(59 days)
The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
The Dermillume Pro1000 device is a compact light source that delivers high intensity narrow band blue and red light to the body for the treatment of acne vulgaris. The light sources are narrow wavelength LEDs that supply a spectral output of 414 ± 5 nm (blue) and 633 ± 5 nm (red). The device supplies 20 and 10 mW/cm² for blue and red light, respectively, at 4.6 inches distance from the skin surface. The principal parts of the device are a light unit, positioning arm and firmware timer to control duration of exposure. Additional off-the-shelf electronic devices related to treatment data acquisition and storage may be supplied as user options.
The Care Electronics, Inc. Dermillume Phototherapy Device is a blue/red light acne treatment lamp (K043575).
Here's an analysis of its acceptance criteria and the supporting study, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Irradiance at 4.6 inches from skin surface (Blue Light) | 20 mW/cm² |
| Irradiance at 4.6 inches from skin surface (Red Light) | 10 mW/cm² |
| Output Wavelength (Blue Light) | 414 ± 5 nm |
| Output Wavelength (Red Light) | 633 ± 5 nm |
| Comparability to Predicate Devices (Irradiance) | Irradiance at a practicable distance (4.6") is comparable with cited predicate devices and in conformance with recommendations of current clinical studies. |
| Mode of Operation | Same as predicate devices. |
| Treatment Area | Same as predicate devices. |
| General Principles for Treatment | Same as predicate devices for the treatment of inflammatory acne vulgaris, including the reduction and elimination of P. acnes. |
| Adverse Reactions | "No significant adverse reactions observed in clinical studies using this technology." (Implies meeting an unstated threshold for acceptable safety.) |
| Efficacy | Device is stated to be "efficacious," with blue light reducing P. acnes and red light improving acne based on a recent clinical study. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "current clinical studies" and a "recent clinical acne treatment study" but does not specify the sample size for any test set from these studies. It also does not directly state the data provenance (e.g., country of origin) or whether the data was retrospective or prospective for these studies. The performance data specifically cited for Dermillume (irradiance, wavelength) comes from "bench testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "recommendations of current clinical studies" and a "recent clinical acne treatment study" but does not detail how ground truth was established within those studies or if experts were involved in a consensus process for a test set specific to this device's submission.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's technical specifications and its substantial equivalence to predicate devices, along with general claims of efficacy and safety supported by unnamed "clinical studies" and "this technology" broadly.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
The Dermillume Phototherapy Device is a physical light-emitting device for treatment, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this device.
7. The Type of Ground Truth Used
The document refers to "recommendations of current clinical studies" and a "recent clinical acne treatment study" as supporting evidence for the efficacy of blue and red light therapy. However, the specific type of ground truth used (e.g., expert consensus on clinical severity scores, photographic assessment, microbiological culture for P. acnes, patient-reported outcomes) within these clinical studies or for this device's specific validation is not detailed. For the physical parameters (irradiance, wavelength), the ground truth is based on bench testing measurements against established specifications.
8. The Sample Size for the Training Set
The document does not provide information on a training set sample size. As a non-AI device, the concept of a "training set" in the context of machine learning does not apply. The device's design is based on established scientific principles of phototherapy and comparison to existing predicate devices.
9. How the Ground Truth for the Training Set was Established
As this is not an AI device, there is no training set in the machine learning sense, and therefore no ground truth establishment for a training set. The device's design and performance claims are based on engineering specifications and the scientific understanding of phototherapy for acne, benchmarked against predicate devices and existing clinical literature.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.