The Metal Hemi 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.

Device Description

The Metal Hemi Implant 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 Metal Hemi Implant requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Metal Hemi Implant." 510(k)s are primarily focused on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a comprehensive study proving the device meets specific acceptance criteria in the way a diagnostic AI or interventional device might.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth types) are not applicable or mentioned in this type of submission. This device is a physical implant, not a diagnostic algorithm or imaging device that would typically involve such studies.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

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

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (OrthoPro Hemi toe, K062908)	The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray.
Intended Use	Designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.
Material Composition	Substrate: CoCrMo alloy per ASTM F75. Plasma spray: commercially pure titanium per ASTM F67 on inferior surface and stem base.
Functional Design	Single stemmed resurfacing prosthesis for the first proximal phalanx. Concave congruent articular surface with mirror finish. Oval shape. Requires minimal bone resection. Provides full range of motion of the first metatarsophalangeal joint (MPJ).

Explanation: For a 510(k) for an implantable device like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a previously legally marketed device (the predicate). The "device performance" is described through its design features, materials, and intended use, which are deemed equivalent to the predicate. There are no quantitative performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic algorithms.

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

Sample size: Not applicable/Not provided. This is an implantable device, not a diagnostic algorithm tested on a dataset of patient images or readings.
Data provenance: Not applicable/Not provided.

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)

Number of experts: Not applicable/Not provided.
Qualifications of experts: Not applicable/Not provided.

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

Adjudication method: Not applicable/Not provided.

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

MRMC study: No, this is not an AI-assisted diagnostic device.
Effect size: Not applicable.

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

This is not an algorithm; it is a physical medical implant. Therefore, a standalone performance study in this context is not applicable.

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

Type of ground truth: For a 510(k) of an implant, the "ground truth" for demonstrating substantial equivalence typically involves engineering testing (e.g., material testing, mechanical load testing, biocompatibility evaluations, sometimes cadaveric studies for range of motion or surgical technique), and clinical experience/literature supporting the safety and effectiveness of the predicate device and the materials used. The document states "The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray." This implies that the 'ground truth' for its performance aligns with the established performance of the predicate and the known properties of the materials.

8. The sample size for the training set

Sample size: Not applicable/Not provided. This is a physical implant, not a machine learning model.

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

Ground truth establishment: Not applicable/Not provided.

Summary

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K071243

510(k) Summary for the Metal Hemi Implant

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

MAY 23 2007

Date Prepared: May 1, 2007

1. Submitter: OrthoPro LLC 3450 Highland Dr. #303 Salt Lake City, UT 84106
  Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
1. Trade name: Common Name: Classification Name:
  Metal Hemi Implant Hemi toe prosthesis, toe, hemi-, phalangeal Class II per 21 CFR section 888.3730 KWD
1. Predicate or legally marketed devices which are substantially equivalent: OrthoPro Hemi toe (K062908) was modified resulting in the Metal Hemi Implant.
1. Description of the device:

Materials:

The substrate of the Metal Hemi Implant is fabricated from CoCrMo alloy per ASTM F75 Plasma spray of commercially pure titanium per ASTM F67 is placed on the inferior surface and base of the stem of the implant

5. Intended Use:

The Metal Hemi Implant is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis.

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

The Metal Hemi Implant does not incorporate any new technological characteristics as compared to the predicate device. The Metal Hemi Implant and the predicate devices are made from the same material. The Metal Hemi Implant has the addition of CP Ti plasma spray.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 or bird-like figure with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OrthoPro LLC % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

AAY 2 3 2007

Re: K071243

Trade/Device Name: Metal Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: May 1, 2007 Received: May 3, 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 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.

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Page 2 Mr. J.D. Webb

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Pauline Brehm

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): KOJ | 2 43

Device Name: _________________________________________________________________________________________________________________________________________________________________

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)

Nehare Buelu Df xox
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K071243

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.