The Javelin Tailor's Bunion Fixation System is indication and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent (13-21 years of age) patients.

Device Description

The Javelin Tailor's Bunion Fixation System is a single-use bone fixation device intended to be permanently implanted. The system consists of a titanium alloy plate and screws that provide fixation for the 5th metatarsal. The plate has 4 screw-receiving holes and is designed to allow for intramedullary insertion and fixation at the proximal end. The associated 2.0mm to 3.0mm diameter titanium screws, locking and non-locking, are designed in lengths of 6 to 16mm. The system is provided non-sterile.

AI/ML Overview

This FDA 510(k) K202657 document does not describe the acceptance criteria, study details, or performance of a device in the context of an AI/ML or diagnostic imaging device that would typically involve a test set, ground truth, expert readers, or MRMC studies.

Instead, the document details the substantial equivalence of the "Javelin Tailor's Bunion Fixation System," which is a metallic bone fixation appliance used in orthopedic surgery. The "acceptance criteria" here refer to performance standards for the mechanical properties of a physical implant, not diagnostic accuracy.

Therefore, most of the requested information (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or present in this document.

Here's an attempt to answer the relevant parts based on the provided text, while clearly stating what information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Type of Testing)	Reported Device Performance
Static Bending (per ASTM F382)	Pass (Substantially equivalent to predicates)
Dynamic Bending (per ASTM F382)	Pass (Substantially equivalent to predicates)
Axial Pull-out (per ASTM F543)	Pass (Substantially equivalent to predicates)
Screw Mechanical Strength (Engineering Analysis)	Pass (Substantially equivalent to predicates)
Overall Conclusion	Does not raise new issues of safety or efficacy compared to predicate devices.

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

Not Applicable. This document describes non-clinical mechanical testing of a physical implant, not a diagnostic device with a "test set" of patient data. The "samples" would refer to the physical devices tested (e.g., number of plates/screws), but the exact quantities are not specified in this summary.

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

Not Applicable. Ground truth, in the context of a diagnostic test (like AI/ML), is not relevant here. The "ground truth" for a bone fixation system's performance is determined by established engineering standards and material properties, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

Not Applicable. As no "test set" of patient data or expert review is involved, no adjudication method is described or necessary.

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 non-clinical evaluation of an orthopedic implant. MRMC studies are used for diagnostic accuracy assessments, typically involving medical imaging and human readers.

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

Not Applicable. This device is a physical bone fixation system; there is no algorithm involved in its direct function.

7. The type of ground truth used:

Engineering Standards and Material Properties: The "ground truth" for the device's performance is based on its compliance with established ASTM (American Society for Testing and Materials) standards for metallic bone fixation appliances and general engineering principles for mechanical strength.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of the Study (Non-Clinical Testing):

The "study" conducted for the Javelin Tailor's Bunion Fixation System was a series of non-clinical mechanical tests to evaluate its physical properties and compare them to legally marketed predicate devices. The tests performed were:

Static Bending (per ASTM F382): Assesses the device's ability to withstand a constant load without permanent deformation.
Dynamic Bending (per ASTM F382): Evaluates the device's resistance to fatigue under repetitive loading conditions that mimic physiological stresses.
Axial Pull-out (per ASTM F543): Measures the force required to pull a screw out from a test material, indicating its fixation strength.
Engineering analysis to evaluate screw mechanical strength: A broader analytical assessment of the screws' structural integrity.

The purpose of these tests was to demonstrate substantial equivalence to existing predicate devices by showing similar performance characteristics. The conclusion was that the device "does not raise new issues of safety or efficacy" compared to the predicates based on these mechanical test results. No human or clinical studies are mentioned for this 510(k) submission summary.

Summary

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December 14, 2020

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Nvision Biomedical Technologies, Inc % Analaura Villarreal-Berain Extremity Project Engineer Nvision Biomedical Technologies 4590 Lockhill Selma San Antonio, Texas 78249

Re: K202657

Trade/Device Name: Javelin Tailor's Bunion 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: September 10, 2020 Received: September 14, 2020

Dear Analaura Villarreal-Berain:

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.

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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

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, 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)

K202657

Device Name Javelin Tailor's Bunion Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

DATE PREPARED

September 10, 2020

MANUFACTURER AND 510(k) OWNER

Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance

REPRESENTATIVE

Analaura Villarreal Berain, Extremity Project Engineer Nvision Biomedical Technologies Telephone: (210) 545-3713 ext. 109 Email: analauravillarreal @nvisionbiomed.com

PROPRIETARY NAME OF SUBJECT DEVICE

Javelin™ Tailor's Bunion Fixation System

COMMON NAME

Plate, Fixation, Bone (primary) Screw, Fixation, Bone

DEVICE CLASSIFICATION

Product Codes: HRS (Primary), HWC Classification Regulations: 21 CFR 888.3030 (Primary): Single/multiple component metallic bone fixation appliances and accessories, 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener; Class II

PREMARKET REVIEW

Orthopedic Device Panel

INDICATIONS FOR USE

The Javelin Tailor's Bunion Fixation System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the foot (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent (13-21 years of age) patients.

DEVICE DESCRIPTION

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PREDICATE DEVICE IDENTIFICATION

The Javelin Tailor's Bunion Fixation System is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer
K152312	Normed* RECON System – V-TEK-IVP Plates andScrews	Primary Predicate
K190365	Paragon 28 Inc. Baby Gorilla/Gorilla Plating System	Additional Predicate
K172148	Stryker Anchorage Bone Plating System	Additional Predicate
K182949	Nvision Biomedical's Healix Compression ScrewSystem	Additional Predicate
K161524	Nvision Biomedical's Tangis Anterior Cervical Plate	Additional Predicate

Subsequently acquired by Zimmer Inc.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Javelin Tailor's Bunion Fixation System. The following testing was performed:

Static and dynamic bending (per ASTM F382)
Axial pull-out (per ASTM F543)
. Engineering analysis to evaluate screw mechanical strength

The results of these tests indicate that the Javelin Tailor's Bunion Fixation System is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the Javelin Tailor's Bunion Fixation System is substantially equivalent to the predicate devices. The subject plates are similar to the predicates in that the geometry, thicknesses and lengths are similar, they are intended for use with ancillary screws, and they incorporate the same number of ancillary screws. Furthermore, the ancillary screws are similar in size. The implants from the Javelin Tailor's Bunion Fixation System are manufactured using Titanium Alloy and the instruments using medical grade Stainless Steel, similar to the predicate.

CONCLUSION

Based on the testing performed, including static and dynamic bending, pull-out, and engineering analysis, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Javelin Tailor's Bunion Fixation System are assessed to be substantially equivalent to the predicate devices.

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.