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The Synthes Mandible Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

The Mandible Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 2.0 mm or 2.4 mm bone screws. A hex driver is used to activate the required distraction.

This document is a 510(k) summary for the Synthes Mandible Distractor (K962272), submitted in 1996. It describes a medical device, its intended use, and its comparison to a predicate device.

Based on the provided text, the document describes a mechanical device, not an AI or software-based device. Therefore, the specific questions related to AI device performance evaluation (acceptance criteria, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not applicable.

The "study" referenced in the document is a mechanical test to demonstrate substantial equivalence to a predicate device, not a clinical study involving diagnostic accuracy or human interpretation.

Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document does not provide specific numerical acceptance criteria (e.g., maximum force, minimum cycles, distraction accuracy tolerance). Instead, the implicit acceptance criterion is that the Synthes Mandible Distractor performs mechanically "similarly" to its predicate device. The "reported device performance" is the conclusion that this similarity has been met based on mechanical testing.

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

• Not Applicable. This was a mechanical test, not a test with a patient or image dataset. The "test set" would refer to the physical devices or components tested. The document does not specify the number of devices or components subjected to mechanical testing.

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

• Not Applicable. This was a mechanical test comparing physical device properties, not an evaluation requiring expert interpretation of clinical data or images.

4. Adjudication method for the test set:

• Not Applicable. Adjudication is relevant for subjective interpretations (e.g., image reading), not for objective mechanical test results.

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 a mechanical device, not an AI or diagnostic imaging device. An MRMC study is not relevant here.

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

• Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used:

• Mechanical Test Results: The "ground truth" for demonstrating substantial equivalence was the performance of the predicate device (Howmedica's Hoffmann® Mini-Lengthening Fixator) in mechanical tests, and the Synthes device's own mechanical test results were compared against this.

8. The sample size for the training set:

• Not Applicable. This refers to machine learning, which is not relevant here.

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

• Not Applicable. This refers to machine learning, which is not relevant here.

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