Use wherever hot applications are desirable for personal comfort and whenever A recommended by a licensed medical professional
Provides temporary relief of minor aches and pains in muscles and joints
Aids in the relaxation of muscles
Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
Provides a temporary increase in local blood circulation

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the BioScan, Inc. Light Patch, indicating that the device has been found substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical trial report or a summary of safety and effectiveness data (SSE).

Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the study proving the device meets them. The document states "we have reviewed your 510(k) notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that BioScan, Inc. submitted data to the FDA in their 510(k) notification, but the specifics of that data are not included in this clearance letter.

To fully answer your request, external documents (such as the actual 510(k) submission, including the summary of safety and effectiveness, or clinical study reports if applicable for this type of device) would be needed.

However, I can extract the "Indications for Use" which the FDA has cleared, and this effectively defines the performance expected of the device in a broad sense, though not as specific quantitative acceptance criteria.

Summary of what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Derived from Indications for Use - qualitative):
- Suitable for hot applications for personal comfort.
- Provides temporary relief of minor aches and pains in muscles and joints.
- Aids in the relaxation of muscles.
- Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief.
- Provides a temporary increase in local blood circulation.
Reported Device Performance: The document states the device is "substantially equivalent" to legally marketed predicate devices for the given indications for use. This means the FDA has accepted that its performance is comparable to existing, legally marketed products performing the same functions. No specific quantitative performance metrics are provided in this letter.

2. Sample size used for the test set and the data provenance:

Not specified in the provided text. The 510(k) letter does not include details on sample size or data provenance (e.g., country of origin, retrospective/prospective nature) of any studies conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in the provided text. This information would typically be found in the manufacturer's 510(k) submission or a related study report, not in the FDA clearance letter itself.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified in the provided text.

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:

Not applicable based on the device type. The "Light Patch" appears to be a therapeutic device providing heat and pain relief, not an AI-assisted diagnostic imaging device requiring human readers. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not specified and likely not applicable. This device is a physical therapeutic product, not an algorithm, so "standalone algorithm performance" is not a relevant concept for this specific product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not specified in the provided text. Given the indications for use (pain relief, muscle relaxation, blood circulation), the ground truth for any underlying studies would likely involve participant-reported outcomes (e.g., pain scales, comfort levels), physiological measurements (e.g., temperature, blood flow), or possibly clinical assessments by healthcare professionals.

8. The sample size for the training set:

Not specified in the provided text. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. As the device is not an AI/ML algorithm, it does not have a "training set" in this context.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2000

Butch Smith, Vice President BioScan, Inc. 6 Walden Road Corrales, New Mexico 87048

Re: K993685 and K993686 Trade Name: BioPack and Light Patch Regulatory Class: II Product Code: ILY Dated: April 5, 2000 Received: April 19, 2000

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the devices referenced we have reviewed four bocker broes are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate use stated in the encrosure) to regary enactment date of the Medical Device Amendments, or to conninered prof to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls and Cosmodo Free (110). The general controls provisions of the Act include requirements for provisions of the Fred "The of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major ( remaince i ffecting your devices can be found in the Code of Federal Regulations, Title 21, regulations and outling your as a vivalent determination assumes compliance with the Current Farts 600 to 65%. I reactice requirements, 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 mspotions, the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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 - Butch Smith

This letter will allow you to begin marketing your devices as described in your 510(k) premarket I mis letter will anow you to obgen makes antial equivalence of your devices to legally marketed nothleate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and If you desire spoonly arriver diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, (201) 594-1659. Naturaliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers 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,

Dune R. bochner

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): K993686

Device Name: Light Patch

Indications for Use:

Use wherever hot applications are desirable for personal comfort and whenever A recommended by a licensed medical professional
Provides temporary relief of minor aches and pains in muscles and joints
Aids in the relaxation of muscles
Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
Provides a temporary increase in local blood circulation

(PLEASE DO NOT WITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over the Counter Use: (Optional Format 1-2-96)

Danne R. Lochness
Division Sign-Off

vision Sign-Off)
vision of General Restorative Devices
(k) Number K993686

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.