Search Results

For use as a Bipolar Shoulder Replacement:

• Aseptic necrosis of the humeral head .
• Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
• Proximal humeral fractures and/or dislocation. .
• Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
• . Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

For use as a Total Shoulder Replacement:

• Aseptic necrosis of the humeral head ●
• Painful, disabling joint disease of the shoulder resulting from: degenerative ● arthritis, rheumatoid arthritis, or post-traumatic arthritis.
• Proximal humeral fractures and/or dislocation.
• Clinical management problems where arthodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
• . Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

This submission is a line extension to the Solar® Shoulder System for a fracture humeral stem. Fracture humeral stems will be based on the humeral component designs of the Solar® Shoulder, Solar® PureFix® HA Shoulder, and the Tornier Aequalis Shoulder Fracture System. The subject stems have suture holes and a bone-grafting window.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance as would be found in a Premarket Approval (PMA) application or a clinical trial report.

Therefore, many of the requested data points (such as sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) are generally not part of a 510(k) submission unless specific performance testing beyond comparison to a predicate is required.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document states: "The test results demonstrate that the subject components are substantially equivalent in strength to the predicate components." However, it does not provide a specific table of acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds) or specific quantitative performance values for the Solar® ReUnion™ Fracture Stem, only a qualitative statement about substantial equivalent strength.

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

• Sample Size for Test Set: Not specified. The document refers to "test results" but does not detail the number of devices or components tested.
• Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer. It is implicitly retrospective as it compares the new device to existing predicate devices.

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

• Number of Experts: Not applicable/not specified. The evaluation is based on mechanical strength testing, not human expert assessment of a condition.
• Qualifications of Experts: N/A.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. The "test results" would refer to objective mechanical testing data, not subjective assessments requiring adjudication.

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 medical implant (shoulder prosthesis), not an AI-enabled diagnostic imaging device or an AI assistant. Therefore, MRMC studies are not relevant to this submission.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device (implant), not an algorithm or software.

7. The type of ground truth used:

• Ground Truth: For demonstrating "substantial equivalence in strength," the ground truth would be accepted engineering standards and validated mechanical testing methods (e.g., measuring forces to failure, fatigue testing, etc.) and comparison to the known performance of predicate devices. The document implies a direct comparison of physical properties.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI/ML model that requires a training set. The "training" for such devices involves design, material selection, and manufacturing processes, which are not based on data sets in the AI sense.

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

• How Ground Truth for Training Set was Established: Not applicable. As explained above, this is not an AI/ML device. The "ground truth" for its development would be based on biomechanical principles, material science, and clinical needs for shoulder prostheses.

Ask a specific question about this device