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The Luminex Infrared Lamp System is intended to emit energy in the visible and near 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, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

The Luminex Infrared Lamp System is an AC operated, non-invasive, therapeutic medical device that provides continuous heat therapy through the use of infrared and visible laser diodes. The system consists of a Control Unit that houses the electronics and controls, and treatment probes that contain the infrared and visible laser diodes. The probes are intended to be placed directly on the skin to provide topical heating.

The provided text describes the Luminex Infrared Lamp System, a therapeutic medical device, and its 510(k) premarket notification. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. The "Testing" section broadly mentions "functional performance testing and electrical safety testing in accordance with all applicable standards for Infrared Lamp Systems of this type," but it does not elaborate on what these tests entailed, what the acceptance criteria were, or the performance results.

Therefore, much of the requested information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies cannot be extracted from this document as these types of detailed studies were not presented.

Here's an attempt to answer the questions based on the available information, with many points noted as "Not Provided" due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not Provided (The document mentions "functional performance testing" and "electrical safety testing" but does not specify the number of devices tested or any patient/subject data if applicable).
• Data provenance: Not Provided (No patient data or human subject studies are detailed. The testing appears to be primarily device-centric and in-house.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Provided (No human subject test set is described where expert ground truth would be established.)

4. Adjudication method for the test set

• Not Provided (No human subject test set is described 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 therapeutic heating, not an AI-assisted diagnostic or interpretive device that would involve human readers or MRMC studies.

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

• Yes, in a sense. The testing described (functional performance and electrical safety) assesses the device's inherent operation without human interpretation. However, it's not an "algorithm-only" performance in the context of AI, but rather the performance of the physical medical device.

7. The type of ground truth used

• Functional Performance: Implicitly, "a level of tissue temperature reported in the literature and accepted by the Federal Food and Drug Administration." This refers to established physiological effects of heat therapy.
• Electrical Safety: Compliance with national/international electrical safety standards.
• Intended Use & Characteristics: Comparison to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable/Not Provided. This device is a physical therapeutic device, not an AI model that requires a training set in the conventional sense.

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

• Not Applicable/Not Provided.

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Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome

The Luminex LL System is a non-thermal, non-invasive, low energy infrared laser, therapeutic medical device that is intended for use as an adjunctive treatment for the temporary relief of hand and wrist pain associated with carpal tunnel syndrome. The Luminex Laser Therapy System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe incorporating three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90mW at the 830 nanometer (nm) wavelength.

The provided text describes a 510(k) premarket notification for the Luminex LL Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing de novo studies with specific acceptance criteria, large sample sizes, and detailed ground truth establishment as would be seen in a PMA (Premarket Approval Application) or clinical trial for a novel device.

Therefore, many of the requested details such as specific acceptance criteria for performance metrics, detailed sample sizes for test/training sets from prospective data, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance studies are not applicable (N/A) in this context as they are not typically part of a 510(k) submission for this type of device.

Here's a breakdown based on the available information:

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

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence to Predicate Devices	Demonstrated substantial equivalence to the Microlight Corporation of America, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009) based on:
   - Same intended uses.	- Intended for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome, matching predicate devices.
   - Similar technical and performance characteristics (infrared lamps, invisible photonic energy to tissue).	- Emits invisible photonic energy to tissue using three 30mW Gallium Aluminum Arsenide (GaAlAs) laser diodes (total 90mW) at 830nm wavelength, similar to predicate devices. Classified as an infrared lamp per 21 CFR 890.5500.
   Functional Performance and Electrical Safety Compliance	- System underwent functional performance testing and electrical safety testing.
   Compliance with FDA's Quality System Regulations and applicable standards for light-emitting medical devices.	- Manufactured to comply with FDA's Quality System Regulations and applicable standards for light emitting medical devices.
   Does not raise new questions of safety or effectiveness.	- Conclusion states the Luminex LL Laser System performs as intended and does not raise any new questions of safety or effectiveness when compared to predicate devices. It is designed to comply with generally accepted therapeutic laser performance specifications as an adjunctive treatment for relief of hand and wrist pain associated with Carpal Tunnel Syndrome. FDA's letter concurs with substantial equivalence.

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

   • N/A. This submission relies on demonstrating substantial equivalence to predicate devices, not on a clinical test set with human subjects to evaluate efficacy against specific metrics for the device itself. The "testing" mentioned is functional performance and electrical safety testing of the device hardware, not a clinical study on patient data.

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)

   • N/A. No clinical "test set" and corresponding ground truth determination by experts are described for this 510(k) submission.

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

   • N/A. No clinical "test set" requiring adjudication is described.

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

   • N/A. This device is a therapeutic laser, not an AI-powered diagnostic imaging device. No MRMC studies were conducted or are relevant.

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

   • N/A. This is a hardware therapeutic device, not a standalone algorithm.

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

   • N/A. Clinical ground truth (e.g., patient outcomes, pathology) for efficacy in a clinical trial setting is not described in this 510(k) for the Luminex LL Laser System itself. The "ground truth" for this 510(k) is the established performance and safety profiles of the legally marketed predicate devices.

8. The sample size for the training set

   • N/A. This device is not an AI/ML algorithm that requires a training set.

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

   • N/A. This device is not an AI/ML algorithm.

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