The Nextremity Solutions Stratur " Reduced Size Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in ostopenic bone.

Device Description

The Stratum™ Reduced Size (RS) Foot Plating System is a foot and ankle plating system consisting of plate and screw implants. The plates range in length from 25.5mm and in width from 6.35mm to 18mm and feature between 2 and 10 screw holes. There is one diameter, 2.4mm, for all screw types including locking, non-locking, and MDS screws. The screws range in length from 8mm to 50mm and are provided sterile. The system also includes a sterile set of accessory instruments along with individually packaged drill guides / drill bits, screw driver shafts, threaded wire with nut, and olive wires designed for preparation of the implant site and insertion of devices into the bone. The plates, screws, instrument kits, drill guide / drill bits, screw driver shafts, threaded wire with nut, and olive wires are all packaged individually in separate sterile packaging. The plates, non-locking and locking screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The multi-directional locking screws are manufactured from Co-Cr-Mo conforming to ASTM F1537.

AI/ML Overview

This document is a 510(k) premarket notification for the Stratum™ Reduced Size Foot Plating System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against defined acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set information is not applicable or available in this document.

Here's an analysis of what can be extracted:

Acceptance Criteria and Device Performance

A formal table of acceptance criteria and reported device performance, as one would see in a detailed performance study, is not provided in this 510(k) submission.

Instead, the submission states that:

Mechanical Testing: "The strength of the worst-case Stratum Reduced Size Foot Plating System plates and screws is substantially equivalent to predicate devices with similar indications and is adequate for their intended use."
Bacterial Endotoxin Testing: "Endotoxin levels meet the requirement of < 20EU/device."

Study Information

The document describes non-clinical testing performed to demonstrate substantial equivalence.

1. Sample Sized used for the test set and the data provenance:

Sample Size: Not explicitly stated as a numerical sample size. The testing was done on "worst case plate" and "worst case screws." This implies a selection of specific configurations for testing, not a large statistical sample.
Data Provenance: Not applicable. This is mechanical and biological testing of physical devices, not clinical data or data from human subjects.

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

Not Applicable. The ground truth for mechanical testing is established by engineering principles and adherence to ASTM standards. For bacterial endotoxin testing, it's a quantitative measurement against a defined threshold. No human experts were involved in establishing "ground truth" for these tests in the way described for AI/diagnostic studies.

3. Adjudication method for the test set:

Not Applicable. As no human expert "ground truth" was established, no adjudication method was needed.

4. 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. This being a physical implantable device, an MRMC study comparing human readers with and without AI assistance is not relevant or described. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Stratum™ Reduced Size Foot Plating System to the predicate devices."

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

Not Applicable. This is a hardware device, not an algorithm.

6. The type of ground truth used:

Mechanical Performance: Adherence to ASTM F382-14 (four-point bending) and ASTM F543-13 (torque to failure, insertion performance, pull-out strength). The "ground truth" is that the device's performance meets or exceeds the mechanical properties suitable for its intended use and is "substantially equivalent" to predicate devices.
Bacterial Endotoxin: Quantitative measurement using the LAL method, per AAMI ST72, USP 161 and USP 85, against a specified limit of < 20 EU/device.

7. The sample size for the training set:

Not Applicable. This is not an AI/ML algorithm that requires a "training set."

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

Not Applicable. Does not apply to this type of device submission.

Summary

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July 27, 2020

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. Both logos are in color.

Nextremity Solutions, Inc. Adam Finley Director of Product Development, Reconstruction 210 North Buffalo Street Warsaw, Indiana 46580

Re: K200785

Trade/Device Name: Stratum™ Reduced Size Foot Plating 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: March 24, 2020 Received: March 26, 2020

Dear Adam Finley:

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/cfpmp/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/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, 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) K200785

Device Name

Stratum™ Reduced Size Foot Plating System

Indications for Use (Describe)

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
Prepared:	March 24, 2020
Submitter:	Nextremity Solutions, Inc.210 North Buffalo StreetWarsaw, IN 46580
Contact:	Adam FinleyDirector of Product Development, ReconstructionAdam.Finley@Nextremity.comPhone: 574-807-6150
Proprietary Name:	Stratum™ Reduced Size Foot Plating System
Common Name:	Bone Plate System
Classifications:	21 CFR §888.3030 (Primary): Single/Multiple Component Metallic BoneFixation Fastener Appliances and Accessories; Class II21 CFR §888.3040: Smooth or Threaded Metallic Bone Fixation Fastener;Class II
Product Codes:	87 / HRS (Primary), 87 / HWC

Substantially Equivalent Devices:

Zimmer Biomet F3™ Fragment Plating System (cleared as the DePuy Small Bone Locking ◆ Plating System), K081546 – Primary Predicate
Zimmer Biomet A.L.P.S. Hand Fracture (cleared as the DePuy Small Bone Locking Plating ↓ System), K081546 – Primary Predicate
Nextremity Solutions MSP Metatarsal Shortening System, K140724 Additional Predicate +
Nextremity Solutions Stratum™ Foot Plating System, K182201 Additional Predicate �

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Device Description:

Intended Use / Indications:

The Nextremity Solutions Stratum™ Reduced Size Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in osteopenic bone.

Summary of Technologies/Substantial Equivalence:

The Stratum™ Plate System Reduced Size is substantially equivalent to the predicate devices in regards to its intended use and indications, materials, designs, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems include plate profiles, geometries and screw hole configurations but do not raise new types of safety and effectiveness questions.

Non-Clinical Testing:

The worst case plate from the Stratum™ Reduced Size Foot Plating System was tested in static and analyzed in dynamic four point bending according to ASTM F382-14. Worst case screws were torqued to failure tested according to ASTM F543-13 and analyzed for insertion performance and pull-out strength. These analyses confirmed that the strength of the worst-case Stratum Reduced Size Foot Plating System plates and screws is substantially equivalent to predicate devices with similar indications and is adequate for their intended use. Bacterial Endotoxin Testing was performed using the LAL method, per AAMI ST72, USP 161 and USP 85, to confirm that endotoxin levels meet the requirement of < 20EU/device.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Stratum™ Reduced Size Foot Plating System to the predicate devices.

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Conclusion/Substantial Equivalence:

Differences between the subject device system and the predicate device systems do not raise new types of safety and effectiveness questions. The Stratum Reduced Size Foot Plating System is substantially equivalent to the predicate devices in regard to its intended use, material, design, sizes, and mechanical properties.

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.