Search Results

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.

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.

Ask a specific question about this device

The DESCRIBE PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using 532, 694, 755, and 1064 nm standard Q-Switched (QS) lasers and 532, 755, 785, and 1064 nm standard picosecond lasers in Fitzpatrick Skin Type I-III patients.

The DESCRIBE® PFD Patch consists of two components: a dual-layer medicalgrade 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 (FluoroMed, LLC).

Here's an analysis of the provided text regarding the DESCRIBE PFD Patch, focusing on the acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided primarily relate to the optical stability and chemical integrity of the patch and its optical clearing agent (PFD) under laser exposure, as well as the stability of the packaging over time. No numerical performance metrics (e.g., accuracy, sensitivity, specificity) were provided for the device's function in aiding tattoo removal, as it is an accessory and not an independently evaluable diagnostic or therapeutic device in that regard.

2. Sample Size Used for the Test Set and Data Provenance

• Bench Performance Testing (Optical & Chemical Stability): The text does not explicitly state a sample size in terms of the number of patches or PFD samples tested for optical and chemical stability. It refers to "the patch and PFD" and "respective associated PFD," suggesting individual or small batches for each test condition.
• Stability Testing:
  • Packaging: Twenty samples of the Patch from identical lots manufactured in 2014 were initially placed in storage. After 3 years, fourteen of these were tested for package burst and bubble emission leak testing.
  • Patch & PFD content: A "representative sample Patch" from the above batch was used to test visual verification, heat seal width, and PFD volume.
• Data Provenance: All data appears to be from bench testing conducted by the manufacturer, Merz North America, Inc. The location of the test facilities is not specified, but the company is based in Raleigh, North Carolina, USA. The studies are not explicitly labeled as retrospective or prospective, but bench tests on manufactured products would generally be considered prospective in their execution.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• This device is an accessory to a laser surgical instrument. The studies described are bench performance and stability tests, not clinical studies involving human patients or complex interpretations. Therefore, there is no mention of experts establishing a "ground truth" for a test set in the conventional sense of clinical or diagnostic performance. The "ground truth" for these tests is based on objective physical and chemical measurements (e.g., spectrophotometry, mass spectrometry, physical dimensions).

4. Adjudication Method for the Test Set

• Not applicable. As described above, these are bench tests with objective measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. The device is a physical accessory, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The DESCRIBE PFD Patch is a physical medical device, not an algorithm or software. Its performance is evaluated through its physical and chemical properties.

7. Type of Ground Truth Used

• The ground truth for the bench tests was based on objective physical and chemical measurements and adherence to established reference standards for these measurements (e.g., UV/VIS/NIR spectroscopy, GC/MS, ISO 11607 for packaging).

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm requiring a training set. The descriptions are of physical product performance and stability testing.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device