(113 days)
The dpl® Faceware is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
The dpl® Faceware is an over-the counter light emitting diode (LED) device, that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses five types of LEDs: 605nm amber, 630nm red, 880nm infrared, and 415 blue. The dpl® Faceware components include the device containing the LED module, USB power cord, and power adapter. The treatment time is controlled by the user. There are no user settings or adjustments required. 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 provided text is a 510(k) summary for the dpl® Faceware device. It describes the device, its intended use, and its comparison to predicate devices, along with performance testing conducted to demonstrate safety and effectiveness. However, it does not explicitly contain a table of acceptance criteria and reported device performance in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC).
Instead, the performance testing described primarily relates to:
- Functional performance testing
- Software validation
- User safety testing
- Compliance with international consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10)
- Usability study
The device is an LED-based device for treating wrinkles and mild to moderate inflammatory acne—it is not an AI/algorithm-based diagnostic or prognostic device that would typically have acceptance criteria such as sensitivity, specificity, or AUC based on ground truth established by experts.
Therefore, many of the requested points related to AI/algorithm performance (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to the information provided in this 510(k) summary.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for device performance in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC), as this is an LED therapy device, not a diagnostic AI. The "performance" described is centered around safety, functionality, and user aBility.
| Acceptance Criteria Category | Specific Criteria (Implied from testing) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device operates as intended | "The system performs as intended" |
| Software Validation | Software meets validation requirements | "The dpl® Faceware software was tested and validated in accordance with FDA's 'Guidance for the content of Premarket Submissions for Software Contained in Medical Devices'." |
| Safety - Electrical | Compliance with IEC 60601-1, IEC 60601-1-2 | Conforms to IEC 60601-1 (2012) and IEC 60601-1-2 (2014) |
| Safety - Biocompatibility | Compliance with ISO 10993 standards | Conforms to ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Intracutaneous reactivity), ISO 10993-10:2010 (Skin Sensitization) |
| Usability | Users can demonstrate light sensitivity test and use device successfully | 100% of participants were able to demonstrate the light sensitivity test. 100% of participants were able to use the device successfully. |
2. Sample size used for the test set and the data provenance
- Test set for Usability Study: 15 participants.
- Data Provenance: Not explicitly stated, but assumed to be from a prospective study conducted for regulatory submission in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. The "ground truth" for a usability study is subjective user experience and objective task completion.
4. Adjudication method for the test set
Not applicable for a usability study of this nature. The results are reported as percentages of participants completing tasks.
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 is an LED therapy device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve a standalone algorithm for diagnostic performance. Its "performance" is its therapeutic effect.
7. The type of ground truth used
For the usability study, the "ground truth" was simple task completion and demonstration, observed directly. For safety and functional testing, the "ground truth" was compliance with established engineering and biocompatibility standards.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm device that requires a training set in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable for this device.
§ 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.