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The Bioplate® Bioclip® Craniotomy Fixation System is intended to re-attach a cranial bone flap to the surrounding cranium after a craniotomy procedure. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® Bioclip® Craniotomy Fixation System is contraindicated in the following conditions: The gap in the cranial bone is greater than 2.5mm for standard sizes. The gap in the cranial bone is greater than 4mm for XT sizes. The skull thickness is less than 4.5mm

The Bioplate® Bioclip® Craniotomy Fixation System consists of a bone plate manufactured of 6Al 4V titanium alloy that utilizes a combination of fastening tabs and spring action to re-attach a cranial bone flap following a craniotomy procedure. Each device is provided non-sterile and must be sterilized prior to use. The device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

This document describes a medical device, the Bioplate® Bioclip® Craniotomy Fixation System, for which the manufacturer is seeking 510(k) clearance. This is a premarket notification process for devices that can be demonstrated to be "substantially equivalent" to a legally marketed predicate device. This process does not typically involve clinical efficacy studies or statistical performance criteria as would be expected for a novel AI/software medical device.

Therefore, a detailed response regarding acceptance criteria, study design for proving performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/software medical devices, cannot be provided from the given text. The provided text focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

However, I can extract the relevant information regarding the device's intended use and contraindications, which act as de facto "performance" boundaries for its application.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical fixation system seeking 510(k) clearance by demonstrating substantial equivalence, there are no specific quantitative "acceptance criteria" and "device performance" metrics in the way one would evaluate an AI algorithm's sensitivity and specificity. Instead, the "performance" is implicitly tied to its ability to reattach a cranial bone flap under certain conditions, and the "acceptance criteria" are defined by its contraindications.

2. Sample size used for the test set and the data provenance:

• Not applicable (N/A). This 510(k) submission does not describe a clinical performance study with a test set of data points in the context of AI/software. It is a mechanical device. The "test" for substantial equivalence would involve comparing the technical characteristics and intended use of the new device to existing predicate devices.

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

• N/A. Ground truth establishment by experts is not described or required for this type of 510(k) submission for a mechanical device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• N/A. Adjudication methods are not described for this type of device submission.

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 a mechanical bone fixation device, not an AI/software medical device that would involve human readers or comparative effectiveness studies with AI assistance.

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

• N/A. This is a mechanical device, not an algorithm.

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

• N/A. The "ground truth" for this device's performance would be engineering specifications, material properties, and in-vitro or in-vivo biomechanical testing (which are not detailed in this summary). The basis for its substantial equivalence is comparison to previously cleared devices, suggesting that the underlying safety and effectiveness of its design principles have been established through those earlier devices.

8. The sample size for the training set:

• N/A. There is no training set in the context of an AI/software device. For a mechanical device, the "training" aspect would relate to design iterations and engineering testing, not data-driven learning.

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

• N/A. No training set or associated ground truth establishment is applicable to this mechanical device submission.

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