TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM by SOFAMOR DANEK USA,INC.

The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System is intended for use in any oral-maxilio-cranio-facial surgical procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together.

Device Description

The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System consists of a system of small plate and screws of various sizes and shapes. The implant components are fabricated from Ti-6Al-4V titanium alloy as described by ASTM F-136 or its ISO equivalent. Alternatively, the entire system or parts of it may be made out of commercially pure titanium. The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System may be supplied either sterile or non-sterile.

AI/ML Overview

This 510(k) premarket notification for the TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System does not contain acceptance criteria for device performance or a study demonstrating the device meets those criteria from an AI/algorithm perspective.

This submission is for a medical device (bone plates and screws) and the assessment of "substantial equivalence" is based on:

Material composition: Ti-6Al-4V titanium alloy (ASTM F-136 or ISO equivalent) or commercially pure titanium.
Intended Use: Oral-maxillio-cranio-facial surgical procedures (orthognathic or trauma) for rigid or semi-rigid internal fixation of bone fragments.
Mechanical Test Data: Literature concerning commercially available predicate devices was supplied, and the submission mentions "Mechanical test data were provided in support of this notification."

Therefore, for the information requested, I can only provide details based on what is available in the provided text.

Analysis based on the provided FDA 510(k) Summary:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit - Substantial Equivalence): The device's materials, intended use, and mechanical properties should be substantially equivalent to predicates legally marketed prior to May 28, 1976. Specific quantitative mechanical performance criteria are not detailed in this summary but are referred to as "Mechanical test data."
- Reported Device Performance: The summary states "Mechanical test data were provided in support of this notification." However, the specific results or how they compare to acceptance criteria for mechanical tests are not included in the provided text. The FDA's letter states that they "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies the mechanical data met the necessary comparison to predicate devices, but the criteria themselves are not explicit.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the provided text. This information would typically come from the detailed mechanical test reports, which are not included. The concept of a "test set" in this context refers to the physical samples of the device undergoing mechanical testing, not a dataset for an algorithm.
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)
- Not Applicable in the provided text. This device is a surgical implant. "Ground truth" for its performance is established through engineering and biological testing (e.g., biocompatibility) and comparison to established medical device standards or predicate device performance, not expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. This device's evaluation relies on objective mechanical and material properties.
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
- No. This is a hardware implant, not an AI or diagnostic algorithm. MRMC studies are irrelevant for this type of device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device (bone plate and screws), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Regulatory Substantial Equivalence / Engineering Standards / Predicate Device Performance. The "ground truth" for this type of device's regulatory clearance is its conformity to material specifications (ASTM F-136, ISO equivalent), its mechanical performance in tests (e.g., fatigue, static strength) being equivalent to or better than a predicate device, and demonstration of biocompatibility. Specific quantitative details are not in the summary.
The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.

Summary of what can be extracted from the document regarding the "study":

The "study" refers to the mechanical testing conducted, as mentioned: "Mechanical test data were provided in support of this notification." This testing would have compared the performance of the TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System to that of legally marketed predicate devices, or against established engineering standards for such implants. The FDA's determination of "substantial equivalence" indicates that these mechanical tests demonstrated acceptable performance relative to existing devices. However, the exact methodology, sample sizes of the test articles, or specific results of these mechanical tests are not detailed within the provided 510(k) summary.

Summary

{0}------------------------------------------------

K973145

TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System NOV 1 9 1997 510(k) Summary

August, 1997

Sofamor Danek USA I. Company: 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133 TIMESH® Titanium Mini-Softplate/Screw and Micro-II. Product Name: Softplate/Screw System Bone plate and smooth or threaded metallic bone Classification Name: fixation fastener
The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw III. System consists of a system of small plate and screws of various sizes and shapes. The implant components are fabricated from Ti-6Al-4V titanium alloy as described by ASTM F-136 or its ISO equivalent. Alternatively, the entire system or parts of it may be made out of commercially pure titanium. The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System may be supplied either sterile or non-sterile.
The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw IV. System is intended for use in any oral-maxilio-craniofacial surgical procedure, either orthognathic or trauma, wherein rigid or semi-rigid internal fixation is utilized as a means of holding bone fragments together.
The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw V. System was claimed to be substantially equivalent to commercially available medical devices. Literature concerning these devices was supplied in support of establishing equivalence.

Mechanical test data were provided in support of this notification.

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Sofamor Danek USA, Incorporated 1800 Pyramid Place Memphis, Tennessee 38132

NOV 1 9 1997

K973145 Re: TIMESH® Titanium Mini-Softplate and Micro-Trade Name: Soft Plate/Screw System Regulatory Class: II Product Code: JEY Dated: August 20, 1997 Received: August 22, 1997

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

{2}------------------------------------------------

Page 2 - Dr. Treharne

not affect any obligation you might have under sections 531 not arrest any obligation devices under the Electronic enrough sadiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regulacion Chercica, Hibbidiang &J Sther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

{3}------------------------------------------------

Page 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System

Indications For Use:

ﺖ

The TIMESH® Titanium Mini-Softplate/Screw and Micro-Softplate/Screw System is intended for use in any oral-maxilio-cranio-facial surgical procedure, either orthognathic intended for ace in ally one semi-rigid internal fixation is utilized as a means of holding bone fragments together.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K973)45

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.