The TriMed Threaded IM Nail System is indicated 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
Metacarpal fractures, non-unions, malunions and corrective osteotomies

Device Description

TriMed Threaded Intramedullary (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 F 136 or 316L Stainless steel per ASTM F138. TriMed is adding 3.6mm Threaded IM Nails with length ranges between 30 and 70mm to the already cleared 1.8mm – 3.0mm diameter ranges

AI/ML Overview

The provided document is a 510(k) summary for a medical device (TriMed Threaded Intramedullary Nail System), which primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical performance testing. It does not describe acceptance criteria for an AI/software device or a study involving human readers or AI performance in a clinical context.

Therefore, most of the requested information (items 2-9) regarding acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document as it pertains to AI/software performance, which is not the subject of this 510(k) submission.

However, I can extract the information related to the non-clinical performance testing conducted for this device to demonstrate its safety and effectiveness.

Here's the relevant information that can be extracted:

1. Table of acceptance criteria and the reported device performance:

The document refers to performance testing based on FDA guidance and ASTM standards. While specific numerical acceptance criteria (e.g., "must withstand X N-mm of torque") and the exact reported values are not provided in this summary, the types of tests and the conclusion can be presented.

Acceptance Criteria (Reference Standard/Guidance)	Reported Device Performance
Per FDA Guidance Document, "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway"	Device was tested per recommendations.
Per ASTM 543-17 for:
- Torsional Strength	Passed.
- Driving Torque	Passed.
- Axial Pullout Strength Calculation	Passed.

Conclusion: The technological characteristics, indications for use, and performance testing support the substantial equivalence of the Threaded IM Nail System with the predicate devices.

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

Sample Size: Not specified in the summary for the non-clinical tests.
Data Provenance: Not applicable as these are non-clinical, in-vitro mechanical tests, not clinical data from patients.

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. Ground truth for mechanical testing is based on objective, quantifiable physical properties and test methods, not expert consensus.

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

Not applicable for non-clinical mechanical testing.

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 for a physical medical device (intramedullary nail), not an AI/software device.

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

Not applicable. This is for a physical medical device (intramedullary nail).

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

For the non-clinical tests, the "ground truth" is derived from the objective physical measurements obtained through standardized mechanical testing methods (e.g., torsional strength, driving torque, axial pullout strength) as defined by ASTM standards and FDA guidance.

8. The sample size for the training set

Not applicable. This is for a physical medical device.

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

Not applicable. This is for a physical medical device.

In summary, the provided document details a 510(k) submission for a physical orthopedic implant (a threaded intramedullary nail system), and the "study" referred to is a series of non-clinical, in-vitro mechanical performance tests to demonstrate substantial equivalence, not a clinical study involving AI or human readers.

Summary

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January 18, 2024

Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TriMed. INC % David Anderson Regulatory Affairs Contractor Tech2Med, LLC 6450 Old Darby TRL NE Ada, Michigan 49301

Re: K234040

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: December 20, 2023 Received: December 21, 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 (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" (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).

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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.

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.

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,

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

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Indications for Use

Submission Number (if known)

K234040

Device Name

TriMed Threaded Intramedullary Nail System

Indications for Use (Describe)

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

Specific indications for TriMed Small Threaded IM Nails include:

1. Phalangeal fractures of the hand, non-unions, malunions and corrective osteotomies
1. 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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K234040

510(k) Summary

Prepared on: 2024-01-16

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	TriMed, INC
Applicant Address	27533 Avenue Hopkins Valencia CA 91355 United States
Applicant Contact Telephone	(661) 255-7406
Applicant Contact	Mr. David Medoff
Applicant Contact Email	davidmedoff@trimedortho.com
Correspondent Name	Tech2Med, LLC
Correspondent Address	6450 Old Darby TRL NE Ada MI 49301 United States
Correspondent Contact Telephone	(574) 377-0111
Correspondent Contact	Mr. David Anderson
Correspondent Contact Email	david.anderson@tech2medllc.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	TriMed Threaded Intramedullary Nail System
Common Name	Screw, Fixation, Bone
Classification Name	Smooth or threaded metallic bone fixation fastener
Regulation Number	888.3040
Product Code	HWC
Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K211783	TriMed Threaded Intramedullary Nail System	HWC
K230749	TriMed Threaded Intramedullary Nail System	HWC
Device Description Summary	21 CFR 807.92(a)(4)
TriMed Threaded Intramedullary (IM) Nail System implants are non-sterile, non-bioabsorbable implantable devices used as aids to thetreatment of certain types of fractures and osteotomies that lend themselves to the principle of nail/rod/screw fixation. TriMed ThreadedIM 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 F 136 or 316L Stainless steel per ASTM F138. TriMed is adding 3.6mm Threaded IM Nails with length ranges between 30 and 70mm to the already cleared 1.8mm – 3.0mm diameter ranges

Intended Use/Indications for Use

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K234040

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

Indications for Use Comparison

The subject device's Indications for Use are identical to the predicate device.

Technological Comparison

The subject devices included in The TriMed Threaded IM Nail System are substantially equivalent to the predicate devices in which basic design features, manufacturing, packaging, and labeling are the same.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

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 543-17: · Torsional Strength

• Driving Torque

• Axial Pullout Strength Calculation

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

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, inclications for use and performance testing support the substantial equivalence of the Threaded IM Nail System with the predicate devices.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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.