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510(k) Data Aggregation
(214 days)
The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne.
The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
The provided 510(k) summary (K070185) for the Tända Skincare System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. This document primarily focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) and detailing safety certifications.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred/stated based on the provided document:
1. Table of acceptance criteria and the reported device performance
The 510(k) summary does not mention specific quantitative acceptance criteria for treating acne or report detailed device performance metrics in relation to such criteria. The document states the device's intended use is "to treat Acne" and indicates that "Blue light modules are indicated to treat mild to moderate inflammatory acne."
2. Sample sized used for the test set and the data provenance
Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the document.
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 mentioned in the document. This device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a light therapy device, not an algorithm. Performance assessment typically involves clinical studies on patients, which are not described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not mentioned in the document. For a physical therapy device like this, ground truth would typically refer to clinical improvement or clearance of acne based on dermatologist assessment or objective metrics.
8. The sample size for the training set
Not applicable/mentioned. This is a physical device, not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
Not applicable/mentioned.
Summary of what is present in the document regarding "proof" of meeting criteria:
The document focuses on establishing substantial equivalence to a predicate device (BLU-U, MODEL 4170, K031805) based on "virtually identical" intended use and technological characteristics. It also states that "Any differences... have no significant influence on safety or effectiveness."
Additionally, it provides safety data demonstrating compliance with:
- IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- ISO 10993 (Biocompatibility)
- IEC 60825-1 (Laser Safety), with an Accessible Emission Limit (AEL) below the Class I threshold.
- Evaluation of ocular hazard levels, concluding no risk of retinal injury from blue-light phototoxic effect, thermal damage, or additive effects.
These safety certifications and comparisons to the predicate device form the basis for the FDA's 510(k) clearance, indicating that the device is deemed as safe and effective as the legally marketed predicate. However, it does not detail specific clinical performance criteria or a study that quantitatively measures the device's efficacy against those criteria.
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(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.
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