· Foot & Ankle: Medial/lateral reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Device Description

The TenoTac® Soft Tissue Fixation System is manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and is comprised of specialized threaded tacks/male implants and associated threaded sleeves/female implants for attaching soft tissue to bone. The tacks and sleeves are available in various sizes and lengths to accommodate different bone sizes.

AI/ML Overview

This document describes a 510(k) premarket notification for the "TenoTac® Soft Tissue Fixation System". The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria for a novel device. Therefore, the information provided does not fully align with the requested format for acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-driven device.

Based on the provided text, here's an attempt to answer the questions in the requested format, acknowledging the limitations due to the nature of a 510(k) for a physical medical device.

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

Since this is a 510(k) for a physical medical device, not an AI/algorithm, "acceptance criteria" here refers to the performance demonstrated to show substantial equivalence to the predicate device. The "reported device performance" is the outcome of the nonclinical testing.

Acceptance Criteria (Demonstrates Substantial Equivalence via Mechanical Properties)	Reported Device Performance (Summary of Test Results)
Mechanical properties equivalent to or better than predicate device (implicitly for soft tissue to bone fixation)	Demonstrated through static pull-apart and static axial pullout testing in bone analog material.
Biocompatibility and Pyrogenicity	Bacterial endotoxin testing demonstrated an endotoxin limit of 20 EU/Device.

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

The document mentions "All necessary testing has been performed on representative TenoTac® Soft Tissue Fixation System devices." However, it does not specify the sample size for the mechanical or biocompatibility tests.

The data provenance is from nonclinical testing of the TenoTac® Soft Tissue Fixation System, developed by Paragon 28, Inc., in the United States (Englewood, Colorado). It is not retrospective or prospective in the sense of clinical study data, but rather laboratory-based testing of a manufactured product.

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

This question is not applicable as the ground truth for a physical medical device's mechanical performance is established through calibrated laboratory testing against engineering standards or comparisons to a predicate device, not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in clinical or imaging studies to establish ground truth from potentially differing opinions. For a physical device's mechanical testing, the "truth" is derived directly from the physical measurements obtained during the tests.

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

This question is not applicable. MRMC studies are specific to evaluating the performance of diagnostic systems (often involving AI) that assist human readers (e.g., radiologists, pathologists). This document is for a physical orthopedic fixation device.

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

This question is not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used

For the mechanical testing, the "ground truth" implicitly refers to the measured mechanical properties (e.g., tensile strength, pullout force) derived from the static pull-apart and axial pullout tests, and the established safety limits for pyrogenicity. The comparison is made against the performance of the legally marketed predicate device (Zimmer Biomet JuggerKnot™ Soft Anchors device, K110145) to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of a 510(k) for a physical medical device. This term is relevant for machine learning algorithms.

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

This question is not applicable. See the answer to question 8.

Summary of the Study:

The study referenced is a nonclinical performance evaluation designed to demonstrate substantial equivalence of the TenoTac® Soft Tissue Fixation System to its predicate device, the Zimmer Biomet JuggerKnot™ Soft Anchors device (K110145).

The types of tests performed include:

Static pull-apart testing: Likely measures the force required to separate the soft tissue from the bone analog material when fixed by the device.
Static axial pullout testing: Likely measures the force required to pull the device out of the bone analog material.
Bacterial endotoxin testing: Used the kinetic turbidimetric method to ensure pyrogenicity (endotoxin limit of 20 EU/Device).

The conclusion of the study, as stated in the 510(k) summary, is that "Side-by-side performance testing demonstrates the substantial equivalence of the TenoTac® Soft Tissue Fixation System to the JuggerKnot™ Soft Anchors." The device is considered substantially equivalent based on its indications for use, design, and function, given the results of these nonclinical tests. Clinical data were not deemed necessary to support the safety and effectiveness.

Summary

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Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Court E, Suite 280 Englewood, Colorado 80112

Re: K182898

Trade/Device Name: TenoTac® Soft Tissue Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 10, 2018 Received: October 16, 2018

Dear Mr. Lintula:

We have reviewed vour 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/cdrb/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 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

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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, ff 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

TenoTac® Soft Tissue Fixation System

Indications for Use (Describe)

The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation.

Specific indications for the TenoTac® include:

· Foot & Ankle: Medial/lateral reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

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 5.

Device Trade Name:	TenoTac® Soft Tissue Fixation System
510(k) Number:	K182898
Manufacturer:	Paragon 28, Inc.4B Inverness Ct, E STE 280Englewood, CO 80112
Contact:	Eric LintulaPhone: 888-728-1888elintula@paragon28.com
Date Prepared:	October 10th, 2018
Common Name:	Soft Tissue Fixation Device
Classification:	21 CFR 888.3040
Class:	II
Product Code:	MBI

Indications for Use:

The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation.

Specific indications for the TenoTac® include:

Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, . hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair

Device Description:

Predicate Devices:

The Zimmer Biomet (formerly Biomet Sports Medicine) JuggerKnot™ Soft Anchors device (K110145) serves as the predicate device.

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Predicate Comparison:

Indications

The subject and predicate devices are intended to be used for soft tissue to bone fixation. Both devices are indicated for use in the foot and ankle. All indications for the subject device are covered within the indications of the predicate.

Technological Characteristics

Both the subject and predicate constructs are designed to achieve temporary fixation of soft tissue to bone. In the case of the TenoTac®, the device goes through the near cortex and engages the far cortex to provide tension and compress the soft tissue and bone. In the case of the predicate device, the device is passed through the bone, and suture provides tension and compresses the soft tissue to the bone. The mechanical testing demonstrates that TenoTac® device is substantially equivalent to the predicate, and introduces no new issues of safety or effectiveness.

Nonclinical Testing

All necessary testing has been performed on representative TenoTac® Soft Tissue Fixation System devices to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices.

The device performance was characterized via static pull apart and static axial pullout testing in bone analog material. Bacterial endotoxin testing using the kinetic turbidimetric method was used for pyrogenicity testing to ensure an endotoxin limit of 20EU/Device. Clinical data are not needed to support the safety and effectiveness of the subject device.

Conclusion

Side-by-side performance testing demonstrates the substantial equivalence of the TenoTac® Soft Tissue Fixation System to the JuggerKnot™ Soft Anchors. The TenoTac® Soft Tissue Fixation System is substantially equivalent to the JuggerKnot™ Soft Anchors (K110145) with respect to its indications for use, design, and function.

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.