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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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The TDP CQG-111A/B. CQG-222A/B. CQG-270A/B and CQG-222D Heat Lamp may be used 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 relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The TDP CQG-111A/B, CQG-222A/B, CQG-270A/B and CQG-222D lamps can be used to emit topical heating to the body of human. The TDP Lamps are specially designed to use a curing plate that is made of a rare earth and minerals. Emission spectrum ranges from 1 to 25 microns. The life of emission curing plate is 1,000 to 1,500 hours. When the curing plate is used up to 1,000 hours, the treatment effect of the curing plate will gradually depressed. After the curing plate is used for 1,500 hours, it should be replaced with a new one. The device manufactured for the United States of America uses 110 volts power and 250 (or 275) watts. All models have 1 safety fuse, 4-swivel heater and a safety grilling cover. All models include a 60-minutes timer. Only difference between Model "A" (or "D") and Model "B" is the control system. Model "A" (or "D") TDP is controlled with a mechanical system, but Model "B" TDP is controlled with an electronic system.

This document, a 510(k) Pre-Market Notification, describes an infrared heat lamp and its substantial equivalence to predicate devices. It primarily focuses on regulatory compliance and does not provide information about clinical studies, acceptance criteria, or performance metrics in the way a modern AI/device study would. Therefore, I cannot extract the requested information in the format requested.

Here's why and what information can be inferred:

• No acceptance criteria for device performance: This submission is for a heat lamp, a well-established device type. The "acceptance criteria" here refer to regulatory acceptance, specifically demonstrating "substantial equivalence" to existing legally marketed devices, rather than performance against pre-defined clinical metrics.
• No study to prove device meets acceptance criteria (in the modern sense): The "study" for this type of device is the demonstration of substantial equivalence through comparison of technological characteristics and intended use with predicate devices. There wouldn't be a clinical trial with performance metrics like accuracy, sensitivity, or specificity.
• No AI component: This is a physical medical device (an infrared heat lamp), not an AI-powered diagnostic or therapeutic tool. Therefore, questions about human readers, AI assistance, training sets, ground truth, or adjudication methods are not applicable.

What can be extracted or inferred from the document regarding its "acceptance":

• Acceptance Criteria (Regulatory): The primary acceptance criterion was demonstrating "substantial equivalence" to legally marketed predicate devices. This means the device has the same intended use and similar technological characteristics to devices already cleared by the FDA.
• Device Performance (Regulatory Equivalence): The report states, "The TDP Lamps manufactured by Chongqing Silicate Research Institute meets the general specifications, criteria, and effectiveness for heat lamps. The TDP Lamps also have the same technological characteristics as their predicate device such as TDP CQ-27 lamp." This is the "performance" claim in this context – it performs equivalently to predicate devices.
• Ground Truth (for regulatory acceptance): The "ground truth" for regulatory acceptance is the established safety and effectiveness profile of the predicate devices.
• Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone/Training Set: These concepts are not applicable to this type of 510(k) submission for a non-AI physical device. The review process involved FDA's evaluation of the submitted documentation, not clinical trials with human readers or AI algorithms.

In summary, as per your request format, this document does not contain the information needed because it's a regulatory submission for a physical medical device, not a performance study for an AI-enabled device.

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