The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.

Device Description

The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.

AI/ML Overview

It appears you've provided a 510(k) Premarket Notification document for a medical device: the Vilex Cannulated Hemi Implant (CHI).

However, this document describes a joint implant, not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. The acceptance criteria and supporting studies described in this document relate to the mechanical performance and biocompatibility of a physical implant, not the performance of an algorithm or the accuracy of a diagnostic reading.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven diagnostic or image analysis device (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.

The performance data section (VII. Performance Data) for this implant focuses on:

Engineering analyses: Bending Stress, Shear Stress, Geometric Analysis, Surface Area Analysis. These are tests to ensure the physical implant is strong enough and fits correctly.

It does not contain information relevant to AI/diagnostic device evaluation, such as:

A table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
Sample sizes for a test set of diagnostic images.
Data provenance for diagnostic images.
Number of experts for ground truth of diagnostic images or their qualifications.
Adjudication methods for diagnostic ground truth.
MRMC studies to show human reader improvement with AI.
Standalone performance of an algorithm.
Type of ground truth (e.g., pathology, outcomes data) for diagnostic purposes.
Training set sample size for an AI model.
How ground truth for a training set was established for an AI model.

In summary, this document is about a physical orthopedic implant, not an AI or diagnostic software. Therefore, it does not contain the information you are requesting about AI device evaluation methods.

Summary

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May 31, 2019

Vilex in Tennessee, Inc. Victor Lavi Executive VP 111 Moffitt Street McMinnville, Tennessee 37110

Re: K190543

Trade/Device Name: Cannulated Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe Joint Phalangeal (Hemi-Toe) Polymer Prosthesis Regulatory Class: Class II Product Code: KWD Dated: March 1, 2019 Received: March 4, 2019

Dear Victor Lavi:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 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,

CAPT Raquel Peat, PhD, MPH, USPHS For: Director 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) K190543

Device Name Cannulated Hemi Implants

Indications for Use (Describe)

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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510(k) Summary Cannulated Hemi Implant

I. Submitter:

Vilex in Tennessee, Inc. 111 Moffitt Street McMinnville, TN 37110

Contact Person: Victor Lavi Executive VP Email: info@vilex.com Phone: 931-474-7550

Date of Summary: February 28, 2019

II: Device

Panel:

Proprietary Name:	Cannulated Hemi Implants (CHI)
Common Name:	Hemi toe implant
Regulatory Class:	Class II
Regulation:	21 CFR 888.3730 – Toe Joint Phalangeal (hemi-toe)polymer prosthesis
Device Product Codes:	KWD

Orthopedic

III. Predicate Devices

Device	Manufacturer	510(k)No.	Clearance Date
Cannulated Metallic Hemi Toe ImplantMet-HeadCannulated Metallic Hemi Implant	Vilex, Inc.	K023684 K070052 K102401	03/01/200403/28/200707/20/2011
HemiCAP MTP Resurfacing Hemi-Arthroplasty System	Arthrosurface, Inc.	K152454	04/11/2016
CAP Great Toe Resurfacing Hemi-Arthroplasty Implant	Arthrosurface, Inc.	K031859	02/18/2004
Arthrosurface Toemotion	Arthrosurface, Inc.	K132496	02/26/2014

IV. Device Description

The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and

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510(k) Summary Cannulated Hemi Implant

MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.

V. Intended Use

VI. Comparison of Technological Characteristics with the Predicate Devices

The CHI is technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance and safety. Testing and analyses confirmed that the CHI is substantially equivalent when compared to the predicate device. The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

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510(k) Summary Cannulated Hemi Implant

VII. Performance Data

Engineering analyses demonstrated that the CHI does not introduce an added risk when compared to the previously cleared Vilex predicates. Analyses included:

Bending Stress
Shear Stress
Geometric Analysis
Surface Area Analysis

Analyses and evaluation concluded that the subject CHI is substantially equivalent to the predicate devices.

VIII. Conclusions

A review of the device indications, material composition, external element design, and technological characteristics confirmed that the CHI are substantially equivalent to the predicate device. While the CHI implants are not identical to the predicate device, comparisons of the subject and predicate device confirmed that any differences between the subject device and predicate do not render the device NSE as there is not a new intended use; and any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the CHI is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.

(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.