The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include: - Arthrodesis; - Joint depression stabilization; - Fracture and/or osteotomy fixation; - Reconstruction; - Revision to be performed for conditions such as Charcot neuroarthropathy.

Device Description

The SOLE™ Medial Column Fusion Plate consists of plate's sizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety of diameters and lengths, in order to address demands of stabilization, fixation and fusion of small bones and small joints within the anatomical area of the foot and ankle. The implants will be offered both in sterile and non-sterile packaging configurations. Plates and screws are intended for single use only. Screws are not intended for use in the spine. The Subject device implants, bone plates and bone screws, are made from Stainless Steel AISI 316 LVM according to Standard ISO 5832-1/ASTM F138. Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments offered by Orthofix are classified as class I devices Exempt from 510(k), under the product code LXH, according to 21CFR 888.4540 Orthopedic Manual surgical instrument. These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6). SOLE™ Medial Column Fusion Plate is designed to be used in the operating theatre only.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the SOLE™ Medial Column Fusion Plate. This documentation focuses on establishing substantial equivalence to existing predicate devices through non-clinical performance data and does not involve AI or machine learning. Therefore, many of the requested criteria (e.g., sample size for test/training set, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth for AI) are not applicable to this submission.

However, I can extract the acceptance criteria and the study type used to prove the device meets these criteria based on the information provided in the "Performance Analysis" section.

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

Acceptance Criteria (from Referenced Standards)	Reported Device Performance (Summary from Performance Analysis)
Mechanical properties as per ASTM F543-17 "Standard Specification and Test Methods for Metallic Medical Bone Screws"	Confirmed to be safe, effective, and performs as well as or better than predicate devices.
Mechanical properties as per ASTM F382 standard "Standard Specification And Test Method For Metallic Bone Plates"	Confirmed to be safe, effective, and performs as well as or better than predicate devices.
Material properties as per ISO 5832-1/ASTM F138 (for implants)	Implants made from Stainless Steel AISI 316 LVM, conforming to these standards.
Material properties as per ASTM F899-12b "Standard Specification for Wrought Stainless Steels for Surgical Instruments" (for instruments)	Instruments made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6), conforming to this standard.
No new risks associated compared to predicate devices	Potential hazards evaluated and controlled through Risk Management activities; relevant information addressed in labeling.
Performance substantially equivalent to predicate devices	Bench testing and engineering assessments on worst cases of subject device and corresponding predicate devices confirm substantial equivalence.

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

The document primarily relies on bench testing and engineering assessments and a review of current clinical literature on predicates and similar devices. It does not describe a clinical study with human subjects, therefore, traditional "test set" and "data provenance" in the context of clinical data are not applicable. The bench testing would involve physical samples of the device; the number of samples is not specified.

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)

Not applicable. This is a device submission based on non-clinical performance data and substantial equivalence to predicates, not a study requiring expert-established ground truth for diagnostic accuracy.

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

Not applicable. No clinical test set requiring adjudication is described.

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 device is not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

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

For the mechanical performance testing, the "ground truth" or reference for acceptable performance are the specified requirements of the referenced ASTM and ISO standards. For the substantial equivalence argument, the performance of the predicate devices serves as a comparative ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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April 20, 2021

Image /page/0/Picture/1 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.

Orthofix SRL % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408

Re: K210157

Trade/Device Name: SOLE™ Medial Column Fusion Plate 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 21, 2021

Dear Cheryl Wagoner:

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)

K210157

Device Name SOLETM Medial Column Fusion Plate

Indications for Use (Describe)

The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation.

The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include:

Arthrodesis;
Joint depression stabilization;
Fracture and/or osteotomy fixation;
Reconstruction;
Revision

to be performed for conditions such as Charcot neuroarthropathy.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Submitter information

Submitter Name	Orthofix Srl
Address	Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719.000
Fax	+ 39 045 6719.380

Contact Person	Gianluca RicadonaSr. Quality & Regulatory Affairs Manager
Address	Via delle Nazioni, 937012 Bussolengo (VR) - Italy
Telephone	+ 39 045 6719 000
Fax	+ 39 045 6719 380
Email address	GianlucaRicadona@orthofix.it
Date of submission	April 16, 2021

Trade Name, Common Name, Classification

Trade Name	SOLE™ Medial Column Fusion Plate
Device	Plate, fixation, bone (Primary)
	Screw, fixation, bone
Product code	HRS (Primary)
	HWC
Panel Code	Orthopedic
Class	Class II
Regulation Number	21 CFR §888.3030 (Primary): Single/multiple componentmetallic bone fixation appliances and accessories;21 CFR §888.3040: Smooth or threaded metallic bone fixationfastener; Class II

Predicate devices and reference devices

Primary Predicate Device	510(k)Number	Manufacturer
Baby Gorilla/Gorilla Plating System (formerlyParaLock Plating SystemTM)	K203511	Paragon 28, Inc.
Additional Predicate Devices
VariAx 2 System	K180500	Stryker GmbH
VLP Foot, Plating, Screw System	K090675	Smith & Nephew, Inc
Salvation 3Di Plating System	K140792	Wright Medical
Reference Devices
Orthofix Fixation Screws with HA coated	K974186	Orthofix Srl
Veronail Screwdriver instrument	K053261	Orthofix Srl
Chimaera - Hip Fracture System	K173458	Orthofix Srl

Device description	The SOLE™ Medial Column Fusion Plate consists of plate'ssizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety ofdiameters and lengths, in order to address demands ofstabilization, fixation and fusion of small bones and small jointswithin the anatomical area of the foot and ankle.
	The implants will be offered both in sterile and non-sterilepackaging configurations.
	Plates and screws are intended for single use only. Screws arenot intended for use in the spine.
	The Subject device implants, bone plates and bone screws, aremade from Stainless Steel AISI 316 LVM according to StandardISO 5832-1/ASTM F138.
	Surgical procedures with the use of the subject implants may beperformed with the support of general orthopedicinstrumentation, to facilitate their proper insertion and removalfrom the patient. The instruments offered by Orthofix areclassified as class I devices Exempt from 510(k), under theproduct code LXH, according to 21CFR 888.4540 OrthopedicManual surgical instrument.
	These instruments are made by medical grade stainless steel(AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) andAluminum alloy (EN-AW 6082 T6).
	SOLE™ Medial Column Fusion Plate is designed to be used inthe operating theatre only.
Indications for use	The SOLE™ Medial Column Fusion Plate is intended to providebone fixation. The SOLE™ Medial Column Fusion Plate isindicated for orthopedic applications within the anatomical areaof the foot and ankle, including but not limited to the medialcolumn (consisting of the first metatarsal, medial cuneiform,navicular and talus). Specific indicated procedures include:- Arthrodesis;- Joint depression stabilization;- Fracture and/or osteotomy fixation;- Reconstruction;- Revisionto be performed for conditions such as Charcotneuroarthropathy.
TechnologicalCharacteristics andIntended Use	The Subject device fundamental scientific principles andtechnological characteristic, including: the intended use, materialand general design, are the same as, or similar to, the chosenpredicate devices.Summary of the technological characteristics and Intended Use:✓ Intended use: identical.✓ Indications for Use, Anatomical sites, operating principlesand conditions of use: are substantially equivalent topredicates; no new risks associated to the Subject devicecompared to those of the Primary predicate and theadditional predicate device which have equivalent indicationsfor use, anatomical sites and conditions of use. Verificationactivities on Subject devices demonstrated substantiallyequivalent performance to the predicate devices.✓ Geometry and size: similar sizes and geometry of the boneplates; similar sizes and geometry of the bone screws.✓ Sterilization, same method as the predicates.
	The technological characteristics of the SOLE™ Medial ColumnFusion Plate are substantially equivalent to the predicatedevices.
PerformanceAnalysis	Subject device has similar configuration, sizes and design as thepredicate devices.Results to support the determination of substantial equivalencefrom bench testing and engineering assessments on worst casesof Subject device and corresponding predicate devices and othersimilar devices, confirm that Subject device, as safe, aseffective, and performs as well as or better than the predicatedevices.Performance mechanical testing on Subject implants item havebeen performed according to: ASTM F543-17 "StandardSpecification and Test Methods for Metallic Medical BoneScrews", ASTM F382 standard "Standard Specification And TestMethod For Metallic Bone Plates", ASTM F543-17 "StandardSpecification and Test Methods for Metallic Medical BoneScrews".Performance mechanical testing specifications on Subjectinstruments according to standard ASTM F899-12b "StandardSpecification for Wrought Stainless Steels for SurgicalInstruments".Any potential hazards have been evaluated and controlledthrough Risk Management activities, and any relevantinformation, have been addressed in the labelling, after allcontrol measures have been implemented.The review of the current clinical literature on the predicates andon other similar devices have been conducted to support theclinical indications of SOLE™ Medial Column Fusion Platewithout requiring further clinical data.
Conclusion	Based upon equivalences in: intended use, site of application,conditions of use, operating principles, and the non-clinicalperformance data, the SOLE™ Medial Column Fusion Plate hasbeen shown to be safe and effective, and to perform equivalentlyas compared to the legally marketed predicate devices.Therefore, the Subject device is substantially equivalent to thelegally marketed predicate devices.

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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.