(80 days)
The Describe® Transparent PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using a 755nm Q-Switched Alexandrite laser in Fitzpatrick Skin Type I-III patients.
The DeScribe Patch consists of two components: a dual-layer medical-grade silicone transparent film, and an optical clearing agent (OCA). The dual-layer silicone film is composed of a thin low-friction silicone membrane and a tacky silicone polymer layer. The low-friction silicone membrane forms the upper layer of the film. The tacky silicone polymer layer (i.e., the lower layer) contacts the patient's skin during the device's use. The OCA in the Device is sterile, high-purity perfluorodecalin (PFD), an inert, non-toxic liquid.
The provided text describes a 510(k) premarket notification for the "DeScribe® Transparent PFD Patch." The document focuses on establishing substantial equivalence to a predicate device and does not involve a traditional algorithm-based AI device with specific performance metrics like sensitivity, specificity, or AUC. Instead, it describes a clinical investigation to demonstrate the safety and efficacy of the device as an accessory to laser tattoo removal.
Therefore, many of the requested criteria (like ground truth, sample size for training, MRMC study effect size, etc.) are not applicable in the context of this specific regulatory submission for a non-AI physical accessory device.
However, I can extract the relevant information regarding the clinical investigation conducted to support the device's efficacy and safety:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficacy: Allow for rapid multi-pass laser treatment of tattoos. (Implicit from the study's objective to investigate "rapid (≤ 5 minute) multi-pass laser treatment"). | The Patch side demonstrated whitening resolution within the treatment period, allowing an average of 3.7 passes to be made. |
| Comparison to Control: Significantly greater number of passes with the Patch. | The control side (conventional laser treatment only) allowed only an average of 1.4 passes. |
| Safety: No serious or unanticipated adverse device effects. | Mild erythema and edema were observed immediately post-treatment, fully resolved at the 1-month follow-up. No serious or unanticipated adverse device effects were observed in any subject. |
2. Sample size used for the test set and the data provenance
- Sample Size: 30 subjects received one treatment session for a single tattoo.
- Data Provenance: Prospective, single-site clinical study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study's "ground truth" was based on direct clinical observation of physical effects and adverse events during a live treatment session, rather than expert interpretation of images or data. The number of passes and adverse effects were directly recorded.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a clinical observation study rather than a reader-based adjudication study. The number of passes performed and adverse effects were recorded by the clinical staff performing the treatment and follow-up.
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 a physical accessory to a laser, not an AI or imaging-based diagnostic/interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical accessory and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context was direct clinical observation of:
- The number of laser passes achieved within a specified time frame (≤ 5 minutes).
- The resolution of whitening (a direct physiological response to laser treatment).
- The occurrence and severity of adverse events.
8. The sample size for the training set
Not applicable. This study describes a clinical investigation (test set) for device efficacy and safety, not the training of a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an algorithm.
§ 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.