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The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

The Compress® Segmental Humeral Replacement System is indicated for:

1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
2. Tumor resections.
3. Revision of previously failed total joint arthroplasty.
4. Trauma.

The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.

The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.

The Compress® Segmental Humeral Replacement System is a set of Compliant - Pre-Stress implants that replace the humeral stems that would normally be used during a proximal or distal humeral replacement surgery.

Here's a summary of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical (bench) testing only. It does not mention a "test set" in the context of patient data.

• Sample Size for Test Set: Not applicable, as no clinical test set was used.
• Data Provenance: Not applicable, as no clinical data was used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. The tests performed are mechanical engineering tests, not clinical evaluations requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with ground truth establishment was performed. The non-clinical tests likely followed standardized engineering practices for evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical medical implant (Compress® Segmental Humeral Replacement System), not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is not relevant.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was based on engineering specifications and predefined performance thresholds for mechanical properties (fatigue life, pull-off strength). This is a form of objective physical measurement against a standard.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI/ML model.

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The indications for use for the Discovery™ – Mosaic™ Total Humerus System include:

• 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
• Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
• 6. Oncology applications
     The Discovery™ - Mosaic™ Total Humerus System is intended for cemented use only.

The Discovery™ - Mosaic™ Total Humerus System includes the components of the Discovery Elbow, the components of the 3 Piece Proximal Humeral Replacement System, and an intercalary segment designed to connect them. The Discovery™ - Mosaic™ Total Humerus System uses the same modular heads and glenoid components that were cleared for use in the predicate 3 Piece Proximal Humeral Replacement System.

The provided 510(k) summary for the Discovery™ - Mosaic™ Total Humerus System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing that would typically be described in an AI/Software as a Medical Device (SaMD) context.

This documentation is for a physical medical device (a shoulder prosthesis), and the submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against quantitative acceptance criteria through new clinical or technological studies in the way you've laid out questions.

Therefore, many of your specific questions regarding AI/SaMD performance evaluation metrics (e.g., sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's what can be extracted and what cannot be from the provided text:

Summary of Device Performance and Equivalence

Device Study Details (As applicable to this physical device)

1. Sample size used for the test set and the data provenance:

   • Not applicable. This submission did not involve a "test set" in the context of evaluating an algorithm or AI model. Performance was based on non-clinical testing (mechanical properties) and comparison to predicate devices, not data analysis of a test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No test set or expert-established ground truth as typically understood for AI/SaMD.

3. Adjudication method for the test set:

   • Not applicable.

4. 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 relates to human-AI collaboration in diagnostics/interpretation, not a physical implant.

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

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

6. The type of ground truth used:

   • For the non-clinical testing, the "ground truth" would be the engineering specifications and mechanical test results that demonstrate the device meets performance standards (e.g., strength, durability) comparable to the predicate devices. This is not explicitly detailed in the summary, but it's the basis for "Non-Clinical Testing" claim ("performance data indicated that the Discovery™ - Mosaic™ Total Humerus System is I ric performally equivalent to the predicate devices for the uses indicated.")

7. The sample size for the training set:

   • Not applicable. No training set was used for an AI/ML model for this physical device.

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

   • Not applicable.

Key Takeaways from the Provided Text:

• Device Type: Physical shoulder prosthesis, not a software or AI device.
• Regulatory Pathway: 510(k) Premarket Notification, relying on substantial equivalence to predicate devices.
• Performance Demonstration:
  • Non-Clinical Testing: Was performed, and indicated "performally equivalent" to predicate devices. Specifics of this testing (e.g., types of tests, specific results, acceptance criteria for these tests) are not provided in this summary.
  • Clinical Testing: "was not required for these components to support substantial equivalence." This is common for devices following the 510(k) pathway when substantial equivalence can be demonstrated through non-clinical means and similarity to well-established predicates.
• Indications for Use: Clearly stated, covering degenerative joint disease, rheumatoid arthritis, revisions, deformity correction, fractures, and oncology applications, for cemented use only.

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The Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Heads are for rne in primary and revision shoulder joint replacement procedures 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
• Conceasin of ranicuonal consic fractures with humeral epicondyle (elbow) involvement or humeral head (shoulder), which are unmanageable using other treatment methods
• · Oncology applications

The Mosaic™ components are made of Co-Cr-Mo per ASTM F 75 and are Device Description: The Prosac componenes and mass offset modular designs are used to wailable in a non-modular proximal body and an EAS offset modular designs are used wallable in a non-modular proximal bone surface or with cleared glenoid components.

The provided text is a 510(k) summary for a medical device (Mosaic™ Non-modular Proximal Body and EAS Offset Modular Humeral Head), which is a premarket notification to the FDA.

Based on the content of this 510(k) summary, the device did not undergo clinical testing to establish substantial equivalence. Instead, the substantial equivalence was demonstrated through non-clinical testing. This means that a study proving the device meets acceptance criteria in the clinical context, as outlined in your request, was not performed or described in this document.

The document explicitly states:

• "Non-Clinical Testing: Non-clinical testing demonstrated substantial equivalence between this device and the predicate devices." (Page 0)
• "Clinical Testing: Clinical testing was not used to establish substantial equivalence." (Page 0)

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as such a study was not conducted or reported for this 510(k) submission.

To directly answer your numbered points based on the provided text, where applicable:

1. A table of acceptance criteria and the reported device performance: Not applicable. Clinical acceptance criteria and device performance based on a study proving it meets these criteria are not reported.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set was used.
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 clinical study, including MRMC, was conducted. This device is a shoulder joint prosthesis, 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.): Not applicable, as no clinical ground truth was established for a performance study.
8. The sample size for the training set: Not applicable, as no clinical training set was used for an AI/algorithm.
9. How the ground truth for the training set was established: Not applicable, as no clinical training set was used.

In summary, this 510(k) relies on substantial equivalence to predicate devices, supported by non-clinical testing, rather than a clinical performance study with acceptance criteria.

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