(225 days)
The Nexus BioWave Series IR Lamp Systems are 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 Nexus Series IR Lamp Systems are intended for use as infrared heat lamps. The Systems are non-invasive devices that emit light energy to the skin-surface of human body for the purpose of causing the therapeutic elevation of tissue temperature.
The Nexus Series IR Lamp Systems deliver an invisible laser light beam in the infrared spectrum at wavelengths of 810 and 980 nm using a gallium aluminum arsenide (GaAlAs) source. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic red laser guide light. The Systems consist of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.
The control consoles are made of standard medical PVC material and are designed to be place on a desktop or table in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.
The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a focusing lens at the aperture, which is made of glass suitable for medical applications.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nexus Series IR Lamp Systems:
The provided document is a 510(k) Notification Supplement for an Infrared Lamp. It describes the device, its intended use, and summarizes the testing performed. However, it's important to note that this document does not describe a study in the context of typical AI/ML medical device evaluations, which involve large datasets, expert ground truth, and statistical performance metrics like sensitivity, specificity, or AUC.
Instead, this document describes bench testing and limited human subject testing to demonstrate physical performance specifications of a medical device (an infrared lamp) and its compliance with relevant standards. The "acceptance criteria" here relate to the device's ability to achieve and maintain a specific therapeutic temperature range on tissue.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Capable of achieving therapeutic temperature range of 40 - 45 degrees Centigrade. | The device achieved a topical temperature range of 41 to 43 degrees Centigrade during exposure after a brief stabilization time. This meets the 40-45°C therapeutic range. |
| Increase in topical heating of the tissue level by at least 5 degrees Centigrade within one (1) minute. | An increase in topical heating of at least 5 degrees Centigrade was reached within one (1) minute. (Pre-exposed temperature ranged from 30-32°C, and exposed temperature ranged from 41-43°C, indicating an average increase of 10-13°C, well above 5°C). |
| Therapeutic temperature range maintained for the 10-minute testing time. | The therapeutic temperature range (41-43°C) was maintained for the 10-minute testing time. |
| Compliance with international standards: EN 60601-1, EN 60601-1-2, ISO 14971. | The Systems are manufactured to comply with these standards. (The document states compliance, but specific test results for each standard are not detailed in this summary). |
| Primary Goal: Substantial equivalence to predicate devices for intended use, functional, and performance characteristics. | Demonstrated through comparison of technical characteristics and the successful physical performance testing (temperature achievement and maintenance). The FDA concurred with the substantial equivalence determination. |
Study Details and Data Provenance
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Sample size used for the test set and the data provenance:
- Sample Size: 3 human subjects.
- Data Provenance: The document does not specify the country of origin of the data, but the applicant (USA Laser Biotech Inc.) is based in the USA. The testing appears to be prospective bench testing and limited human subject testing, not a retrospective or prospective clinical trial with a large patient cohort.
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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. For this type of device (infrared lamp) and the specific testing described (temperature achievement on skin), there are no "experts" establishing a diagnostic "ground truth" in the way one would for an imaging or AI diagnosis device. The "ground truth" is the objective measurement of temperature using calibrated equipment, conforming to generally accepted physiological temperature ranges for therapeutic heat. The document refers to "generally accepted topical temperature range for therapeutic heat of 40 - 45 degrees centigrade" as the standard.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on ambiguous medical cases in AI/ML performance studies. This is not reported as such a study. The data appears to be direct physical measurements (temperature readings).
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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:
- No. An MRMC study is not relevant or applicable to this device or the described testing. This device is an infrared heat lamp, not an AI-powered diagnostic tool intended to assist human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, but not as an "algorithm." The core "performance" tested was the device's inherent ability to generate and maintain heat. This is a standalone device function, independent of human interpretation or AI algorithms. The measurements of temperature were objective, not subjective "readings."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective physical measurement (temperature) against established physiological and therapeutic thresholds. Specifically, reaching and maintaining a topical tissue temperature of 40-45 degrees Centigrade, and increasing pre-exposed temperature by at least 5 degrees Centigrade within one minute. There is no expert consensus, pathology, or outcomes data used to establish this specific "ground truth."
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The sample size for the training set:
- Not Applicable. This device does not employ an AI/ML algorithm that requires a training set. The "testing" described is for functional and electrical safety performance of a physical medical device.
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How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
§ 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.