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The SmartScrew™ is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.

The SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures, 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

The SmartScrew™ is composed of poly-L,D-lactide copolymer. It is supplied fully threaded with diameters 2.0mm - 4.5mm and lengths 10 - 70mm.

This 510(k) premarket notification for the SmartScrew™ bioabsorbable fixation rod does not contain the detailed information typically found in a clinical study report or a pre-market approval (PMA) submission regarding acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving safety and effectiveness through new clinical trials as would be required for a PMA. Therefore, most of the information requested in your prompt (e.g., specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not present.

The key points from this document relevant to your request are:

• Basis of Approval: The approval is based on a determination of substantial equivalence to previously cleared predicate devices (K952471, K974876, K992947, K003077). This means the FDA found the new device to be as safe and effective as the predicate devices, not that it met specific, predefined performance acceptance criteria from a new study.
• Similarities to Predicate Devices: The document explicitly states the new SmartScrew™ has the same indicated use, operating principle, basic design, dimensions, packaging, sterilization, shelf life, and trade name as the cleared SmartScrew (K003077). It further states that minor technological differences do not raise new issues of safety or effectiveness. This is the "proof" provided for a 510(k) – alignment with a device already deemed safe and effective.

Given this, I will answer the questions based on the absence of the requested information, which is characteristic of a 510(k) submission focused on substantial equivalence rather than new performance studies.

1. Table of acceptance criteria and the reported device performance

Note: For a 510(k) submission, "acceptance criteria" are generally met by demonstrating that the device is as safe and effective as a legally marketed predicate device. This often involves comparison of technological characteristics and performance data (e.g., mechanical testing, biocompatibility) if differences exist, but not necessarily against predefined clinical performance thresholds for a novel device.

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

Not applicable. This 510(k) submission does not describe a new clinical "test set" or a new clinical study with a sample size. The approval is based on substantial equivalence to existing devices.

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

Not applicable. This 510(k) submission does not describe a new clinical study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This 510(k) submission does not describe a new clinical study involving a test set or 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

Not applicable. This device (a bioabsorbable fixation implant) is a physical surgical implant, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a physical surgical implant, not an algorithm or AI device.

7. The type of ground truth used

Not applicable. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, manufacturing processes, and intended use, rather than through new clinical performance data that would require "ground truth" as typically understood in diagnostic or AI studies. The "ground truth" effectively comes from the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This 510(k) submission does not describe an AI/ML device that requires a training set.

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

Not applicable. This 510(k) submission does not describe an AI/ML device or a training set.

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