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The TiMesh System is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semirigid internal fixation is utilized as a means of holding bone fragments together. Alternatively, the TiMesh System is also indicated for use in reinforcing weak bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

Device Description

The device consists of a system of mesh, wire, screws, and plates of various sizes and shapes to be used for rigid or semi-rigid internal fixation.

AI/ML Overview

This document (K062348) is a 510(k) summary for the TiMesh® System. It describes the device and its intended use, and claims substantial equivalence to previously cleared TiMesh® System devices (K974017, K923419).

Acceptance Criteria and Study for Device Performance:

The provided 510(k) summary does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically seen with performance data for AI/ML devices. This document is a premarket notification for a medical device that appears to be a physical implant system (mesh, wire, screws, plates) for bone fixation, not a digital health or AI/ML device that would require performance metric-based acceptance criteria in the same way.

The basis for clearance is substantial equivalence to predicate devices, meaning the manufacturer determined that the materials, intended use, and fundamental scientific technology are the same as previously cleared devices. This implies that the safety and effectiveness are established by the already cleared predicates, rather than by a new performance study with specific metrics.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training data is not applicable or not provided in this type of 510(k) submission for a physical implant.

However, to directly address your prompt as much as possible, here's what can be inferred or stated from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments / Source
Substantial Equivalence to Predicate Devices	Achieved	The submission states, "Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the TiMesh System products compared to the predicate and currently marketed devices." The FDA concurred with this determination, issuing a letter stating the device is "substantially equivalent." This is the primary "acceptance criterion" for this type of 510(k) submission.
Material Composition	Same as predicate devices	The submission states, "Medtronic Neurosurgery submits that the materials of fabrication... of the TiMesh System is the same as the previously reviewed and cleared TiMesh System."
Intended Use	Same as predicate devices	The submission states, "Medtronic Neurosurgery submits that the... intended use... of the TiMesh System is the same as the previously reviewed and cleared TiMesh System." (Confirmed by identical "Indications for Use" section to the predicate's description).
Fundamental Scientific Technology	Same as predicate devices	The submission states, "Medtronic Neurosurgery submits that the... fundamental scientific technology of the TiMesh System is the same as the previously reviewed and cleared TiMesh System."

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

Not Applicable / Not Provided. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical or performance test set with a specific sample size. No data provenance is mentioned as no new data study is presented.

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

Not Applicable / Not Provided. There is no "test set" in the context of performance metrics for an AI/ML device. The "ground truth" for the substantial equivalence claim is based on the prior clearance of the predicate devices by the FDA, which involves regulatory review expertise rather than medical expert consensus on a test set.

4. Adjudication method for the test set

Not Applicable / Not Provided. No test set for performance evaluation is described.

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 / Not Provided. This device is a physical bone fixation system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies comparing human readers with and without AI assistance are irrelevant to this submission.

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

Not Applicable / Not Provided. This is a physical non-AI device.

7. The type of ground truth used

Regulatory Precedent / Predicate Device Clearance: The "ground truth" for this submission is the established safety and effectiveness of the previously cleared predicate devices (TiMesh® System K974017, K923419) based on their compliance with regulatory requirements and existing medical evidence at the time of their clearance.

8. The sample size for the training set

Not Applicable / Not Provided. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable / Not Provided. As this is not an AI/ML device, there is no training set or associated ground truth establishment process described.

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