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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.

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.

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

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.

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