OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM by OSTEOMED L.P.

Indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful metatarsophalangeal joint. OsteoMed 1st MPJ Hemi Implants are intended for single use only.

Device Description

The OsteoMed 1st MPJ Hemi Implant is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the distal base of the proximal phalanx and provide a smooth articular surface for the adjacent first metatarsal head. It is available in several sizes in direct per portion to the anatomic construct of the distal base of the proximal phalanx. Primary fixation is intended via a press fit bone implant interface. The OsteoMed 1* MPJ Hemi Implant is made of cobalt chromium (ASTM F-799) and may also be provided with a titanium plasma coated stem.

AI/ML Overview

This document, K060536, is a 510(k) premarket notification for the OsteoMed 1st MPJ Hemi Implant System, a medical device. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your request, highlighting what information is available and what is not typically found in a 510(k) summary for this type of device:

Key Takeaway: This 510(k) submission seeks clearance based on substantial equivalence to existing devices, not a clinical study proving new acceptance criteria. Therefore, the requested information about device performance, ground truth, expert review, and sample sizes for a study proving acceptance criteria will largely be absent because such a study was not conducted or required for this type of submission.

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

Acceptance Criteria: Not explicitly stated as "acceptance criteria" in the context of a performance study with numerical targets. For a 510(k) based on substantial equivalence, the "acceptance criteria" are typically that the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to predicate devices.
Reported Device Performance: No clinical performance data is reported or provided in this 510(k) summary. The document states, "Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed 1st MPJ Hemi Implant System does not present new safety or effectiveness issues." This indicates reliance on the established safety and effectiveness of the predicate devices.

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

Not Applicable. No clinical test set or data provenance is mentioned as part of this 510(k) submission. This is typical for Class II devices seeking substantial equivalence through material and design similarity, especially when there are no new technological characteristics.

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. As no clinical test set was used to establish an "acceptance criteria" for a new performance claim, there was no need for experts to establish ground truth in that context. The "ground truth" for this submission is established by the FDA's existing clearances for the predicate devices.

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

Not Applicable. No clinical test set requiring adjudication was used.

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 passive, implantable orthopedic prosthetic (a hemi-implant for a toe joint), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to 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.)

Implicit Ground Truth: The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate devices (BioPro Hemi MP Joint (K041555), Kinetikos Medical, K2 Hemi Toe Implant System (K023770), and Fii tira BioMedical Metal Hemi Toe Implant (K971047)) as previously determined by the FDA. Its own safety and effectiveness are inferred by its substantial equivalence to those devices.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.

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

Not Applicable. As there is no training set mentioned, this question is not relevant to the information provided in the 510(k) summary.

Summary of what the K060536 document does provide:

Predicate Devices: Clearly identifies three predicate devices for comparison.
Intended Use: The intended use of the OsteoMed 1st MPJ Hemi Implant System is for "treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal joint."
Materials: Made of cobalt chromium (ASTM F-799) and may also be provided with a titanium plasma coated stem, similar to the materials of predicate devices.
Design and Operational Principle: Stated to be similar to predicate devices.

For a 510(k) based on substantial equivalence, the "study" demonstrating that the device meets "acceptance criteria" is typically the submission itself, arguing that the device is so similar to existing cleared devices that it inheres their safety and effectiveness profile, without requiring new clinical trials or performance studies.

Summary

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K060536 F

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510(k) Summary

Device Proprietary Name:

Device Common Name:

Classification Name:

Name of Submitter:

OsteoMed 1st MPJ Hemi Implant System

Hemi Toe Implant

KWD Prosthesis, Toe, Hemi, Phalangeal

OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601

Contact Person:

Dawn D. Tindall

Date Prepared:

May 9, 2006

Summary:

The OsteoMed 186 MPJ Hemi Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; hallux valgus, hallux rigidus, and an unstable or painful metatarsophiangeal joint. OsteoMed 18 MPJ Hemi Implants are intelded for single use only.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the BioPro Hemi MP Joint (K041555), the Kinetikos Medical, K2 Hemi Toe Implant System (K023770) and the Fi; tira BioMedical Metal Hemi Toe Implant (K971047).

Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed 1ª MPJ Hemi Implant System does not roisoned new safety or effectiveness issues.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

Ms. Dawn D. Tindall Regulatory Affairs OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001

K060536 Re:

Trade/Device Name: 1st MPJ Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: K WD Dated: May 10, 2006 Received: May 11, 2006

Dear Ms. Tindall:

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 - Ms. Dawn D. Tindall

forth in the quality systems (OS) 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 vou 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,

Mark N. Melkerson, M.S.

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): KO(0.536

Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

(Posted November 13,

(Posted November 13, 2400k) Number__ K060536

Page 1_of_1

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.