(203 days)
The Gaunying Infrared Lamp ( Model #: IL50) 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, or muscle spasm; the temporary increase in local blood circulation.
Gaunying Infrared Lamp (Model#: IL50) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.
Here's an analysis of the Gaunying Infrared Lamp (Model IL50) based on the provided 510(k) summary, aiming to answer your specific questions.
Important Note: This device is a basic therapeutic heating lamp. The acceptance criteria and testing described are for physical performance and safety, not for diagnostic accuracy or complex AI performance metrics like those seen in medical imaging.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Heat Output: Maintain temperatures above 40°C for at least 10 minutes within a 15-minute cycle. | - Maintained >40°C for at least 10 minutes. |
- Sensor (skin) temperature never exceeded 45°C. |
| | Temperature Homogeneity/Consistency (implied by predicate comparison) | Device "tracks temperature readings" of the predicate device, indicating comparable heat output. |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, UL 60601-1 standards. | Device is "manufactured to comply" with these standards. (No specific test results detailed, but compliance is stated). |
| Usability | Operating Instructions (OI) are clear and allow safe and effective operation by lay people. | Initial study showed questions, but revised OI led to no difficulties for a new study group. Concluded OI clear and effective. |
| Equivalence to Predicate | Similar intended use and comparable performance (specifically heat output characteristics). | Same intended use. Wavelength difference considered not to affect effectiveness. Bench test showed temperature readings tracked predicate device. Concluded "as safe and effective as the predicate device" and "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Functional Performance Test: 2 devices (Gaunying Infrared Lamp Model IL50).
- Data Provenance: Not explicitly stated, but implies internal bench testing conducted by the manufacturer, likely in China (where the company is based). This is a retrospective evaluation of a manufactured product.
- Usability Test: An initial group of 10 people (5 females, 5 males). A second group of 10 people for re-testing.
- Data Provenance: Not explicitly stated, but implies internal testing by the manufacturer. This would be a prospective user study.
- Comparison Temperature Test: Not explicitly stated, but assumed to be 1 subject device (IL50) and 1 predicate device (Xinfeng Heating Lamp).
- Data Provenance: Not explicitly stated, but implies internal bench testing. This is a retrospective evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There are no "experts" in the traditional sense of medical specialists establishing ground truth for this type of device. The ground truth for functional performance (temperature output) is based on instrument measurements (digital temperature sensor) and engineering specifications (e.g., target temperature ranges).
For the Usability Test, the "ground truth" was an observable measure of user comprehension and ability to operate the device based on the Operating Instructions, observed by the study facilitators. No specific "experts" in usability were mentioned, but the observers effectively served this role.
4. Adjudication Method for the Test Set
- Functional Performance Tests: No explicit adjudication method described. The results are quantitative measurements from instruments. The two devices in the initial heat output test tracked "near 100%", implying consistency without needing further adjudication.
- Usability Test: The adjudication was based on direct observation of user interaction and their verbal feedback/questions. The Operating Instructions were revised based on this feedback. The re-test observed a lack of difficulties, effectively adjudicating the revised instructions as clear. There's no "2+1" or similar method, as it's a qualitative observation of user behavior.
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. This device is an infrared lamp for therapeutic heating, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The functional performance and comparison tests were standalone in the sense that they evaluated the device's physical output (heat generation) directly through measurement, without human intervention affecting its output. The "algorithm" here is the device's internal mechanism for generating infrared light and heat. Its performance was measured intrinsically.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Functional Performance:
- Instrumental Measurements: Digital temperature sensor readings served as the primary ground truth for heat output.
- Engineering/Physiological Specifications: The desired effective temperature (>40°C) and the safety threshold (
§ 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.