(123 days)
GIGALaser 1801 is intended to emit energy in the visible and near infraced spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of min and stiffhess, minor arthritis pain, or muscle spassn; the temporary increase in local blood circulation; and for the temporary relaxation of muscles.
The GIGALaser 1801 is a non-invasive, low level therapeutic laser lamp. The control unit contains the power supply and the user interface panel. The IR laser lamp is placed on a folding arm which is attached to the base unit. The interface panel consists of three buttons for 'STOP', 'START' AND 'PAUSE' and there are 6 buttons for the 6 different pre-programmed treatment programs labeled 1 - 6. The buttons light up when selected. A LED segment tells the user the time the treatment has run. The GIGALaser 1801 is also equipped with a main key power switch and an emergency stop. The GigaLaser is a medical device, which is delivered with a user and therapy manual and a complete labeling for the user.
Here's a summary of the acceptance criteria and the study details for the GIGALaser 1801, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Therapeutic Heat Temperature Range | Achieve 40 - 45 degrees Celsius. | The GIGALaser 1801 is capable of achieving a therapeutic heat temperature range of 40 - 45 degrees Celsius. |
| Rate of Temperature Increase | Increase topical heating of the tissue level by at least 5 degrees Celsius within 1 minute. | An increase of at least 5 degrees Celsius in topical heating of the tissue level was reached within one (1) minute. |
| Duration of Therapeutic Temperature | Maintain therapeutic temperature range for at least 10 minutes. | The therapeutic temperature range (40-45 degrees Celsius) was maintained for at least ten (10) minutes. These data demonstrate the GIGALaser 1801 meets the generally accepted topical temperature range for therapeutic heat during the recommended treatment time of 10 minutes. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 4 subjects.
- Data Provenance: Not explicitly stated, but the submission is from PowerMedic ApS in Denmark. The clinical testing was conducted by or for the manufacturer, likely in Denmark or a location accessible to them. The study is described as "clinical testing conducted," implying it was specifically designed for this submission, likely making it prospective relative to the submission date.
3. Number of Experts and Qualifications for Ground Truth
- The document does not describe the use of "experts" to establish ground truth in the traditional sense of a diagnostic study. Instead, the "acceptance criteria" for temperature range (40-45°C) and the "at least 5°C increase within 1 minute" are referred to as "generally accepted by the FDA." This suggests that these are established and recognized physiological responses or therapeutic targets for heat therapy. There's no mention of individual expert opinions being adjudicated for the test results.
4. Adjudication Method for Test Set
- Not applicable. The study involved direct physical measurements of temperature and timing, not subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a therapeutic lamp, not an imaging or diagnostic device that typically requires human reader interpretation. The study focused on the device's ability to achieve and maintain therapeutic temperatures.
6. Standalone Performance Study (Algorithm Only)
- Yes, the study described is effectively a standalone performance study of the device itself. It measures the physical output and effect (heating) of the GIGALaser 1801, without any human-in-the-loop interaction beyond operating the device and monitoring the temperature.
7. Type of Ground Truth Used
- The ground truth used is based on physiologically accepted therapeutic temperature ranges and responses for heat therapy, specifically "40 - 45 degrees centigrade as accepted by the FDA" and "an increase in topical heating of the tissue level by at least 5° centigrade." These are objective, measurable physiological targets rather than subjective expert consensus, pathology, or outcomes data from a larger clinical trial.
8. Sample Size for Training Set
- Not applicable. This is a physical device, and the "study" described is a performance verification of its physical output and physiological effect, not an algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Not applicable, as there is no training set for an 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.