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510(k) Data Aggregation
(34 days)
CARE ELECTRONICS, INC.
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.
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(59 days)
CARE ELECTRONICS, INC.
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.
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