TIMESH SELF DRILLING SCREW by MEDTRONIC NEUROSURGERY

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.

Summary

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KO62348

4. 510(k) Summary

SEP - 8 2006

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.

Establishment Registration Number:	2021898
Address of Manufacturer:	Medtronic Neurosurgery125 Cremona DriveGoleta CA, 93117(805) 968-1546 ext. 1773Fax: (805) 968-9336
Contact Person:	Jeffrey Henderson
Date:	August 3, 2006
Trade or Proprietary Name:	TiMesh® System
Common usual or Classification Name:	Single/multiple component metallic bone fixationappliances and accessories (888.3030)
Predicate Device Identification:	TiMesh® System (K974017, K923419)

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.

Intended Use: The TiMesh System is intended for use in any oral-maxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semi-rigid 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 tissue in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

Intended Use of predicate device(s): The TiMesh System is intended for use in any oralmaxillo-cranio-facial surgical reconstructive procedure, either orthognathic or trauma, wherein rigid or semi-rigid 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 tissue in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, and cement restriction. This product is not intended for spinal use.

Technological comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, and the fundamental scientific technology of the TiMesh System is the same as the previously reviewed and cleared TiMesh System. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and

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Ka2348

efficacy of the TiMesh System products compared to the predicate and currently marketed devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is composed of thick, curved lines, and the text is in a simple, sans-serif font. The overall design is clean and professional.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 8 2012

Medtronic Neurosurgery % Mr. Jeffrev Henderson Vice President, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117

Re: K062348 Trade/Device Name: TiMesh® System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 3, 2006 Received: August 16, 2006

Dear Mr. Henderson:

This letter corrects our substantially equivalent letter of September 8, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical

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device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Millerm

Mark N. Melkerson Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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II. Statement of Indications for Use

510(k) Number (if known):

K062348

Device Name: TiMesh® System

Indications for Use:

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

BBKind

(Division & . . Oft) Division of argical, Orthopedic, and Restorative Devices

510(k) Number K062348 44

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.