(101 days)
The model CG-4000 Cell Gen laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.
The Cell Gen CG-4000 laser is a non-invasive, diode laser system consisting of an enclosure which contains the control unit and a treatment probe connected by an optic fiber.
The provided text is a 510(k) summary for the Cell Gen Laser, Model CG-4000. It focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or effectiveness.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth cannot be extracted from this document because such a study is not described.
Here's a breakdown of what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document implies the overarching acceptance criterion is substantial equivalence to the predicate device (Neurolase150, K032787) in terms of function, performance, energy source, and intended uses. Specifically, it aims to comply with "generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration." No specific numerical thresholds or performance metrics are provided as acceptance criteria for clinical efficacy.
- Reported Device Performance: The document states that the device "has similar function, performance, energy source and intended uses" to the predicate. It also mentions "producing a level of tissue temperature reported in literature." However, no specific performance data from a clinical study (e.g., pain reduction scores, range of motion improvements, objective temperature measurements in a clinical setting) are reported to demonstrate effectiveness against stated acceptance criteria.
| Acceptance Criteria (Inferred/Implied) | Reported Device Performance (from text) |
|---|---|
| Substantial Equivalence to Predicate Device (Neurolase150, K032787) | "The CG-4000 and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices use infrared laser diodes to generate topical heating for temporary relief of muscle and joint pain. The overall safety and effectiveness of the CG-4000 is not affected by differences in design from the predicate devices." |
| "In consideration of the testing and comparison to the predicate devices, the CG-4000 has similar function, performance, energy source and intended uses to these devices." | |
| Compliance with accepted therapeutic heat performance specifications | "This laser is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration." (No specific temperature range or data provided from the device's own testing in the summary). |
| Safety | "Testing of the CG-4000 will include performance testing and electrical safety testing in accordance with all applicable standards for this type of medical device." (No specific safety incident rates or data are reported in the summary.) |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. The document describes "performance testing and electrical safety testing" but does not mention a clinical "test set" or study involving human subjects to assess the device's efficacy for pain relief or other intended uses. The focus is on technical compliance and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. No clinical ground truth or experts for such a purpose are mentioned, as no clinical efficacy study is detailed.
4. Adjudication method for the test set:
- Not Applicable / Not Provided.
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:
- Not Applicable. This device is an infrared lamp for therapeutic heat, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant to this product submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See point 5.
7. The type of ground truth used:
- The "ground truth" for the submission is primarily the predicate device (Neurolase150), which was previously cleared by the FDA. The submission's "truth" is that the new device is substantially equivalent to this already-approved device, and therefore can be considered safe and effective for the stated indications.
- Additionally, "generally accepted therapeutic heat performance specifications" and "literature" are cited as a basis for understanding effective tissue temperature.
8. The sample size for the training set:
- Not Applicable / Not Provided. No machine learning or AI component that would require a training set is mentioned.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided.
§ 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.