The Lever Action Plate System is a distal radius plate implanted in the treatment of distal radius fractures, non-unions, or osteotomies. The system consists of the plates, screws, beams, beam screws and instrumentation. The plates have either 1 or 2 beam slots which allow for implantation of the beams into the distal radius bone. The beams and their supporting beam screws are intended for maintaining volar correction intra-operatively. The plate and beam(s) are used in conjunction with screws and beam screws to fixate fragments in the wrist. The implants are composed of Ti-6Al-4V and are available in multiple configurations and sizes.

AI/ML Overview

This FDA 510(k) summary is for the Lever Action Plate System, a medical device used for bone fixation. It describes the device's indications for use, its similarity to a predicate device, and the preclinical testing performed.

Here's an analysis based on your request, highlighting that this is a mechanical device clearance, not an AI/software device, which impacts the applicability of many of your requested points.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Mechanical Properties): The document implies that the acceptance criteria for the Lever Action Plate System's mechanical properties were established by demonstrating equivalence to the predicate device and by conforming to relevant ASTM standards. The specific quantitative thresholds for acceptance (e.g., minimum bending strength in Newtons) are not explicitly stated in the provided text. Instead, the acceptance is based on demonstrating that the subject device's mechanical strength is "equivalent" to the predicate and "sufficient" for its intended use.

Acceptance Criteria Category	Reported Device Performance
Static Mechanical Compression Bend Testing	The subject plates demonstrated equivalent strength in comparison to the predicate device (Trimed Bearing Plate).
Dynamic Mechanical Compression Bend Testing	The subject plates demonstrated equivalent strength in comparison to the predicate device (Trimed Bearing Plate).
Static Torsion Testing (Screws)	The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543).
Driving Torque Testing (Screws)	The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543).
Removal Torque Testing (Screws)	The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543).
Static Axial Pullout Testing (Screws)	The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543).
Disassembly Pushout Testing (Beams/Plate Interface)	The fixation components were demonstrated to be of sufficient strength, fixation, and usability for their intended use.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes preclinical mechanical testing of physical device components, not a study involving human subjects or data sets.

Sample Size for Test Set: Not specified in terms of "test set" as typically understood for software or clinical studies. The mechanical tests would have involved a certain number of device samples (plates, screws, beams) for each test condition, but these specific numbers are not detailed in the summary.
Data Provenance: The data comes from in-vitro (benchtop) mechanical testing conducted on the manufactured device components. The country of origin for this testing is not specified, but it's related to the manufacturer (McGinley Orthopaedic Innovations in Wyoming, USA) and regulatory consultants (MCRA, LLC in Washington, DC, USA). The testing is prospective for the purpose of demonstrating substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to this type of device clearance. Ground truth, in the context of expert consensus, is typically established for diagnostic algorithms or subjective assessments. For a mechanical device, the "ground truth" for performance is determined by objective physical measurements conforming to engineering standards (e.g., ASTM F543) and direct comparison of mechanical properties. There were no human experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

This question is not applicable. The "test set" relates to mechanical testing where outcomes are objective measurements, not subjective human assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of mechanical bone fixation device. MRMC studies are typically performed for imaging diagnostics or AI-assisted diagnostic tools to assess how human reader performance changes with or without AI assistance. This device is a physical implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is a physical medical implant, not an algorithm or AI software. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.

7. Type of Ground Truth Used

The "ground truth" for this mechanical device application is established through objective mechanical testing against established industry standards (e.g., ASTM F543) and direct comparison of mechanical properties to a legally marketed predicate device. The document states, "The testing demonstrated that subject plates have equivalent strength in comparison to the predicate" and that screws/components are of "sufficient strength" and "fixation and usability."

8. Sample Size for the Training Set

This question is not applicable. This is a physical device, not an AI or machine learning model. There is no concept of a "training set" in the context of its development and preclinical testing as described.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reasons as point 8.

Summary

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June 25, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

McGinley Orthpaedic Innovations, LLC % David McGurl Director, Regulatory Affairs MCRA. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K200834

Trade/Device Name: Lever Action Plate 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: June 12, 2020 Received: June 15, 2020

Dear David McGurl:

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.

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

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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, 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) K200834

Device Name Lever Action Plate System

Indications for Use (Describe)

The Lever Action Plate System is indicated for:

1. Fixation of fractures or non-unions of the distal radius

Osteotomies of the distal radius to correct malunion

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

Experimental Use (21 CFR 56.102(d)) (Check if applicable)
For the Convenience (21 CFR 312.8)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

Device Trade Name:	Lever Action Plate System
Manufacturer:	McGinley Orthopaedic Innovations2435 King Blvd, Ste 230Casper, WY 82604
Contact:	Mr. Adam M. JohnsonDirector of EngineeringMcGinley Orthopaedic Innovations2435 King Blvd, Ste 230Casper, WY 82604Phone: (307) 315-6403Email: adam@mcginleyinnovations.com
Prepared by:	Mr. Dave McGurlDirector, Regulatory AffairsMCRA, LLC1050 K Street NE, Suite 1000Washington, DC 20005Phone: 202.552.5800Email: dmcgurl@mcra.com
Date Prepared:	6/25/2020
Classification:	21 CFR 888.3030 Single/multiple component metallic bone fixationappliances and accessories.
Common Name:	Plate, Fixation, Bone
Class:	II
Product Code:	HRS
Predicate Devices:	Trimed Bearing Plate: Trimed Volar Bearing Plate (K040112)
Indications for Use:	The Lever Action Plate System is indicated for:1. Fixation of fractures or non-unions of the distal radius2. Osteotomies of the distal radius to correct malunion

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Device Description:

Substantial Equivalence:

The subject device has the identical indications for use as the predicate device. Both devices are intended to be used in the distal radius for fracture and osteotomies. Both the subject and predicate device use the same inherent technology, screw and plate components to fixate bone fragments to allow for bone healing. Both systems are manufactured from the same metallic components (i.e. Ti alloy). There are differences in the design of the plate and screws but these differences do not raise new questions of safety and effectiveness. Testing was provided to support the plate and screw constructs have equivalent strength.

Therefore, the Lever Action Plate System is substantially equivalent to the predicate devices cited on the previous page with respect to indications, design, function, and performance.

Preclinical Testing:

Static and dynamic mechanical compression bend testing was conducted of the Lever Action Plate System (i.e. subject plates, the subject plates beams, and beam screws) and a predicate. The testing demonstrated that subject plates have equivalent strength in comparison to the predicate.

Static Torsion, Driving Torque, Removal Torque, and Static Axial Pullout Testing was conducted on Level Action Plate System screws per ASTM F543. The testing demonstrate that the screws are of sufficient strength for their intended use. Disassembly pushout testing was conducted on the beams/plate interface. The testing demonstrate that the fixation components are of sufficient strength, fixation and usability for their intended use.

Clinical Testing:

Clinical testing was not necessary to support equivalence.

Conclusion:

The Lever Action Plate System possesses the similar intended use and technological characteristics as the predicate device. Additionally, the preclinical testing support the substantial equivalence of the Lever Action Plate System to the predicates. Therefore, the Lever Action Plate System is substantially equivalent for its intended use.

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.