(84 days)
The dpl® II Panel system is an Over-the Counter (OTC) device intended for use in treating wrinkles.
The dpl® II Panel system is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles. The device uses four type of LEDs: 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adjustments required. The dpl® II Panel system components include the panel unit containing the LED module, power supply, goggles, and 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 Ove The Counter (OTC).
Here's an analysis of the provided text regarding the acceptance criteria and study information for the dpl® II Panel device:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly state quantitative "acceptance criteria" for clinical performance (e.g., a specific percentage reduction in wrinkles). Instead, the performance testing focuses on safety, functionality, and usability. The "reported device performance" is mainly qualitative or based on demonstrating successful use and safety.
| Category | Acceptance Criteria (Implicit from text) | Reported Device Performance |
|---|---|---|
| Functional Performance | Conformance to international consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-10) | Device conforms to specified standards. |
| Software Validation | Conformance to FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices" | Software was tested and validated in accordance with FDA guidance. |
| Usability (Light Sensitivity) | All participants able to demonstrate the light sensitivity test. | 100% of participants were able to demonstrate the light sensitivity test. |
| Usability (Device Use) | All participants able to use the device successfully. | 100% of participants were able to use the device successfully. |
| Substantial Equivalence | No significant differences in safety or effectiveness compared to predicate device K141181, and no new safety/effectiveness issues. | The device has the same intended use, similar output, wavelengths, treatment duration, and regimen as the predicate, performing as intended without new safety/effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: A "Usability Study" was conducted with 16 participants.
- Data Provenance: The document does not specify the country of origin. The study appears to be a prospective usability study conducted for this specific device submission. There is no information about retrospective data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the use of "experts to establish ground truth" in the traditional sense for the usability study. The "ground truth" for the usability study comprised participants successfully completing tasks. There were no clinical endpoints requiring expert interpretation of results.
4. Adjudication Method for the Test Set
Not applicable for this type of usability study. There's no indication of any adjudication method as the "ground truth" was direct observation of task completion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a usability study, not a clinical effectiveness study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The dpl® II Panel is a physical light therapy device, not an AI algorithm. Its performance is inherent to the device's light emission and intended use as an OTC wrinkle reduction device.
7. Type of Ground Truth Used
For the usability study, the "ground truth" was based on direct observation of participants successfully completing tasks (demonstrating light sensitivity and using the device). For the overall device, the implicit ground truth for "effectiveness in treating wrinkles" is established by its substantial equivalence to a legally marketed predicate device with the same indications for use, rather than a de novo clinical trial demonstrating efficacy.
8. Sample Size for the Training Set
Not applicable. The dpl® II Panel is a hardware device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this hardware 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.