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510(k) Data Aggregation
(188 days)
FIR HEAT THERAPHY SYSYEMS
The FIR 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 FIR 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 nyloncotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.
Here's a breakdown of the acceptance criteria and study information for the FIR Heat Therapy Systems, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical efficacy. Instead, the acceptance criteria are largely based on demonstrated equivalence to a predicate device and adherence to relevant safety and performance standards. The performance testing focuses on physical characteristics supportive of its intended use and safety.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Safety & Biocompatibility | Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). | Patient contacting materials (Nylon-cotton blend pad, ABS plastic cover, Nylon Velcro fastener) are compliant with ISO 10993-1. (Note 1) |
| Compliance with ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity). | Patient contacting materials are compliant with ISO 10993-5. | |
| Compliance with ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity). | Patient contacting materials are compliant with ISO 10993-10. | |
| Electrical Safety | Compliance with IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety). | The power supply (6Vdc, 8W) is compliant with IEC 60601-1. (Note 2) |
| EMC | Compliance with IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests). | The device is compliant with IEC 60601-1-2. |
| Infrared Spectrum | Emits within the therapeutic range of 5-15 microns, with a center around 9 microns (matching predicate). | The subject device emits the main infrared electromagnetic spectrum of 5-15 microns, with a center around 9 microns. |
| Therapeutic Temperature | Core temperature range of heating pad is within 40-45°C (matching predicate and FDA's generally considered therapeutic range). | The infrared energy test (Thermal Distribution Map) shows that the core temperature range of the heating pad is about 44°C. |
| Skin Temperature Reach | Time for skin surface to reach 40°C. | The skin temperature test shows that the time for skin surface to reach therapeutic temperature range 40°C is about 5 minutes. |
| Time for skin surface to reach maximum temperature (comparable to predicate or within therapeutic range). | The skin temperature test shows that the time to reach maximum temperature 42°C is about 10 minutes. (Note: Predicate had ~44°C for Low setting, but the subject device's 41-42°C is noted as being within the 40-45°C therapeutic range.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a clinical "test set" in the sense of a patient population for evaluating clinical outcomes. The performance testing described (skin temperature, infrared energy/spectrum) appears to be laboratory-based testing of the device itself, not human subjects. Therefore, sample size and data provenance relating to human subject data are not applicable here.
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)
This information is not applicable. The ground truth for the performance tests (e.g., infrared spectrum, temperature measurements) would be established by standard scientific measurement techniques and instrumentation, not expert human assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or mentioned. This device is a heat therapy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical therapy device with a direct effect, not an algorithmic diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests mentioned:
- Infrared spectrum and energy: Ground truth would be established by calibrated scientific instruments (e.g., spectrometers, thermal cameras/sensors) and physical principles.
- Temperature measurements: Ground truth would be established by calibrated thermometers or thermal probes.
8. The sample size for the training set
This information is not applicable. There is no indication of a "training set" as this device does not involve machine learning or AI models. This is a traditional medical device demonstrating substantial equivalence through standard performance testing and comparison to a predicate.
9. How the ground truth for the training set was established
This information is not applicable, as there was no training set.
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