(189 days)
The HEALITE II system is intended for the following: For use in temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and to temporarily increase local blood circulation where applied.
The HEALITE Hesystem is a light emitting diode (1) ED) with high-spectral purity - Thissystem is packaged with an LED head for the particular intended use of the system. The wavelength of the HEALITE II is 830 nm. Additionally there is a 590 nm aiming beam. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.
The provided text is a 510(k) summary for the Lutronic Corporation HEALITE II device. The key takeaway regarding acceptance criteria and supportive studies is explicitly stated: "Performance Data: None presented."
This means the submission does not include direct clinical performance data or studies to establish acceptance criteria for the device itself. Instead, the fundamental argument for clearance is based on substantial equivalence to a predicate device.
Therefore, for almost all the requested information, the answer is "not applicable" or "not provided" based on the document.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
- Explanation: The document states "Performance Data: None presented." This implies that specific, measurable acceptance criteria based on studies, along with corresponding performance outcomes, were not part of this 510(k) submission. The clearance was based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set data was presented.
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)
- Not applicable. No test set data was presented, and therefore no ground truth was established by experts for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set data was presented.
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. No clinical studies, including MRMC studies, were presented. The device is a physical light therapy device, not an AI diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The HEALITE II is a physical light therapy device, not an algorithm, so "standalone" performance in the context of AI algorithms is not relevant here. No performance studies were conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No performance data or ground truth was established or used in this submission. The basis for clearance was substantial equivalence to a predicate device.
8. The sample size for the training set
- Not applicable. No training set was used. This device is a medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.