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The THØR DDII 1R Lamp System is intended to emit energy in the visible and 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 THØR DDII IR Lamp System is a portable, AC and battery operated noninvasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency. The System consists of a Drive Unit/Power Supply that houses the electronics and controls and optional treatment probes that contain the visible and infrared radiating elements. Various Cluster Probes are available accessories with the Drive Unit.

The THOR DDII IR Lamp System is designed to emit energy in the visible and near-infrared spectrum for topical heating. It aims to provide temporary relief from minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, temporarily increase local blood circulation, and/or temporarily relax muscles.

Acceptance Criteria and Device Performance:

Study Information:

1. Sample Size used for the test set and data provenance:
   The provided document does not specify a separate "test set" sample size for clinical validation. The testing seems to focus on functional performance and electrical safety rather than a clinical trial with a defined patient cohort. The data provenance is not explicitly stated as country of origin, but the submission is to the US FDA, and the company is based in the UK. The nature of the testing (functional/electrical) suggests neither retrospective nor prospective clinical data in the typical sense for algorithm evaluation. Instead, it's about physical device characteristics.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. The document does not describe a test set requiring expert-established ground truth in the context of diagnostic or interpretive performance. The "ground truth" for this device likely refers to meeting engineering specifications for heat output and electrical safety, and clinical intent is tied to established therapeutic heat principles.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This type of adjudication is typically used in clinical studies where expert consensus is needed for interpreting medical images or patient outcomes. The provided document details functional and safety testing of a physical device.

4. 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. The THOR DDII IR Lamp System is a therapeutic device (infrared lamp), not a diagnostic or interpretive AI-assisted system for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Yes, in a sense. The testing was on the device's inherent performance (functional and electrical safety) in a standalone capacity, without human interpretive input as part of its primary function. It's a device that delivers physical therapy, not an algorithm providing diagnostic outputs.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For functionality, the "ground truth" was likely engineering specifications and established therapeutic heat performance standards referenced in literature and accepted by the FDA. For safety, it would be compliance with electrical safety standards. The claim of "temporary relief of minor muscle and joint pain..." is based on the accepted physiological effects of therapeutic heat.

7. The sample size for the training set:
   Not applicable. This is a medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device is designed based on known physics and engineering principles for infrared heat generation, not statistical learning from a dataset.

8. How the ground truth for the training set was established:
   Not applicable, as there is no "training set" for this type of device. The design and validation are based on established scientific principles of therapeutic heat and direct physical testing against performance and safety standards.

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The THØR DDII 830CL3 Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

THØR DDII 830CL3 Laser System is a handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser that is intended for use as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. The THØR 830CL3 Laser System incorporates three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90 milliwatts (mW) at 830 nanometer (nm) wavelength.

The provided text describes a 510(k) premarket notification for the THØR DDII 830CL3 Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a medical device meets specific performance acceptance criteria through clinical studies directly. Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication, and clinical study details (MRMC, standalone performance, training sets) is not applicable or not found within this type of regulatory submission.

However, based on the provided text, we can extract details related to the device's technical characteristics, intended use, and the regulatory pathway.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (as per regulatory compliance) and the Reported Device Performance:

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

• Not applicable / Not found. This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI/algorithm-driven device. The equivalence is based on technical characteristics and intended use compared to legally marketed predicate devices.

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

• Not applicable / Not found. No ground truth establishment for a test set is described.

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

• Not applicable / Not found. No test set or adjudication method 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:

• Not applicable / Not found. This device is a low-level laser system for pain relief, not an AI-driven diagnostic or assistive tool for human readers.

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

• Not applicable / Not found. This device is a physical therapeutic laser system, not an algorithm.

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

• Not applicable / Not found. The "ground truth" in this context is established through the regulatory acceptance of predicate devices and the demonstration of substantial equivalence based on technical specifications and safety/performance characteristics. There isn't a direct "ground truth" for a diagnostic outcome being evaluated.

8. The sample size for the training set:

• Not applicable / Not found. This document does not describe a machine learning algorithm or a training set.

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

• Not applicable / Not found. This document does not describe a machine learning algorithm or a training set.

Summary of the Study (as presented in the 510(k) notification):

The "study" described is a Premarket Notification (510(k)) which aims to demonstrate that the THØR DDII 830CL3 Laser System is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway, not a clinical effectiveness study in the typical sense applied to diagnostic or AI devices.

The evidence presented for substantial equivalence consists of:

• Comparison of Intended Use: The device shares the identical intended use (adjunctive use in temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome) with predicate devices.
• Comparison of Technical Characteristics: The device utilizes similar physical principles (non-heating infrared lamps, infrared diodes emitting photonic energy) and specifications (e.g., 830nm wavelength, output power) to predicate devices.
• Compliance with Recognized Standards: The device was tested and found to comply with relevant European standards for medical electrical equipment, medical laser equipment, EMC, and the Medical Device Directive. This includes functional performance testing and electrical safety testing.

The conclusion is that the device "has the same intended uses, with similar functional and performance characteristics" and "performs as intended and does not raise any new safety or efficacy issues," thus establishing substantial equivalence to the predicate devices.

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