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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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Indications For Use:

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

• 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. 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. Reverse application is limited to proximal humeral replacement in the United States.

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.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the shoulder joint. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullay replacement of bone. The components of the Comprehensive SRS system have previously been cleared for use in hemi and anatomic total shoulder replacement. The current submission is to expand the indications to include reverse shoulder applications. All components have been previously cleared.

I am sorry, but based on the provided text, I cannot provide the detailed information you requested about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA to Biomet Manufacturing Corp. It determines substantial equivalence for the Comprehensive Segmental Revision System (SRS) to legally marketed predicate devices.

Here's why I cannot fulfill your request based on this document:

• No specific acceptance criteria or performance metrics are listed for the device itself. The document only details the "Indications for Use" for the device, which are the medical conditions or purposes for which it is intended.
• The document states "No new testing provided" under "Non-Clinical Tests" and "None provided" under "Clinical Tests" for the current submission (K173411). This means the FDA's substantial equivalence determination for this specific submission was based on existing data from previous clearances (K111746) and comparison to the predicate device, not on new studies conducted for this K173411.
• The details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for either training or test sets are not present in this regulatory letter. These types of details would typically be found in the comprehensive testing reports that accompany a 510(k) submission, not in the FDA's determination letter itself.

In summary, the provided text confirms the FDA's decision regarding substantial equivalence but does not contain the specific performance data, acceptance criteria, or study details you are asking for.

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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. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. 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.

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 and total humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The Comprehensive® SRS address the needs of the upper extremity, especially in cases where there is marked bone loss. Applications of the system include proximal humeral (shoulder) replacements distal humeral (elbow) replacements and total humeral replacements. Components of the system include humeral heads, proximal humeral bodies, intercalary segments, humeral stems, total humeral couplers, distal bodies with a modular flange, and modular tissue attachment augments.

The provided text describes a 510(k) submission for the "Comprehensive® Segmental Revision System (SRS)," a shoulder, elbow, and total humeral replacement prosthesis. The submission details the device's characteristics and its substantial equivalence to predicate devices based on non-clinical testing. Crucially, the document explicitly states, "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."

Therefore, many of the requested elements regarding acceptance criteria and studies (especially clinical ones) cannot be extracted from this document, as they were not conducted or submitted for this device.

Here's a breakdown of the information that can be provided based on the input:

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

The document lists "Performance Data" which are summaries of non-clinical tests. It does not explicitly state numerical acceptance criteria for these tests, but implies that the device "performed within the intended use" and was comparable to the predicate devices.

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 non-clinical tests. Non-clinical mechanical testing typically involves a small number of samples depending on the test type (e.g., typically N=3 to N=6 or more for fatigue testing per ISO standards).
• Data provenance: The tests are non-clinical, so country of origin of patient data is not applicable. The tests were performed as part of a 510(k) submission in the US. The design of these tests suggests they are prospective in nature within a laboratory setting.
• Retrospective or prospective: The non-clinical tests are, by nature, prospective in that they were designed and executed to evaluate specific performance aspects of the newly designed device.

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)

• Not applicable. As "No clinical data submitted" there was no ground truth established by experts for a test set in the clinical sense. The "ground truth" for non-clinical tests would be the established engineering and materials science principles and standards against which the device performance was measured. These would typically be evaluated by engineers and materials scientists.

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

• Not applicable, as no clinical test set with expert adjudication was involved.

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. No MRMC study was conducted. This device is a physical implant, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical 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" was based on established engineering principles, material properties standards (e.g., relevant ASTM standards like F2182-09 for MR Compatibility), and performance characteristics of predicate devices. The goal was to demonstrate that the new device performed equivalently or acceptably according to these engineering benchmarks, not against clinical outcomes or expert diagnoses.

8. The sample size for the training set

• Not applicable. As no clinical data was submitted and the device is a physical implant, there was no "training set" in the context of machine learning or AI models. The design and testing of the device would have involved an iterative process where engineering data might inform design changes, but this is not analogous to a machine learning training set.

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

• Not applicable, as there was no training set in the context of machine learning or AI models.

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