(157 days)
The Thermotex Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
The Thermotex Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nylon-cotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
The provided submission for the Thermotex Heat Therapy Systems (K092589) does not contain detailed acceptance criteria or a specific study proving the device meets particular numerical performance targets that would typically be seen in studies for AI/ML-based medical devices. This submission is for an electrically-powered pad that generates infrared radiation, a type of device where performance is generally demonstrated through bench testing and animal studies to ensure safety and function, rather than diagnostic accuracy or effectiveness against a specific disease outcome in humans with statistical metrics.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the submission for this physical medical device (infrared heating pad) does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or quantitative clinical outcomes data typically found for diagnostic or treatment AI algorithms. Instead, the "performance" discussed relates to its technological characteristics and safety.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Infrared Radiation Capability | Demonstrated during laboratory bench testing. |
| Safety (General) | Demonstrated during laboratory bench testing and animal studies. |
| Heat Control Functionality | User-controlled 3-position switch for heat maintenance. |
| Substantial Equivalence to Predicate | The manufacturer stated that technological differences do not raise new questions of safety and effectiveness, supported by preclinical bench and animal testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a human clinical test set for diagnostic performance. The submission refers to "laboratory bench testing" and "animal studies." No specific numbers for animals or test configurations are provided.
- Data Provenance: The studies were described as "laboratory bench testing" and "animal studies." No country of origin is specified for these studies, nor is it explicitly stated if they were retrospective or prospective, though preclinical studies are typically prospective by nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a therapeutic heating pad, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. Ground truth for its performance would entail measuring physical parameters (e.g., temperature, infrared output) and observing physiological responses in animal models, not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as there is no human test set requiring adjudication in the context of diagnostic or treatment efficacy evaluation that would typically use methods like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for evaluating the impact of AI/ML on human reader performance, typically in imaging diagnostics. This device is not an AI/ML diagnostic tool, nor does it assist human readers in interpretation.
6. Standalone (Algorithm Only) Performance Study
No. This is not an algorithm-only device. It is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for this type of device would be based on:
- Physical measurements: During bench testing to confirm infrared output, temperature control, and electrical safety.
- Physiological observations: In animal models to assess safety (e.g., tissue damage) and potentially the intended therapeutic effect (e.g., local circulation increase, muscle relaxation - though specific metrics are not detailed).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The submission indicates that the Thermotex Heat Therapy Systems' performance and safety were demonstrated through:
- Laboratory Bench Testing: This testing was used to evaluate infrared radiation capability and overall safety. It likely involved measuring the device's physical output (e.g., wavelength, intensity of IR radiation) and confirming its electrical and mechanical safety features.
- Animal Studies: These studies were conducted to further demonstrate the safety of the device. Animal models are often used to assess potential for thermal injury, tissue response, and possibly to observe physiological effects in vivo that are relevant to its indications for use (e.g., local circulatory changes, if measured).
The overall goal of these studies, as stated by the manufacturer, was to demonstrate that "the technological differences between the Thermotex Heat Therapy Systems and the predicate device do not raise new questions of safety and effectiveness." The FDA's 510(k) clearance (K092589) confirms that, based on the submitted information (including the preclinical bench and animal testing), the device was found to be substantially equivalent to its predicate device (BIO-MAT 2000, K072534) for its stated indications for use. This substantial equivalence determination implies that the device met the necessary safety and effectiveness standards relevant to its classification as a Class II device.
§ 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.