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The SBI Ulnar Head Implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.

The uHead™ Ulnar Head Replacement prosthesis is currently approved under 510(k) K010786 and marketed by Small Bone Innovations. This device is used to treat patients with rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection. The sigmoid notch component is used in conjunction with the uHead™ device. Dependent upon the severity of degenerative joint disease and forearm stability, the sigmoid notch component can be used to restore stabile wrist function and improve forearm kinematics that is not always obtainable with the uHead™ prosthesis alone.

This 510(k) summary for the SBI Ulnar Head Implant primarily focuses on establishing substantial equivalence to previously marketed devices. It does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on a specific study conducted for this 510(k) submission to demonstrate performance against acceptance criteria. Instead, it refers to documentation showing substantial equivalence.
• Details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The provided text is a regulatory submission for premarket notification (510(k)) for a medical device. A 510(k) typically demonstrates substantial equivalence to existing devices rather than requiring an extensive de novo clinical trial with defined acceptance criteria for performance in the same way a PMA submission might.

Therefore, many of your requested points cannot be answered from the provided text.

Here's what can be extracted from the document:

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

• Not Available. The document does not provide specific performance acceptance criteria or a "reported device performance" table as if from a study designed to meet specific metrics. It states, "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. There is no mention of a "test set" or a study in this context that would involve a sample size for performance evaluation. The substantial equivalence argument likely relies on design, material, and intended use comparison to predicate devices, rather than a new performance study.

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 / Not Available. This information is not relevant to a 510(k) substantial equivalence submission for this type of device. There is no mention of a "ground truth" establishment process within this document.

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

• Not Applicable / Not Available. No test set or adjudication method is described.

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

• No. This is a physical implant device, not an AI diagnostic tool. Therefore, an MRMC study and AI assistance are not applicable.

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

• No. This is a physical implant device.

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

• Not Applicable / Not Available. The concept of "ground truth" as typically applied to diagnostic algorithms or imaging interpretation is not relevant for this device's 510(k) submission.

8. The sample size for the training set

• Not Applicable / Not Available. This is a physical implant device, not an AI algorithm. Therefore, there is no "training set."

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

• Not Applicable / Not Available. As above, no training set exists for this device.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states: "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

This indicates that the "study" proving the device meets acceptance criteria (which, in a 510(k), are generally met by demonstrating equivalence to a predicate device) is a comparison against legally marketed predicate devices. The specific details of that "documentation" are not elaborated on in this summary but would typically include:

• Comparison of Intended Use: Showing the new device has the same intended use as predicate devices. (The document explicitly lists the intended use).
• Comparison of Technological Characteristics: Demonstrating that the new device has substantially similar technological characteristics (e.g., materials, design principles, operating principles) to predicate devices. (The document mentions material: "implantable grades of cobalt chrome (ASTM 1537-94), with CpTi coating.").
• Performance Data (if necessary): For an implant, this would primarily involve non-clinical testing (e.g., mechanical testing, biocompatibility testing) to ensure it performs safely and effectively in a similar manner to the predicate, or that any differences do not raise new questions of safety and effectiveness. This summary does not detail these non-clinical tests, but they would be part of the "documentation."

In summary, the provided text is a high-level summary for a 510(k) premarket notification. It asserts substantial equivalence to predicate devices as the basis for marketing clearance, rather than detailing a specific clinical performance study against pre-defined acceptance criteria.

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