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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 components of the Comprehensive Segmental Revision System (SRS) components may be combined to create a proximal humeral replacement, distal humeral replacement and total humeral replacement. Previously cleared for use in conjunction with Biomet's Discovery Elbow System, the Comprehensive SRS system is being expanded to be compatible with the Zimmer Nexel Total Elbow. To accomplish this, the only component requiring modification is the Distal Humeral Body. The modified distal humeral bodies will be available in left and right configurations in three sizes 50, 60 and 70mm utilizing the same modular flange as the predicate device. The yoke geometry will match that of the humeral component in the Nexel Total Elbow System.

This document describes a 510(k) premarket notification for the "Comprehensive SRS/Nexel Elbow" device. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study demonstrating the device meets a specific set of acceptance criteria in the context of an AI/algorithm-based medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/algorithm-based device is not present in the provided document.

The document details a traditional medical device submission for an elbow prosthesis. The key points from the provided text are:

1. A table of acceptance criteria and the reported device performance:
Not applicable. This document is for a medical implant (elbow prosthesis) and focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific performance metrics for an AI/algorithm. Performance is generally assumed to be equivalent to the predicate if design, materials, and intended use are similar.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No "test set" in the context of an AI/algorithm is mentioned. The submission relies on an engineering analysis to determine that modified components do not present a new worst-case condition, rather than a clinical study with a test set.

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. No ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is mentioned.

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 is not an AI/algorithm-based device, so an MRMC study related to AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth in the context of evaluating an AI/algorithm is mentioned.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device, so there is no training set.

9. How the ground truth for the training set was established:
Not applicable. There is no training set.

Summary of Device and Evidence provided in the document:

• Device Name: Comprehensive SRS/Nexel Elbow
• Purpose of Submission: K153398 is a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device.
• Predicate Device: Comprehensive Segmental Revision System (SRS) - K111746, with additional reference to Zimmer Nexel Total Elbow – K123862.
• Device Description: The Comprehensive SRS components can be combined for proximal, distal, and total humeral replacement. The current submission expands compatibility with the Zimmer Nexel Total Elbow by modifying the Distal Humeral Body to mate with the Nexel Elbow's humeral component.
• Evidence for Substantial Equivalence:
  • Intended Use: Identical to the predicate.
  • Indications for Use: Identical to the predicate.
  • Materials: Identical to the predicate.
  • Design Features: Identical to the predicate, "except that the geometry has been modified to mate with the Nexel Elbow."
  • Sterilization: Identical to the predicate.
  • Non-Clinical Tests: "None Provided. Engineering analysis and MR assessment to determine that the modified components do not present a new worst case condition."
  • Clinical Tests: "None Provided."
• Conclusion: The sponsor claims the proposed device has the same intended use and similar technological characteristics as the predicate, and that differences do not raise new questions of safety and effectiveness, making it at least as safe and effective as the predicate.

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