The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.

Device Description

The TriMed Staple is a sterile, non-bioabsorbable, implantable device designed to address common types of deformity corrections, fractures and osteotomies in extremities amenable to staple fixation, all depending on the size, shape, and location of the fractured bone and bone fracture fragments. TriMed Staples are manufactured from medical grade Nitinol. Two types of staple leg configuration are available; symmetrical and asymmetrical. The staple is implanted with a set of re-usable instruments designed for: preparation of the implant site and insertion of the implant into bone.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TriMed Nitinol Staple System based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (TriMed Nitinol Staple System). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a novel AI or diagnostic system. Therefore, some of the requested information (like expert consensus, AI assistance, human readers, training sets) is not applicable to this type of device and submission. The questions related to these aspects will be marked as "Not Applicable".

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for clinical accuracy or performance metrics as would be typical for an AI diagnostic device. Instead, it describes performance tests conducted to demonstrate equivalence to a predicate device. The goal is to show the device performs similarly or within acceptable limits compared to the predicate in mechanical and material properties.

Acceptance Criteria (Implied by equivalence testing)	Reported Device Performance (Compared to Predicate K112794)
Equivalent or acceptable Pull-Out Fixation Strength	Testing conducted, results compared to predicate
Equivalent or acceptable Elastic Static Bending	Testing conducted, results compared to predicate
Equivalent or acceptable Constant Amplitude Bending Fatigue	Testing conducted, results compared to predicate
Equivalent or acceptable Corrosion Susceptibility	Testing conducted, results compared to predicate
Equivalent or acceptable Titanium Oxide Layer Thickness (Quantified)	Testing conducted, results compared to predicate
Quantification of Transformation Temperature (At)	Testing conducted, results reported (implied comparison to known Nitinol properties or predicate)

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

The document does not specify sample sizes (e.g., number of staples tested) for the mechanical and material tests. It mentions "TriMed conducted the following tests," implying laboratory testing on physical device samples.

Sample Size: Not specified.
Data Provenance: The tests were conducted by TriMed, Inc. and are laboratory/benchtop 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

Not Applicable. This device is a mechanical implant, not a diagnostic or AI device requiring expert interpretation of results or ground truth establishment in a clinical context.

4. Adjudication method for the test set

Not Applicable. This is a mechanical/material performance evaluation, not a clinical study requiring adjudication of diagnostic findings.

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 medical implant, 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 mechanical implant, not an algorithm.

7. The type of ground truth used

For the mechanical and material tests, the "ground truth" is defined by the established scientific engineering principles and material specifications for Nitinol implants, as well as the performance characteristics of the predicate device (K112794). The goal is to show that the new device meets these engineering benchmarks or performs equivalently to the already cleared predicate.

8. The sample size for the training set

Not Applicable. This is a medical implant, not a machine learning model requiring a training set.

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

Not Applicable. This is a medical implant, not a machine learning model.

Summary

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July 1, 2019

TriMed, Inc. % Jean Asquith Regulatory Affairs Consultant Jean Asquith 4221 Lost Oasis Hollow Austin, Texas 78739

Re: K190166

Trade/Device Name: TriMed Nitinol Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: JDR Dated: May 24, 2019 Received: May 30, 2019

Dear Jean Asquith:

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.

For Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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) K190166

Device Name TriMed Nitinol Staple System

Indications for Use (Describe)

The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.

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) Summary

1. SUBMITTER INFORMATION

TriMed, Inc. 27533 Avenue Hopkins Santa Clarita, CA 91355

Company Contact:	David MedoffTel: (661) 255-7406Fax: (661) 254-8485
Email:	davidmedoff@trimedortho.com
510(k) Consultant Contact:	Jean AsquithTel: (512) 680-5802
Email:	jtasquith.ra@gmail.com
Date Prepared:	June 21, 2019

2. DEVICE IDENTIFICATION

Device Trade Name:	TriMed Nitinol Staple
Device Common Name:	Staple, Fixation, Bone
Regulation Number:	21 CFR 888.3030
Regulation Description:	Single/multiple component metallic bone fixation applianceand accessories
Product Code:	JDR
Device Class:	Class II
Classification Panel:	Orthopedic

3. DEVICE DESCRIPTION

4. INDICATIONS FOR USE

The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.

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5. COMPARISON TO PREDICATE DEVICES

The TriMed Nitinol Staple System is substantially equivalent to the following device:

510(k) Number	Device	Applicant
K112794	Eleos Staple (included as part ofthe TriMed EOS Small BoneFixation System)	TriMed

The TriMed Nitinol Staple is substantially equivalent to the Eleos Staple when comparing the following characteristics:

Intended Use ●
Principles of Use
Fundamental Technology
Basic Design ●
Materials Used ●
Where used ●
Sterilization Method o

6. TESTING AND PERFORMANCE DATA

To demonstrate product performance, TriMed conducted the following tests and compared the results to the predicate device.

Pull-Out Fixation Strength; ●
Elastic Static Bending;
Constant Amplitude Bending Fatigue; ●
Corrosion Susceptibility Testing; and ●
Quantification of the titanium oxide layer thickness ●

In addition, the transformation temperature (At) was quantified.

7. CONCLUSIONS

The TriMed Nitinol Staple is substantially equivalent to the predicate device as the basic design features and intended uses are the same. Any differences between the subject and predicate devices are considered minor and do not raise questions concerning safety or effectiveness. Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed, Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device.

Regulation Number and Section

N/A