The MetaSurg cannulated titanium hemi implant is indicated for use in the treatment of degenerative arthritis in the 1st metatarsal joint along with the following clinical conditions: Hallux Limitus or Hallux Rigidus, Hallux Valgus and pain or instability in the metatarsophalangeal joint.

The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.

The MetaSurg cannulated titanium hemi implant is intended for single use only.

Device Description

The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the MetaSurg Cannulated Titanium Hemi Implant. This summary focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific performance metrics such as accuracy, sensitivity, or specificity. Therefore, many of the requested criteria for studies that evaluate device performance (like AI algorithms) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown based on the information available:

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

The document does not specify "acceptance criteria" in terms of performance metrics typical for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on:

Acceptance Criteria (Substantial Equivalence)	Reported Device Performance (MetaSurg Cannulated Titanium Hemi Implant)
Indications for Use: Must be equivalent to predicate devices.	Indicated for treatment of degenerative arthritis in the 1st metatarsal joint, Hallux Limitus/Rigidus, Hallux Valgus, and pain/instability in the metatarsophalangeal joint. This aligns with predicate devices.
Material of Construction: Must be equivalent to predicate devices.	Made of Titanium Alloy (Ti-6AL-4V ELI). This aligns with predicate devices (implied through substantial equivalence claim).
Sizes: Must be comparable to predicate devices.	Offered in 5 sizes ranging from 15 - 23mm in diameter. This aligns with predicate devices (implied through substantial equivalence claim).
Shape: Must be equivalent to predicate devices.	Designed as an anatomical replacement for the base of the phalanx. This aligns with predicate devices (implied through substantial equivalence claim).
Implant Type: Must be equivalent to predicate devices.	Cannulated titanium hemi implant, intended for press fit, uncemented use. This aligns with predicate devices (implied through substantial equivalence claim).

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission for a physical implant, not a study involving a "test set" of data for performance evaluation in the context of AI or diagnostic accuracy. The substantial equivalence determination is based on device characteristics and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This type of evaluation is not performed for physical implants demonstrating substantial equivalence. The "ground truth" for the predicate devices would have been established through clinical use and regulatory clearance, which is then used as a reference point for the new device.

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

Not applicable. No test set or adjudication method is described for this type of submission.

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 surgical implant, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation in the context of an MRMC study.

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

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

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

For the purpose of substantial equivalence, the "ground truth" is effectively the regulatory clearance and established safety and effectiveness of the predicate devices: Vilex hemi implant (K023684) and BioPro hemi implant (K041595). The new device is compared against these already-cleared devices based on their characteristics and intended use. No new clinical 'ground truth' in the sense of diagnostic accuracy is established in this document.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI model requiring a training set.

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

Not applicable. No training set is involved.

Summary

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11. K083469

510(k) Summarv

Date Prepared:

Sponsor:

Company Contact:

Device Trade Name:

Classification Name:

Common Name:

Substantial Equivalence:

Device Description:

Intended Usage:

Material:

November 21, 2008

FEB 1 3 2009

MetaSurg 16350 Park Ten Place, Suite 101 Houston, TX 77084

Mark Myers Phone: (281) 398-5656 Fax: (281) 398-5660

MetaSurg Cannulated Titanium Hemi Implant

Toe joint phalangeal (hemi-toe) polymer prosthesis (21 CFR 888.3730, Product Code KWD, Class II)

Hemi Toe Implant

Documentation is provided to demonstrate the MetaSurg hemi implant to be substantially equivalent to the Vilex hemi implant (K023684) and the BioPro hemi implant (K041595). The methods used to establish equivalence are indications for use, material of construction, sizes, shape and implant type.

The MetaSurg cannulated titanium hemi implant is designed to be an anatomical replacement for the base of the phalanax. The implant is offered in 5 sizes ranging from 15 - 23mm in diameter.

The MetaSurg cannulated titanium implant is intended for press fit, uncemented use.

The MetaSurg cannulated titanium hemi implant is intended for single use only.

Titanium Alloy (Ti-6AL-4V ELI)

Section 5 - Page 1 of 1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing strength and protection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2009

MetaSurg % Mr. Mark Myers 16350 Park Ten Place. Suite 101 Houston, TX 77084

Re: K083469

Trade/Device Name: MetaSurg Cannulated Titanium Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II . . . . . Product Code: KWD Dated: February 2, 2009 Received: February 3, 2009

Dear Mr. Myers:

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. Mark Myers

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark H. Mulkerson

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K083469

Device Name: MetaSurg Cannulated Titanium Hemi Implant

Indications for Use:

The MetaSurg cannulated titanium hemi implant is intended for press fit, uncemented use.

The MetaSurg cannulated titanium hemi implant is intended for single use only.

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

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

K08346

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millberg

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

Si0(k) Number

Section 4 - 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.