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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 Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• · Rheumatoid arthritis
• · Revision where other devices or treatments have failed
• · Correction of functional deformity
• Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
• · Traumatic arthritis
• · Oncology applications including bone loss due to tumor resection.
• · Significant humeral resection which are unmanageable using other treatment methods

The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.

The Equinoxe Mega Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreparable and grossly deficient, and a functional deltoid muscle is present.

The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, press-fit use.

The Equinoxe Mega Prosthesis differs from conventional Total Shoulder Arthroplasty implants in that it is intended to replace both the articulating surface (humeral head) as well as the resected humerus. The modular design allows for the surgeon to construct the middle and proximal segments of the prosthesis in various lengths in order to match the length of resected bone, and to maintain the patient's natural arm length.

The prosthesis is manufactured from Ti-6A1-4V and has both Titanium Plasma Spray and HA coated regions. The proximal bodies are available in four sizes (Small, Medium, Large, Extra-Large) and two lengths (+0mm, +12.5mm). The middle segments are available in 3 lengths (25mm, 50mm, 75mm) with one diameter (20mm). The distal stems are available in 3 lengths (80mm, 120mm, 200mm) and 6 diameters (6mm, 7mm, 8mm, 9mm, 11mm, 13mm). The distal fixation rings are available in 17 diameters (17.5mm-33.5mm, 1mm increments). The distal fixation rings are intended for press-fit fixation. The proximal bodies and middle segments have suture through holes to facilitate soft tissue attachment.

This document is a 510(k) premarket notification for the Exactech Equinoxe Mega Prosthesis, which is a medical device. The primary purpose of this type of submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness or safety through extensive clinical trials as would be required for a PMA. Therefore, the information typically requested for acceptance criteria and studies (especially those involving human subjects, ground truth, experts, and statistical analysis with sample sizes) for AI/ML devices is not explicitly detailed in this type of submission for a traditional medical implant.

However, I can extract the relevant information regarding the non-clinical testing performed to support substantial equivalence.

Here's an attempt to fill in the requested table and information based on the provided document, acknowledging the limitations for a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Based on provided text, acknowledging this is a mechanical device, not AI/ML):

The document describes a submission for a traditional medical device (Exactech Equinoxe Mega Prosthesis), not an AI/ML device. Therefore, many of the requested categories like "test set," "training set," "ground truth," "experts," and "MRMC comparative effectiveness study" are not applicable in the context of an AI/ML diagnostic system. The evaluation here is based on non-clinical (bench and cadaveric) testing and comparison to a predicate device for substantial equivalence.

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 (Test Set): Not explicitly stated in the summary for each test. For mechanical tests like fatigue, torsion, pull-off, etc., sample sizes would typically be determined by relevant ASTM or ISO standards but are not reported in this summary. For the cadaveric study, the sample size (number of cadavers or specimens) is not specified.
• Data Provenance: The studies are non-clinical (bench and cadaveric). Country of origin is not specified, but the applicant (Exactech, Inc.) is based in Gainesville, Florida, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

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)

• Number of Experts/Qualifications: Not applicable in the context of this traditional device submission. For a cadaveric study, surgeons might be involved in evaluating surgical technique or fit, but they are not "establishing ground truth" in the diagnostic sense. The "ground truth" for mechanical testing is derived from engineering principles and standards.

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

• Adjudication Method: Not applicable. This concept belongs to expert review of diagnostic cases, which is not the nature of these non-clinical tests.

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

• MRMC Study: No. This is a traditional medical device, not an AI/ML diagnostic.

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

• Standalone Study: Not applicable. This is a physical implant, not an algorithm.

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

• Type of Ground Truth:
  • For mechanical tests (Fatigue, Torsion, Taper, Axial Pull-Off, Suture Abrasion, Plasma Spray Characterization): The "ground truth" is adherence to established engineering standards (e.g., ASTM, ISO) and successful demonstration of mechanical integrity and performance under simulated physiological conditions.
  • For the Cadaveric Study: The "ground truth" would be the observed biomechanical performance, surgical fit, and handling characteristics within the cadaveric specimen, assessed against expected anatomical and surgical outcomes.
  • For Clinical Literature Review: The "ground truth" is established medical knowledge and previous clinical outcomes reported in peer-reviewed literature for similar devices or surgical approaches.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. There is no AI/ML model being trained. The design of the device is based on engineering principles and existing knowledge.

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

• Ground Truth Establishment (Training Set): Not applicable.

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