(130 days)
HeatLux is over the counter hand held device intended to emit energy in the visible and near IR spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and temporary relaxation of muscles.
HeatLux is a hand held device battery operated that uses low power light spectrum, LED, at wavelength of 645 ±10 nm, combine with tip temperature stabilizer at 41°C. The emitting optical power is in a uniform distribution with no hot spots.
The provided 510(k) summary for the HeatLux device (K120582) describes primarily bench testing for performance verification and does not mention a clinical study with human participants. Therefore, an in-depth analysis of acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, or comparative effectiveness studies (MRMC) for clinical outcomes is not available from this document.
However, based on the information provided, here's a breakdown of the available details:
1. Acceptance Criteria and Reported Device Performance
The document describes bench testing to ensure the device performs as intended with regard to temperature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reach idle temperature of 41°C | Verified through bench testing |
| Maintain 41°C over time | Verified through bench testing |
| Uniform temperature output | Verified through bench testing (thermal camera) |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not applicable, as detailed clinical testing with a specific "test set" of human subjects is not described. The bench testing involved "multiple body areas and skin types" for thermal camera measurements, but specific participant numbers are not provided.
- Data Provenance: The testing was likely conducted in Israel, the country of origin of the manufacturer (Home Skinovations Ltd.). It was retrospective in the sense that it was performed as part of the device development and verification process.
3. Number of Experts and Qualifications
Not applicable. This information is not provided in the context of the bench testing described. Expert involvement for ground truth establishment is typically relevant for clinical studies involving diagnostics or subjective assessments.
4. Adjudication Method
Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies between expert assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on device technical performance (heating capability) and substantial equivalence to predicate devices based on technical specifications and intended use. The document does not describe studies on how human readers (or users) improve with or without AI assistance, as AI is not a component of this device.
6. Standalone Performance Study
A standalone performance bench test was done to verify the device's ability to reach and maintain a target temperature. This is analogous to standalone performance for hardware, ensuring it functions according to specifications.
- Test 1: Temperature sensor attached to the metal surface of the device monitored temperature as a function of time.
- Test 2: A thermal camera was used to monitor skin temperature and uniformity on multiple body areas and skin types.
7. Type of Ground Truth Used
For the bench testing, the "ground truth" was established by engineering measurements of temperature using sensors and a thermal camera, verifying adherence to the designed temperature output (41°C).
8. Sample Size for the Training Set
Not applicable. This device is a physical therapeutic device, not an algorithm that requires a "training set" of data in the machine learning sense.
9. How Ground Truth for the Training Set Was Established
Not applicable, as no training set for an algorithm is involved.
§ 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.