(500 days)
Genesis Health Light's CS1000 Light Therapy Device is a hand held device used for the treatment of pain by emitting energy in the near IR spectrum for the temporary relief of minor muscle and joint pain, and muscle spasm; relieving stiffness, promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Genesis Health Light's CS1000 Light-based heat Therapy Device is a hand held device used for the treatment of pain. The primary components of the device are a motor and fan, light bulb, lens and the plastic injection molded housing which encapsulates the device. Cooling liquid is located within the lens assembly. An electric cable is attached to the internal workings of the device and it plugs into a standard 120V electrical outlet to power the device.
The provided text describes a 510(k) premarket notification for the Genesis Health Light Corporation's CS1000 Light-based heat Therapy Device. This submission primarily focuses on establishing substantial equivalence to predicate devices, rather than an extensive clinical trial to demonstrate new efficacy.
Here's an analysis of the provided information concerning acceptance criteria and the "study" that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety - Skin Surface Temperature: Device applies heat within a safe and effective range for pain relief, avoiding burns. (Implied by the function of a heat therapy device) | The CS1000 device is "capable of heating the skin surface to 40°-45°C." |
| "In high power setting, the skin temperature takes 3-4 minutes to get 40°C, while 8-9 minutes when it is in low power setting." | |
| "Over the entire test period, the temperature doesn't exceed 42°C." | |
| "The skin color tone doesn't impact skin surface temperature." | |
| Intended Use Equivalence: Device performs similarly to predicate devices for pain relief via near IR energy. (Explicit goal of 510(k)) | The subject and predicate devices are "equivalent in terms of intended use, technology and materials." (This is a claim of equivalence, not a direct performance metric). |
Important Note: The provided document is a 510(k) summary. For devices seeking 510(k) clearance, the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate device. This means demonstrating that the new device is as safe and effective as the predicate, not necessarily proving de novo efficacy through extensive clinical trials. The "performance test" on skin temperature is a supporting data point for safety and controlled heating, aligning with what would be expected of such a device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 7 people
- Data Provenance: The study was conducted on "7 people with light and dark skin color tone." The location or country of origin of these participants is not explicitly stated. Given the manufacturer is based in Canada, it's plausible the testing occurred there, but this is an inference. The study appears to be prospective as measurements were actively taken during the device's operation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth in the context of the skin surface temperature test. The test measured a physical parameter (temperature) directly. Such measurements typically rely on calibrated instruments rather than expert subjective assessment for ground truth.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method. Since the test involved objective temperature measurements, adjudication by multiple readers or experts is not applicable in this context.
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
This is not applicable. The device is a physical light therapy device, not an AI software or diagnostic tool that would involve human readers or interpretation of cases. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI" was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical medical device, not an algorithm, so a standalone algorithm performance study was not conducted. The skin temperature test evaluates the device's physical output.
7. The Type of Ground Truth Used
The ground truth for the skin surface temperature test was direct objective measurement of skin temperature using a "laser temperature reader."
8. The Sample Size for the Training Set
There is no mention of a training set. This is not an AI or machine learning device that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or applicable for this type of device, this question is 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.