SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 by SURGITECH, INC.

to support and/or immobilize for functional improvement.
for conservative treatment of symptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist.
to keep wrist motion to a minimum while worn allowing the body to recover from the damage of repetitive motion or other injuries.
to provide temporary relief of associated symptoms of some wrist conditions.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from K031576 does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance for the Spartan Orthopaedic Wrist Brace, Model SCT-1.

This document is an FDA 510(k) clearance letter, which means the device was found substantially equivalent to a predicate device already on the market. This type of clearance typically relies on demonstrating similarity to existing devices rather than extensive new clinical studies with detailed acceptance criteria and performance reports as would be expected for novel or higher-risk devices.

Therefore, I cannot provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts or their qualifications for ground truth.
Adjudication method.
Information on MRMC comparative effectiveness study.
Information on standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document only states the device's indications for use and confirms its substantial equivalence to a legally marketed predicate device. It does not include performance data or studies defining and meeting specific acceptance criteria.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2003

Mr. Christopher Crowell Quality Assurance Manager SurgiTech, Inc. 2424 Vista Way, Suite 300 Oceanside, CA 92054-6174

Re: K031576

Trade/Device Name: Spartan Orthopaedic Wrist Brace, Model SCT-1 Regulation Number: 21 CFR 890.3475 Regulation Name: Limb orthosis Regulatory Class: I Product Code: IQI Dated: June 30, 2003 Received: July 7, 2003

Dear Mr. Crowell:

We have reviewed vour 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. Christopher Crowell

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N Milburn

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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3.0 Revised Statement of Indications for Use

An orthosis worn on the wrist for medical purposes:

to support and/or immobilize for functional improvement. .
. for conservative treatment of s mptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist.
to keep wrist motion to a minimum while worn allowing the body . to recover from the damage of repetitive motion or other injuries.
to provide temporary relief of associated symptoms of some . wrist conditions.

Mark N. Milliken

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

510(k) Number K031576
K031576 mnm

Regulation Number and Section

§ 890.3475 Limb orthosis.

(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.