(61 days)
Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome
The Luminex LL System is a non-thermal, non-invasive, low energy infrared laser, therapeutic medical device that is intended for use as an adjunctive treatment for the temporary relief of hand and wrist pain associated with carpal tunnel syndrome. The Luminex Laser Therapy System incorporates an AC or battery powered Control Unit and a hand-held laser diode probe incorporating three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90mW at the 830 nanometer (nm) wavelength.
The provided text describes a 510(k) premarket notification for the Luminex LL Laser System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing de novo studies with specific acceptance criteria, large sample sizes, and detailed ground truth establishment as would be seen in a PMA (Premarket Approval Application) or clinical trial for a novel device.
Therefore, many of the requested details such as specific acceptance criteria for performance metrics, detailed sample sizes for test/training sets from prospective data, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance studies are not applicable (N/A) in this context as they are not typically part of a 510(k) submission for this type of device.
Here's a breakdown based on the available information:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Substantial Equivalence to Predicate Devices Demonstrated substantial equivalence to the Microlight Corporation of America, Inc., MicroLight 830 Laser System (K010175), the Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657), and the Meridian Co., Ltd., Lapex 2000 (K034009) based on: - Same intended uses. - Intended for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome, matching predicate devices. - Similar technical and performance characteristics (infrared lamps, invisible photonic energy to tissue). - Emits invisible photonic energy to tissue using three 30mW Gallium Aluminum Arsenide (GaAlAs) laser diodes (total 90mW) at 830nm wavelength, similar to predicate devices. Classified as an infrared lamp per 21 CFR 890.5500. Functional Performance and Electrical Safety Compliance - System underwent functional performance testing and electrical safety testing. Compliance with FDA's Quality System Regulations and applicable standards for light-emitting medical devices. - Manufactured to comply with FDA's Quality System Regulations and applicable standards for light emitting medical devices. Does not raise new questions of safety or effectiveness. - Conclusion states the Luminex LL Laser System performs as intended and does not raise any new questions of safety or effectiveness when compared to predicate devices. It is designed to comply with generally accepted therapeutic laser performance specifications as an adjunctive treatment for relief of hand and wrist pain associated with Carpal Tunnel Syndrome. FDA's letter concurs with substantial equivalence. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission relies on demonstrating substantial equivalence to predicate devices, not on a clinical test set with human subjects to evaluate efficacy against specific metrics for the device itself. The "testing" mentioned is functional performance and electrical safety testing of the device hardware, not a clinical study on patient data.
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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)
- N/A. No clinical "test set" and corresponding ground truth determination by experts are described for this 510(k) submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical "test set" requiring adjudication is described.
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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
- N/A. This device is a therapeutic laser, not an AI-powered diagnostic imaging device. No MRMC studies were conducted or are relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a hardware therapeutic device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Clinical ground truth (e.g., patient outcomes, pathology) for efficacy in a clinical trial setting is not described in this 510(k) for the Luminex LL Laser System itself. The "ground truth" for this 510(k) is the established performance and safety profiles of the legally marketed predicate devices.
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The sample size for the training set
- N/A. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- N/A. This device is not an AI/ML algorithm.
§ 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.