(90 days)
The dpl® SpotLite is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
The dpl® SpotLite is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of mild to moderate inflammatory acne. The device uses two types of LEDs, 630nm red and 415nm blue. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® SpotLite components include the unit containing the LED module. 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).
Here's an analysis of the provided text regarding the acceptance criteria and study information for the dpl® SpotLite device:
Based on the provided text, the submission focuses on substantial equivalence to a predicate device rather than demonstrating the device meets pre-defined acceptance criteria through a specific clinical study for efficacy. The performance testing mentioned is primarily for safety, functional performance, software validation, and usability, not clinical effectiveness.
Therefore, the requested information elements (especially those related to clinical effectiveness studies, sample sizes for test/training sets, expert ground truth, adjudication, and MRMC studies) are largely not present in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| IEC 60601-1 (Basic Safety & Essential Performance) | Conforms to standard. |
| IEC 60601-1-2 (EMC) | Conforms to standard. |
| ISO 10993-5 (Cytotoxicity Test) | Conforms to standard. |
| ISO 10993-10 (Intracutaneous reactivity test) | Conforms to standard. |
| ISO 10993-10 (Skin Sensitization Test) | Conforms to standard. |
| Functionality: | |
| Functional Performance Testing | Performed. |
| Software Validation | Tested and validated (Guidence for the content of Premarket Submissions for Software Contained in Medical Devices). |
| Usability: | |
| Ability to demonstrate light sensitivity test | 100% of participants successful. |
| Ability to use the device successfully | 100% of participants successful. |
| Substantial Equivalence to Predicate: | |
| Same intended use | Yes (treatment of mild to moderate inflammatory acne). |
| Similar output (mW/cm²) | Yes. |
| Same treatment duration | Yes (3 minutes per treatment). |
| Similar recommended treatment regimen | Yes. |
| Similar technological characteristics | Yes (red and blue diodes at 630 and 415 nm, similar power output, direct skin placement, similar materials). |
| No new safety or effectiveness issues raised | Stated that no new issues arise. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size (for clinical effectiveness/efficacy): Not applicable. The document does not describe a clinical effectiveness study with a test set for efficacy.
- Test Set Sample Size (for usability study): 16 participants.
- Data Provenance: Not specified for the usability study (e.g., country of origin). The study is described as a "Usability Study," implying it was prospective for that purpose.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No experts were used to establish ground truth for a clinical effectiveness test set because such a study is not described. The usability study's "ground truth" would be the successful completion of tasks by the participants itself, not an expert panel reviewing outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical effectiveness test set or complex judgment of outcomes requiring adjudication is described.
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 applicable. This device is an LED therapy device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is a direct-treatment device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For safety and functional testing: Ground truth is conformity to established international consensus standards (IEC, ISO).
- For software validation: Ground truth is adherence to FDA guidance for software in medical devices.
- For usability study: Ground truth is the direct observation of participants' ability to successfully perform specified tasks (demonstrating light sensitivity test, using the device successfully).
8. The sample size for the training set
Not applicable. No clinical effectiveness study is described, and thus no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
Not applicable. As no training set is discussed, the method for establishing its ground truth is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (reVive Light Therapy® LED Cleansing System K180447) rather than a de novo clinical study proving effectiveness against specific acceptance criteria.
The "study" component consists of:
- Functional Performance Testing: Confirmed the device's operational capabilities. The details or results are not explicitly provided beyond stating that it was conducted.
- Software Validation: Tested and validated in accordance with FDA guidance, ensuring its proper functioning.
- User Safety Testing: Demonstrated conformity to various international consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10). These tests cover electrical safety, electromagnetic compatibility, cytotoxicity, intracutaneous reactivity, and skin sensitization.
- Usability Study: Conducted with 16 participants. The study proved that 100% of participants could successfully demonstrate the light sensitivity test and use the device.
The overall conclusion is based on comparing the dpl® SpotLite's intended uses, technological characteristics (wavelengths, irradiance source, treatment time, class, output, treatment regimen, materials), and safety performance to the predicate device. The manufacturer asserts that the device is "as effective" and "performs as well as the legally marketed devices" because "no significant differences exist between the subject device and predicate, and no different questions of safety and effectiveness arise." This indicates that the primary "proof" of meeting efficacy criteria is through the established safety and efficacy of the predicate, to which the dpl® SpotLite is deemed substantially equivalent.
§ 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.