The OPTIX H2 Patient Specific Instrument System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The OPTIX H2 Patient Specific Instrument System is intended for use with Vilex's Hintermann Series H2 Total Ankle System and its cleared indications for use. The OPTIX H2 Patient Specific Instrument System is indicated for single use only and is generated from CT imaging data.

Device Description

OPTIX H2 Patient Specific Instrument System is patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides and models are designed and manufactured from patient imaging data (CT) and are made from biocompatible nylon. The surgical guides in combination with Hintermann reusable instruments, facilitate the positioning of the Hintermann Series H2 Total Ankle implants. Vilex's OPTIX H2 PSI System produces a variety of patient specific outputs including surgical guides, anatomic models, and case reports.

AI/ML Overview

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information that would typically be required to fill out all aspects of your request for the OPTIX H2 Patient Specific Instrument System. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than providing granular performance data against predefined acceptance criteria.

However, I can extract the information that is present and indicate where details are missing.

Here's a breakdown based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Objective: Demonstrate that the OPTIX H2 PSI System allows for an equivalent implantation of the Hintermann Series H2 Total Ankle System implants as compared to the Hintermann instrumentation.	An analysis of the surgical procedures performed during the validation lab showed that the OPTIX H2 PSI System does provide an equivalent implantation of the Hintermann Series H2 Total Ankle implants as compared to the Hintermann Series H2 instrumentation.
Objective: Satisfy the clinically justified acceptance criteria of the Hintermann Series H2 Total Ankle System.	The OPTIX H2 PSI System is shown to satisfy the clinically justified acceptance criteria of the Hintermann Series H2 Total Ankle System.
Debris generation by OPTIX H2 PSI guides (compared to a legally marketed device composed of a similar patient-specific instrumentation system).	The debris generated by the OPTIX H2 PSI System was found to be acceptable compared to the legally marketed device.

Missing Details: The document does not specify what the "clinically justified acceptance criteria of the Hintermann Series H2 Total Ankle System" are (e.g., specific angular tolerances, cut depths, etc.), nor does it provide quantitative performance data (e.g., "equivalent implantation within X degrees of rotation" or specific debris generation measurements).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The text refers to "surgical procedures performed during the validation lab," but does not give a number of cases or procedures.
Data Provenance: The study was a "validation lab" setting, implying a prospective, controlled environment, likely in the US or wherever Vilex, LLC is based. No specific country of origin for patients or data is mentioned, as it appears to be a benchtop/ cadaveric study rather than a clinical trial with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated.
Qualifications of Experts: The study involved "surgical procedures" and assessed "implantation" equivalence, so it implicitly involved surgeons or trained personnel. However, their specific qualifications (e.g., "orthopedic surgeon with 10 years of experience in total ankle arthroplasty") are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The document states "An analysis of the surgical procedures performed during the validation lab showed...", but doesn't detail how multiple assessments were reconciled (e.g., 2+1, 3+1, or if a single assessor was used).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to the provided text. This device is a patient-specific instrument system for surgery, not an AI-assisted diagnostic or imaging interpretation tool that would typically involve "human readers" in an MRMC study context.
Effect Size of Improvement with AI: Not applicable, as this is not an AI-reader assistance device. "Software-assisted design" is mentioned for the guides, but the performance validation described is on the physical instruments' ability to facilitate implantation, not on human interpretation skills.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable in the sense of an "algorithm only" performance study. The device is a physical instrument system. Its "software-assisted design" is part of its creation process, but the validation focuses on the physical instrument's performance in surgery, which inherently involves human interaction.

7. The Type of Ground Truth Used

Ground Truth: The "ground truth" implicitly used was the outcome of the surgical procedures performed with both the subject device (OPTIX H2 PSI System) and the predicate device (Hintermann H2 Total Ankle System instrumentation). The comparison aimed to establish "equivalent implantation," suggesting a direct comparison of surgical results (e.g., placement accuracy, bone cuts) facilitated by each system. This is a form of empirical comparison against established surgical practice using the predicate device.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable/not provided. The device relies on patient-specific CT imaging data to create the guides. The "design of the patient specific guides, models, and pre-operative plan is software-assisted," suggesting algorithms or software are used for individual patient customization, but there is no mention of a traditional "training set" in the context of machine learning model development for a generalized diagnostic/predictive task. Each guide is custom-designed based on an individual patient's CT data.

9. How the Ground Truth for the Training Set Was Established

Training Set Ground Truth: Not applicable for the reasons mentioned in point 8. The "ground truth" for the patient-specific design system relies on accurate interpretation of the individual patient's CT imaging data and established surgical principles for total ankle replacement.

Summary

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July 17, 2023

Vilex, LLC Brock Johnson President, Vilex, LLC 111 Moffitt Street McMinnville, Tennessee 37110

Re: K230462

Trade/Device Name: OPTIX H2 Patient Specific Instrument System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN, OYK Dated: April 19, 2023 Received: April 21, 2023

Dear Brock Johnson:

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-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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230462

Device Name

OPTIX H2 Patient Specific Instrument System

Indications for Use (Describe)

The OPTIX H2 Patient Specific Instrument System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The OPTIX H2 Patient Specific Instrument is intended for use with Vilex's Hintermann Series H2 Total Ankle System and its cleared indications for use. The OPTIX H2 Patient Specific Instrument System is indicated for single use only and is generated from CT imaging data.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Device Trade Name	OPTIX H2 Patient Specific Instrument System
Date	02/17/2023
Sponsor	Vilex, LLC111 Moffitt StreetMcMinnville, TN 37110
Contact Person	Brock JohnsonPresident(801)916-4157brock.johnson@vilex.com
Device Common Name	OPTIX H2 PSI System
Device Classification	Class II
Classification Name	Ankle Joint Metal/Polymer Semi-Constrained CementedProsthesis
Regulation	21 CFR 888.3110
Device Regulation Panel	Orthopedic
Device Product Code	HSN, OYK
Predicate Device	Hintermann Series H2 Total Ankle System, K171004

Purpose:

The purpose of this Traditional 510(k) submission is to gain clearance for the OPTIX H2 Patient Specific Instrument System.

Device Description:

Indications for Use:

Technological Characteristics:

The OPTIX H2 Patient Specific Instrument System is indicated for use in conjunction with the Hintermann Series H2 Total Ankle System. The OPTIX H2 Patient Specific Instrument System

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is intended to aid with the bone preparation of the H2 System. After bone preparation, the Hintermann H2 Total Ankle System surgical technique is followed for implantation of the Hintermann H2 implants. Therefore, the technological characteristics of the devices implanted with the OPTIX H2 PSI System and the predicate are identical.

The OPTIX H2 PSI System is comprised of single use instruments composed of DuraForm ProX PA® (SLS) and stainless steel. The predicate device uses reusable stainless-steel and polymer instrumentation. The proper biocompatibility endpoints of ISO 10993-1 have been evaluated for DuraForm ProX PA® and have shown no questions with respect to safety. Both the OPTIX H2 PSI System and the predicate device instrumentation are steam sterilized by the end user prior to use.

The OPTIX H2 PSI System is comprised of patient specific instruments generated from CT imaging. The predicate device uses instrumentation that is not patient specific. The OPTIX H2 PSI System allows the surgeon to create an operating plan before the surgery to visualize how the final implants and instruments will interface with patient anatomy. The OPTIX H2 PSI System also provides patient specific bone models to allow the surgeon to confirm the correct placement of the PSI Cut Guides. The preoperative plan and bone models facilitate the preparation of the bone for the Hintermann H2 Total Ankle Implants. The design of the patient specific guides, models, and pre-operative plan is software-assisted. The predicate device does not contain a preoperative plan, bone models, or software-assisted design.

The technological differences between the OPTIX H2 PSI System and the predicate device allow the OPTIX H2 PSI System to facilitate the implantation of the predicate device. These technological differences are considered minor and raise no questions of safety or effectiveness.

Assessment of performance data:

Validation testing was performed for the OPTIX H2 PSI System in comparison with the Hintermann H2 System. The objective of this testing was to demonstrate that the OPTIX H2 PSI System allows for an equivalent implantation of the Hintermann Series H2 Total Ankle System implants as compared to the Hintermann instrumentation. To accomplish this objective, Hintermann H2 Total Ankle surgical procedures were performed head-to-head using the OPTIX H2 PSI System and the Hintermann H2 Total Ankle System instrumentation.

An analysis of the surgical procedures performed during the validation lab showed that the OPTIX H2 PSI System does provide an equivalent implantation of the Hintermann Series H2 Total Ankle implants as compared to the Hintermann Series H2 instrumentation. In addition, the OPTIX H2 PSI System is shown to satisfy the clinically justified acceptance criteria of the Hintermann Series H2 Total Ankle System. Therefore, it is concluded that the subject device is substantially equivalent to the predicate device with respect to its mechanical performance.

Debris generation testing was performed for the OPTIX H2 PSI guides in a benchtop setting. The results were compared against a legally marketed device composed of a similar patientspecific

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instrumentation system. The debris generated by the OPTIX H2 PSI System was found to be acceptable compared to the legally marketed device.

Conclusion:

Based upon the similarities of the OPTIX H2 Patient Specific Instrument System and the predicate device, the OPTIX H2 Patient Specific Instrument System is substantially equivalent to the predicate device. The similarities in technological characteristics and performance data demonstrate substantial equivalence.

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.