(260 days)
- Use wherever hot applications are desirable for personal comfort and whenever A recommended by a licensed medical professional
- Provides temporary relief of minor aches and pains in muscles and joints
- Aids in the relaxation of muscles
- Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief
- Provides a temporary increase in local blood circulation
Not Found
This document is a 510(k) clearance letter from the FDA for the BioScan, Inc. Light Patch, indicating that the device has been found substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria or specific study results that would typically be found in a clinical trial report or a summary of safety and effectiveness data (SSE).
Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the study proving the device meets them. The document states "we have reviewed your 510(k) notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that BioScan, Inc. submitted data to the FDA in their 510(k) notification, but the specifics of that data are not included in this clearance letter.
To fully answer your request, external documents (such as the actual 510(k) submission, including the summary of safety and effectiveness, or clinical study reports if applicable for this type of device) would be needed.
However, I can extract the "Indications for Use" which the FDA has cleared, and this effectively defines the performance expected of the device in a broad sense, though not as specific quantitative acceptance criteria.
Summary of what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
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Acceptance Criteria (Derived from Indications for Use - qualitative):
- Suitable for hot applications for personal comfort.
- Provides temporary relief of minor aches and pains in muscles and joints.
- Aids in the relaxation of muscles.
- Helps provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief.
- Provides a temporary increase in local blood circulation.
-
Reported Device Performance: The document states the device is "substantially equivalent" to legally marketed predicate devices for the given indications for use. This means the FDA has accepted that its performance is comparable to existing, legally marketed products performing the same functions. No specific quantitative performance metrics are provided in this letter.
2. Sample size used for the test set and the data provenance:
- Not specified in the provided text. The 510(k) letter does not include details on sample size or data provenance (e.g., country of origin, retrospective/prospective nature) of any studies conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text. This information would typically be found in the manufacturer's 510(k) submission or a related study report, not in the FDA clearance letter itself.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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 based on the device type. The "Light Patch" appears to be a therapeutic device providing heat and pain relief, not an AI-assisted diagnostic imaging device requiring human readers. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not specified and likely not applicable. This device is a physical therapeutic product, not an algorithm, so "standalone algorithm performance" is not a relevant concept for this specific product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified in the provided text. Given the indications for use (pain relief, muscle relaxation, blood circulation), the ground truth for any underlying studies would likely involve participant-reported outcomes (e.g., pain scales, comfort levels), physiological measurements (e.g., temperature, blood flow), or possibly clinical assessments by healthcare professionals.
8. The sample size for the training set:
- Not specified in the provided text. 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 the device is not an AI/ML algorithm, it does not have a "training set" in this context.
§ 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.