The AcuMed Laser 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, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

Device Description

The AcuMed Laser is a portable, hand held, AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.

AI/ML Overview

The provided text describes the AcuMed Laser System, an infrared lamp, and its submission for a 510(k) premarket notification to the FDA. The information focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not directly available in the provided document, as the submission relies on the established safety and effectiveness of predicate devices and general heating principles.

Here's a breakdown of the available information and areas where details are missing:

Acceptance Criteria and Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Intended uses align with predicate devices for topical heating and temporary relief of minor pain/stiffness, arthritis pain, increased circulation, muscle relaxation.	The AcuMed Laser has the "same intended uses" as predicate devices (Thor IR Lamp System/Super Nova/Acubeam systems).
Functional and performance characteristics are similar to predicate devices.	The AcuMed Laser possesses "similar functional and performance characteristics" to predicate devices. It is a portable, hand-held, AC operated non-invasive, low-level infrared lamp providing continuous heat therapy at a fixed frequency.
Device performance adheres to generally accepted therapeutic heat performance specifications.	The AcuMed Laser is "designed to comply with the general accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration." This implies it achieves therapeutic tissue temperature.
No new safety or efficacy issues are raised.	The AcuMed Laser "performs as intended and do not raise any new safety or efficacy issues."
Compliance with electrical safety standards.	Electrical safety testing was performed. Specific standards or results are not detailed.
Compliance with general controls provisions of the Act (e.g., registration, labeling, GMP).	The FDA's 510(k) clearance states the device is subject to general controls provisions, but this is a regulatory requirement, not a performance criterion demonstrated by a study.

Study Details and Ground Truth

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

Sample Size: Not applicable. The document describes a comparison to predicate devices and functional/electrical safety testing, not a clinical study with a "test set" of patients or data in the typical sense.
Data Provenance: Not applicable. There is no mention of country of origin or whether any data used for comparison (e.g., literature on therapeutic heat) was retrospective or prospective.

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

Not applicable. No ground truth was established by experts for a specific "test set" as part of this submission. The submission relies on the established understanding of infrared therapy and predicate devices.

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

Not applicable. There was no clinical test set requiring adjudication.

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:

No. This device is an infrared lamp for heat therapy, not an AI-assisted diagnostic tool, so an MRMC study is not relevant and was not performed.

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

Not applicable. This is a physical therapy device (infrared lamp), not an algorithm or AI system.

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

The "ground truth" for this 510(k) submission, implicitly, is the established scientific and medical understanding of therapeutic heat and the demonstrated safety and efficacy of legally marketed predicate infrared lamp devices. The submission asserts that the AcuMed Laser produces "a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration," indicating reliance on existing knowledge and regulatory acceptance of therapeutic heating.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

Summary of what was done for the AcuMed Laser System:

The submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices (Thor IR Lamp System/Super Nova/Acubeam systems). This approach for a 510(k) premarket notification means the device's safety and effectiveness are established by showing it has the same intended uses and similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate.

The "testing" mentioned included:

Functional performance testing: To ensure it operates as intended (e.g., emits infrared energy for heating). Specific parameters tested or results are not detailed.
Electrical safety testing: To ensure it meets electrical safety standards. Specific standards or results are not detailed.

The core argument is that, because it functions similarly to approved devices and produces therapeutic heat levels consistent with accepted literature, it is substantially equivalent and thus safe and effective for its stated indications.

Summary

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Appendix A

K060153

510 (k) Premarket Notification Summary (Per 21 CFR 807.92)

SEP 2 Y 2006

AcuMed Laser System

I. Applicant Laser Thera, LLC Shelly Henry, President 11108 Ashford Drive Yukon OK 73099

II. Device Name: Proprietary Name: AcuMed Laser Common/Usual Name: Infrared lamp Classification Name: Infrared lamp (21 CFR 890.555) Product Code ILY
III. The AcuMed Laser System is substantially equivalent to other infrared lamps currently in commercial distribution such as the Thor IR Lamp System/ Super Nova/ Acubeam systems.

IV. Intended use of the Device

V. Description of Device

The AcuMed Laser is a portable, hand held, AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.

VI. Summary of the technical characteristics of the AcuMed The AcuMed and the aforementioned predicate devices are an infrared lamp as defined in 21 CFR 890.5500. These devices utilize 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 muscle spasm, the temporary increase in local circulation and the temporary relaxation of muscle. The systems are intended to be placed directly on the skin to provide heating.

VII. Testing

Testing of the AcuMed Laser included functional performance testing and electrical safety testing.

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VIII. Conclusions

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

The AcuMed Laser performs as intended and do not raise any new safety or efficacy issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laser Thera, LLC % Ms. Shelly Henry President 11108 Ashford Drive Yukon, Oklahoma 73099

Re: K060153

Trade/Device Name: AcuMed Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: July 6, 2006 Received: July 7, 2006

Dear Ms. Henry:

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. 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 (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. Shelly Henry

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for
Mark N. Melkerson

Mark N. kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060153

Device Name: AcuMed Laser

Indications For Use:

The AcuMed Laser is an infrared lamp that 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, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.

Prescriptions Use (Part 21 CFR 801 Subpart D)	x
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	166153
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Regulation Number and Section

N/A