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The Frontier Devices Neuro System is intended for use in selective trauma of the cranial skeleton and cranial surgery.

The Frontier Devices Neuro System consists of titanium bone plates and screws of various shapes and sizes. The plates are made from unalloyed titanium that conforms to the ASTM F67 standard. Plates are 0.4 and 0.6 mm thick and come in a variety of shapes and sizes that are designed for cranial closure applications. The shapes and corresponding sizes include: Straight plates 9-12mm long (1x1, 2x2, 5 and 7 holes), Box plates 10mm x 10mm to 16mm x 16mm (4 hole), X-plate 8mm x 8mm (4 hole), Y-plate 16mm long (6 and 8 holes), Double Y-plate 18mm to 21mm long (6 and 8 hole), Strut plate 24 and 35mm long (6 and 8 hole). The burr hole covers are are made from unalloyed titanium that conforms to the ASTM F67 standard. They are 0.4 and 0.6 mm thick and are circular in shape with equi-spaced drill holes around the circumference. The burr hole covers have two basic shapes. The burr hole cover for shunt has a segment of the circular burr hole cover missing which is where a shunt device is placed. The other burr hole cover is a complete circle. The corresponding sizes include: Burr hole covers 12mm to 24mm diameter, Burr hole covers for shunt 12mm to 24mm diameter. The mesh is made from unalloyed titanium that conforms to ASTM F67 standard. They are 0.4 and 0.6mm thick and rectangular in shape, 90mm x 120mm. The screws are self-drilling screws that do not require a pre-drilled pilot hole and are made from a titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard. Screws are 1.5 to 1.8 mm in diameter and range in length from 3 to 6 mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Frontier Devices Neuro Closure System:

Summary of Device Performance and Acceptance Criteria

This 510(k) submission for the Frontier Devices Neuro Closure System (K100205) describes a medical device seeking substantial equivalence to predicate devices, rather than establishing entirely new performance criteria. Therefore, the "acceptance criteria" are primarily based on demonstrating similarity to existing, legally marketed devices.

The performance testing focused on demonstrating that the new device performs similarly to the predicate devices and meets relevant safety standards for its materials.

Details of the Study/Testing:

Based on the provided text, the "study" conducted for this device appears to be a series of bench tests and material characterization tests aimed at demonstrating "substantial equivalence" to predicate devices, rather than a clinical trial or a study involving human or animal subjects for efficacy or safety in a real-world scenario.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for each test, but referred to as "representative screws" for insertion tests and "screws, plates and mesh devices" for endotoxin testing. No specific number for each item is provided.
   • Data Provenance: The tests were conducted internally by the manufacturer (Frontier Devices) or a contracted lab. The document does not specify the country of origin of the raw materials, but the company is based in Pelham, AL, USA. The testing is presumably prospective for this specific device.

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

   • Not applicable. This device relies on physical and chemical testing against established material standards (ASTM F67, ASTM F136) and comparative bench testing against predicate devices. There is no "ground truth" established by human experts in the way clinical diagnostic devices require. The "ground truth" for material standards is the standard itself.

3. Adjudication method for the test set:

   • Not applicable. As this involves objective physical and chemical measurements against standards and predicate device performance, there isn't a need for expert adjudication of results. The results are quantitative (e.g., endotoxin levels, screw insertion test results).

4. 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 implantable device (plates and screws), not a diagnostic or AI-driven system that would involve human readers or AI assistance.

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

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the material components is adherence to established ASTM material standards (ASTM F67 for unalloyed titanium, ASTM F136 for Ti-6Al-4V titanium alloy) and meeting biological safety standards (LAL endotoxin limit of < 0.06 EU/ml). For mechanical performance (screw insertion), the ground truth is simply achieving results similar to the predicate devices.

7. The sample size for the training set:

   • Not applicable. This device did not involve machine learning or AI algorithms, so there is no "training set."

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

   • Not applicable, as there was no training set.

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