Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
Metacarpal fractures, non-unions, malunions and corrective osteotomies

Device Description

TriMed Threaded Intramedulary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to the treatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed Threaded IM Nail System implants are cannulated, partially threaded, intramedullary fixation nails used to align and stabilize fractures and osteotomies of short tubular bones. TriMed threaded IM Nails are either made from Ti-6AL-4V ELI per ASTM F136 or 316L Stainless steel per ASTM F138. TriMed Threaded IM Nails are offered in diameters ranging from 1.8mm - 3.0mm in diameter and lengths between 12mm and 70mm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "TriMed Threaded Intramedullary Nail System." This documentation focuses on establishing substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a study with acceptance criteria in the typical sense of a diagnostic or AI device.

Therefore, many of the requested details about acceptance criteria, test set, ground truth, and human reader performance are not applicable to this type of submission. The device is a bone fixation fastener, not a diagnostic tool or an AI-powered system where such metrics would be relevant.

However, I can extract information related to the non-clinical performance data that was used to demonstrate substantial equivalence, which can be seen as meeting "acceptance criteria" related to mechanical properties.

Here's a breakdown of the available information based on your request:

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

The submission refers to meeting the recommendations of specific standards and guidance documents, which inherently contain "acceptance criteria" for mechanical performance. The document doesn't explicitly state the numerical acceptance criteria values or the reported device performance values in a direct table format within the provided text. Instead, it states that tests were performed "per the recommendations" and "per ASTM F543-17." This implies that the device met the criteria outlined in those documents.

Acceptance Criteria (Implied)	Reported Device Performance
Torsional Strength requirements per ASTM F543-17 and FDA Guidance	Tested and found to meet requirements per ASTM F543-17 and FDA Guidance
Driving Torque requirements per ASTM F543-17 and FDA Guidance	Tested and found to meet requirements per ASTM F543-17 and FDA Guidance
Axial Pullout Strength Calculation requirements per ASTM F543-17 and FDA Guidance	Tested and found to meet requirements per ASTM F543-17 and FDA Guidance

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

Sample size for test set: Not explicitly stated. For mechanical tests like these, sample size would typically be determined by the specific ASTM standard (e.g., ASTM F543-17) and internal quality control procedures.
Data provenance: Not explicitly stated in terms of country of origin of data. The tests are "non-clinical evidence" conducted on the device itself.

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

Not Applicable. This is a mechanical device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement of the device's properties.

4. Adjudication method for the test set

Not Applicable. See point 3.

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 bone fixation fastener, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a bone fixation fastener, not an algorithm.

7. The type of ground truth used

Physical Measurements/Engineering Standards: The ground truth for mechanical tests like Torsional Strength, Driving Torque, and Axial Pullout Strength is established by standardized physical measurements according to validated testing methods outlined in documents like ASTM F543-17.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

Not Applicable. See point 8.

Summary

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April 17, 2023

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

Re: K230749

Trade/Device Name: TriMed Threaded Intramedullary Nail System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: March 17, 2023 Received: March 17, 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, M.P.H. 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) K230749

Device Name

TriMed Threaded Intramedullary Nail System

Indications for Use (Describe)

The TriMed Threaded IM Nail System is intented for the treatment of select fractures and corrective of short tubular bones.

Specific indications for TriMed Small Threaded IM Nails include:

Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
Metacarpal fractures, non-unions, malunions and corrective osteotomies

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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K230749

Image /page/3/Picture/1 description: The image shows the logo for TriMed. The logo consists of a blue symbol that looks like an umbrella with a line through the middle. To the right of the symbol is the word "TriMed" in blue, with a horizontal line underneath.

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:	March 17, 2023
(a)(2). Proprietary Name:	TriMed Threaded Intramedullary Nail System
Common Name(s):	Screw, Fixation, Bone
Classification Name:	21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener
Regulatory Class:Product Codes:	IIHWC
(a)(3). Predicate Device:	Primary PredicateK211783 - Threaded Intramedullary Nail System / TriMedInc. (USA)

(a)(4). Device Description

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Image /page/4/Picture/1 description: The image shows the logo for TriMed. The logo consists of a blue symbol on the left and the word "TriMed" in blue on the right. The symbol is an abstract design, and the word "TriMed" is in a sans-serif font. There is a blue line underneath the word "TriMed".

(a)(5). Indications for Use

The TriMed Threaded IM Nail System is intended for the treatment of select fractures and corrective osteotomies of short tubular bones.

Specific indications for TriMed Small Threaded IM Nails include:

Phalangeal fractures of the hand. non-unions, malunions and corrective osteotomies 1.
1. Metacarpal fractures, non-unions, malunions and corrective osteotomies

(a)(6). Technological Characterizes

The subject devices included in The TriMed Threaded IM Nail System are similar to predicate devices in material, size, and have the same indications for use.

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

The TriMed Threaded IM Nail System implants were tested per the recommendations cited in the FDA Guidance Document, Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway, and per ASTM F543-17:

Torsional Strength ●
0 Driving Torque
Axial Pullout Strength Calculation ●

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

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

(b)(3). Substantial Equivalence - Conclusions

TriMed Threaded IM Nail System nails, surgical instrument, and tray designs do not adversely affect product performance, cleanability, and sterilization and therefore do not raise any new concerns of safety and efficacy. The similar technological characteristics, indications for use and performance testing support the substantial equivalence of the Threaded IM Nail System with the predicate devices.

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.