(134 days)
The Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
The Synthes Low Profile Neuro System consists of titanium plates, meshes, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.
Based on the provided documents, the Synthes Low Profile Neuro System is a medical device, and the information given pertains to its 510(k) premarket notification to the FDA. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a study in the way a new drug or novel medical device might.
Therefore, many of the requested categories for a study proving device performance are not applicable in this context. The provided text describes a regulatory clearance process, not a clinical or performance study with detailed acceptance criteria and expert reviews.
Here's a breakdown of what can be extracted and what is not applicable:
- A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance / Outcome |
|---|---|
| Primary Acceptance Criteria | |
| Substantial Equivalence to Predicate Device | Documentation provided established substantial equivalence to other legally marketed devices. |
| Indications for Use | Intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. (This is taken from the "Indications for Use" statement, not a performance criterion, but a key regulatory approval aspect). |
| Device Description (Materials) | Plates & Meshes - Titanium; Screws - Titanium Alloy. (This is a factual description, not a performance metric). |
Explanation for "Reported Device Performance": In a 510(k) submission for a device like this, the "performance" is primarily demonstrated through substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness. The document states "Documentation was provided which demonstrated the Synthes Low Profile Neuro System to be substantially equivalent to other legally marketed devices." It does not report quantitative performance metrics (e.g., tensile strength, fatigue life, or clinical success rates) against specific numerical acceptance criteria within these documents.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The provided submission documents do not describe a "test set" in the context of a clinical performance study. The substantial equivalence determination relies on comparisons to predicate devices and potentially bench testing data or existing clinical literature on similar devices, but not a specific clinical "test set" with a defined sample size as would be used in a randomized controlled trial.
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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. There is no mention of a "test set" or "ground truth" establishment by experts in the context of a performance study in these documents. The "experts" involved are likely the regulatory reviewers at the FDA and the engineers/scientists at Synthes who conducted the equivalence analysis and prepared the submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or independent adjudication method is described.
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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 device (Synthes Low Profile Neuro System) is a hardware implant (plates, meshes, screws for cranio-facial procedures), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance metrics are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. See point 5. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. Given that this is a 510(k) clearance based on substantial equivalence, the "ground truth" is established through the regulatory process comparing the device's design, materials, and intended use against already approved predicate devices. There's no clinical trial "ground truth" derived from patient outcomes or pathology described in these documents.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI or machine learning device requiring model training.
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How the ground truth for the training set was established:
- Not applicable. 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.