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The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.

The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains smooth variable angle locking pegs and K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws, pegs and washer), and Stainless Steel per ASTM F-138( K-wires). The modifications to the plates include the new material of CP Titanium per ASTM F-67 and the screw modifications include the new dual lead technology. The rest of the system has already been cleared through OsteoMed wrist predicate 510(k) K120015. The modification also introduced new sterile packaging configurations for the implants and disposable instruments. The system instruments included facilitate modification and insertion of the implants.

The provided text describes the OsteoMed ExtremiLOCK Wrist Plating System, a medical device, and the basis for its 510(k) clearance. It does not contain information about a study proving that the device meets acceptance criteria related to a diagnostic or AI-driven system.

The "Performance Characteristics & Testing & Clinical" section explicitly states: "Clinical Testing is not required to support substantial equivalence." Instead, the performance evaluation was based on mechanical strength testing of the plates and screws compared to predicate devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving a device meets them, as the provided document does not detail such a study in the context of diagnostic performance, AI, or human-in-the-loop improvements. The information requested (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typical for the validation of diagnostic algorithms or AI systems, which is not what this document describes for the OsteoMed ExtremiLOCK Wrist Plating System.

The document focuses on the mechanical and material performance of a bone fixation system, establishing substantial equivalence to existing predicate devices based on:

• Mechanical strength testing: Plates and screws were tested against predicate devices to ensure they met required mechanical strength criteria for their intended use.
• Material comparison: The system uses materials (Titanium, Titanium Alloy, Stainless Steel) per ASTM standards, similar to predicates.
• Design and Technology: Similarities in design, technology (e.g., variable angle locking), and operational principles to predicates.

In summary, the provided text discusses regulatory clearance for a medical device based on non-clinical, mechanical performance comparisons, not a clinical study assessing diagnostic accuracy or AI performance.

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The Distrax is intended for mandibular symphyseal widening and mandibular lengthening by distraction osteogenesis. Following the distraction osteogenesis, the Distrax may also be used for temporary stabilization during the consolidation phase. The Distrax is intended for single patient use only.

Distrax™ is a preassembled distraction system consisting of the following major components: Distraction Screw, Distractor Arms, Fixed Screw, Threaded Tube, Locknut (optional). Titanium Bone Screws (K063298) and brackets (surgical stainless steel, 24 gauge) are required for use and should be obtained by the surgeon and orthodontist, respectively. An Activation Key is also supplied to turn the Distraction Screw. The patient contact materials of the Distrax are made of austenitic stainless steel type 304 (chromium-nickel stainless class) and type 316 (chromium-nickel class containing 2-3% molybdenum). These materials are specified in ISO standards 5832-1 and 5832-9 for medical implant applications. The device must be cleaned and sterilized before use.

The provided text is a 510(k) summary for the Distrax™ device. It doesn't contain information about specific acceptance criteria or the study that proves the device meets those criteria in the traditional sense of a performance study with quantitative results.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Modus Modular Distraction Osteogenesis System - K051946). This means the device is considered safe and effective because it is similar in intended use, materials, design, and operating principles to a device already legally marketed.

Therefore, many of the requested categories for acceptance criteria and study details cannot be filled from this document.

Here's how to address the request based on the provided text:

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

This information is not provided in the 510(k) summary. The acceptance criteria for substantial equivalence are based on demonstrating similarity to a predicate device, not on specific quantitative performance metrics tested in a clinical trial.

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

Not applicable. This is not a study that involved a "test set" of patient data for performance evaluation in the way implied by the question.

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 applicable. Ground truth establishment for a patient test set is not part of a substantial equivalence determination based on device design and materials.

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

Not applicable. This is not a study that involved adjudication of performance on a test set.

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. MRMC studies are typically for diagnostic or interpretive devices, often involving AI. This device is a surgical implant for distraction osteogenesis.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device (Modus Modular Distraction Osteogenesis System - K051946) to which Distrax™ is substantially equivalent.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. See point 8.

Summary of the basis for acceptance:

The Distrax™ device was accepted based on its substantial equivalence to the predicate device, the Modus Modular Distraction Osteogenesis System (K051946). This equivalence was established by demonstrating similarities in:

• Intended Use: Both devices are for mandibular symphyseal widening and mandibular lengthening by distraction osteogenesis, and temporary stabilization during the consolidation phase.
• Materials: Both use stainless steel (Distrax specifies austenitic stainless steel types 304 and 316, compliant with ISO standards). The predicate also mentions implant steel and titanium.
• Design: While Distrax is preassembled and customized, and the Modus is modular, both serve the function of distraction.
• Operational Principles: Both operate on the principle of gradual bone distraction osteogenesis.
• Sterilization: Both are supplied non-sterile with instructions for sterilization.
• Single Use: Distrax is single-use; the predicate's single-use status is not known from the document.

The FDA reviewed the submission and determined that Distrax™ is substantially equivalent to the predicate device for its stated indications for use. This means the device meets the regulatory requirements for marketing based on its similarity to an already approved device, without requiring a new clinical performance study with specific quantitative acceptance criteria.

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