(238 days)
The Multi-Channel Laser Therapy System (Model no.: LA-400) 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-400 is a noninvasive, conamic casel Therapy System LA-400 is a not deliver light energy to the target tissue. It is intended to emit energy in the infrared spectrum for the purpose of temporary relief of minored spectrum for the purpos temporary relief of minor muscle and the joint pain associated with arthritis, for the temporary increase in local circulation where arthritis, for the temporary increase in le l Lacer The (Model no.: LA-400) is interapy System infrared spectrum to provide to emit energy in the infrared spectrum to provide topical heating for the of elevating tissue temporature for the purpose of elevating tissue temperature for the temporary relief of temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied minor muscle and the joint pain and stiffness, for the temporary relia temporary relief of miner in in in in the LA-400 is the low level laser of two wave bands. One is 660nm (red light, visibility) and the other is 808nm (infrared light, invisibility). LA-400 contains four (4) channels of laser. For each channel of the Multi-Channel Laser Therapy System , LA-400 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. Note A : Basic operation and treatment of LA-400 is utilizing the laser module mounted in the cup (we call laser module cup) which will be hand-held and put on skin easily.
The provided 510(k) summary for the Multi-Channel Laser Therapy System, Model no.: LA-400, focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and conformance to safety and EMC standards. It does not contain information about a clinical study involving human participants, performance metrics like sensitivity or specificity, or any form of a multi-reader multi-case (MRMC) study.
Therefore, many of the requested sections regarding acceptance criteria and a study proving those criteria cannot be directly answered from the provided text. The "performance summary" in this document refers to compliance with engineering and safety standards, not a clinical performance study in the way typically associated with diagnostic or AI-powered devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria and reported "performance" for this device, as described in the 510(k) summary, are related to its adherence to electrical safety and electromagnetic compatibility (EMC) standards, not clinical efficacy or diagnostic accuracy.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance |
|---|---|
| ISO 13485 (Quality Management System) | Conforms |
| IEC 60825-1 (Laser Safety) | Conforms |
| IEC 60601-1 (Medical Electrical Equipment - Basic Safety and Essential Performance) | Conforms |
| IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic Compatibility) | Conforms |
| Clinical Efficacy for Intended Use | Demonstrated by substantial equivalence to predicate device (ACUMED LASER, MODEL 1000, K060153) based on similar intended use and technological characteristics. Bench testing confirmed differences do not raise new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set data is described in this 510(k) summary. The performance summary refers to bench testing for conformance to standards, not a clinical study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of a test set requiring expert ground truth in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in this submission.
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. A multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this is a laser therapy system for pain relief, not a diagnostic imaging device typically associated with such studies. The device does not involve AI or human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical therapy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth data is discussed for this device in the provided text. The "ground truth" for this submission revolves around compliance with established engineering and safety standards for medical devices and demonstration of similar intended use and technology to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth for one.
§ 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.