The VersaNail™ is intended for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.

Device Description

The VersaNail™ is a straight, cannulated intramedullary nail available in diameters of 10 and 12 mm and lengths of 15, 20, 25 and 30 cm. Holes in the nail allow for proximal and distal locking. The VersaNail™, the end cap and the screws are all manufactured from Ti-6AL-4V alloy.

AI/ML Overview

The provided text is a 510(k) summary for the ACE® VersaNail™, an intramedullary fixation rod. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics for an AI/ML medical device.

The 510(k) process for devices like the VersaNail™ (an intramedullary fixation rod) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a performance study with detailed acceptance criteria as would be typical for an AI/ML diagnostic or assistive device. The "acceptance criteria" here are inherent in showing that the new device performs as safely and effectively as the predicate devices, which is typically done through design comparisons, material testing, and reference to existing clinical use of the predicate devices.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set size) are not applicable or findable in this type of 510(k) submission for a physical orthopedic implant.

Here's a breakdown based on the information available and what is not applicable to this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices in design, materials, manufacturing, and intended use.	The ACE® VersaNail™ is described as being substantially equivalent to the ACE® AIM® Titanium Supracondylar Nail, ACE® AIM® TTC Fusion Nail, Biomet Ankle Arthrodesis Nail, Smith and Nephew Intramedullary Nail, and Encore® UltiMax Ankle Fusion Rod based on:Similarities of designCommonly used materials (Ti-6AL-4V alloy)Identical sterilization processesEquivalent indications for use

2. Sample size used for the test set and the data provenance

Not Applicable. This 510(k) submission is for a physical orthopedic implant and does not involve a "test set" of clinical data to evaluate AI/ML performance. Substantial equivalence is primarily demonstrated through engineering design comparisons, material specifications, and comparison of intended uses with predicate devices.

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

Not Applicable. As above, no "test set" or diagnostic ground truth establishment is described in this submission.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication process 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 is not an AI/ML device. No MRMC study or AI-assisted performance evaluation was conducted or is relevant to this type of device submission.

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

Not Applicable. This is not an AI/ML device.

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

Not Applicable. The "ground truth" for this device revolves around its physical properties and biocompatibility matching established standards and predicate devices, not diagnostic accuracy against a specific medical condition.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device and does not involve a training set.

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

Not Applicable. This is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this 510(k) submission):

The "study" proving the device meets acceptance criteria in this context is the substantial equivalence comparison. The sponsor, DePuy ACE®, Inc., asserts that the ACE® VersaNail™ is substantially equivalent to several predicate intramedullary fixation rods based on:

Design Similarities: The VersaNail™ is described as a "straight, cannulated intramedullary nail available in diameters of 10 and 12 mm and lengths of 15, 20, 25 and 30 cm," with "holes in the nail allow for proximal and distal locking." This design is compared to the designs of the predicate devices.
Material Equivalence: All components (VersaNail™, end cap, screws) are manufactured from Ti-6AL-4V alloy, which is a commonly used material for such implants and presumably the material of the predicate devices.
Identical Sterilization Processes: While not detailed, the submission states that identical sterilization processes are used, implying consistency with established safety protocols for the predicate devices.
Equivalent Indications for Use: The VersaNail™'s intended uses for tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia, including specific indications like "revision after failed ankle arthrodesis," "absent talus," "post traumatic or primary arthrosis," "rheumatoid hindfoot," "avascular necrosis of the talus," "previously infected arthrosis," and "failed total ankle arthroplasty," as well as "non-union ankle arthrodesis," "osteoarthritis," "post-traumatic and degenerative arthritis," "neuroarthropathy or neuropathic ankle deformity," "neuromuscular disease with severe deformity and Charcot foot," are all covered by the indications cleared for the predicate devices (Biomet Ankle Arthrodesis Nail, Smith and Nephew Intramedullary Nail, and/or Encore® UltiMax Ankle Fusion Rod).

The FDA reviewed this submission (K023115) and determined on December 18, 2002, that the device is substantially equivalent to the legally marketed predicate devices, thereby allowing it to proceed to market. This determination by the FDA serves as the regulatory "proof" that the device meets its acceptance criteria for market authorization based on the substantial equivalence pathway.

Summary

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510(k): ACE® VersaNail™

KONSILS

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510(k) Summary

Name of Sponsor:	DePuy ACE®, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910	DEC 1 8 2002
510(k) Contact:	Dina L. Weissman, J.D.Legal consultant, Regulatory AffairsPhone: (574) 371-4905FAX: (574) 371-4987
Trade Name:	ACE® VersaNail™
Common Name:	Intramedullary Fixation Rod
Classification:	Class II Device per 21 CFR 888.3020:Rod, Fixation, Intramedullary and Accessories
Device Product Code:	87HSB
Substantially Equivalent Devices:	ACE® AIM® Titanium Supracondylar NailACE® AIM® TTC Fusion NailBiomet Ankle Arthrodesis NailEncore® UltiMax Ankle Fusion RodSmith and Nephew Intramedullary Nail	K974781 K003797 K982953 K991790 K983942
Device Description:	The VersaNail™ is a straight, cannulated intramedullary nailavailable in diameters of 10 and 12 mm and lengths of 15, 20, 25and 30 cm. Holes in the nail allow for proximal and distallocking. The VersaNail™, the end cap and the screws are allmanufactured from Ti-6AL-4V alloy.
Intended use:	The VersaNail™ is intended for use in tibiotalocalcanealfusions and treatment of trauma to the hindfoot and distaltibia.

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023115
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510(k) Summary (continued)

Indications include: revision after failed ankle arthrodesis with Indications for use: subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Additional indications also include nonunion ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.

This submission covers these additional indications for use: non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot.

These indications have been cleared previously for the Biomet Ankle Arthrodesis Nail, the Smith and Nephew Intramedullary Nail and/or the Encore® UltiMax Ankle Fusion Rod.

Based on similarities of design, commonly used materials, Substantial equivalence: identical sterilization processes, and indications for use, DePuy believes the ACE® VersaNail™ to be substantially equivalent to the following FDA cleared devices: the ACE AIM® Titanium Supracondylar Nail, the ACE® AIM® TTC Fusion Nail, the Biomet Ankle Arthrodesis Nail, the Smith and Nephew Intramedullary Nail and the Encore® UltiMax Ankle Fusion Rod.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines extending from the head, representing the flow of ideas and services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2002

Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy ACE, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988.

Re: K023115

Trade/Device Name: ACE® VersaNail™ Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 18, 2002 Received: September 19, 2002

Dear Ms. Weissman:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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);

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Page 2 - Ms. Dina L. Weissman, J.D.

labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

forCelia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

ACE® VersaNail Device Name:

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Muriane C. Provost

ivision Sign-Off) Vivision of General, Restorative and Neurological Devices

Number K0231/5

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.