The Metal Hemi Toe implant is a cobalt chrome alloy, one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the base of the proximal phalanx and provide a smooth articular surface for the adjacent metatarsal head. Primary fixation of the grit-blasted version of the device is via a press fit. This is consistent with the description and intended use of the Swanson Titanium Great Toe Implant. The titanium plasma spray coated version of this device is intended for use with bone cement.

AI/ML Overview

This 510(k) submission for the Futura Biomedical Metal Hemi Toe Implant is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, it does not contain a study with detailed acceptance criteria and performance metrics in the way a clinical trial or a machine learning device study would. Instead, the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics and intended use.

Here's an analysis based on the provided document:

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

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Intended Use: Must be equivalent to the predicate device.	The Metal Hemi Toe implant's intended use is to supplement the first metatarsal phalangeal joint arthroplasty, replacing the base of the proximal phalanx and providing a smooth articular surface. This is stated to be consistent with the description and intended use of the Swanson Titanium Great Toe Implant. Indications for use: Hallux limitus or rigidus, painful hallux valgus, revision of failed previous surgery, painful arthritis. These indications are provided without direct comparison to the predicate, but implied to be equivalent.
Technological Characteristics: - Design - Material composition - Fixation method - Sizing	Design: Anatomic design to minimize complications (joint instability, shortening, painful/limited ROM), thin inferior aspect for flexor brevis tendon. Material: Cobalt Chrome Alloy (main difference from predicate, which is Titanium). Fixation: Press fit for grit-blasted version, bone cement for titanium plasma spray coated version. Sizing: Offered in sizes that fit within the size range of the Swanson Titanium Great Toe Implant. Both are one-piece, single-stemmed, press-fit into intramedullary canal, with a curved articular surface.
Safety and Effectiveness: Material differences should not adversely affect safety and effectiveness.	Cobalt Chrome is widely used in metallic implants, commonly favored as an articular surface, and has a 40-year history. Referenced studies on metallic hemi toe implants using Cobalt Chrome (Townley and Taranow) or Titanium (Leavitt et al.), and general orthopedic implant use. ASTM standards (F 67, F 75) exist for both Titanium and Cobalt-Chromium-Molybdenum for surgical implant applications. Conclusion: Material difference (Cobalt Chrome vs. Titanium) does not adversely affect safety and effectiveness.
Predicate Device Performance (Implied Baseline): Implied that the predicate device (Swanson Titanium Great Toe Implant) is safe and effective when marketed.	Not explicitly stated as "performance" in numerical terms, but the predicate's long-standing market presence and FDA clearance (K864492) serve as the benchmark for safety and effectiveness.

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

This submission does not describe a "test set" in the context of a statistical study with a specific sample size. The device approval is based on a comparison of its design, materials, and intended use against a legally marketed predicate device, rather than a clinical trial with a "test set" of patients.

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. Ground truth, in this context, refers to the established safety and effectiveness of the predicate device and the accepted scientific and engineering principles for implant materials. There's no mention of a ground truth established by a panel of experts for a specific dataset within this document. The FDA's review process itself involves expert evaluation.

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

Not applicable. No "test set" or adjudication method for interpreting outcomes of a clinical study are 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 is a premarket notification for a physical medical implant, not an AI/software device. Hence, no MRMC study, human readers, or AI assistance is relevant here.

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

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

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

The "ground truth" for this 510(k) submission is primarily:

Regulatory Precedent: The established safety and effectiveness of the predicate device (Swanson Titanium Great Toe Implant, K864492), as determined by its prior FDA clearance and market history.
Scientific and Engineering Consensus: The widely accepted knowledge and standards regarding the biocompatibility, mechanical properties, and clinical performance of implant materials like Cobalt Chrome and Titanium, supported by published literature (e.g., Townley and Taranow, Leavitt et al.) and ASTM standards (F 67, F 75).

8. The sample size for the training set

Not applicable. This is a device approval based on substantial equivalence, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set mentioned, there is no description of how its ground truth was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Futura Biomedical. The logo consists of a black square with a white "F" inside, followed by the word "FUTURA" in large, bold, black letters. Below "FUTURA" is the word "BIOMEDICAL" in smaller, bold, black letters. There is a black line separating the two words.

JUN 20 1997

510(k) Summary

Submitted by:

Jamal D. Rushdy (Point of Contact) Futura Biomedical, L.L.C. 9369 Carroll Park Drive, Suite A San Diego, CA 92121 (619) 643-5149 (619) 452-9945 facsimile

Date of preparation: June 11, 1997

Trade Name: Futura Biomedical Metal Hemi Toe Implant

Common Name: Metal Hemi Toe Implant

Classification Name: Phalangeal Hemi-Toe Prosthesis per 888.3730 (Class II)

Substantially Equivalent to (predicate device): Swanson Titanium Great Toe Implant by Dow Corning, 510(k) number K864492

Description/Intended Use:

Indications for use of this implant are:

Hallux limitus or hallux rigidous. .
Painful hallux valgus. .
. Revision of failed previous surgery.
Painful arthritis. .

Technological Characteristics:

The implant has an anatomic design which helps minimize the complications often seen with arthroplasty of this joint such as: joint instability, shortening of the hallux, painful or limited range of motion. The thin inferior aspect allows the normal anatomic insertion of the flexor brevis tendon to be maintained.

There are two versions of the Metal Hemi Toe. One version has a roughened grit blasted surface on the stem and back surfaces in contact with the resected base of the phalanx. The other version is coated with a rough coating of titanium plasma spray to encourage osseous ingrowth.

The main difference between the Metal Hemi Toe and the Swanson Titanium Great Toe is the material. While the Metal Hemi Toe and Swanson Titanium Great Toe are both metallic implants, the Metal Hemi Toe is fabricated mainly of a Cobalt Chrome Alloy rather than Titanium. Both materials are widely used in metallic implants, but Cobalt Chrome is generally favored as an articular surface. Cobalt Chrome is currently used as

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an articular surface for a phalangeal hemi toe (ref 510(k) K911378 BIOPRO, INC.), and has a 40 year history, as reported by Townley and Taranow. The American Society for Testing of Materials (ASTM) has developed voluntary standards for the materials used in the Metal Hemi Toe:

F 67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications F 75, Standard Specification for Unalloyed Cast Cobalt-Chromium-Molybdenum for Surqical Implant Applications

Conclusions:

The Metal Hemi Toe and Swanson Titanium Great Toe are both metallic hemi prosthesis used to supplement first metatarsal phalangeal joint arthroplasty. They are both onepiece, single stemmed implants which press fit into the intramedullary canal of the proximal phalanx. They both have a curved articular surface for the first metatarsal head to articulate against. The Metal Hemi Toe is offered in sizes that fit within the size range of the Swanson Titanium Great Toe Implant.

The main difference between the two devices is the materials. Cobalt chrome is commonly used in implant fabrication. There are published studies of metallic hemi toe implants using either cobalt chrome (Townley and Taranow) or titanium (Leavitt et. al.), and numerous studies of the use of both of these materials in general in orthopaedic implants. In addition, there are published ASTM standards for the component materials which are intended for surgical implant applications. Based on these data, and the comparisons described above, we feel the material difference of the substrate material (cobalt chrome) from the predicate device (titanium) does not adversely affect the safety and effectiveness of the device, and that the Futura Biomedical Hemi Toe Implant is substantially equivalent to the Dow Corning Swanson Titanium Great Toe Implant.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 1997

Mr. Jamal D. Rushdy General Manager. Futura Biomedical, L.́L.C. 9369 Carroll Park Drive, Suite A San Diego, California 92121

Re : K971047 Metal Hemi Toe Implant Trade Name: Regulatory Class: II Product Code: KWD Dated: March 19, 1997 Received: March 21, 1997

Dear Mr. Rushdy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will

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Page 2 - Mr. Jamal D. Rushdy

verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number: K971047

Device Name: Metal Hemi Toe

The titanium plasma spray coated version of this device is intended for use with bone cement.

Indications for Use:

. Hallux limitus or hallux rigidous.
. Painful hallux valgus.
•
. Painful arthritis.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K971047
510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

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.