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K Number
K990233
Device Name
ST-302 INFRAREX
Manufacturer
SKYLARK DEVICE CO., LTD.
Date Cleared
1999-10-27

(275 days)

Product Code
ILY
Regulation Number
890.5500
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The INFRAREX temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ST-302 Infrarex." This letter does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The letter is a regulatory document stating that the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device, allowing the manufacturer to market it. It details regulatory provisions and contact information but does not include technical study details.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample sized used for the test set and the data provenance: This information is not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
  4. Adjudication method for the test set: This information is not present.
  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: This information is not present. The device is a "ST-302 Infrarex," which is likely a physical therapy or pain relief device, not an AI-assisted diagnostic tool for human readers.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. Again, this type of study is irrelevant for the described device.
  7. The type of ground truth used: This information is not present.
  8. The sample size for the training set: This information is not present.
  9. How the ground truth for the training set was established: This information is not present.

§ 890.5500 Infrared lamp.

(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.