(34 days)
The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarity increase local blood circulation.
The Dermillume Red HR1000 lamp is a compact light source that delivers high intensity narrow band red and near infrared light to the skin surface. The light sources are narrow bandwidth LEDs mounted in an array to give even and safe illumination of skin surfaces. The principal parts of the lamp are a light unit, positioning arm and firmware timer to control duration of exposure.
The Dermillume Red HR1000 infrared lamp is intended for therapeutic use. The provided text, however, focuses on a 510(k) summary for substantial equivalence to predicate devices, rather than a study proving specific acceptance criteria related to its therapeutic efficacy.
Therefore, the response below reflects the information available regarding the performance data provided for demonstrating substantial equivalence, which is a regulatory pathway, not a clinical efficacy study with acceptance criteria in the traditional sense of a clinical trial.
Here's the breakdown based on the provided document:
1. Table of "Acceptance Criteria" and Reported Device Performance
It's important to clarify that this 510(k) summary doesn't present "acceptance criteria" in the typical sense of a clinical study (e.g., target RMSE, sensitivity, specificity for a diagnostic device). Instead, the performance data provided is to demonstrate substantial equivalence to predicate devices. The "criteria" are implicit in proving comparability.
| Acceptance "Criteria" (Implicit for Substantial Equivalence) | Reported Device Performance (Dermillume Red HR1000) |
|---|---|
| Irradiance at practicable distance from skin surface | Comparable with cited predicate lamps. The device performs similarly to existing, legally marketed infrared therapy lamps in terms of energy delivery to the skin surface. |
| Mode of operation, technology, and general principles | Same as the predicate lamps. This indicates functional and technological similarity to established devices. |
| Safety profile | No significant adverse reactions observed in clinical studies using this technology. The device is considered safe based on existing knowledge and absence of new safety concerns compared to predicate devices. |
| Efficacy | Efficacious. The efficacy is indirectly supported by its substantial equivalence to predicate devices that are considered effective for their intended use. The 510(k) process doesn't require a new clinical efficacy study if substantial equivalence can be demonstrated. It is intended for relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains, and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation. |
| Spectral output | Substantially equivalent to predicate lamps. |
| Operating principles | Substantially equivalent to predicate lamps. |
| General and specific indications for use | Substantially equivalent to predicate lamps. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention a "test set" or a sample size for a clinical study to evaluate the device's therapeutic efficacy. The performance data discussed is from "bench testing" to compare the irradiance. Data provenance is not specified beyond being "bench testing." This is typical for a 510(k) where the primary goal is often to demonstrate equivalence, not necessarily de novo clinical efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. The text does not describe a clinical study requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Not Applicable. There is no mention of a clinical study or associated adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The provided text does not describe an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human readers interpret results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is an infrared therapy lamp, not an algorithm. The concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant here.
7. The Type of Ground Truth Used
Not Applicable. The document does not describe a clinical study that would require a "ground truth" (e.g., pathology, outcomes data). The performance data cited is for "bench testing" to compare irradiance.
8. The Sample Size for the Training Set
Not Applicable. This is an infrared therapy lamp, not an AI/ML algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, this is not an AI/ML 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.