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The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).

The subject device includes several different designs of implantable distractors intended for bone lengthening or stabilization. The subject device is not supplied sterile. The subject device consists of: Transpalatal Distractor TPB (Module Size #1 (1 - 21mm), Module Size# 2 (16 - 31mm), Module Size# 3 (22 - 49mm), Module Size# 4 (26 - 59mm), Abutment Plate, Osteosynthesis Screws); Transmandibular Distractor TMD (Vertical Footplates with rods, Osteosynthesis Screws); Mandibular Distraction Dynamic Osteosynthesis MD-DOS (Posterior Fixation Unit (PFU), Fixation Screws, Distraction Unit (DU), Anterior Fixation Unit (AFU), Spacer). The subject device requires patient activation at specified times post-operatively using a provided spanner. The device is composed of Titanium Allov Grade 2 and 5 per ASTM F-67 and ASTM F-136 requirements.

The provided FDA 510(k) Premarket Notification for the Surgi-Tec - Bruges Distraction - Anchoring - Osteosynthesis System does not contain a study that proves the device meets specific quantitative acceptance criteria in terms of performance metrics.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is essentially the same as a legally marketed device that does not require premarket approval.

Here's how the information provided relates to your request, with the understanding that a traditional performance study with quantitative acceptance criteria is not presented:

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

• Acceptance Criteria: The primary "acceptance criterion" in this 510(k) submission is substantial equivalence to the listed predicate devices (Howmedica Leibinger Guerrero-Bell Distractor, Martin Zurich Distraction System, Medartis MODUS Mandibular Reconstruction System). This is evaluated based on:
  • Identical Indications for Use: The devices can be used for the same medical conditions and purposes.
  • Similar Technological Characteristics: The devices operate on similar principles and have similar design features.
  • Identical Material Composition: The devices are made of the same materials.
  • Safety and Effectiveness: The device does not raise new issues of safety or effectiveness compared to the predicate.
• Reported Device Performance:
  • Material Composition: "The device is composed of Titanium Alloy Grade 2 and 5 per ASTM F-67 and ASTM F-136 requirements." This matches the material used in predicate devices.
  • Intended Use: "The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate)." This is identical to the predicate devices.
  • Technological Approach: "The subject device is based on a similar technological approach by using intra-oral bone-borne titanium components to stabilize and/or lengthen the oral cavity (mandible, ramus, ridge, and palate)."
  • Clinical Usage (Historical): "Additionally, this device has been successfully used in Europe for several years." and "Lastly, clinical usage has found the subject device to produce satisfactory results and function safely as a medical device." This refers to real-world experience, though no specific data or metrics are provided.

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

• Not applicable. This submission does not include a formal test set with a specific sample size as would be found in a performance study with quantitative metrics. The evaluation is based on a comparison to predicate devices and general clinical experience.

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

• Not applicable. No ground truth for a test set was established by experts in the context of this 510(k) as there was no such study performed.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication was used.

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

• No. This is not an AI/software device, but a physical implantable device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

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

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

• The "ground truth" implicitly used is the historic safety and effectiveness of the predicate devices in clinical practice, and the clinical experience with the subject device in Europe. This is not a formally collected "ground truth" data set in the typical sense of a clinical trial.

8. The sample size for the training set

• Not applicable. As this is not an AI/machine learning device, there is no training set.

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

• Not applicable. As there is no training set, there is no ground truth for it.

In summary:

This 510(k) submission successfully established substantial equivalence by comparing the device's materials, intended use, and technological characteristics to legally marketed predicate devices, and by citing prior clinical usage in Europe. It does not contain data from a formal performance study with predefined quantitative acceptance criteria and a test set involving expert ground truth, as would typically be seen for a novel device or diagnostic algorithm.

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