non-clinical tests.
• Data Provenance: Not specified. The tests are non-clinical (mechanical, software, cadaveric), so country of origin for patient data is irrelevant. Whether the tests were retrospective or prospective is not mentioned, but for mechanical and cadaveric testing, this distinction is less common than for clinical studies.

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):

This information is not applicable as the submission is for a medical device (a shoulder prosthesis) and relies on non-clinical testing for substantial equivalence, not expert-adjudicated clinical data to establish ground truth in the context of image interpretation or diagnosis.

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

Not applicable. As noted above, this submission focuses on non-clinical testing for a device, not on diagnostic performance where expert adjudication for ground truth would be required.

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:

Not applicable. This device is a shoulder prosthesis, not an AI-powered diagnostic tool. No MRMC study was performed or required for this type of submission.

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

Not applicable. This device is a physical shoulder implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be established by engineering standards and validated physical measurements or simulations, rather than clinical consensus or pathology. For example:

• Compressed Shear Load to Failure Testing: Ground truth would be the mechanical properties of the materials and design under load, validated by destructive testing.
• Software Validation: Ground truth would be the specified functional requirements and expected outputs of the software, validated through testing.
• Cadaver Validation: Ground truth would relate to the anatomical fit, surgical procedure, and stability of the implant within a cadaveric model, evaluated by anatomists or orthopedic surgeons.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for a physical medical device.

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