(147 days)
The Multi-Channel Laser Therapy System (Model no.: LA-1200) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and the joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
The Multi-Channel Laser Therapy System LA-1200 is a noninvasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles. LA-1200 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-1200 contains twelve (12) channels of laser. For each channel of the Multi-Channel Laser Therapy System, LA-1200 makes use of cup + laser diode assembly hand-held to deliver the light energy to the designated treatment areas. The cup_ + laser diode assembly are put on the skin for treatment.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Multi-Channel Laser Therapy System, Model LA-1200:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|
| Increase the temperature of the skin exposed to the laser module cup | Device demonstrated it "increases the temperature of the skin exposed to the laser module cup." |
| Maintain a skin temperature of 40 ~ 45°C (104 ~ 113°F) following 15 minutes exposure to the light. | Device demonstrated it "maintains a skin temperature of 40 ~ 45°C (104 ~ 113°F) following 15 minutes exposure to the light." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "bench testing was also performed." However, it does not specify the sample size used for this testing. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond simply being "bench testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for the test set. The validation appears to be based on direct physical measurements of temperature during bench testing.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the validation was based on direct physical measurements rather than expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:
No MRMC comparative effectiveness study was mentioned. The study described is bench testing of the device's physical performance, not a study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a physical therapeutic laser system, not an algorithm. Therefore, the concept of a "standalone" or "algorithm-only" performance study is not applicable in this context. The described bench testing assesses the standalone performance of the physical device.
7. The Type of Ground Truth Used:
The ground truth used was direct physical measurement (temperature readings) during bench testing.
8. The Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a training set. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for an AI/ML algorithm, this information is not applicable.
§ 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.