The MIS Precision Chevron Bunion System is indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

Device Description

The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.

AI/ML Overview

Based on the provided text, the device is the "MIS Precision Chevron Bunion System," which is a metallic bone fixation fastener (specifically, cannulated headless compression screws) used for foot osteotomies. The text does NOT describe an AI/ML-based device.

Therefore, many of the requested criteria such as acceptance criteria for AI performance (e.g., sensitivity, specificity), sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable. The provided document is a 510(k) summary for a medical device (surgical system), not for an AI/ML algorithm.

I can, however, extract the relevant performance evaluation information for this non-AI medical device.

Acceptance Criteria and Reported Device Performance (Non-AI Device)

For this type of medical device (bone fixation fastener and surgical system), acceptance criteria are typically related to mechanical performance, biocompatibility, sterility, and usability, rather than diagnostic accuracy metrics.

Acceptance Criteria (Type of Test)	Reported Device Performance (RELJA System)	Predicate Comparison (if applicable)
Biocompatibility	Complies with ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization).	Not directly compared, but compliance indicates meeting safety standards.
Sterility	Complies with ISO 11137-1 and ISO 11137-2 (radiation sterilization). Bacterial endotoxin testing in accordance with FDA guidance.	Not directly compared, but compliance indicates meeting accepted standards.
Shelf Life	Confirmed five-year shelf-life with accelerated aging per ASTM F1980. Packaging integrity verified per ASTM F1886, ASTM F2096, and ASTM F88.	Not directly compared, but compliance indicates meeting accepted standards.
Static Torsion	Stronger than the predicate in torsion, per ASTM F543.	RELJA screw is stronger than the predicate (Stryker Fixos Screw System).
Driving Torque	Meets FDA requirements for non-spinal metallic screws, per ASTM F543.	Meets FDA requirements. Predicate comparison not explicitly stated for this metric, but implying comparable or better.
Axial Pullout Strength	Meets FDA requirements for non-spinal metallic screws, in accordance with FDA Guidance Document.	Meets FDA requirements. Predicate comparison not explicitly stated for this metric, but implying comparable or better.
Performance/Usability (Simulated Surgical Procedures)	Procedure successfully completed on male (14 total) and female (11 total) feet ranging in size from small to large. Precision osteotomy guide was properly positioned on any size foot. Fixation and fluoroscopy images showed proper location of osteotomy and implant placement.	Compared favorably in usability; the RELJA system uses single-use sterile instrumentation, while the predicate uses metal and/or reusable instruments, suggesting a potential improvement in handling or sterility control.

As this is not an AI/ML device, the following points are not directly applicable. However, I will state what could be inferred if one were to try to map the request to the provided information, noting the disclaimers.

2. Sample size used for the test set and the data provenance:
- Test Set (Performance/Usability Evaluation): 25 cadaveric surgical procedures (14 male, 11 female feet).
- Data Provenance: Cadaveric tissue, implying a laboratory/simulated setting, no country of origin specified. Retrospective/Prospective is not applicable in this context; it's a prospective in vitro (cadaveric) study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The "experts" were "trained foot and ankle physicians" who conducted the performance and usability testing. The number is not specified, but it was stated as "physicians" (plural). Their qualifications are "trained foot and ankle physicians." Ground truth in this context is successful completion of the procedure and proper placement as verified by fixation and fluoroscopy images, and the ability to position the guide on various foot sizes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of device performance testing. The "adjudication" was the successful completion and observation of proper placement during the simulated surgeries by the performing physicians.
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 physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an AI system. The mechanical testing (Static Torsion, Driving Torque, Axial Pullout Strength) could be considered "standalone" in mechanical terms, but not in the context of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical tests: Engineering standards (ASTM F543) and FDA guidance for screws.
- For usability/performance: Successful completion of surgical steps, proper guide positioning, and visual confirmation of osteotomy and implant placement via fluoroscopy images during simulated procedures. This is a form of "expert judgment/observation" within a cadaveric model.
8. The sample size for the training set:
- Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI model to train.

Summary

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January 31, 2022

RELJA Innovations, LLC % Allison Komiyama Principal AcKnowledge Regulatory Strategies, Inc. 2251 San Diego Ave, Suite B-257 San Diego, California 92110

Re: K211628

Trade/Device Name: MIS Precision Chevron Bunion 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 30, 2021 Received: December 30, 2021

Dear Allison Komiyama:

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.

For: 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211628

Device Name MIS Precision Chevron Bunion System

Indications for Use (Describe)

The MIS Precision Chevron Bunion System is indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

Type of Use (Select one or both, as applicable)
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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 K211628

1. Submitted By:	RELJA Innovations LLC17145 W. Bluemound Rd.Suite #J-265Brookfield, WI 53005
Date:	January 27, 2022
Contact Person:	David PancratzChief Operating OfficerPhone: 210-383-3907Email: dave@reljainnovations.com
Regulatory Consultant:	Allison Komiyama, Ph.D., RACLucie Dalet, Ph.D.RQM+Phone: 412-816-8253Email: akomiyama@rqmplus.com ldalet@rqmplus.com
2. Proprietary Name:	MIS Precision Chevron Bunion System
Common Name:	Screw, Fixation, Bone
Classification Name and Reference:	21 CFR 888.3040 – Class IISmooth or threaded metallic bone fixation fastener
Device Product Code, Device Panel:	HWC, Orthopedic
3. Primary Predicate:	Stryker Fixos Screw System, K070039

4. Device Description:

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single, sterile-packaged SKU that contains both implants and instruments needed for the procedure.

The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm.

There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire.

Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.

1. Indications for Use
  The MIS Precision Chevron Bunion System is indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
1. Technological Characteristics Comparison
  The MIS Precision Chevron Bunion System™ utilizes a 3.5 mm diameter cannulated compression screw made of titanium alloy for fixation of a chevron osteotomy of the hallux. Similarly, the Memometal Fixos Screw System recommends a 3.5 mm diameter cannulated compression screw made of titanium alloy for fixation of a chevron osteotomy of the hallux. The Memometal Fixos Screw System also includes numerous other sizes of screws recommended for other surgical procedures.

The MIS Precision Chevron Bunion System™ also includes single-use sterile instrumentation to assist in making the chevron osteotomy and placing the implant. The Memometal Fixos system utilizes metal and/or reusable instruments for performing the same procedure.

1. Substantial Equivalence Non-Clinical Evidence
- Biocompatibility: The subject device was subjected to biocompatibility testing in compliance to ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization.

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Sterility and shelf life: The final, finished subject device was subjected to sterility testing in compliance with ISO 11137-1 Sterilization of health care products - Radiation - Part 1 : Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. Bacterial endotoxin testing in accordance with recommendations in the FDA Guidence Document, Pyrogen and Endotoxin Testing: Ouestions and Answers and shelf-life testing confirming five-year shelf-life was also completed on the final finished device. Accelerated aging according to ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices was completed. Packaging integrity on the aged devices was verified according to ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection, ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test), and ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials.
Performance evaluation: Testing included Static Torsion and Driving Torque per ASTM -F543 Standard Specification and Test Methods for Metallic Medical Bone Screws, and predicted Axial Pullout Strength in accordance with FDA Guidance Document. The results of the Static Torsion testing show that the RELJA screw is stronger than the predicate in torsion. The results of Driving Torque and Axial Pullout Strength analysis show that the RELJA screw meets FDA requirements for non-spinal metallic screws.
Performance evaluation: Performance and usability testing of the subject device by trained foot and ankle physicians were conducted in twenty-five simulated surgical procedures using cadaveric tissue, on five separate dates. The procedure was successfully completed on male (14 total) and female (11 total) feet ranging in size from small to large. Results show that the precision osteotomy guide is able to be properly positioned on any size foot by following the surgical technique. Fixation and fluoroscopy images showed proper location of the osteotomy and placement of the implant after each simulated procedure.

The safety and effectiveness of the MIS Precision Chevron Bunion System™ is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket submission.

1. Substantial Equivalence Clinical Evidence Not applicable.
1. Substantial Equivalence Conclusions

The design characteristics of the subject devices do not raise any new types of questions regarding safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.

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.