(60 days)
The KLS-Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.
The device is comprised of two (2) interchangeable distraction arms, a central body which allows angular adjustment of the arms and pin clamps. The pin clamps will accept 2.0mm and 2.7mm Molina (K994154) pins. Bone stabilization can be achieved with carbon rods after distraction.
The provided document is a 510(k) summary for the KLS Martin 3DX External Distraction System. This type of document is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as it is a summary of the notification process, not a performance study report.
510(k) submissions typically rely on comparisons to existing devices (predicate devices) and may include bench testing or non-clinical performance data to demonstrate that the new device performs as intended and is as safe and effective as the predicate. However, detailed acceptance criteria and a structured study demonstrating primary endpoint achievement against these criteria are not typically a required component of the 510(k) summary itself, nor are they usually presented in the format requested.
Therefore, I cannot provide the requested information based on the text provided. The document states that "Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment." This suggests that the "study" demonstrating performance was a comparison to predicate devices, rather than a standalone clinical trial with specific acceptance criteria.
To address the prompt directly based on the provided document, the response would be:
1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not specified in the provided document.
* Reported Device Performance: The document states that "Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment" against predicate devices. The exact performance metrics or quantitative results are not detailed.
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/Not provided. The document does not describe a "test set" in the context of human clinical data or a specific performance study. The comparison is against predicate devices and clinical literature.
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/Not provided. No "test set" or ground truth establishment by experts is described for this device in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided.
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/Not provided. This device is an external distraction system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable/Not provided in the context of a performance study. The "ground truth" for substantial equivalence is implicitly the performance and safety established by the predicate devices through their own regulatory pathways and clinical use.
8. The sample size for the training set:
* Not applicable/Not provided. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
* Not applicable/Not provided.
In summary, the provided 510(k) document is a regulatory notification focusing on substantial equivalence to predicate devices, rather than a detailed report of a performance study with explicit acceptance criteria and corresponding results for the KLS Martin 3DX External Distraction System.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.