The Radian MS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

Device Description

The Radian MIS Bunion 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 first metatarsal in the correction of a bunion. The plate has 4 screw-receiving holes. It is designed to allow for intramedullary insertion of the 2 proximal screws and medial insertion of the 2 distal screws. The plate is provided in 1 size and 1 configuration that can be used across all patient anatomy. The locking 3.0mm diameter titanium screws are designed in lengths of 14mm to 30mm in increments of 2mm. The system is provided non-sterile.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding "The Radian MIS Bunion System". This document focuses on the regulatory clearance of a medical device (a bone fixation system) based on its substantial equivalence to previously cleared predicate devices.

The document does not describe any acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm's performance.

Instead, it details the physical and mechanical performance testing of the Radian MIS Bunion System hardware (plate and screws), which are orthopedic implants, to demonstrate their safety and efficacy for their intended use.

Therefore, I cannot extract the information required to populate the fields related to an AI/ML study, as no such study is mentioned or relevant to this specific FDA clearance.

Here's a breakdown of what is available regarding the device (not an AI algorithm):

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

Acceptance Criteria	Reported Device Performance
Mechanical Performance:
Static bending (per ASTM F382)	Results indicate substantial equivalence to predicate devices.
Dynamic bending (per ASTM F382)	Results indicate substantial equivalence to predicate devices.
Engineering analysis to evaluate screw mechanical strength	Results indicate substantial equivalence to predicate devices.
Material Composition:
Implants (plate and screws): Titanium alloy	Manufactured using Titanium.
Instruments: Medical grade Stainless Steel	Manufactured using medical grade Stainless Steel.

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 for the mechanical tests, but these would typically involve a set number of physical devices/components for destructive and non-destructive testing.
Data Provenance: Not applicable in the context of patient data. The tests were laboratory-based mechanical tests.

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" in this context refers to the physical properties and performance of medical hardware, not interpretation of data by human experts for diagnostic purposes. These properties are established by standardized testing methods (e.g., ASTM F382) and engineering principles.

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

Not applicable. Adjudication methods are used for resolving disagreements in expert interpretations or labels, which is not relevant to mechanical testing of hardware.

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:

No, not specified and not applicable. This type of study is for evaluating diagnostic performance, typically of AI tools, and is not mentioned for this orthopedic device.

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

No, not applicable. This document is about a physical medical device, not an algorithm.

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

Not applicable in the AI/ML sense. For mechanical testing, the "ground truth" is defined by the physical behavior of the materials and constructs under tested conditions as measured by calibrated equipment and compared against established engineering standards (e.g., ASTM F382) and the mechanical performance of predicate devices.

8. The sample size for the training set:

Not applicable. There is no AI/ML algorithm discussed that would require a training set.

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

Not applicable. There is no AI/ML algorithm discussed.

Summary of the Study Discussed (Mechanical Testing):

The "study" described in the 510(k) summary is a set of non-clinical mechanical tests performed on the Radian MIS Bunion System.

Tests performed:
- Static bending (per ASTM F382)
- Dynamic bending (per ASTM F382)
- Engineering analysis to evaluate screw mechanical strength
Purpose: To demonstrate that the Radian MIS Bunion System is "substantially equivalent" to predicate devices in terms of safety and efficacy, particularly regarding its mechanical performance.
Conclusion: The tests indicate that the device does not raise new issues of safety or efficacy and is substantially equivalent to the predicate devices.

Summary

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November 24, 2021

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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: K211650

Trade/Device Name: The Radian MIS Bunion 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 Dated: October 27, 2021 Received: October 28, 2021

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 (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) K211650

Device Name Radian MIS Bunion System

Indications for Use (Describe)

The Radian MS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K211650

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510(k) Summary

DATE PREPARED

November 23, 2021

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

Radian MIS Bunion System

COMMON NAME Bone Plate

DEVICE CLASSIFICATION

Single/multiple component metallic bone fixation appliances and accessories (Classification Regulations: 21 CFR 888.3030, Product Codes: HRS, Class: II)

PREMARKET REVIEW

Orthopedic Device Panel

INDICATIONS FOR USE

The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.

DEVICE DESCRIPTION

PREDICATE DEVICE IDENTIFICATION

The Radian MIS Bunion System is substantially equivalent to the following predicates:

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510(k) Number	Predicate Device Name / Manufacturer	Predicate
K212487	In2Bones USA CoLink Vallux Plating System	Primary
K172178	Trilliant Surgical LTD– Minimally Invasive BunionPlating System	Additional
K181872	CrossRoads Extremity Systems, LLC - MIS BunionSystem	Additional
K202657	Nvision Biomedical's Javelin Tailor's Bunion FixationSystem	Reference

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Radian MIS Bunion System. The following testing was performed:

Static and dynamic bending (per ASTM F382) ●
Engineering analysis to evaluate screw mechanical strength

The results of these tests indicate that the Radian MIS Bunion System is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Nvision believes that the Radian MIS Bunion 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 similar number of ancillary screws. Furthermore, the ancillary screws are similar in size. The implants from the Radian MIS Bunion System are manufactured using Titanium and the instruments using medical grade Stainless Steel, identical to Javelin Tailor's Bunion Fixation System (K202657).

CONCLUSION

Based on the testing performed, including static and dynamic bending, 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 Radian MIS Bunion 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.