Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, of application malleolus, distal ulna, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used I he uccision to use a specific xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx the circumstances and configuration of the injury.

Device Description

AI/ML Overview

The provided text is a 510(k) submission for a medical device called "TriMed tension band sleds" (also referred to as "Tension Band Wire"). This document outlines the device's description, intended use, and technological characteristics, and includes the FDA's letter of substantial equivalence.

However, a 510(k) submission for this type of device (a bone fixation fastener) does not typically include detailed studies proving performance against specific acceptance criteria in the way that, for instance, an AI/ML software device would. The FDA's substantial equivalence determination for such a device is primarily based on showing that it is as safe and effective as a legally marketed predicate device, rather than on extensive clinical trials with specific performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided document because they are generally not required or part of a 510(k) submission for this class of device. The primary "study" is the comparison to predicate devices, which the document implicitly covers by stating the device has "identical characteristics to existing pins and wires commonly in use."

Here's a breakdown based on the information available and not available in the provided text:

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

Not Applicable/Not Provided. The document is a 510(k) submission for a mechanical implant (tension band wire). The acceptance criteria for such a device are primarily related to material specifications, dimensional characteristics, and an overall demonstration of substantial equivalence to existing predicate devices in terms of safety and efficacy for its intended use. There are no specific numerical performance metrics (like sensitivity, specificity, or accuracy) reported that would typically be found for a diagnostic or AI/ML device.

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

Not Applicable/Not Provided. This information pertains to studies typically conducted for AI/ML or diagnostic devices. For a mechanical implant, testing might include mechanical strength tests or biocompatibility tests, but these are not described in the terms of a "test set" as requested here. The "data provenance" for a material or mechanical device usually refers to where the materials were sourced or manufactured, not clinical data sets.

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):

Not Applicable/Not Provided. This is relevant for diagnostic performance studies. The "ground truth" for a bone fixation device is its ability to physically hold bone fragments.

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

Not Applicable/Not Provided. This applies to methods for resolving discrepancies in expert interpretations, common in diagnostic imaging studies.

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. MRMC studies are associated with evaluating the performance of diagnostic imaging devices or AI-assisted diagnostic tools. This device is a surgical implant.

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

Not Applicable/Not Provided. This concept is only applicable to AI/ML algorithms. The device is a physical implant.

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

Not Applicable. The "ground truth" for this device's performance would be clinical outcomes related to fracture healing and stability, as well as mechanical testing results to ensure its structural integrity. These are not detailed in the provided 510(k) summary. The summary itself relies on the "substantially equivalent" principle to predicate devices, implying similar safety and efficacy without explicitly detailing new "ground truth" studies.

8. The sample size for the training set:

Not Applicable/Not Provided. This is relevant for AI/ML model development.

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

Not Applicable/Not Provided. This is relevant for AI/ML model development.

Summary of Device and Basis for Marketing:

Device: TriMed tension band sleds (tension band wire forms)
Intended Use: Aid to fracture healing by stabilizing bone fragments until healing occurs, used in conjunction with screws, washers, and/or plates of the same material. Applicable to fractures amenable to tension band wiring.
Technological Characteristics: Described as having "identical characteristics to existing pins and wires commonly in use."
Basis for Acceptance: Substantial equivalence to predicate devices (TriMed small fragment clamp and buttress pin, Smith and Nephew Kirschner wires and Steinman pins, Zimmer Kirschner wires and Steinman pins). The FDA granted 510(k) clearance based on this demonstration of substantial equivalence, as stated in the letter dated June 6, 2001. This means the FDA determined the device is as safe and effective as devices already on the market without requiring new clinical trials that would generate performance metrics or refer to "test sets" or "ground truth" in the manner requested.

Summary

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May 29, 2001

Food and Drug Administration Center for Devices and Radiologic Health 510(k) Document Mail Center, HFZ-401 9200 Corporate Blvd Rockville, MD 20850

Robert J Medoff, MD 159 Ku'ukama St Kailua, HI 96734 Phone: 808-261-4658 Fax: 808-263-2036 email: rmedoff@lava.net

510(k) Submission, supplemental information Re: Tension band wire forms 510(k) number: K010545

Attention: Document Control Clerk

Dear Ms. Zimmerman:

Thank-you for the information regarding the 510(k) summary. I was unable to find the exact statute, but I did find some information on your web site that discusses the requirements of 21CFR 807.92.

I have attached the summary sheet as you have requested. Please let me know if there is any other information that you require.

Yours truly,

Rc Muddy

Robert J. Medoff, MD

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Page 1 of 2 510(k) summary

May 29, 2001

510(k) SUMMARY.

510(k) nmbr: K010545

Submitted by: TriMed. Inc. Prepared by: Contact person: Date prepared: Proprietary Name: Classification Name: Common/Usual Name:

25768 Parada Drive Valencia, California 91355 800-633-7221 Robert J. Medoff, MD Robert J. Medoff, MD May 29, 2001 TriMed tension band sled Tension band wire TriMed tension band wire TriMed Patellar tension band wire TriMed Olecranon tension band wire TriMed Malleolar tension band wire TriMed Ulnar Styloid tension band wire TriMed Proximal humerus tension band wire TriMed Distal humerus tension band wire TriMed Patellar sled TriMed Olecranon sled TriMed Malleolar sled TriMed Ulnar Styloid sled (other names reserved for future sites of application)

Sample Predicate Devices:

TriMed small fragment clamp and buttress pin (510(k) K951303) Smith and Nephew Kirschner wires and Steinman pins Zimmer Kirschner wires and Steinman pins

Class: II, Sec. 888.3040 Smooth or threaded metallic bone fixation fastener.

Classification Panel: These devices are reviewed by an orthopaedic panel (888)

Product Code: LRN

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Description of the device:

The TriMed tension band sleds are double 'U' shaped wire implants that are used as an aid to fracture fixation. They are manufactured from either medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy and vary in diameter from .028" to .250". Detailed dimensional characteristics of the devices has been provided in enclosure 1 of the original 510(k) application.

Intended use of the Device:

The TriMed tension band sleds are intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. They are intended to be used in conjunction with screws, washers, and/or plates of the same material. Any fracture that is applicable to the approach of tension band wiring currently being done with separate component pins and wires is a suitable indication for this single component implant.

Technological characteristics:

The TriMed tension band wires sleds have identical characteristics to existing pins and wires commonly in use. Sample existing implant sales literature is supplied with enclosure 5 of the original 510(k) application, and material specification sheets are supplied with enclosure 6 of the original 510(k) application.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three horizontal lines forming its wings and a curved line representing its body.

JUN - 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Robert J. Medoff, M.D. Tri-Med, Inc. 159 Ku'ukama Street Kailua, Hawaii 96734

Re: K010545

Trade Name: TBW (Tension Band Wire) Regulation Number: 888.3040 Regulatory Class: II Product Codes: NDL Dated: February 17, 2001 Received: February 23, 2001

Dear Dr. Medoff:

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 control provisions of the Act. The general control 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

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Page 2 – Robert J. Medoff, M.D.

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) 594-4659. 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 premarket notification" (21 CFR 807.97). Other 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

hheeeermsto

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_supplemental 1 of 3

510(k) Nmber: K010545

Device Name: Tension Band Wire

Indication for use:

The decision to use a specific implant as well as the size and shape of the implant used I he uccision to use a specific xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx the circumstances and configuration of the injury.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Precscription use: X (Per 21 CFS 801.109) OR

Over-the-counter Use __

(Optional Format 1-2-96)

Bstmhrellos for cam

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative
Division of General, Devices Division of South of Cources

1010945 510(k) Number

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.