(81 days)
The Soliton Acoustic Wave Device (AWD) is indicated for use as an accessory to laser tattoo removal procedures using a 1064 nm Q-Switched laser in Fitzpatrick Skin Type I-III patients.
The Soliton Acoustic Wave Device (AWD) is designed as an accessory to laser treatments for tattoo removal. The AWD uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laserinduced whitening. This allows multiple laser passes in a single session, resulting in fewer office visits.
The Soliton AWD is composed of three parts: the Console, the Hand Piece and the connecting Cable. The Console supplies saline to the Hand Piece to enable formation of the shock wave within the acoustic pulse chamber. The Hand Piece generates acoustic waves in the saline. The acoustic waves pass through the acoustically transparent Window and acoustic ultrasound gel or similar hydrogel pad, which when placed against the surface of the tattoo to be removed, penetrates the skin to the typical depth of tattoo ink.
The shape, frequency and repetition rate of these acoustic waves are optimized to diffuse gas bubbles (vacuoles) caused by the use of a Q-switched laser without damaging adjacent non-pigmented tissue. Removing them by using the Soliton AWD allows another Q-switched laser treatment to be performed immediately instead of waiting for the body to remove the gas pockets and heal over a period of 4-6 weeks between standard laser treatments.
Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text:
Device: Soliton Acoustic Wave Device (AWD)
Intended Use: As an accessory to laser tattoo removal procedures using a 1064 nm Q-Switched laser in Fitzpatrick Skin Type I-III patients.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the clinical study. Instead, it describes a primary effectiveness endpoint and states whether it was met. The implied acceptance criterion for effectiveness is that the mean number of laser passes delivered with AWD treatment should be significantly greater than 1 beyond typical single-pass laser treatment, or at least a statistically significant improvement justifying its use for multiple passes. The acceptance criterion for safety would be that the device is safe, with adverse events being mild or moderate and expected, and not causing patients to discontinue treatment.
| Acceptance Criterion (Implied/Deduced) | Reported Device Performance |
|---|---|
| Effectiveness: Mean number of laser passes delivered in a single treatment session with AWD should be significantly increased (e.g., demonstrably more than a single pass typical of laser-only treatment). | The mean number of laser passes delivered in a single treatment session with AWD treatment was 4.16, with a lower limit of 95% confidence interval of 3.97. |
| Safety: All adverse events should be mild or moderate and expected, with no serious or severe adverse events, and no patient discontinuations due to adverse events. | All adverse events observed were categorized as mild or moderate and were expected. All symptoms resolved by the end of the study. No adverse events were identified as serious or severe. No patients asked to stop treatment or dropped out. |
| Comparison to Predicate Device: Performance and safety profile should be similar to the predicate device. | The Soliton AWD was found to have a safety and effectiveness profile that is similar to the predicate device (ON Light Science's DeScribe® Transparent PFD Patch). Clinical testing confirmed that technological differences did not adversely impact performance. |
2. Sample Sizes and Data Provenance
- Clinical Study Test Set Sample Size: 24 subjects with 35 tattoos.
- Data Provenance: Single-center, prospective study conducted at an investigational site in the U.S.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Unspecified number of "blinded independent evaluators" in addition to "the study investigator."
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. It mentions that subjects' tattoos were evaluated by "blinded independent evaluators, as well as the study investigator." This suggests a consensus or independent assessment approach, but no specific adjudication rule (e.g., 2+1, 3+1) is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not explicitly conducted in the sense of comparing human readers' diagnostic performance with and without AI assistance. This device is an accessory to a laser, not an imaging diagnostic AI. The clinical study did compare the device's performance (Laser+AWD) against a control (Laser Only) on different sections of the same tattoo, which serves as a clinical comparative effectiveness study for the device itself rather than human reader improvement with AI.
- Effect Size: The study measured the number of laser passes possible. Without AWD, the typical is a single pass. With AWD, the mean was 4.16 passes. This directly quantifies the improvement in procedure efficiency/capability provided by the device.
6. Standalone Performance
This device is an accessory to a laser, designed to be used in conjunction with it. Therefore, a "standalone (algorithm only without human-in-the-loop performance)" is not applicable or meaningful in the typical AI sense. The performance evaluated was the device's effect in conjunction with the laser treatment.
7. Type of Ground Truth Used for the Test Set
The ground truth for the clinical study was established by:
- Objective Measurement: Recording the number of laser treatment passes delivered in a single session. This is a direct, quantitative measure of the primary effectiveness endpoint.
- Expert Evaluation: "Blindied independent evaluators" and "the study investigator" assessed the subjects' tattoos. While the specific metrics they evaluated are not detailed regarding effectiveness, they would contribute to the overall assessment of the procedure's success and safety endpoints.
- Safety Data: Collection of adverse events reported during the study and their categorization (mild, moderate, serious, severe).
- Photographic Assessment: For the pre-clinical animal study, photographic appearance after healing was used as ground truth.
8. Sample Size for the Training Set
The document makes no mention of a training set or the use of machine learning that would typically require one. The Soliton Acoustic Wave Device (AWD) is described as generating acoustic waves, not as an AI/ML-driven device. Thus, the concept of a "training set" for an algorithm is not applicable to this device submission. The performance data presented are for the device's physical/mechanical function and clinical outcomes, not an AI model.
9. How Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" is not applicable for this device, as it is not an AI/ML product.
§ 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.