The 3S Hemi Toe Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. This device is for uncemented use.

Device Description

The 3S Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The 3S Hemi Toe requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).

AI/ML Overview

The provided document is a 510(k) summary for the "3S Hemi Toe Implant," which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally does not include extensive clinical studies with detailed acceptance criteria and performance metrics in the way that a new, high-risk device might.

The 510(k) process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness. Therefore, the document focuses on comparison to existing devices rather than presenting novel clinical study data with acceptance criteria.

Based only on the provided text, here is why a direct answer to your request regarding acceptance criteria and a study proving their fulfillment cannot be fully provided:

No specific acceptance criteria are listed for the device performance. The document describes the device, its intended use, and compares its material and technological characteristics to predicate devices. It does not define quantitative performance metrics (e.g., success rates, complication rates, range of motion improvements) that the device must achieve to be considered "accepted."
No dedicated clinical study is described that "proves the device meets the acceptance criteria." The 510(k) process generally doesn't require new clinical trials for substantial equivalence unless specific concerns about safety or effectiveness arise due to novel technology or intended use. The document relies on the existing safety and effectiveness of the predicate devices.
The document explicitly states: "The 3S Hemi Toe does not incorporate any new technological characteristics as compared to the predicate device. The 3S Hemi Toe and the predicate devices are made from the same material." This indicates that the justification for market clearance is based on similarity to already approved devices, not on new performance data from a specific study.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" because this information is not present in the provided 510(k) summary.

However, I can extract the following relevant information about this device for context:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the 3S Hemi Toe Implant. The "acceptance" under the 510(k) pathway is based on demonstrating substantial equivalence to predicate devices regarding intended use and technological characteristics, and not raising new questions of safety and effectiveness.
Reported Device Performance: Not provided as specific clinical outcomes or statistical performance data from a dedicated study of the 3S Hemi Toe Implant in this document.

Acceptance Criteria Category	Specific Metric/Threshold	Reported Device Performance	Comments
Intended Use	Same as predicate devices	Designed to supplement first metatarsal phalangeal joint arthroplasty; Indications: hallux limitus/rigidus, painful hallux valgus, revision of failed previous surgery, painful arthritis. (Matches predicate's use)	Substantially equivalent to predicate devices.
Technological Characteristics	Same as or similar to predicate devices, without raising new S&E questions	Fabricated from CoCrMo alloy per ASTM F799 or F75. Single stemmed resurfacing prosthesis; concave congruent articular surface with mirror finish; oval shape.	No new technological characteristics compared to predicates.
Material Safety	Biocompatibility consistent with predicate material	CoCrMo alloy per ASTM F799 or F75.	Same material as predicate devices, implying equivalent biocompatibility.

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

No test set or associated sample size is mentioned. The submission is based on comparison to predicate devices, not on a new clinical study with a test set.

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. No test set or ground truth establishment process is described in the provided document.

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

Not applicable. No test set or adjudication method 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 a physical hemi toe implant, not an AI or imaging diagnostic device, so an MRMC study is irrelevant for this product.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. No new clinical data requiring ground truth for validation is presented. The "ground truth" for the 510(k) pathway is the established safety and effectiveness record of the predicate device(s).

8. The sample size for the training set

Not applicable. No training set is mentioned as this is a physical device, not an AI or machine learning algorithm.

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

Not applicable. No training set is mentioned.

Summary

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510(k) Summary for the 3S Hemi Toe Implant

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the 3S Hemi Toe Implant.

Date Prepared: October 11, 2007

1. Submitter:

Trilliant Surgical LTD 1630 W. 13th Street03 Houston, TX 77008

Contact Person:

NOY 2 8 2007

J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199

3$ Hemi Toe Implant 2. Trade name: Hemi toe Common Name: prosthesis, toe, hemi-, phalangeal Classification Name: Class II per 21 CFR section 888.3730 KWD
Predicate or legally marketed devices which are substantially equivalent: 3. Futura Biomedical Metal Hemi Toe Implant (K971047), Kinetikos Medical K2 Hemi Toe Implant System (K023770), and Townley Great Toe Joint (K911378).

4. Description of the device:

The 3$ Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The 3S Hemi Toe requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).

Materials:

The substrate of the 3S Hemi Toe is fabricated from CoCrMo alloy per ASTM F799 or F75.

5. Intended Use:

The 3S Hemi Toe Implant is designed to supplement first metatarsal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. This device is for uncemented use.

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

The 3S Hemi Toe does not incorporate any new technological characteristics as compared to the predicate device. The 3S Hemi Toe and the predicate devices are made from the same material.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2007

Trilliant Surgical Ltd. % Mr. J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681

Re: K072922

Trade/Device Name: 3S Hemi Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: K.WD Dated: October 11, 2007 Received: October 15, 2007

Dear Mr. Webb:

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); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. J. D. Webb

forth in the quality systems (QS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millikan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __K072922

Device Name: __3S Hemi Toe Implant

Indications for Use:

Prescription Use _ X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

vision Sign-Off) Division of General, Restorative, and Neurological Devi

510(k) Number

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.