(88 days)
The dpl® SpectraLite is an Over-the-Counter (OTC) device intended for use in treating wrinkles within periorbital region.
The dpl® SpectraLite system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles within the periorbital region. The device uses four types of LEDs: 605nm amber, 625nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® SpectraLite system components include the device containing the LED module, USB charging cord, and a storage case. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over The Counter (OTC).
The provided text is a 510(k) Summary for the dpl® SpectraLite device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics for the new device's clinical efficacy in treating wrinkles.
Therefore, many of the requested data points, particularly those related to clinical performance, ground truth, expert adjudication, and sample sizes for effectiveness studies, are not explicitly available in this submission. The submission primarily addresses safety, technological characteristics compared to the predicate, and usability.
However, I can extract information related to safety, usability, and the general approach of the substantial equivalence claim.
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for the clinical performance of this device as a medical treatment (i.e., its effectiveness in reducing wrinkles) is not directly addressed in this 510(k) summary in the way a clinical trial would define it. Instead, the focus is on demonstrating substantial equivalence to a legally marketed predicate device (dpl® Nüve for Wrinkles) in terms of its intended use, technological characteristics, and safety profiles.
The "performance" reported primarily relates to safety and functional aspects, rather than direct measurements of wrinkle reduction from a standalone clinical trial of the dpl® SpectraLite.
Here's a table based on the information provided, interpreting "acceptance criteria" as compliance with standards and successful usability testing, and "reported device performance" as the documented outcomes of those tests:
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Compliance with Medical Electrical Equipment (Basic Safety and Essential Performance - IEC 60601-1) | Yes, the dpl® SpectraLite system conforms to IEC 60601-1. |
| Compliance with Photobiological Safety (IEC 62471) | Yes, the dpl® SpectraLite system conforms to IEC 62471. |
| Compliance with Electromagnetic Compatibility (IEC 60601-1-2) | Yes, the dpl® SpectraLite system conforms to IEC 60601-1-2. |
| Software Validation (in accordance with FDA guidance) | Yes, the dpl® SpectraLite system software was tested and validated in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices". |
| Usability Testing: Ability to perform light sensitivity test | 100% of participants were able to demonstrate the light sensitivity test. |
| Usability Testing: Ability to use the device successfully | 100% of participants were able to use the device successfully. |
| Biocompatibility (US FDA 21 CFR 177.1810 for Styrene block polymers – TPE Test) | Yes, tested against US FDA 21 CFR 177.1810, and no new biocompatibility issues are introduced with the addition of TPE Silicone. |
| Substantial Equivalence to Predicate Device (K141181) for intended use, output, wavelengths, treatment duration, and regimen | "No significant differences exist between the subject device and predicate, and no different questions of safety and effectiveness arise." The device has the same intended use (treatment of wrinkles), similar output (61.59 mW/cm² vs 62.07 mW/cm²), same number of wavelengths (4), same treatment duration (3 minutes), and same regimen (5 days/week for 8 weeks). |
Study Details
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Sample size used for the test set and the data provenance:
- Usability Study: 15 participants.
- Data Provenance: Not specified, but likely prospective for the usability study. The submission itself is dated July 4, 2017, and refers to testing performed by LED Technologies, Inc.
- For the core claim of substantial equivalence regarding effectiveness, the "test set" is essentially the comparison between the new device's specifications and the predicate device's established performance, rather than a separate clinical trial test set for the new device's efficacy.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided for clinical effectiveness. The usability study involved participants, not "experts" establishing a clinical ground truth for wrinkle reduction. The claim of effectiveness is derived from equivalence to the predicate, whose effectiveness would have been established previously.
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Adjudication method for the test set:
- Not applicable / Not provided for clinical effectiveness. The usability study's success rates (100%) suggest direct observation or self-reporting, rather than a complex adjudication process.
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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:
- No, a MRMC comparative effectiveness study was not done. This device is an LED-based therapeutic device, not an AI-powered diagnostic imaging device that would involve human readers or AI assistance in interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the typical sense. This device is a therapeutic device, not an "algorithm." Its performance is its light emission properties and how it's used. The primary "standalone" performance testing mentioned refers to functional and safety compliance (e.g., electrical safety, photobiological safety).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For safety and functional performance: Ground truth is established by engineering specifications, international consensus standards (IEC), and FDA guidance for software and biocompatibility.
- For usability: Ground truth is based on participant successful completion of tasks (light sensitivity test, using the device).
- For clinical effectiveness (wrinkle reduction): The ground truth for the dpl® SpectraLite is assumed to be equivalent to the predicate device (dpl® Nüve for Wrinkles), which had already established its effectiveness. The submission does not provide new effectiveness outcome data for the dpl® SpectraLite.
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The sample size for the training set:
- Not applicable / Not provided. This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As it's not an AI/machine learning device, there's no training set or associated ground truth establishment process in that context.
§ 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.