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The Waveon™ WRx (WristRocket™ Distal Radius System) is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:

• Joint destruction and/or subluxation visible on x-ray;
• Osteotomy and repair of distal radius malunion with or without bone graft;
• Non-displaced fractures.
• Transverse fractures of the distal radius with or without comminution (e.g. AO classifications A2 and A3);
• Transverse fractures of the distal radius with an extension into the joint with or without comminution (e.g. AO classification C2 and C1 respectively);
• Failed fracture fixation with or without bone graft for the types of fractures above;
• The above types of fractures (i.e. AO classifications non-displaced transverse, A2, A3, C1 and C2) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.

The WavEon™ WRx configuration consists of a flexible implant manufactured from stainless steel.

This 510(k) summary describes a new version of an intramedullary distal radius fixation device called WavEon™ WRx, which is an updated version of a predicate device, the Ensplint Rx. The submission primarily seeks to extend the indications for use to include C2 Distal Radius fractures.

Here's an analysis of the provided text with respect to the requested information:

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

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

The document mentions "cadaver studies" for the surgical feasibility performance data.

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Test set: The "test set" would be the cadaver specimens used in the studies.

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 specified. The document only states "cadaver studies demonstrate." It does not mention who conducted these demonstrations or established the ground truth for "safe insertion, reduction, and fixation."

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

Not applicable/Not specified. The study described is a non-clinical cadaver study focused on the physical manipulation and fixation of the device, not an assessment of medical images or patient outcomes requiring expert adjudication in that context.

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 a medical device (intramedullary fixation) and not an AI/imaging diagnostic device. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.

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

Not applicable. This is a medical device (intramedullary fixation) and not an AI/imaging diagnostic device.

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

For the mechanical performance (ASTM 1264), the ground truth is defined by the standardized test methods and acceptance criteria of ASTM 1264.

For the cadaver studies, the "ground truth" would be the physical demonstration of safe insertion, reduction, and fixation of C2 fractures as observed and assessed by the surgical team or researchers conducting the cadaveric procedures. This is an observational, procedural ground truth rather than a diagnostic one.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI model that requires a training set.

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

Not applicable. This device is a physical implant, not an AI model that requires a training set.

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