The TriMed Clavicle Fixation System is a multi-indication plate and screw fixation system which provides surgical options for fractures, malunions, non-unions and osteotomies of the Clavicle.

TriMed Clavicle Plates have been updated for better plate contour fit to bone, updated lengths (so there is less subcutaneous plate prominence for the patient), and reduced plate thickness. TriMed Clavicle Plates are compatible with 2.7mm / 3.2mm locking and non-locking screws.

All TriMed plates and screws are manufactured from implant grade 316 stainless steel.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the TriMed Clavicle Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies in the same way a new, novel AI/software medical device would.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software medical device, specifically with details like "sample size used for the test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "stand-alone performance," "type of ground truth," and "training set size," is not directly applicable to this document.

This document describes a hardware medical device (bone fixation plates and screws), not an AI or software device. The "study" mentioned is a non-clinical performance evaluation (mechanical testing), not a study involving human readers or AI algorithms.

Here's a breakdown of the relevant information from the document, interpreted in the closest possible way to your request, but highlighting the fundamental difference in the type of device and evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

For this hardware device, "acceptance criteria" are related to mechanical properties and biocompatibility, typically established by recognized standards, and "reported device performance" refers to the results of tests demonstrating compliance with these standards.

Acceptance Criteria (from recognized standards)	Reported Device Performance
Static and endurance 4-point bending (per ASTM F382-17)	Implants were evaluated. (Specific values not provided in this summary, but implied to meet standards if substantial equivalence is claimed.)
Cytotoxicity, Sensitization, and Irritation testing (in accordance with ISO 10993-1:2018)	Implants were evaluated. (Implied to meet standards.)
Torsional Strength, Driving Torque, Axial Pullout Strength Calculation (for all system screws, per FDA Guidance FDA-2019-D-1652 (ASTM D543-17))	Screws were tested. (Implied to meet standards.)

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

Test set size: Not applicable in the context of clinical data for an AI device. For mechanical testing, the sample size would refer to the number of plates and screws subjected to each test. This specific number is not disclosed in the 510(k) summary, but standard testing regimens for ASTM and ISO typically involve multiple samples to ensure statistical validity.
Data provenance: Not applicable in the sense of country of origin for clinical data. The data provenance here refers to the laboratory and testing methods, which follow established international standards (ASTM, ISO, FDA Guidance).

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

This is not applicable as the device is a hardware implant, not an AI/software device requiring expert interpretation of outputs or images to establish ground truth. Ground truth for mechanical properties is typically based on physical measurements and adherence to specified limits in standards.

4. Adjudication method for the test set

Not applicable for this type of device. Adjudication methods are relevant for subjective interpretations, like image analysis in AI 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. This is a hardware medical device, not an AI device. No MRMC studies were conducted as there is no AI component.

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

Not applicable. This is a hardware medical device, not an AI algorithm.

7. The type of ground truth used

For this device, the "ground truth" for non-clinical testing refers to:
- Mechanical properties and limits defined by recognized standards (ASTM F382-17, ASTM D543-17). These standards prescribe methodology and expected performance ranges for bone fixation devices.
- Biocompatibility requirements outlined in ISO 10993-1:2018. These standards define acceptable levels for cytotoxicity, sensitization, and irritation based on material properties and biological responses.

8. The sample size for the training set

Not applicable. This is a hardware medical device. There is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for a hardware device.

Conclusion from the document:

The 510(k) submission states: "Clinical testing was not necessary for the determination of substantial equivalence." and "Mechanical testing data and engineering analyses show the subject devices are substantially equivalent to that of the predicate devices for the desired indications." This indicates that the device's acceptable performance is demonstrated through its fulfillment of established mechanical and biocompatibility standards, and importantly, its similarity ("substantial equivalence") to already legally marketed devices with a known safety and efficacy profile.

Summary

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September 1, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

TriMed, Inc. % David Anderson Principle Consultant Tech2Med. LLC 6450 Old Darby TRL NE Ada. Michigan 49301

Re: K230805

Trade/Device Name: TriMed Clavicle Fixation 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: June 5, 2023 Received: June 5, 2023

Dear David Anderson:

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 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

For comprehensive regulatory information about medical devices and radiation-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,

Shumaya Ali-S

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K230805

Device Name TriMed Clavicle Fixation System

Indications for Use (Describe)

The TriMed Clavicle Fixation Plates and Screws are in fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

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)

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

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Image /page/3/Picture/0 description: The image shows the TriMed logo. The logo consists of a blue umbrella-like symbol on the left, followed by the word "TriMed" in blue, with a horizontal blue line underneath. The logo is simple and clean, with a focus on the company name and a memorable symbol.

K230805 510(K) SUMMARY

(a)(1). Submitted By:	TriMed, Inc.27533 Avenue HopkinsSanta Clarita, CA 91355United States of America
Contact Person:	David AndersonPrinciple Regulatory ConsultantOffice – (574) 377-0111Fax – (661) 254-8485
Date:	August 31, 2023
(a)(2). Proprietary Name:	TriMed Clavicle Fixation System
Common Name(s):	Plate, Fixation, BoneScrew, Fixation, Bone
Classification Name:	21 CFR 888.3030 (Primary): Single/multiple componentmetallic bone fixation appliances and accessories.21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener
Regulatory Class:	II
Product Codes:	HRS (Primary), HWC
(a)(3). Predicate Device:	Primary Predicate DeviceK112509 – TriMed Clavicle Fixation System, TriMed, Inc.(USA)Additional Predicate DeviceK201321 – DePuy Synthes 2.7mm VA LCP Clavicle PlateSystem (CHE)

(a)(4). Device Description

The TriMed Clavicle Fixation System is a multi-indication plate and screw fixation system which provides surgical options for fractures, malunions, non-unions and osteotomies of the Clavicle.

All TriMed plates and screws are manufactured from implant grade 316 stainless steel.

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Image /page/4/Picture/0 description: The image shows the logo for TriMed. The logo consists of a blue symbol that looks like three interconnected arches, followed by the text "TriMed" in blue. A blue line is underneath the text.

(a)(5). Indications for Use

The TriMed Clavicle Fixation Plates and Screws are intended for use in fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

(a)(6). Technological Characteristics

The subject TriMed Clavicle Fixation System devices are similar to the predicate devices in material, size, packaging, sterility, and has similar indications for use. The TriMed Subject devices have been updated for better plate contour fit to bone, updated lengths (so there is less subcutaneous plate prominence for the patient), and reduced plate thickness as compared to predicate devices (K112509). Plate thickness and length ranges are comparable to predicate devices (K201321).

(b)(1). Substantial Equivalence: - Non-Clinical Evidence Performance Data

TriMed Clavicle Fixation System Implants were evaluated for following:

Static and endurance 4-point bending per ASTM F382-17. ●
Cytotoxicity, Sensitization and Irritation testing in accordance with ISO 10993-1:2018
All system screws were tested per FDA Guidance FDA-2019-D-1652 (ASTM D543-17) for: ●
- Torsional Strength O
- Driving Torque o
- Axial Pullout Strength Calculation O

(b)(2). Substantial Equivalence: - Clinical Evidence

Clinical testing was not necessary for the determination of substantial equivalence.

(b)(3). Substantial Equivalence - Conclusions

TriMed Clavicle Fixation System devices are substantially equivalent to the predicate devices in which basic design features, intended uses, indications for use, manufacturing, packaging, and labeling are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness.

Mechanical testing data and engineering analyses show the subject devices are substantially equivalent to that of the predicate devices for the desired indications.

Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed Inc. has determined that the proposed devices 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.