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The MediLaser 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.

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

Here's an analysis of the provided text regarding the acceptance criteria and study for the MediLaser System, structured as requested:

Acceptance Criteria and Study for the MediLaser System (K063745)

The provided document is a 510(k) Premarket Notification Summary for the MediLaser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results against specific acceptance criteria for performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical test set with a specific sample size. The testing mentioned (functional performance and electrical safety) likely refers to bench testing and engineering verification, not human subject studies. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of a clinical test set.

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

This information is not applicable. The submission is a 510(k) for an infrared lamp, demonstrating substantial equivalence to legally marketed predicate devices. It does not involve a clinical study with a ground truth established by medical experts for a diagnostic or treatment outcome. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices in the infrared lamp category.

4. Adjudication Method for the Test Set

This information is not applicable, as there was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic imaging devices to compare the performance of human readers with and without AI assistance. The MediLaser is a therapeutic device (infrared lamp), and the submission focuses on substantial equivalence based on physical characteristics and intended use.

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

This information is not applicable as the device is a hardware-based therapeutic infrared lamp, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is based on the established safety and effectiveness of legally marketed predicate devices (e.g., Thor IR Lamp System/ Super Nova/ Acubeam systems) and compliance with generally accepted therapeutic heat performance specifications. The device's performance aligns with the expected output and effects of these predicate infrared lamps, which have a long history of safe use for the stated indications.

8. The Sample Size for the Training Set

No training set for an algorithm was used or described, as this device does not involve AI or machine learning.

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

This is not applicable, as there was no training set for an algorithm.

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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.

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.

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

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.

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