(211 days)
The L-SER-KO IR Lamp 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 joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
The L-SER-KO IR Lamp is intended for use as an infrared heat lamp. The L-SER-KO IR Lamp is a non-invasive device that emits light energy to the skin surface of the human body for the purpose of causing the therapeutic elevation of tissue temperature. The L-SER-KO IR Lamp delivers an invisible laser beam in the infrared spectrum at wavelengths of 810 nm using a gallium aluminum arsenide (GaAlAs) source. The laser beam is generated by an IR diode. The tissue to be treated is illuminated by non-therapeutic red LED guide lights. The L-SER-KO IR Lamp consists of only one hardware component, a handpiece containing the controller, user interface display and the treatment aperture. The handpiece is made of standard medical PVC material.
The document provided is a 510(k) Premarket Notification for the L-SER-KO IR Lamp. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving independent efficacy through clinical trials with acceptance criteria. Therefore, several of the requested sections (acceptance criteria, specific study design details like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth descriptions for training/test sets) are not applicable or explicitly stated in this type of regulatory submission.
Here's the information that can be extracted from the provided text, and where gaps exist due to the nature of a 510(k) submission:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" in the context of device performance, as typically understood for a clinical study proving efficacy, is not directly present in this 510(k) summary. Instead, the "acceptance" is based on demonstrating substantial equivalence to a legally marketed predicate device. The performance is assessed against the predicate devices' characteristics and through compliance with recognized standards.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (L-SER-KO IR Lamp) |
|---|---|---|
| Indications for Use | Substantially equivalent indications to predicate devices: topical heating for temporary relief of minor muscle/joint pain and stiffness, minor arthritis pain, muscle spasm; temporary increase in local blood circulation; temporary relaxation of muscle. | Meets these indications (stated in Section III and V). |
| Power Supply | Comparable to predicate devices (e.g., 115-120V, 50-60 Hz) | 115V single-phase 50-60 Hz |
| Heat Source | GaAlAs diode | GaAlAs diode |
| Wavelength | Comparable to predicate devices (e.g., 665/808 nm, 660/980 nm, 665/810 nm) | 665/810 nm |
| Average Power Output | Within a comparable range of predicate devices (e.g., 1.0 - 7.5 W range) | 1.2 W |
| Treatment Mode | Modulated | Modulated |
| Treatment Times | Variable | Variable |
| Delivery System | Diode or fiberoptic cable/handheld probe | Diode (handpiece containing aperture) |
| Safety and Standards | Compliance with relevant electrical safety and performance standards (e.g., 21 CFR 1010, 21 CFR 1040, EN 60601-1, EN 60601-1-2, ISO 14971) | Complies with these standards (Section VI). |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the "acceptance criteria" (defined here as substantial equivalence and compliance with standards) is primarily the 510(k) Premarket Notification submission itself and the testing outlined in Section VI.
The regulatory pathway for this device is based on substantial equivalence to predicate devices already on the market (USA Laser Biotech Inc. LUMINA 1600 Infrared Lamp Therapy System K052814 and Avicenna ALT Laser Model VTR 75 K031612). The "study" therefore consists of:
- Comparison to Predicate Devices: Section IV and V provide a detailed comparison of the L-SER-KO IR Lamp's characteristics (power supply, heat source, wavelength, average power output, treatment mode, treatment times, delivery system) to the identified predicate devices, demonstrating they are fundamentally similar.
- Functional Performance Testing: Section VI states that "functional performance testing" was conducted. This testing would verify that the device operates according to its specifications (e.g., emits at the specified wavelength, power output). Specific results are not detailed in this summary, but the conclusion (Section VII) states it "performs as intended."
- Electrical Safety Testing: Section VI also states "electrical safety testing" was performed to ensure compliance with a list of international standards (21 CFR 1010, 21 CFR 1040, EN 60601-1, EN 60601-1-2, ISO 14971).
Additional Information as Requested:
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is a submission demonstrating substantial equivalence to a predicate device, not a statistically powered clinical trial with a "test set" of patients/data. The "test set" refers to the device itself being tested for functional performance and electrical safety.
- Data Provenance: The device characteristics are reported by the manufacturer, YA-MAN LTD (Japan). The testing would have been conducted by or for YA-MAN LTD.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" derived from expert consensus on a test set of clinical cases in this 510(k) submission. The "ground truth" for the device's technical specifications is established by the manufacturer and verified through testing against engineering standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a 510(k) device specific to hardware performance and safety based on substantial equivalence.
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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:
- Not applicable. This device is an infrared lamp, not an AI-powered diagnostic tool. There are no "human readers" or AI assistance involved.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical therapy device, not an algorithm. However, the device itself is "standalone" in its operation for emitting infrared light.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the technical specifications and performance characteristics of the device, verified through engineering testing and compliance with recognized standards. For the purpose of substantial equivalence, the "ground truth" also effectively includes the established safety and efficacy profiles of the predicate devices. There is no clinical "ground truth" from pathology or outcomes data presented in this document.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- 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.