The Leith Medical Foot and Ankle System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

The Leith Medical Ankle Fracture Plates are intended and designed for open reduction, internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, and non-unions of the distal tibia and fibula.

The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st TMT joint due to degenerative joint disease and/or hallux valgus, or revision of prior 1st TMT joint arthrodesis.

The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula.

The Leith Medical First Metatarsal Phalangeal Joint Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st MTP joint due to degenerative joint disease and/or hallux valgus, revision of prior 1st MTP joint arthrodesis, or revision of failed 1st MTP joint implant arthroplasty.

The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Device Description

The Leith Medical Foot and Ankle System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, a highly radiused edge configuration, capability of dynamic/manual compression. All plates have standard screw holes with a locking feature, and some plates have oval screw holes for compressing the fracture intraoperatively. The system also consists of cortical screw with multiple lengths and diameters.

AI/ML Overview

The provided text describes a medical device submission (K200062) for the Leith Medical Foot and Ankle System. This document does not describe an AI/ML device nor a study proving it meets specific acceptance criteria based on its performance in aiding human readers or as a standalone diagnostic tool.

Instead, this is a 510(k) Premarket Notification for a traditional medical device (bone plates and screws). The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to evaluate diagnostic performance or AI model efficacy.

Therefore, most of the questions regarding acceptance criteria for an AI device, human reader studies, ground truth establishment, and training/test set details are not applicable to this document.

Here's what can be extracted and inferred from the provided text, focusing on the device's substantial equivalence claim:

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

Since this is a substantial equivalence submission for a traditional implantable device, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, they are related to the material, mechanical properties, and safety of the device compared to predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence	"The Leith Medical Foot and Ankle System and the predicate devices are all intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device."
Material Equivalence	"The Leith Medical Foot and Ankle System uses the same material as the predicates." (Materials are Titanium alloy, Ti-6Al-4V per ASTM F136; Nitinol per ASTM F2063).
Design Equivalence	"The Foot and Ankle System and the predicates are equivalent in terms of shape and function."
Dimensions Equivalence	"The Leith Medical Foot and Ankle System and the predicates are equivalent in their dimensions."
Mechanical Strength Equivalence/Superiority	"The Leith Medical Foot and Ankle System has greater or equivalent strength values compared to the predicates." This was evaluated through non-clinical mechanical testing:
* Static and dynamic 4-point bending	Tested per ASTM F382-17. Results indicate equivalence.
* Torsional Properties	Tested per ASTM F543-17, Annex 1. Results indicate equivalence.
* Driving Torque	Tested per ASTM F543-17, Annex 2. Results indicate equivalence.
* Axial Pullout	Tested per ASTM F543-17, Annex 3. Results indicate equivalence.
Biocompatibility/Sterilization Efficacy	* Bacterial Endotoxins Test (BET): Tested per AAMI ST72. Results indicate compliance.
Packaging Performance and Stability	* Package Performance and Stability Testing: Performed. Results indicate compliance.
Overall Substantial Equivalence to Predicate Devices	"The results of these evaluations indicate that the Leith Medical Foot and Ankle System is equivalent to predicate devices.""Leith Medical considers the Leith Medical Foot and Ankle System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use."

The following questions are NOT APPLICABLE to this document as it pertains to a traditional non-AI medical device submission:

Sample sized used for the test set and the data provenance: Not applicable. No test set of data (e.g., medical images for AI evaluation) was used for performance assessment in this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. There is no AI model to train.
How the ground truth for the training set was established: Not applicable.

Summary

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February 22, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Leith Medical LLC % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401

Re: K200062

Trade/Device Name: Foot and Ankle 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: January 21, 2021 Received: January 25, 2021

Dear J.D. Webb:

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 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

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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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200062

Device Name Leith Medical Foot and Ankle System

Indications for Use (Describe)

The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixation of fractures, and non-unions of the distal tibia and fibula.

The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

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

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510(k) Summary: Leith Medical Foot and Ankle System

Date Prepared	January 12, 2021
Submitted By	Leith Medical LLC4705 Eagle Feather DrAustin, TX 78735
Primary Contact	J.D. Webb4313 W. 3800 SWest Haven, UT 84401512-590-5810 Telee-mail: jdwebb@orthomedix.net
Trade Name	Leith Medical Foot and Ankle System
Common Name	bone plate & screws
Classification Name	Single/multiple component metallic bone fixation appliances and accessoriesSmooth or threaded metallic bone fixation fastener
Class	II
Product Code	HRS / HWC
CFR Section	21 CFR section 888.3030 / 888.3040
Device Panel	Orthopedic
Primary PredicateDevice	ORTHOLOC 3Di Ankle Plating System - Wright Medical Technology (K102429 / K131093)
Secondary PredicateDevices	ORTHOLOC ® 3Di MTP Fusion Plate / ORTHOLOC® 3Di Foot Reconstruction System -Wright Medical Technology (K152974 / K120359)Small Fragment Set - Stryker (K060514)LCP Anterolateral Distal Tibia Plates / Variable Angle LCP TMT Fusion Plates /2.4/2.7Synthes 2.7mm/3.5mm Cortex Screw - Synthes (K121601 / K100776 / K112583ARSENAL Foot Plating System - Trilliant Surgical (K191009)
Device Description	The Leith Medical Foot and Ankle System consists of various shape and size plates forthe management of small bone orthopedic osteotomies, reconstruction, and trauma.Features include a low profile, limited contact, a highly radiused edge configuration,capability of dynamic/manual compression. All plates have standard screw holes with alocking feature, and some plates have oval screw holes for compressing the fractureintraoperatively. The system also consists of cortical screw with multiple lengths anddiameters.
Materials	Titanium alloy, Ti-6Al-4V (per ASTM F136)Nitinol (per ASTM F2063)
Intended Use	The Leith Medical Foot and Ankle System is intended for use in trauma and reconstructiveprocedures of the small bones in the hand/foot, ankle, and other bones appropriate for thesize of the device.
SubstantialEquivalence Claimedto Predicate Devices	The Leith Medical Foot and Ankle System is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanical safety andperformances.
Indications for Use	The Leith Medical Ankle Fracture Plates are intended and designed for open reduction,internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, andnon-unions of the distal tibia and fibula.The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intendedand designed for primary arthrodesis of the 1st TMT joint due to degenerative joint diseaseand/or hallux valgus, or revision of prior 1st TMT joint arthrodesis.The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixationof fractures, osteotomies, and non-unions of the distal tibia and fibula.The Leith Medical First Metatarsal Phalangeal Joint Arthrodesis Plates are intended anddesigned for primary arthrodesis of the 1st MTP joint due to degenerative joint diseaseand/or hallux valgus, revision of prior 1st MTP joint arthrodesis, or revision of failed 1stMTP joint implant arthroplasty.The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy,arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for thesize of the device.
Summary of thetechnologicalcharacteristicscompared topredicate	Intended UseThe Leith Medical Foot and Ankle System and the predicate devices are all intended foruse in trauma and reconstructive procedures of the small bones in the hand/foot, ankle,and other bones appropriate for the size of the device.MaterialsThe Leith Medical Foot and Ankle System uses the same material as the predicates.DesignThe Foot and Ankle System and the predicates are equivalent in terms of shape andfunction.DimensionsThe Leith Medical Foot and Ankle System and the predicates are equivalent in theirdimensions.StrengthThe Leith Medical Foot and Ankle System has greater or equivalent strength valuescompared to the predicates.
Non-clinical TestSummary	The following analyses were conducted:● Static and dynamic 4-point bending: ASTM F382-17● Torsional Properties: ASTM F543-17, Annex 1● Driving Torque: ASTM F543-17, Annex 2● Axial Pullout: ASTM F543-17, Annex 3● Bacterial Endotoxins Test (BET): AAMI ST72
	• Package Performance and Stability Testing
	The results of these evaluations indicate that the Leith Medical Foot and Ankle System isequivalent to predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions: Non-clinical and Clinical	Leith Medical considers the Leith Medical Foot and Ankle System to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.