(191 days)
The proposed intended use of the Lightfusion™ LED system is to emit energy in the RED and Near Infra-Red (NIR) regions of the spectrum and is indicated for the treatment of periorbital wrinkles.
The LIGHTFUSION™ LED system is a table top, portable phototherapy device whose purpose is to produce an even, cool, narrow-band of light for the treatment periorbital wrinkles. The system consists of a main body or controller that controls the 3 LED face pads. The controller switches the LEDs ON/OFF and controls power to the face pads. The controller contains a timer display consisting of a Dot matrix display. The controller contains software that monitors the face pad temperature via thermistors within the face pads contain the light emitting diodes (LEDs). The LEDs generate the light. The LEDs emit light energy in the red and near infrared light wavebands with peak wavelengths of 630nm +/-10nm, NIR: 830nm +/-17.5nm (Spectral range: Red 620-640nm, NIR 812.5-847.5nm). The therapy heads are designed to be placed over the forehead, sides of the face and chin. The power supply is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard coaxial connector. The face pads are connected to the controller by individual connectors that are sealed within the controller and cannot be removed by the user. The face pads contain a temperature sensor (thermistor) that feeds the temperature back to the controller. The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent. LIGHTFUSION Light emitting diode (LED) system emits light energy in the red and near infra-red (NIR) region of the light spectrum and is intended to treat periorbital wrinkles through a non-thermal mechanism of Photobiomodulation. Photobiomodulation is a form of light therapy that utilizes non ionizing forms of light sources such as LEDs, in the visible and near infrared spectrum. It is a non thermal process involving endogenous chromophores eliciting photophysical and photochemical events at various biological scales.
This document is a 510(k) premarket notification for a medical device called the "LIGHTFUSION LED System." It seeks to demonstrate that the device is substantially equivalent to a legally marketed predicate device, "Young Again LED mask (K124064)."
The key takeaway is that this document does NOT describe clinical studies or acceptance criteria based on clinical performance of the device. Instead, it focuses on demonstrating substantial equivalence through non-clinical performance and safety data, as well as by comparing technological characteristics with the predicate device.
The document explicitly states: "Since the LIGHTFUSION™ LED system raises no new questions in terms of safety and efficacy clinical data is not required." This means there are no "acceptance criteria" related to a quantitative, clinical assessment of device effectiveness in terms of, for example, reduction in wrinkle severity, as might be found in a clinical trial.
Therefore, I cannot provide the requested information for acceptance criteria and study that proves the device meets them, as described in your prompt, because such a study was explicitly deemed not required for this 510(k) submission.
However, I can extract information related to the non-clinical performance and safety criteria the device did meet:
1. A table of acceptance criteria and the reported device performance
Since no clinical performance acceptance criteria or clinical study results are presented, the "acceptance criteria" here relate to compliance with regulatory standards for safety and non-clinical performance.
| Acceptance Criteria Category | Specific Criteria/Standard (Implicit Acceptance) | Reported Device Performance (Compliance) |
|---|---|---|
| General Requirements & Safety | Compliance with IEC 60601-1: "Medical Electrical Equipment Part 1 - General Requirements for Basic Safety and essential performance" | The Light fusion LED system complies with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC/EN 60601-1-2: "Collateral Standard: Electromagnetic Compatibility – Requirements and test." | The Light fusion LED system complies with IEC/EN 60601-1-2. |
| Photobiological Safety | Compliance with EN62471: "Photobiological Safety of Lamps and Lamp Systems" regarding retinal injury, phototoxic effect, or thermal damage. | The results demonstrate that it poses no risk of retinal injury due to phototoxic effect, or the thermal damage mechanism. |
| Usability | Compliance with IEC 62366: "Medical devices - Application of usability engineering to medical devices." | The LIGHTFUSION™ LED System was assessed with regards to usability for compliance with IEC 62366. |
| Software Safety (IEC 62304) | Software safety classification: Class A (lowest risk). | VITAGE LED Ltd has allocated a software safety classification of Class A for the LIGHTFUSION LED system. |
| Software Safety (FDA Level of Concern) | FDA level of concern for device software: Minor. | The level of concern for the device software is: Minor. |
| Biocompatibility | Compliance with ISO 10993 and FDA - Blue Book Memorandum #G95-1. | VITAGE LED Ltd believes that the device is safe and compliant with the requirements of ISO 10993 and FDA - Blue Book Memorandum #G95-1, supported by ISO 10993-1:2009 annex B. |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable for a clinical test set, as no clinical study was conducted. The tests performed are engineering/performance tests on the device itself.
- Data Provenance: The tests are standard-based engineering and safety assessments of the device hardware and software, rather than data collected from human subjects. The details of where these tests were performed (e.g., in-house, by a certified lab) are not provided in this summary, nor is the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts/Qualifications: Not applicable. Ground truth, in the context of clinical device performance (e.g., diagnosis, outcome), was not established because no clinical study was performed. The "ground truth" for the non-clinical tests is adherence to established engineering, safety, and quality standards (e.g., IEC, EN, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This concept applies to the reconciliation of disagreements among multiple human readers/experts, which was not part of this "non-clinical" performance assessment.
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
- MRMC study: Not applicable. This device is a light-therapy system, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is not an algorithm for diagnosis or image interpretation. The "performance" is the device's ability to emit light within specified parameters and meet safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth: For the non-clinical tests, the "ground truth" is compliance with international and national safety, electrical, software, and biocompatibility standards (e.g., IEC 60601-1, IEC 60601-1-2, EN 62471, IEC 62366, IEC 62304, ISO 10993). There is no "pathology" or "outcomes data" ground truth as no clinical trials were conducted.
8. The sample size for the training set
- Training set sample size: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Training set ground truth: Not applicable, as there is no training set.
§ 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.