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K Number
K031576
Device Name
SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
Manufacturer
SURGITECH, INC.
Date Cleared
2003-07-31

(72 days)

Product Code
IQI
Regulation Number
890.3475
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

An orthosis worn on the wrist for medical purposes:

  • 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:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method.
  5. Information on MRMC comparative effectiveness study.
  6. Information on standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. 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.

§ 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.