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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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