(129 days)
Treatment of cranial or midfacial conditions for which reconstructive osteotomy and segment advancement are indicated. The indications include conditions such as syndromic craniosynostosis (e. g. Apert, Crouzon, Pfeiffer, Antley Bixler) and midfacial retrusion. The device is intended to provide temporary stabilization and gradual lengthening of facial bones of the cranium and the midface. It is not intended to be used in the mandible.
The Leibinger Advance Internal Midface Distraction System is a distraction system consisting of the following major components: distractor frame, which incorporates connection screws for the plates, a removable activation rod, plates, and an activation key. The plates and frame initially stabilize and then gradually distract the osteotomy. The removable activation rod, covered with a protective sheath, is connected to the frame and provides the point of attachment for the activation key used to initiate the distraction of the osteotomy.
The provided text is a 510(k) summary for a medical device called "The Leibinger Advance Internal Midface Distraction System." This document is for a bone distraction system, which means it is a physical device used in surgery, not a diagnostic AI/ML algorithm.
Therefore, many of the requested fields related to AI/ML software performance (like sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of device and are not present in the provided text.
The information that can be extracted relevant to the "acceptance criteria" for a physical device typically comes from performance testing (e.g., mechanical, biocompatibility) demonstrating its safety and effectiveness, usually against established standards or predicate devices. However, this 510(k) summary provides a high-level overview and does not detail specific acceptance criteria or the studies that prove they are met in a quantitative manner (e.g., stress tests to a specific load, cycle tests to a specific number of cycles).
Here's a breakdown of what can be inferred or stated as "not applicable" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied/General) | Reported Device Performance (Implied/General) |
|---|---|
| Safety and Effectiveness for intended use | Substantially equivalent to legally marketed predicate devices. |
| Biocompatibility | (Not explicitly detailed in this summary, but would be part of a full submission) |
| Mechanical Performance (e.g., strength, durability, distraction capability) | "The plates and frame initially stabilize and then gradually distract the osteotomy." (Specific quantitative performance not provided in this summary). |
| Functionality (e.g., activation mechanism) | "Removable activation rod... provides the point of attachment for the activation key used to initiate the distraction of the osteotomy." (Specific quantitative performance not provided). |
| Intended Use Compatibility | Demonstrated to be suitable for "cranium and mid-face for which osteotomy and segmental advancement are indicated." |
| Regulatory Compliance | Reviewed by FDA as "substantially equivalent" to predicates, subject to general controls. |
Note: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific quantitative performance acceptance criteria and results. A full 510(k) submission would contain detailed test reports.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is a physical medical device. Performance is typically evaluated through bench testing (mechanical, material, sterility, biocompatibility) rather than a "test set" of data like an AI/ML algorithm.
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):
- N/A. Ground truth establishment is relevant to diagnostic or AI/ML devices. For a physical device, performance is evaluated against engineering specifications, regulatory standards, and clinical outcomes (which are not detailed in this summary).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. See point 3.
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:
- N/A. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. See point 3. The "truth" for this device's performance would be its ability to physically distract bones safely and effectively, demonstrated through mechanical tests and potentially clinical data (though not detailed here).
8. The sample size for the training set:
- N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- N/A. See point 8.
§ 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.