PALOMAR LIGHTCUBE by PALOMAR MEDICAL PRODUCTS, INC.

The ThermaPulse™ at the power settings in the range of 5-50 Watts (power density 75-500 mW/cm2) 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. the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the ThermaPulse™ may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Device Description

The ThermaPulse™ delivers infrared light with a wavelength of 810 +/-20 nm. The complete system consists of a laser unit, a ThermaPulse™ footswitch, and a handpiece connected to the laser unit with an umbilical. In standard use, the ThermaPulse is positioned at an average distance of 23 cm from the treatment area. The ThermaPulse is equipped with a fan to offer greater patient's comfort. System parameters and other features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.

AI/ML Overview

The provided document is a 510(k) summary for the Palomar SLP 1000 ThermaPulse, dated June 4, 2003. This document, and the associated FDA letter, assert substantial equivalence to predicate devices rather than providing a study demonstrating the device meets explicit acceptance criteria with quantitative performance metrics.

Therefore, the information requested in the prompt, which is typical for performance studies with acceptance criteria, is not present in this document. The document explicitly states: "Performance Data: differences in the specifications of the The ThermaPulseTM and the predicate devices do not result in different performance or raise new questions of safety or efficacy."

Here's how the information would be presented if it were available in the document, along with an explanation of why each point cannot be answered:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
No specific performance metrics or acceptance criteria are provided in the document.	None specified.	None specified.

Explanation: The document does not define specific quantitative acceptance criteria (e.g., a certain percentage of pain relief, a measurable increase in circulation by a specific amount). Instead, it relies on the concept of "substantial equivalence" to predicate devices for its claims of safety and efficacy.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not applicable. No dedicated performance study with a test set is described.
Data Provenance: Not applicable. The document does not describe a clinical study with a test set, so there is no information on country of origin or whether hypothetical data would be retrospective or prospective.

Explanation: The 510(k) summary is a regulatory submission for substantial equivalence, not a report of a new clinical efficacy study with acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No dedicated performance study with a ground truth established by experts is described.
Qualifications: Not applicable.

Explanation: As no clinical study or test set is detailed, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No dedicated performance study with a test set requiring adjudication is described.

Explanation: Without a clinical study, there is no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect Size of Human Readers with AI vs. without AI assistance: Not applicable. This device is an infrared heating lamp and does not involve AI or human image interpretation.

Explanation: MRMC studies are typically for diagnostic imaging devices where human readers interpret results, often with AI assistance. This device is a therapeutic heating lamp.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? No. This device is a physical therapeutic device, not an algorithm.

Explanation: A "standalone" study refers to the performance of an AI algorithm alone, without human interaction. This concept does not apply to a physical medical device like an infrared heating lamp.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. No dedicated performance study requiring a specific type of ground truth (e.g., pathology, outcomes data) is described.

Explanation: Ground truth is established for diagnostic or prognostic claims, typically requiring a reference standard. For a therapeutic device like this, efficacy might be assessed through patient-reported outcomes or physiological changes, but no such study is presented here.

8. Sample Size for the Training Set

Sample Size: Not applicable. This device is a physical therapeutic device and does not involve a "training set" in the context of machine learning or AI.

Explanation: The concept of a "training set" belongs to machine learning and AI development.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth was Established: Not applicable.

Explanation: As no training set exists for this device, there is no ground truth to be established for it.

Summary from the Document:

The Palomar SLP 1000 ThermaPulse was deemed substantially equivalent to legally marketed predicate devices (K020851-TDP Heat Lamp; K021956, MHS Med Light 1000; K003538, TDP CQ-27 Heat Lamp). The performance data section explicitly states: "differences in the specifications of the The ThermaPulseTM and the predicate devices do not result in different performance or raise new questions of safety or efficacy."

The intended use of the device is to provide topical heating for the temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and muscle relaxation, potentially also helping muscle spasms, minor sprains, strains, and muscular back pain, using infrared light at a wavelength of 810 +/- 20 nm and power settings of 5-50 Watts (power density 75-500 mW/cm2). The FDA's 510(k) clearance indicates agreement with the claim of substantial equivalence.

Summary

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024179/51 1/2

JUN - 4 2003

Attachment 4

510(K) Summary of Safety and Effectiveness

This 510(K) Summary of Safety and Effectiveness for the Palomar SLP 1000 ThermaPulse™ is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.

Applicant:	Palomar Medical Technologies, Inc.
Address:	82 Cambridge St.Burlington, MA 01803
Contact Person:	Marcy Moore
Telephone:	919-363-2432
Preparation Date:	December 12, 2002
Device Trade Name:	Palomar ThermaPulse™
Common Name:	ThermaPulse™
Classification Name:	Infrared Heating Lamp (see: 21 CFR 890.5500)
Legally-Marketed Predicate Device:	K020851-TDP Heat Lamp; K021956, MHS MedLight 1000; K003538, TDP CQ-27 Heat Lamp

System Description:

The ThermaPulse™ delivers infrared light with a wavelength of 810 +/-20 nm.

The complete system consists of a laser unit, a ThermaPulse™ footswitch, and a handpiece connected to the laser unit with an umbilical. In standard use, the ThermaPulse is positioned at an average distance of 23 cm from the treatment area. The ThermaPulse is equipped with a fan to offer greater patient's comfort. System parameters and other features are controlled from the user interface panel on top of the laser unit, which provides an interface to the system computer.

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024179/81 4/2

Intended Use of the Device:

Performance Data: differences in the specifications of the The ThermaPulseTM and the predicate devices do not result in different performance or raise new questions of safety or efficacy. Conclusion: Based on the foregoing, the ThermaPulse™ is substantially equivalent to the legally-marketed claimed predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white 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" around the edge. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2003

Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Technologies, Inc. 131 Kelekent Lane Cary, North Carolina 27511

Re: K024179

Trade/Device Name: Palomar ThermaPulseTM Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared heating lamp Regulatory Class: II Product Code: ILY Dated: March 5, 2003 Received: March 6, 2003

Dear Ms. Moore:

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. Marcy Moore

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 (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) you may obtain. 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 vours.

Mark McMullen

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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INDICATIONS FOR USE STATEMENT

510(K) Number: K024179

ThermaPulse™ Device Name:

Indications for Use:

The ThermaPulse™ at the power settings in the range of 5-50 Watts 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, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the ThermaPulse™ may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR
Over-the-Counter Use
(per 21 CFR 801.109)

(Division Sigr
Division of G Restorative
and Neurological Devices

Number K024179

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.