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The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.

The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.

The OsteoMed ExtremiLOCK Foot Plating System consists of plates of various shapes and sizes featuring compression, locking, elongated or compression elongated holes, angulated locking, non-locking and cannulated screws, implantable K-Wires, washers, and appropriate instrumentation. Modifications to plates of the subject system include increasing the thickness of the plates, material changes, and addition of features.

The implants of the OsteoMed ExtremiLOCK Foot Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

The provided text describes a medical device submission (K131445) for the OsteoMed ExtremiLOCK Foot Plating System. It's a 510(k) submission, which focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical efficacy studies.

Here's an analysis of the acceptance criteria and study information based on the document:

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

The document does not specify quantified acceptance criteria in terms of performance metrics (e.g., specific thresholds for strength, accuracy, or clinical outcomes). Instead, the acceptance criteria are implicitly met by demonstrating performance equivalence to predicate devices.

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 does not provide details on the sample size for specific mechanical tests or their provenance. The device's clearance is based on non-clinical tests (mechanical verification and comparisons) rather than human clinical trials.

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)

This information is not applicable as the clearance is based on non-clinical, mechanical testing and comparisons to predicate devices, not on expert clinical evaluation of cases.

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

This information is not applicable as the clearance is based on non-clinical, mechanical testing and comparisons to predicate devices, not on expert clinical evaluation of cases.

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

This information is not applicable. The device is a surgical fixation system, not an AI or diagnostic imaging tool. No MRMC study was performed.

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

This information is not applicable. The device is a surgical fixation system, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering specifications and established mechanical testing standards for bone fixation devices, aiming to demonstrate equivalence to predicate devices that have prior regulatory clearance.

8. The sample size for the training set

This information is not applicable as there is no mention of a training set; the evaluations are based on mechanical verification and comparative analysis.

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

This information is not applicable as there is no training set involved in this regulatory submission for a physical medical device.

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