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510(k) Data Aggregation
(139 days)
The Oxylight is intended for dermatological use by physicians and healthcare professionals for the following:
LED Technology is intended for:
-Blue LED = 465nm - to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
-Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions.
- Yellow LED 590nm - treatment of periorbital wrinkles and rhytides.
Microdermabrasion is intended for exfoliation of the skin.
Oxygen spray is intended to refresh the skin.
The Oxylight system is a skin therapy system that uses three major modalities delivered by different attachments powered from a single energy source and operated from a universal control unit. The treatments include, LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray. The Oxygen Spray is delivered through the same panel used for LED light therapy and separate handpieces.
The provided document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than providing extensive clinical study data to prove novel efficacy or meet specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, and detailed clinical study methodologies is not available in this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of specific clinical acceptance criteria or human-centered performance metrics. Instead, it compares the technical characteristics of the Oxylight device (the "subject device") with predicate devices to argue for substantial equivalence in safety and efficacy.
The relevant "performance data" section focuses on safety testing against recognized electrical and electromagnetic compatibility standards.
| Standard | Test Title | Test Article | Acceptance Criteria (Implicit) | Reported Performance |
|---|---|---|---|---|
| IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 | Medical electrical equipment Part 1: General requirements for basic safety and essential performance | OxyLight | Compliance with standard IEC 60601-1 | Pass |
| EN 60601-1-2:2015, EN 61000-3-2:2014, EN 61000-2-3:2013 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Sapphire 3 OxyLight | Compliance with standard EN 60601-1-2 et al. | Pass |
| ISO 14971:2012 | Medical devices – Application of risk management to medical devices | Not directly tested (risk management applied) | Application of risk management principles | Applied |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Clinical testing was not performed with this device."
Therefore, there is no test set in the sense of a patient cohort, nor data provenance from such a set. The "test article" for safety testing was the device itself (OxyLight / Sapphire 3 OxyLight).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical testing was performed, no ground truth was established by experts for a test set in a clinical context.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as indicated by the statement "Clinical testing was not performed with this device."
The document does not mention any human reader performance or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Oxylight is a physical device (LED panel, microdermabrasion, oxygen spray) for dermatological use, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the purpose of substantial equivalence, the "ground truth" implicitly relies on the established safety and efficacy of the predicate devices with similar technical characteristics and indications for use. For the safety tests conducted, the ground truth was compliance with the specified international safety and EMC standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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(253 days)
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face
The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-U Treatment time is controlled by the operator
The provided text describes the 510(k) summary for the Omnilux Clear-U device, which is an LED array for treating mild to moderate acne. However, it does not include acceptance criteria for device performance or a study that directly proves the device meets specific performance criteria in terms of clinical efficacy.
Instead, the submission relies heavily on demonstrating substantial equivalence to predicate devices (Omnilux Revive, Omnilux blue, Omnilux revive/Omnilux blue combination) by arguing that "no significant differences exist" and therefore "raises no new issues of safety or effectiveness."
The "Performance Data" section mentions two tests related to user comprehension and usability, but these are about the user interface and labeling, not the therapeutic efficacy of the light treatment itself.
Here's a breakdown based on the information available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no specific performance-based acceptance criteria for the clinical efficacy regarding acne treatment explicitly stated, nor is there reported device performance against such criteria.
The document focuses on usability and safety, as well as substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Efficacy: (e.g., reduction in acne lesions by X% in Y weeks) | Not provided in the document. The submission relies on substantial equivalence to predicate devices for efficacy claims. |
| Usability Test Critical Objectives Comprehension Rate | Minimum comprehension rate of 88% at 95% confidence level |
| Self-Selection Test Critical Objectives Comprehension Rate | Minimum comprehension rate of 93% at 95% confidence level |
| Overall Performance Characteristics Analysis | Performed (stated to be a basis for belief in no significant differences), but specific results or metrics are not detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Self-Selection Test: A "sample representative population" was used. The exact sample size is not specified, but it was sufficient to determine a minimum comprehension rate of 93% at a 95% confidence level.
- Usability Test: A "sample representative population" was used. The exact sample size is not specified, but it was sufficient to determine a minimum comprehension rate of 88% at a 95% confidence level.
Data Provenance: Not explicitly stated, but given the submitter's address (Carlsbad, California) and the context of a 510(k) submission to the FDA, it is highly likely these tests were conducted in the United States. The document does not specify if these were retrospective or prospective studies; however, usability and self-selection tests are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable for the reported tests. The self-selection and usability tests evaluate user comprehension and ability to use the device based on labeling, not clinical outcomes that would require expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication methods (like 2+1, 3+1) are described as the tests were user comprehension/usability evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document does not mention any MRMC study. The comparison is made to predicate devices based on perceived "no significant differences" rather than a direct comparative effectiveness study involving human readers or clinicians.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The Omnilux Clear-U is a therapeutic light device, not an AI or algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device itself is the standalone therapy.
7. The Type of Ground Truth Used
For the usability and self-selection tests, the "ground truth" was likely defined by pre-established correct answers or critical objectives of the product labeling, against which user responses were measured for comprehension. For instance, correctly identifying the treatment duration or safety warnings.
For the inherent therapeutic claims, the "ground truth" (or basis of equivalence) relied on the established safety and effectiveness profile of the predicate devices, which would have been supported by their own clinical data (not detailed in this specific 510(k) summary).
8. The Sample Size for the Training Set
Not applicable as this is not an AI/ML device that requires training.
9. How the Ground Truth for the Training Set was Established
Not applicable as this is not an AI/ML device that requires training.
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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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