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ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

For example, ReFIX pins are intended for use in the following procedures:

• fixation of phalangeal fusion and fracture .
• repair of metacarpal fusion and fracture
• fixation of hand and wrist fractures .
• fixation of metatarsal osteotomies .
• correction of hallux valgus .

Brief Description of Internal Fracture Fixation Devices based upon ReFIX™ Pins are comprised of themal Package Pakken Divers are widely used in the orthopaedic specialty. The ReFTX Pins are manufactured from PLLA and PLGA. The pins are available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, each supplied in a length of 70mm. The pins are sized and trimmed intraction and materials are de length of 70mm. The pins are sized and unimited misues and materials are designed to address the indications cited.

This 510(k) premarket notification for the ReFIX™ Internal Fixation Pins does not involve a study to prove the device meets acceptance criteria in the context of AI/ML performance. Instead, it demonstrates substantial equivalence to previously marketed devices. Therefore, most of the requested information about acceptance criteria, study design, and performance metrics for AI/ML devices is not applicable.

Here's the information that can be extracted from the provided document, framed within the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a traditional medical device (fixation pins), there are no explicit "acceptance criteria" for AI/ML performance or specific device performance metrics reported in the way they would be for an AI-powered diagnostic or therapeutic device. The "acceptance criteria" here are met by demonstrating equivalence to predicate devices, focusing on the device's fundamental characteristics and intended use.

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

Not applicable. This is not an AI/ML study involving a "test set" of data for performance evaluation. The "test" is the comparison against predicate devices through documentation and engineering analysis.

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

Not applicable. No ground truth was established by experts for a test set in the context of AI/ML performance. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances.

4. Adjudication Method for the Test Set

Not applicable. There was no test set or adjudication process for AI/ML performance.

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-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices. The submission relies on the concept that if the new device is substantially equivalent in terms of intended use, technological characteristics (materials, design), and operational principles to existing cleared devices, then it can also be considered safe and effective.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML training set.

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

Not applicable. There is no AI/ML training set.

Summary of the Document's Focus:

The provided document describes a 510(k) premarket notification for the ReFIX™ Internal Fixation Pins, a biodegradable internal fixation device. The basis for its clearance is substantial equivalence to a list of previously cleared predicate devices. This means that instead of conducting a new clinical trial or performance study, the manufacturer demonstrates that their device is as safe and effective as existing legally marketed devices, based on similar intended use, materials (PLLA and PLGA), and operational principles.

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