the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm;
the temporary increase in local circulation; and / or
the temporary relaxation of muscle.

Device Description

The SSIR System is a modern, safe, and easy-to-use devices, which provide continuous heat therapy. The SSIR System consists of a power supply that houses the electronics and controls and treatment module (Velcro Strap Model) that contain the infrared radiating element. The power supply is manufactured from a plastic material that is used in similar products currently in commercial distribution by various medical device companies. The power supply houses a green LED light to indicate when the unit is active.
The Velcro Strap Model is a treatment module comprised of a silicon diode in a black anodized aluminum housing with attached velcro straos. The area of this module that comes in contact with the treatment site is covered with black cotton feit.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SSIR System, an infrared lamp. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance metrics as would be expected for a novel device or a Premarket Approval (PMA) application. Therefore, much of the requested information regarding "acceptance criteria" and "studies proving the device meets acceptance criteria" in terms of clinical performance, sample sizes for test/training sets, expert adjudication, or MRMC studies is not present in the document.

The document primarily discusses the device's intended use, description, and "testing" in a general sense, noting "functional performance testing and electrical safety testing." It concludes that the device "has the same intended uses, with similar functional and performance characteristics" to predicate devices and "performs as intended and does not raise any new safety or efficacy issues." This language refers to the regulatory standard of substantial equivalence, not a clinical superiority or non-inferiority trial against specific clinical endpoints.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

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

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance
Intended Use: - Temporary relief of minor muscle, joint pain, stiffness, arthritis pain, muscle spasm.- Temporary increase in local circulation.- Temporary relaxation of muscle.	The SSIR System "has the same intended uses" as predicate devices.
Functional/Performance Characteristics: - Emit energy in the infrared spectrum.- Provide topical heating to elevate tissue temperature.- Comply with generally accepted therapeutic heat performance specifications.	"Utilizes infrared diodes to generate topical heating." "Designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration." "Performs as intended."
Safety: - Electrical safety compliance.- No new safety issues.	"Electrical safety testing" was performed. "Does not raise any new safety... issues."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "functional performance testing" and "electrical safety testing" but does not detail the nature of these tests, the number of units tested, or if any human subject testing was part of this.
Data Provenance: Not specified. It's likely these tests were internal to the manufacturer (Russian-American Technology Associates, Inc. in Alabama, USA), but this is not explicitly stated. The nature of a 510(k) for an infrared lamp typically focuses on engineering and bench testing rather than clinical trials with human participant data of the kind where provenance would be a key detail.
Retrospective or Prospective: Not applicable, as no clinical study with human subjects is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for this type of device (infrared lamp) in a 510(k) context would be based on engineering specifications and compliance with recognized standards, not expert clinical consensus on patient data.

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

Not applicable. No expert adjudication process for a clinical test set is described.

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. The device is an infrared lamp for therapeutic heat, not a diagnostic AI system with "human readers" or "AI assistance."

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

Not applicable. The device is a physical therapeutic device, not an algorithm.

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

The "ground truth" for the SSIR System's performance in this 510(k) submission appears to be based on:

Engineering specifications and functional testing: Ensuring the device emits infrared, produces heat, and meets electrical safety standards.
Regulatory compliance: Adherence to 21 CFR 890.5500 (Infrared lamp classification).
Existing literature and accepted standards: "producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration." This refers to general scientific understanding and regulatory acceptance of therapeutic heat levels, not specific clinical outcomes data for this particular device.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a "training set."

Summary

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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters are 'K014208'. The characters are written in a simple, slightly rough style, suggesting they were written quickly or with a thick marker. The numbers are easily readable.

510(k) PREMARKET NOTIFICATION SUMMARY (per 21 CFR 807.92)

SSIR SYSTEM

I. Applicant:

Russian-American Technology Associates, Inc. 23667 Patterson Road Robertsdale, AL 36567 USA

Key Contact: Floyd T. Neth, Ph. D. President

Date Revised: June 30, 2002

II. Device Name

Proprietary Name:	SSIR System
Common / Usual Name:	Infrared Lamp
Classification Name:	Infrared Lamp (21 CFR 890.555)
Product Code:	ILY

III. Predicate Device

The SSIR System is substantially equivalent to other infrared lamps currently in commercial distribution such as the Photonic Stimulator manufactured by Bales Scientific, Inc., the Super Nova / Acubeam systems manufactured by Light Force Technology, Inc., Light Patch manufactured by BioScan, Inc., and Nu Photonics Pain Therapist system manufactured by Nu Photonics, Inc.

IV. Intended Use of the Device

The SSIR System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:

the temporary relief of minor muscle and joint pain and stiffness, minor p arthritis pain, or muscle spasm;
the temporary increase in local circulation; and / or
the temporary relaxation of muscle. や

V. Description of the Device

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distribution by various medical device companies. The power supply houses a green LED light to indicate when the unit is active.

The Velcro Strap Model is a treatment module comprised of a silicon diode in a black anodized aluminum housing with attached velcro straos. The area of this module that comes in contact with the treatment site is covered with black cotton feit.

VI. Summary of the technical characteristics of the SSIR System to the referenced predicate devices.

The SSIR System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. The device utilizes infrared diodes to generate topical heating for the purpose of elevating tissue temperatures for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or musde spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The System is intended to be placed directly on the skin to provide heating.

VII. Testing

Testing of the SSIR System included functional performance testing and electrical safety testing.

VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the SSIR System has the same intended uses, with similar functional and performance characteristics. The SSIR System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature1 and accepted by the Federal Food and Drug Administration.

The SSIR System performs as intended and does not raise any new safety or efficacy issues.

ર્ભ

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

JUL = 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Russian-American Technology Association, Inc. c/o Ms. M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 8303 S.W. Freeway, Suite 835 Houston, Texas 77074-1601

Re: K014208

Trade/Device Name: SSIR System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: April 18, 2002 Received: April 19, 2002

Dear Ms. Heinrich:

We have reviewed your 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. Iisting 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 - Ms. Joyce Heinrich

.. . . . . .

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

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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Statement of Indications for use

510(k) Number (if known):

Device Name: SSIR System

Indications for Use:

The SSIR System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:

the temporary relief of minor muscle and joint pain and stiffness, minor > arthritis pain, or muscle spasm;
the temporary increase in local circulation; and / or
the temporary relaxation of muscle. >

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: OR
(Per 21 CFR 801.109)

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

(Division Sign-Off)

510(k) Number_________________________________________________________________________________________________________________________________________________________________

3 of 3

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.