The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intra- and extraarticular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization and fixation of fragments in fresh fractures.

ORTHOLOC™ 3Di Locking Screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, ostectorny, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

Device Description

The subject ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is designed to facilitate fracture fixation of the fibula and tibia. The system achieves its intended effect through the use of the various titanium alloy (Type II Anodized) straight, anatomical, and contoured plates and both locking and non-locking screws.

AI/ML Overview

This document, a 510(k) Premarket Notification from the FDA, pertains to a medical device: the "ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System". It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to predicate devices, but does not involve an AI/ML component. Therefore, most of the requested information regarding AI/ML acceptance criteria and study details (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.

The document discusses non-clinical evidence to support substantial equivalence, primarily mechanical testing and engineering justification. It explicitly states "N/A" for clinical evidence.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is not:

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

The document does not provide a table of acceptance criteria in the context of an AI/ML model's performance. Instead, it describes mechanical testing conducted to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly meeting the performance of the predicate device.

Test Performed (Non-Clinical)	Acceptance Criteria (Implied)	Reported Device Performance
Plates tested per ASTM F382:
- Static Four-Point Bend	Performance comparable to predicate device	Demonstrated substantial equivalence
- Fatigue Four-Point Bend	Performance comparable to predicate device	Demonstrated substantial equivalence
Tests per ASTM F2182 (MRI Environment):
- RF Heating	Compatibility with MRI environment	Established compatibility
- Induced Forces	Compatibility with MRI environment	Established compatibility
- Induced Torques	Compatibility with MRI environment	Established compatibility
- Image Artifact	Compatibility with MRI environment	Established compatibility
Engineering Justification for Additional Screw Lengths	Substantial equivalence to predicate screws in ASTM F543	Determined to be substantially equivalent by dimensional comparison
Pyrogenicity Analysis (Bacterial Endotoxins Test - BET/LAL)	Compliance with ANSI/AAMI ST72:2011	Testing conducted, assumed to have met standards for safety

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes non-clinical mechanical testing, not a study involving patient data for an AI/ML model. The "test set" in this context refers to the physical devices undergoing mechanical stress tests. The document does not specify the number of devices tested, but rather the standards followed (ASTM F382, ASTM F2182).

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)

This is not applicable. There is no "ground truth" established by experts in the context of mechanical testing. The results are based on objective physical measurements and engineering evaluations.

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

This is not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert consensus for labeling data, which is not present here.

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

This is not applicable. This document does not describe the evaluation of an AI-assisted device. There were no human readers whose performance was being assessed.

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

This is not applicable. This document does not describe an algorithm or AI model.

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

This is not applicable. The "ground truth" for this device's evaluation relies on established engineering standards and physical properties, not clinical or pathological outcomes.

8. The sample size for the training set

This is not applicable. There is no AI/ML model described in this document, and therefore no training set.

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

This is not applicable. No training set or associated ground truth establishment process is relevant to this device's submission.

In summary: The provided FDA document is a 510(k) for a traditional medical device (bone fixation plates and screws). It demonstrates substantial equivalence through mechanical and engineering testing, not through clinical or AI/ML performance studies. Therefore, most of your questions, which are highly relevant to AI/ML device evaluations, are not addressed by this document.

Summary

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January 8, 2021

Wright Medical Technology, Inc. Anna Hinton Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K201259

Trade/Device Name: ORTHOLOC 2 Pilon Fracture 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: November 23, 2020 Received: November 25, 2020

Dear Anna Hinton:

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-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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, 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

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Indications for Use

510(k) Number (if known) K201259

Device Name

ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System

Indications for Use (Describe)

ORTHOLOC™ 3Di Locking Screws are intended for use with Wright's ORTHOLOC 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, ostectorny, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

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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1023 Cherry Road Memphis, TN 38117 wright.com

510(k) SUMMARY

In accordance with the Food and Drug Administration rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System.

a)(1) MANUFACTURER IDENTIFICATION

Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	December 22, 2020
Contact Person:	Anna HintonRegulatory Affairs SpecialistOffice: (901)451-6362
(a)(2) SUBJECT DEVICE INFORMATION
Proprietary Name:	ORTHOLOC™ 2 with 3Di Technology Pilon FracturePlating System
Common Name:Classification Name & Reference:	Bone PlateSingle/multiple component metallic bone fixationappliances and accessories21 CFR 888.3030 (primary) – Class IISmooth or threaded metallic bone fixation fastener21 CFR 888.3040 – Class II
Device Product Code & Panel:	HRS - OrthopedicHWC- Orthopedic
(a)(3) PREDICATE DEVICE INFORMATION
ORTHOLOC 3Di Ankle Fracture Plating SystemORTHOLOC 3Di Small Bones Forefoot SystemDARCO Small ScrewORTHOLOC 2.0/2.4 Plate System	K163044 (primary)K163039 (additional)K082320 (additional)K000692 (additional)

K102429 (additional)

ORTHOLOC 3Di Hallux System K120359 (additional) NCB Plating System Distal Femur and Proximal Tibia K192217 (additional)

ORTHOLOC 3Di Ankle Plating System, ORTHOLOC Bone Screw

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(a)(4) DEVICE DESCRIPTON

(a)(5) INTENDED USE

The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is indicated for complex intraand extra-articular fractures, osteotomies, and non-unions of the distal tibia, and fracture fixation of the fibula in skeletally mature patients. This includes periarticular stabilization of fragments in fresh fractures.

ORTHOLOC™ Locking Screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.

(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON

The ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System is manufactured from identical materials (i.e Titanium Alloy) and has identical sterilization methods as the legally marketed predicate device. The subject plates of the system are available in straight, anatomical, and contoured plates in the left and right orientations designed to maintain an anatomical fit across the bone, similar to the predicate plates. In order to achieve the intended effect, the subject and predicate plates and screws are both used to provide stabilization and to facilitate bone fusion. The subject plates are technologically substantially equivalent in material, size and bending strength to the predicate plates. The subject screws only vary in length from the predicate screws and the subject washers are unchanged from the predicate washers.

(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE

The following evaluations were conducted to support the safety and efficacy of the ORTHOLOC™ 2 with 3Di Technology Pilon Fracture Plating System:

Comparative, mechanical tested to predicate devices demonstrated substantial equivalence.

। Plates were tested per ASTMF382:
- . Static Four-Point Bend
- . Fatigue Four-Point Bend
Tests Performed per ASTM F2182 to establish compatibility with a Magnetic Resonance । Environment:
- RF Heating
- Induced Forces .
- Induced Torques
- . Image Artifact

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Engineering Justification for Additional Screw Lengths: by dimensional comparison, the additional screw lengths are substantially equivalent to the predicate screws in ASTM F543
-Pyrogencity Analysis: Pyrogen testing was conducted using the bacterial endotoxins test (BET) also known as LAL according to ANSI/AAMI ST72:2011, Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing.

(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A

(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS

The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. 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

§ 888.3030 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.