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GIGALaser 1801 is intended to emit energy in the visible and near infraced spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of min and stiffhess, minor arthritis pain, or muscle spassn; the temporary increase in local blood circulation; and for the temporary relaxation of muscles.

The GIGALaser 1801 is a non-invasive, low level therapeutic laser lamp. The control unit contains the power supply and the user interface panel. The IR laser lamp is placed on a folding arm which is attached to the base unit. The interface panel consists of three buttons for 'STOP', 'START' AND 'PAUSE' and there are 6 buttons for the 6 different pre-programmed treatment programs labeled 1 - 6. The buttons light up when selected. A LED segment tells the user the time the treatment has run. The GIGALaser 1801 is also equipped with a main key power switch and an emergency stop. The GigaLaser is a medical device, which is delivered with a user and therapy manual and a complete labeling for the user.

Here's a summary of the acceptance criteria and the study details for the GIGALaser 1801, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: 4 subjects.
• Data Provenance: Not explicitly stated, but the submission is from PowerMedic ApS in Denmark. The clinical testing was conducted by or for the manufacturer, likely in Denmark or a location accessible to them. The study is described as "clinical testing conducted," implying it was specifically designed for this submission, likely making it prospective relative to the submission date.

3. Number of Experts and Qualifications for Ground Truth

• The document does not describe the use of "experts" to establish ground truth in the traditional sense of a diagnostic study. Instead, the "acceptance criteria" for temperature range (40-45°C) and the "at least 5°C increase within 1 minute" are referred to as "generally accepted by the FDA." This suggests that these are established and recognized physiological responses or therapeutic targets for heat therapy. There's no mention of individual expert opinions being adjudicated for the test results.

4. Adjudication Method for Test Set

• Not applicable. The study involved direct physical measurements of temperature and timing, not subjective assessment requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a therapeutic lamp, not an imaging or diagnostic device that typically requires human reader interpretation. The study focused on the device's ability to achieve and maintain therapeutic temperatures.

6. Standalone Performance Study (Algorithm Only)

• Yes, the study described is effectively a standalone performance study of the device itself. It measures the physical output and effect (heating) of the GIGALaser 1801, without any human-in-the-loop interaction beyond operating the device and monitoring the temperature.

7. Type of Ground Truth Used

• The ground truth used is based on physiologically accepted therapeutic temperature ranges and responses for heat therapy, specifically "40 - 45 degrees centigrade as accepted by the FDA" and "an increase in topical heating of the tissue level by at least 5° centigrade." These are objective, measurable physiological targets rather than subjective expert consensus, pathology, or outcomes data from a larger clinical trial.

8. Sample Size for Training Set

• Not applicable. This is a physical device, and the "study" described is a performance verification of its physical output and physiological effect, not an algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

• Not applicable, as there is no training set for an algorithm.

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The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.

The PowerLaser is a hand-held, battery operated, non-invasive, low level infrared therapeutic laser lamp. A separate battery charger can recharge the battery when it is removed from the PowerLaser. PowerLaser is a medical device, which is delivered packed with battery charger and complete labeling for the user.

The provided text is a 510(k) summary for the PowerLaser device. It outlines the device description, its intended use, and its substantial equivalence to other legally marketed infrared lamps. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document is a regulatory submission for premarket notification, focusing on demonstrating that the PowerLaser is substantially equivalent to previously cleared devices based on its intended use, design, and adherence to safety standards. It does not include the results of performance studies as one might find in a clinical trial report or a detailed engineering verification and validation document.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided input.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. This information is not present in the 510(k) summary. Acceptance criteria and device performance results from specific studies are typically detailed in separate sections of a full 510(k) submission or in technical reports, which are not included here.

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

• Cannot be provided. The document does not describe any specific test sets or studies that would involve a sample size.

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)

• Cannot be provided. No test sets or ground truth establishment are discussed.

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

• Cannot be provided. No test sets or adjudication methods are discussed.

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

• Cannot be provided. The device is an infrared lamp, not an AI or imaging diagnostic device that would typically involve a multi-reader multi-case study with human readers.

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

• Cannot be provided. The device is a physical therapeutic lamp, not an algorithm.

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

• Cannot be provided. No ground truth is discussed.

8. The sample size for the training set

• Cannot be provided. The device is not an AI/machine learning model, so there is no concept of a "training set" in this context.

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

• Cannot be provided. As above, no training set or ground truth for it is relevant or discussed.

What is present in the document:

• Intended Use/Indications for Use: The PowerLaser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.
• Substantial Equivalence: The device claims substantial equivalence to the PowerLaser 90 (K030692) and the Vectra Genisys Laser System (K040662).
• Device Description: A hand-held, battery-operated, non-invasive, low-level infrared therapeutic laser lamp.
• Compliance: Demonstrates compliance to relevant safety standards, EMC standards, and standards for low-level infrared laser equipment.

To get the information requested, you would need to consult a more detailed technical file or clinical study report associated with the PowerLaser, if such documents exist and are publicly available. The 510(k) summary itself focuses on regulatory justification for marketing, not detailed performance metrics from a study.

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