The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Futura Biomedical Classic Great Toe Implant:

Observation: The provided text is a 510(k) summary for a medical device (toe implant). It describes the device, its intended use, and argues for its substantial equivalence to a previously marketed device. Crucially, it does not contain information about acceptance criteria or a study proving device performance against such criteria. It's a regulatory submission focused on demonstrating equivalence and safety, not on a performance study with specific metrics and acceptance thresholds.

Therefore, the following points cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study results.
Standalone algorithm performance results.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a performance study.
Sample size for the training set.
How ground truth for the training set was established.

Instead, the text focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be inferred or stated based on the provided document:

Summary of Device and Regulatory Context (Based on the provided text):

The document is a 510(k) Pre-market Notification for the Futura Biomedical Classic Great Toe Implant, specifically introducing a new, larger size (size 60) for an existing line of implants. The notification aims to demonstrate substantial equivalence to the original Futura Biomedical Classic Great Toe Implant (K023086).

1. Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or performance study results are reported in this 510(k) submission. The submission's purpose is to demonstrate substantial equivalence to a predicate device, not to present a new performance study with pass/fail criteria.
The argument for equivalence is based on the new device (larger size) having similar design characteristics, materials, intended use, and mechanism of action as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This document does not describe a performance study involving a test set of data. It is a regulatory submission for a physical implant.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. No such "ground truth" establishment in the context of a performance study is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document does not mention or present an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not for physical implants in a 510(k) of this nature.

6. Standalone (Algorithm Only) Performance Study:

No. This device is a physical toe implant, not an algorithm. Therefore, a standalone performance study in that context is not relevant and not discussed.

7. Type of Ground Truth Used:

Not applicable. No performance study employing a "ground truth" (expert consensus, pathology, outcomes data) is described in this submission. The "truth" in this context is the comparison of the new device's characteristics against the predicate device.

8. Sample Size for the Training Set:

Not applicable. This device is a physical implant, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, there is no AI algorithm or training set described.

Conclusion from the provided text:

The 510(k) submission for the Classic Great Toe Implant (size 60) does not contain information about acceptance criteria for a performance study or details of such a study. Instead, it focuses on demonstrating substantial equivalence to an existing, legally marketed predicate device (the original Classic Great Toe Implant, with sizes 20, 30, 40, 50). This equivalence is reasoned based on identical intended use, materials, basic design principles (double-stemmed silicone prosthesis, constrained, intramedullary canal fixation), and manufacturing processes. The only difference highlighted is the addition of a new, larger size (size 60) to the existing product line.

Summary

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510 (k) Summary

NOV 1 3 2002

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

Prepared:	October 21, 2002
Applicant:	Futura Biomedical990 Park Center Drive, Suite HVista, CA 92083
Telephone:	760-599-1670
Fax:	760-599-1675
Contact:	Louise M. Focht
Device Name:	Prosthesis, Toe, Constrained, Polymer
Device Trade Name:	Classic Great Toe Implant
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Regulation Number	888.3720
Product Code:	87 KWH
Original Predicate Device:	Futura Biomedical Classic Great Toe Implant – K023086
Registration Number:	2030833
Owner Operator Number:	9028319

Device Description:

Indications for Use:

Futura Biomedical Classic Great Toe Implant is indicated for:

Hallux limitus or hallux rigidus ●
Painful rheumatoid arthritis .
Hallux abducto valgus associated with arthritis ●
Unstable or painful joint from previous surgery .

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Comparison to the Original Predicate Device:

ca 35cx
page ofa

The legally marketed predicate device to which this device is substantially equivalent is the same device, the Futura Biomedical Classic Great Toe Implant

Regulatory Class: II Product Code: 87 KWH

Comparison of original Futura Biomedical Classic Great Toe Implant to the new configuration the larger size Classic Great Toe Implant.

Item	Original Futura Product	Proposed product configuration
Product Name	Classic Great Toe Implant	Classic Great Toe Implant, size 60
Use	Single use	Single use
Fixation	Stem in intramedulary canal	Stem in intramedulary canal
Constraint	Constrained	Constrained
Material	Silicone	Silicone
Sizes	4 sizes, 20, 30, 40, 50	5 sizes 20, 30, 40, 50, 60
Indications for use	Hallux limitus or hallux rigidus	Hallux limitus or hallux rigidus
	Painful rheumatoid arthritis	Painful rheumatoid arthritis
	Hallux abducto valgus associatedwith arthritis	Hallux abducto valgus associatedwith arthritis
	Unstable or painful joint fromprevious surgery	Unstable or painful joint fromprevious surgery

Similarities of the Futura Classic Great Toe Implant and Classic Great Toe Implant size 60 include:

Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the metatarsal and phalangeal bones; Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92083

Re: K023562

Trade Name: Classic Great Toe Implant Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: II Product Code: KWH Dated: October 21, 2002 Received: October 23, 2002

Dear Ms. Focht:

We have reviewed your Section 510(k) premarket 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) 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 (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.

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Page 2 - Ms. Louise M. Focht

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark N Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If Known):	K023562
Device Name:	Classic Great Toe Implant

Indications for Use:

Futura Biomedical Classic Great Toe Implant is indicated for

. Hallux limitus or hallux rigidus
Painful rheumatoid arthritis ●
Hallux abducto valgus associated with arthritis .
Unstable or painful joint from previous surgery .

Marl N Miller

Page

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

510(k) Number_

Prescription Use

Yes/No

Over the counter use

Yes/No

Regulation Number and Section

§ 888.3720 Toe joint polymer constrained prosthesis.

(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.