Search Results

Synthes CSC is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.

The CSC is contraindicated in the following situations: in patients with a skull thickness less than 4 mm; or when the gap surrounding the bone flap is greater than 2 mm.

The CSC is MRI Compatible.

Synthes Cranial Spring Clip (CSC) is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The CSC has a T-profile, which consists of two semi-circular tabs, and two projections that are bent into springs to lodge in the diploe of the cranial bone surrounding the osteotomy. The two tabs are 0.2 mm thick and rest on the superior surfaces of the cranial flap and the surrounding cranial bone. The CSC has a low profile, is 11.5 mm in length, 9.0 mm in width, and is 4.2 mm in height (0.2 mm above the cranial surface). 1.5 mm Ti Alloy Bone Screws will be inserted laterally through the CSC and into the diploe. The CSC is for single use only.

This document is a 510(k) summary for the Synthes (USA) Cranial Spring Clip (CSC), a medical device intended to reattach cranial bone flaps. This type of document does not typically contain the detailed acceptance criteria or results of a study proving the device meets specific performance metrics in the way an AI/ML device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be answered directly from the provided text. I will provide information based on what is available and indicate where the information is not present.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. A 510(k) notification focuses on substantial equivalence to a predicate device, rather than explicit performance acceptance criteria and results from a clinical study as would be typical for an AI/ML device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present. The document does not describe a test set or data provenance in the context of device performance testing.

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)

This information is not present. This summary does not mention a test set with ground truth established by experts.

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

This information is not present.

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

This information is not present. The device is a physical medical implant, not an AI/ML algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

This information is not present. The device is a physical medical implant, not an AI/ML algorithm, so "standalone algorithm performance" is not applicable.

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

This information is not present. As it's a physical device, the concept of "ground truth" for algorithmic performance isn't applicable in this context. The safety and effectiveness are typically demonstrated through mechanical testing, biocompatibility, and clinical experience with similar predicate devices.

8. The sample size for the training set

This information is not present. This device is not an AI/ML algorithm, so there is no "training set."

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

This information is not present. This device is not an AI/ML algorithm, so there is no "training set" or ground truth for it.

Summary based on the provided document:

The provided document is a 510(k) summary for a physical medical device (Synthes Cranial Spring Clip). Its purpose is to demonstrate "substantial equivalence" to a predicate device (Synthes Midfacial System, K953806), rather than providing detailed performance metrics from a de novo clinical study with acceptance criteria. As such, the information typically requested for AI/ML device studies (test sets, training sets, ground truth establishment, expert adjudication, MRMC studies) is not found in this type of submission.

The document describes the device's physical characteristics, intended use, and contraindications. It states that the device is "MRI compatible." The FDA's review confirms substantial equivalence, allowing the device to be marketed, subject to general controls and good manufacturing practice regulations.

Ask a specific question about this device