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510(k) Data Aggregation
(260 days)
SL-8813 is an Over The Counter (OTC) handheld device intended for in the treatment of full face wrinkles
SL-8813 is a handheld ergonomically designed ABS plastic housed device with a locking Medical Grade Stainless Steel retainer holding in place a Medical Grade USP Class polycarbonate lens from which high spectral purity LED light in 4 (four) specific wavelengths is emitted. By design the optical output has a high degree of homogenous light distribution. The output wavelengths are actuated via a simple on-off swipe button and are in the visible Red and the Infrared spectrum. SL8813 is powered by a built in (non user accessible) Lithium lon Battery which can be charged as required via a supplied UL listed AC/DC wall mounted unit. Treatment time for light outputs is controlled by the operator as per Treatment Protocols listed in User Documentation. Audible announcement is provided to the user for timing intervals of treatments and is so noted in User Documentation.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary focused on substantial equivalence rather than a detailed clinical trial report. As such, some typical clinical study details (like specific effect sizes for human readers or ground truth details for a training set) are not applicable or not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific wrinkle reduction percentages). Instead, the acceptance criteria are framed in terms of substantial equivalence to predicate devices, particularly regarding "electro-optical performance" and safety. The performance reported focuses on meeting the claimed fluence levels of predicate devices and adherence to international safety standards.
| Acceptance Criterion (Implicit) | Reported Device Performance and Compliance |
|---|---|
| Electro-optical performance verification of LED power densities (mW/Cm²), pattern homogeneous-ness, and electrical performance, referencing international standards. | "SL-8813 electro-optical performance verification of LED power densities (mW/Cm²), pattern homogenous-ness and electrical performance were conducted referencing Table 1 International Standards." |
| "SL-8813 optical energy output fluences are set in each specific wavelength to minimally meet the claimed fluence levels in each of the specific wavelengths as the Primary Predicate devices." | |
| Safety and essential performance designed for and validated, referencing international standards. | "Safety and essential performance designed for and validated referencing Table 1 International Standards." |
| Identical indications for use as predicate devices (treatment of full face wrinkles). | "The SL-8813 and the Predicate devices are hand held LED emitting devices intended for Over The Counter patient usage to specifically reduce facial wrinkles." |
| Identical target patient population as predicate devices. | "The target patient population for SL-8813 is identical to the population of the predicate devices." |
| Similar light energy frequencies/wavelengths and fluence levels (65mW/cm²) as predicate devices. | "SL-8813 and the Primary Predicate devices claim to emit identical frequencies or wavelengths of LED light energy with all claiming to meet 65mW/cm² fluence levels with specific irradiance level distributions for the wavelengths and using the same treatment methods for the same treatment areas." |
| Human safe classification (Red and Infrared region within EC 62471 and EU DIRECTIVE 2006/25/EC). | "All devices emit in the Red and Infrared region within the 'human safe' EC 62471 AND EU DIRECTIVE 2006/25/EC classification." |
| No new questions of safety compared to secondary predicate (StarLite-LM K092460). | "Based on an identical physical design and fitment... PSAE believes that no significant differences in those specific characteristics exists between the SL-8813 and the previously approved StarLite-LM device (K092460). Therefore SL-8813 raises no new questions of safety..." |
| Adequate Usability/Self-Selection for "Human Factors - Usability comprehension" due to packaging/indications differences. | "...an addendum Usability Study was performed to evaluate Self Selection and other considerations for Human Factors - Usability comprehension to assess differences in packaging design and modified indications for use between the SL-8813 and the Secondary Predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not describe a clinical "test set" with a specific sample size for evaluating wrinkle reduction in humans. The testing described focuses on the device's physical and electro-optical performance and safety, as well as an "addendum Usability / Self Selection study."
- Data Provenance: The document does not provide details on the country of origin for any human subject data, nor does it specify if data was retrospective or prospective for the Usability/Self-Selection study. The electro-optical and safety tests would have been performed in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not specified for the primary performance evaluations described. The review of the device's technical specifications and compliance with standards would be done by technical professionals. For the Usability/Self-Selection study, the method for establishing "ground truth" (e.g., what constitutes adequate usability) and the experts involved are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. The document primarily discusses technical compliance and a usability study, not a clinical trial with adjudicated outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly described or performed. This device is an Over-The-Counter cosmetic device for wrinkle reduction, and the submission is a 510(k) for substantial equivalence, which typically relies on comparisons to legally marketed predicate devices and technical testing rather than complex clinical effectiveness trials involving multiple human readers/evaluators and AI.
- Effect Size of AI vs. Without AI Assistance: Not applicable, as no AI component or human reader performance comparison is mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: No, this device is a physical LED light therapy device, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. The device's performance is inherently "standalone" in that it performs its function without an AI algorithm or direct human-in-the-loop influence during its operation, other than user control.
7. Type of Ground Truth Used
- Ground Truth: In the context of this 510(k), the "ground truth" primarily refers to:
- International Standards: Compliance with ANSI/AAMI ES60601-1, IEC 61000-4-3, CEI/IEC 62304, IEC 61000-4-2, ANSI/AAMI IEC 60601-2, EN ISO 14791, and IEC/TR 62471-2 (as listed in Table 1).
- Predicate Device Specifications: The "ground truth" for the device's intended performance (e.g., fluence levels, wavelengths, safety profile) is established by the specifications and regulatory clearance of the predicate devices.
- Usability/Self-Selection Study Observations: For the usability study, the ground truth would be observed user behavior and feedback regarding comprehension and ease of use.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the traditional sense for algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no training set for an algorithm.
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