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The OSTEOMED ExtremiLOCK Ankle Plating System is intended for fixation of fractures, and non-unions of the tibia and fibula as well as arthrodesis of the ankle including Tibiotalocalcaneal joint. The ExtremiLOCK Ankle Plating System implants are intended for single use only.

The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.

The OSTEOMED ExtremiLOCK Ankle Plating System can be used for adult and adolescent (greater than 12-21 years of age) patients.

The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are a line extension to be included in the OsteoMed ExtremiLOCK Ankle Plating System (previously cleared for market in premarket notification K133691). The OsteoMed ExtremiLOCK Ankle Plating System provides a comprehensive solution for ankle fractures and ankle fusion management. The OsteoMed ExtremiLOCK Ankle Plating System plates, screws, washers and instrumentation are contained in a single instrument tray. The system instrumentation is used to facilitate placement, screw insertion and/or removal of implants.

The OsteoMed ExtremiLock Lateral Ankle Fusion Plates are designed for use in Tibiotalar (TT) and Tibiotalocalcaneal (TTC) arthrodesis procedures through a lateral transfibular approach. The plates feature universal holes that accept angulated locking and standard non-locking 3.5mm and 4.0mm screws and 4.0mm fully threaded cannulated double lead screws. The TT and TTC plates have been designed to optimize compression, strength, and construct stability by providing up to 5 points of fixation in the tibia, talus and calcaneus. The innovative plate design, rounded edges and highly polished surface allows for reduced dissection of soft tissue structures and minimizes soft tissue irritation. Both plates offer multiple compression hole options including oblong holes, transfixation holes, and an anatomic transfixation 5.5mm lag screw compression hole. The 5.5mm transfixation lag screw hole is designed to cross the arthrodesis site within the plate maximizing uniform axial compression across the joint and capturing the medial tibial side.

The OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates are made from commercially pure titanium grade 4 (ASTM F67). The plates are intended for single use only.

The provided text describes a 510(k) premarket notification for the "OsteoMed ExtremiLOCK Lateral Ankle Fusion Plates." This submission is for a medical device that is a metallic bone fixation appliance, not an AI/ML powered device. As such, the acceptance criteria and study information typically associated with AI/ML device evaluations (e.g., test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or detailed in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing rather than clinical or AI performance studies.

Here's a breakdown of the available information based on the questions, with an emphasis that this is not an AI/ML device submission:

1. Table of Acceptance Criteria and 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)

This information is not applicable and not provided. The evaluation was primarily bench testing of physical devices, not data-driven analysis from a test set of patient cases.

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 and not provided. "Ground truth" in the context of AI/ML algorithms, derived from expert review of medical data, is not relevant to this device's evaluation.

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

This information is not applicable and not provided. Adjudication methods are used for resolving disagreements among experts when establishing ground truth for AI/ML performance evaluation.

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 and not provided. An MRMC study is relevant for evaluating the impact of AI assistance on human performance, which is not the subject of this 510(k) submission.

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

This information is not applicable and not provided. "Standalone performance" refers to the performance of an AI algorithm without human involvement, which is not relevant for this physical medical device.

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

This information is not applicable and not provided. The "ground truth" for this device would relate to its structural integrity and material properties, confirmed by engineering standards and bench testing, not clinical diagnoses or outcomes data in the sense of AI/ML evaluation.

8. The sample size for the training set

This information is not applicable and not provided. Training sets are used for developing AI/ML algorithms.

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

This information is not applicable and not provided. Training sets and their associated ground truth are specific to AI/ML development.

In summary: The provided document details a 510(k) submission for a metallic bone fixation device, not an AI/ML product. Therefore, the evaluation criteria and study methods are based on mechanical bench testing and material biocompatibility, focusing on demonstrating substantial equivalence to predicate devices, rather than the performance metrics and study designs used for AI/ML medical devices.

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