The Vantage® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage® Total Ankle System is indicated for cemented use only.

Device Description

The Vantage® Total Ankle System is a system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components:

3D Tibial Plates
3D+ Tibial Plates ●
3D/3D+ Locking Clips ●

The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.

AI/ML Overview

The provided text describes the 510(k) summary for the Exactech® Vantage® Total Ankle System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, many of the requested details, such as those pertaining to a multi-reader multi-case (MRMC) study, human reader improvement with AI assistance, standalone algorithm performance, or the sample size and ground truth establishment for training and test sets of an AI/ML device, are not applicable to this 510(k) submission.

This submission is for a traditional medical device (total ankle system implants and components), not an AI/ML-driven diagnostic or prognostic device that would typically involve the types of studies described in the prompt. The "acceptance criteria" here refer to the demonstration of substantial equivalence through non-clinical performance testing of mechanical properties and material characteristics, rather than diagnostic accuracy metrics.

Here's a breakdown of the available information based on your request, highlighting what is present and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a traditional medical device like this are primarily based on established ASTM standards and demonstrating mechanical equivalence to a predicate device. The performance is shown through passing these tests, rather than providing specific numerical thresholds for diagnostic accuracy.

Acceptance Criteria (Type of Non-Clinical Testing)	Reported Device Performance
Tibial Plate Fatigue Testing per ASTM F2665	Sufficient strength for intended use and substantially equivalent to legally marketed predicate devices.
Tibial Plate Fixation Stability Testing	Sufficient strength for intended use and substantially equivalent to legally marketed predicate devices.
Locking Mechanism Fatigue Testing	Sufficient strength for intended use and substantially equivalent to legally marketed predicate devices.
Residual Particulate Count Studies	(Not explicitly detailed, but implied to meet standards)
Porous Surface Characterization Testing:
- Stereological Evaluation per ASTM F1854	(Implied to meet standards)
- Static Shear Testing per ASTM F1044	(Implied to meet standards)
- Tension Testing per ASTM F1147	(Implied to meet standards)
- Abrasion Resistance Testing per ASTM F1978	(Implied to meet standards)
- Shear Fatigue Testing per ASTM F1160	(Implied to meet standards)
- Compression Testing	(Implied to meet standards)
Pyrogenicity Testing	Endotoxin limit is less than 20 EU/device.

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

Not Applicable: This is not a study involving a "test set" of clinical data or images for an AI/ML algorithm. The "testing" refers to mechanical and material performance testing of the device components themselves.

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

Not Applicable: "Ground truth" in this context refers to the defined mechanical and material properties as per ASTM standards, not expert medical opinion on clinical cases.

4. Adjudication method for the test set

Not Applicable: No adjudication method for a test set of clinical data is described. The "adjudication" would be related to the interpretation and validation of engineering test results, which is part of standard test protocols.

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

No: This is a mechanical implant device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

No: This is a mechanical implant device, not a standalone AI algorithm.

7. The type of ground truth used

For mechanical and material testing, the "ground truth" is based on established engineering principles and recognized consensus standards (e.g., ASTM F2665, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1160, ASTM F1854). These standards define the parameters and methodologies for evaluating the device's performance characteristics.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device that requires a training set of data.

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

Not Applicable: As above, this is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical engineering and material characterization tests designed to demonstrate the substantial equivalence of the Exactech® Vantage® Total Ankle System to a legally marketed predicate device (K152217).

Objective: To show that the proposed new components (3D Tibial Plates, 3D+ Tibial Plates, and 3D/3D+ Locking Clips) have comparable safety and effectiveness to the predicate device, despite minor design and manufacturing differences (e.g., additive manufacturing, additional sizes).
Methodology: A battery of tests was performed on the device components, adhering to recognized ASTM standards for total ankle replacement devices. These tests evaluated:
- Fatigue strength of tibial plates and locking mechanisms.
- Fixation stability of tibial plates.
- Characteristics of porous surfaces (stereological evaluation, shear, tension, abrasion resistance, compression).
- Residual particulate count.
- Pyrogenicity.
Conclusion: The tests concluded that the strength of the new components is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The pyrogenicity test demonstrated endotoxin levels below the specified limit (< 20 EU/device).

In essence, the "acceptance criteria" for this device are the successful completion of these non-clinical tests, demonstrating that the device components meet the necessary mechanical, material, and safety requirements to perform as intended and are comparable to existing, cleared devices on the market.

Summary

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October 12, 2023

Exactech, Inc. Pedro Ravelo Regulatory Affairs Specialist 2320 NW 66th Ct. Gainesville, Florida 32653

Re: K230717

Trade/Device Name: Exactech® Vantage® Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: September 13, 2023 Received: September 13, 2023

Dear Pedro Ravelo:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

Lixin Liu -S

Lixin Liu. Ph.D Assistant Director DHT6A: Division of Joint Arthroplasty 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) K230717

Device Name Exactech® Vantage® Total Ankle System

Indications for Use (Describe)

The Vantage® Total Ankle System is indicated for cemented use only.

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

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Exactech® Vantage® Total Ankle System Traditional 510(k) - 510(k) Summary

		Exactech, Inc.2320 NW 66th CourtGainesville, FL 32653
Sponsor		Phone: (352) 377-1140Fax: (352) 378-2617FDA Establishment Number 1038671
Contact Person		Pedro RaveloRegulatory Affairs Specialist
Date		14 March 2023
Proprietary Name		Exactech® Vantage® Total Ankle System
Common Name		Ankle Arthroplasty Prosthesis
Regulation Number /		21 CFR 888.3110 – Ankle joint metal/polymer semi-
Classification Name		constrained cemented prosthesis
Device Class		Class II
Product Code		HSN - Prosthesis, Ankle, Semi-Constrained, Cemented,Metal/Polymer
Classification Panel		Orthopedic

510(K) SUMMARY

Device Description

3D Tibial Plates
3D+ Tibial Plates ●
3D/3D+ Locking Clips ●

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Exactech® Vantage® Total Ankle System Traditional 510(k) - 510(k) Summarv

Indications for Use

The Vantage® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage® Total Ankle System is indicated for cemented use only.

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K152217	Exactech® Vantage® Total Ankle System	Exactech, Inc

Legally Marketed Reference Devices

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K192097	Exactech® Equinoxe® Stemless Humeral Components	Exactech, Inc

Substantial Equivalence Discussion

The proposed Vantage 3D Tibial Plates, 3D* Tibial Plates, and 3D/3D* Locking Clips are made from Ti-6A1-4V ELI that conforms to ASTM F3001-14 or ASTM F136-13. The subject devices and their respective predicates have similar technological characteristics and the minor differences do not raise any different issues of safety and effectiveness. The rationale for substantial equivalence is based on consideration of the following device use, design characteristics, and performance requirements:

Indications for Use

The proposed and predicate devices have the same indications for use.

Materials

The proposed and predicate devices are composed of the same or similar biocompatible materials.

Design Features The proposed and predicate devices have the same or similar design features.

Dimensions

The proposed and predicate devices are dimensionally comparable.

Sterilization

The proposed and predicate devices are provided sterile for single use only.

Performance Requirements

The proposed and predicate devices conform to the same recognized performance standards for total ankle replacement devices.

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Exactech® Vantage® Total Ankle System Traditional 510(k) - 510(k) Summary

Non-Clinical Testing

The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech® Vantage® 3D Tibial Plates, 3D+ Tibial Plates and 3D/3D+ Locking Clips function as intended and are substantially equivalent to the identified predicate devices:

Tibial Plate Fatigue Testing per ASTM F2665 ●
Tibial Plate Fixation Stability Testing ●
Locking Mechanism Fatigue Testing ●
Residual Particulate Count Studies
Porous Surface Characterization Testing ●
- Stereological Evaluation per ASTM F1854 O
- Static Shear Testing per ASTM F1044 O
- Tension Testing per ASTM F1147 O
- Abrasion Resistance Testing per ASTM F1978 O
- Shear Fatigue Testing per ASTM F1160 O
- Compression Testing o

The results of this non-clinical testing show that the strength of the Vantage 3D Tibial Plates, 3D Tibial Plates and 3D/3D Locking Clips is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. Pyrogenicity testing was also conducted and demonstrates that the endotoxin limit is less than 20 EU/device.

Conclusion

Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Exactech® Vantage® Total Ankle System is substantially equivalent to the identified predicate device.

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.