(115 days)
This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
LeForte Neuro System Bone Plate is made of unalloyed titanium (ASTM F67) and is manufactured and intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD(93/42/EEC) and ISO 14630:1997 from the device design to manufacturing and QC.
The provided text is a 510(k) summary for the Jeil Medical Corporation's "LeForte Neuro System Bone Plate." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria in the manner of a clinical trial for an AI/software device.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this document. The LeForte Neuro System Bone Plate is a physical medical device (bone plate) made of titanium, not an AI or software device.
The "study" presented here is a comparison to a predicate device to establish substantial equivalence, which is a regulatory pathway for physical devices.
Here's a breakdown of what is available in the provided text in relation to your prompt, and why specific points are not applicable:
1. Table of acceptance criteria and the reported device performance:
- Not Applicable in the context of an AI/software device study. This document doesn't present performance metrics against specific quantitative acceptance criteria like sensitivity or specificity.
- Instead, the "performance" is demonstrated by showing similarity in material, dimensions, characteristics, and intended use to the predicate device.
2. Sample size used for the test set and the data provenance:
- Not Applicable. There is no "test set" in the context of an AI/software device study described here. The evaluation is based on the device's design, materials, and intended use, compared to an already-approved predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. "Ground truth" from experts for a physical bone plate isn't established in the way it would be for an AI diagnostic device. The "truth" here is based on engineering specifications and clinical consensus on the function of such devices.
4. Adjudication method for the test set:
- Not Applicable. No test set requiring adjudication in the context of AI/software device evaluation.
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. This is a physical bone plate, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the AI/software sense. The "truth" for this device is its adherence to material standards (ASTM F67 for unalloyed titanium), manufacturing quality according to MDD(93/42/EEC) and ISO 14630:1997, and its functional equivalence to the predicate device.
8. The sample size for the training set:
- Not Applicable. No training set exists for a physical hardware device like a bone plate.
9. How the ground truth for the training set was established:
- Not Applicable. No training set.
Summary of the Device and its "Acceptance" (Regulatory Equivalence):
The LeForte Neuro System Bone Plate is deemed acceptable by the FDA through the 510(k) pathway by demonstrating "Substantial Equivalence" to a legally marketed predicate device.
Predicate Device: Synthes (USA) Neuro Plate and Screw System (K042365)
Table of Comparison (Regulatory "Acceptance Criteria" for Substantial Equivalence):
| Feature | LeForte Neuro System Bone Plate | Predicate Device (Synthes Neuro Plate & Screw System) | "Acceptance" (Equivalence) |
|---|---|---|---|
| Material | Titanium (ASTM F67) | Titanium, Titanium Alloy | Equivalent |
| Intended Use | Selective trauma of mid-face, craniofacial skeleton, craniofacial surgery, reconstructive procedures, orthognathic surgery of maxilla and chin | Selective trauma of mid-face, craniofacial skeleton, craniofacial surgery, reconstructive procedures, orthognathic surgery of maxilla and chin | Identical |
| Single Use | Single Use | Single Use | Identical |
| Sterile | Non-sterile | Non-sterile | Identical |
| Classification | Class II, 21 CFR 872.4760 (Bone Plate) | Class II, 21 CFR 872.4760 (Bone Plate), etc. | Equivalent |
| Potential Adverse Affects & Complications | Listed in Section 8 (e.g., poor bone formation, migration, metal sensitivity, nonunion) | Common to all devices of this type | Identical |
| Manufacturing Standards | MDD(93/42/EEC) and ISO 14630:1997 (internal quality control) | Implied by regulatory approval (K042365) | Implied Equivalence |
Conclusion from the 510(k) Summary (Page 2):
"In all respects, the LeForte Neuro System Bone Plates are the equivalent of currently marketed devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of the predicate device."
The Study that Proves Acceptance Criteria:
The "study" is the 510(k) premarket notification process itself, which relies on demonstrating the LeForte Neuro System Bone Plate is substantially equivalent to the predicate device. This is achieved by:
- Engineering Comparison: Directly comparing the materials (unalloyed titanium), intended use, single-use status, sterility, and classification to the predicate device.
- Risk Analysis: Stating that the potential adverse effects and complications are identical to those of the predicate device and common to all devices of this type.
- Manufacturing Quality: Jeil Medical Corporation states it "utilizes the state of the art technology and apply the essential requirement of MDD(93/42/EEC) and ISO 14630:1997 from the device design to manufacturing and QC." While not a clinical study, this indicates adherence to recognized quality system standards.
In essence, the device "meets the acceptance criteria" because its characteristics, as detailed in the submission, are found by the FDA to be sufficiently similar to a previously cleared device, indicating that it is as safe and effective.
§ 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.