(90 days)
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:
| Acceptance Criteria (Intended Use) | Reported Device Performance |
|---|---|
| Emit energy in the visible and near-infrared spectrum to provide topical heating. | Utilizes infrared diodes to generate 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 designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration." The device performs as intended and does not raise new safety or efficacy issues. |
| Maintain safety standards. | Functional performance testing and electrical safety testing were conducted. The device performs as intended and does not raise new safety or efficacy issues. The FDA determined the device to be substantially equivalent to legally marketed predicate devices, implying it meets established safety and effectiveness standards for this product type. |
Study Information:
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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. -
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. -
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. -
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. -
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. -
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. -
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. -
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.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.