ST-302 INFRAREX by SKYLARK DEVICE CO., LTD.

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:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample sized used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
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.
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.
The type of ground truth used: This information is not present.
The sample size for the training set: This information is not present.
How the ground truth for the training set was established: This information is not present.

Summary

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1999

Mr. George K. C. Chen President and CEO Skylark Device Company Limited 12 Floor, Section 3 34 Chung Shan North Road Taipei, Taiwan

к990233 Re: Trade Name:ST-302 Infrarex Requlatory Class: II Product Code: ILY Dated: July 30, 1999 Received: August 2, 1999

Dear Mr. Chen:

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, 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 (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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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.

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Page 2 - Mr. George K. C. Chen

This letter will allow you to begin marketing your device as Inis letter will area your your more to a lease described in your 510(k) prematice of your device to a legally finding of substancial equivalinos on a classitication for your marketed predicate device rocared in the market.

If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 crk rate sontact the Office of vitro draghostic devices// productionally, for questions on Compilance at (501) 331 is not device, please contact the promotion and advertising or job4-4639. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97) . . . . . . . . . . . premarket notification - (2) circles under the Act may be information on your responsiblic and Manufacturers Assistance ontained from the Division of Small Harrastadol (433–659) or all at ICS Coll-free number (000)-05-08-08-08 10:00 pm
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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(210 (k) NUMBER (IF KNOWN) : 1890233 ST-302 INFRAREX DEVICE NAME:

INDICATIONS FOR USE:

carions FOR USE:
The INFRAREX temporarily increases local blood circulation where The INFRAREX temporarily increases local been and joint aches
applied, and temporarily relieves minor muscle and joint aches
and temporarily relieves minor muscle and joint and pains.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (SAGE FOR FREE PAGE ( IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Prescripció CFR 801 109)

ﺎﺩ .

Over-The-Counter-Use
(Optional Format 1-2-96)

(Division Sign Off)

Division of General Restorative Device 510(k) Number .

Regulation Number and Section

§ 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.