TriMed Bridge Plates by TriMed, Inc.

TriMed Bridge plates are temporary joint spanning plates are indicated to be used as an aid to the treatment of fractures, osteotomies and non-unions of the radius. TriMed Bridge plates are manufactured from medical grade stainless steel. There plates are compatible with 2.7mm and 3.2mm locking and non-locking screws. Devices included in this application will be distributed as part of the TriMed Wrist Fivation Sustom 3 cleared under K222637.

AI/ML Overview

This document describes the premarket notification for the TriMed Bridge Plates (K241942). The information provided focuses on the substantial equivalence of the device to a legally marketed predicate and does not detail specific acceptance criteria or a study proving those criteria are met for the device performance in a way that would typically apply to software or AI/ML devices.

Instead, the provided text describes the non-clinical testing conducted to demonstrate the safety and effectiveness of the physical medical device.

Therefore, many of the requested sections (2-9), which are highly relevant to AI/ML device studies, are not applicable in this context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to mechanical testing based on FDA guidance and ASTM standards, rather than clinical performance metrics. The "acceptance criteria" here are compliance with these mechanical test standards.

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Compliance with ASTM F382-17	TriMed Bridge Plates were tested per the recommendations in the FDA Guidance Document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway". Static and dynamic four-point bending were conducted per ASTM F382-17.
	(Specific quantitative results of the bending tests are not provided in this summary but are implied to have met the standards.)

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

Not applicable. The study involved mechanical testing of physical device prototypes, not a test set of data.

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

Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on images) is not relevant to mechanical device testing. The "ground truth" for mechanical testing is established by the specifications and performance metrics outlined in the ASTM standard.

4. Adjudication method for the test set

Not applicable. No expert adjudication process similar to clinical or image review was 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. This is a physical medical device (bone fixation plate), not an AI/ML software. No MRMC study was performed.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

For the mechanical testing, the "ground truth" is compliance with the established ASTM F382-17 standard for static and dynamic four-point bending. This is a standardized performance benchmark for the physical properties of the material and design.

8. The sample size for the training set

Not applicable. No training set as understood for AI/ML was used. The focus is on the physical properties of the device.

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

Not applicable.

Summary regarding the "study that proves the device meets the acceptance criteria":

The provided text indicates that the "study" was a series of non-clinical mechanical tests performed on the TriMed Bridge Plates. These tests were conducted according to the recommendations in the FDA Guidance Document, "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway," and specifically followed the ASTM F382-17 standard for static and dynamic four-point bending.

The purpose of these tests was to demonstrate the device's substantial equivalence to the predicate device in terms of its mechanical properties, thereby inferring its safety and effectiveness for its intended use. The statement "Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed Inc. [believes] that the proposed devices (Bridge plates, 2.7mm locking screws) are substantially equivalent to the currently marketed predicate device" confirms that these non-clinical tests served as the basis for the equivalence determination.

Clinical studies were explicitly stated as NOT having been conducted for the subject devices. This is typical for Class II devices seeking 510(k) clearance where substantial equivalence can often be demonstrated through non-clinical testing and comparison to predicates.

Summary

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September 17, 2024

TriMed, Inc. Divya Raghavi Nandakumar Regulatory Affairs Supervisor 27533 Avenue Hopkins Santa Clarita, California 91355

Re: K241942

Trade/Device Name: TriMed Bridge Plates 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: July 1, 2024 Received: July 2, 2024

Dear Divya Raghavi Nandakumar:

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Christopher Ferreira -S

Christopher Ferreira. M.S. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241942

Device Name

TriMed Bridge Plates

Indications for Use (Describe)

TriMed Bridge Plate is indicated for fixation of fractures, and nonunions of the radius.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) #:	K241942	510(k) Summary	Prepared on:	2024-09-11
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Contact Details	21 CFR 807.92(a)(1)
Applicant Name	TriMed, Inc.
Applicant Address	27533 Avenue Hopkins Santa Clarita CA 91355 United States
Applicant Contact Telephone	(661) 255-7406
Applicant Contact	Mrs. Divya Raghavi Nandakumar
Applicant Contact Email	divyarnandakumar@trimedortho.com

Device Name	21 CFR 807.92(a)(2)
Device Trade Name	TriMed Bridge Plates
Common Name	Plate, Fixation, Bone (primary)
Classification Name	Single/multiple component metallic bone fixation appliances and accessories (primary)
Regulation Number	888.3030 (primary), 888.3040
Product Code(s)	HRS (primary), HWC

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
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Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K131764	Acumed Wrist Spanning Plate	HRS

Device Description Summary	21 CFR 807.92(a)(4)
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Intended Use/Indications for Use	21 CFR 807.92(a)(5)
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TriMed Bridge Plate is indicated for fixation of fractures, osteotomies, and nonunions of the radius.

Indications for Use Comparison	21 CFR 807.92(a)(5)
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TriMed Bridge Plate has the same Indications for Use as the referenced predicate device.

Technological Comparison	21 CFR 807.92(a)(6)
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TriMed Bridge Plate is manufactured from 316L Stainless Steel, whereas the predicate device is manufactured from titanium alloy. TriMed Bridge Plate is substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness

Non-Clinical and/or Clinical Tests Summary & Conclusions	21 CFR 807.92(b)
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TriMed Bridge Plates were tested per the recomment, on the FDA Guidance Document, Orthopedic Fracture Fixation Plates -Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff. Stafic and dynamic four-point bending were conducted per ASTM F382-17.

Clinical studies were not conducted for the subject devices.

Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed Inc. hat the proposed devices (Bridge plates, 2.7mm locking screws) are substantially equivalent to the currently marketed predicate device.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.