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510(k) Data Aggregation
(88 days)
Soliton Inc.
The Soliton Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for long-term improvement in the appearance of cellulite as supported by clinical data demonstrating treatment benefits up to 1 year of observation.
The Soliton Resonic™ Rapid Acoustic Pulse device is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of cellulite. Resonic uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in accelerated tattoo fading and fewer office visits to achieve sufficient tattoo fading. When used for improving the appearance of cellulite, the acoustic waves induce physical effects in the fibrous structures, such as the fibrous septa in the subcutaneous tissue.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Soliton Resonic™ Rapid Acoustic Pulse Device
Intended Use: Long-term improvement in the appearance of cellulite.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Effectiveness) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: A blinded physician panel correctly identifies long-term (>52-weeks) post-treatment photographs. (Specific threshold for correct identification is not explicitly stated as a percentage in the acceptance criteria, but implied by the reported performance). | The blinded physician panel correctly identified the long-term (>52-weeks) post-treatment photograph in 95.2% of the cases. |
| Mean Cellulite Severity Score Reduction: (Specific target reduction not explicitly stated, but implied as a measure of improvement). | The mean cellulite severity score reduction was 1.09. |
| Patient Satisfaction (at 52 weeks): Implied, as the study collected patient satisfaction responses and aimed to demonstrate maintained treatment benefits. (Specific percentage target not explicitly stated in acceptance criteria). | At 52 weeks, all participants found their treatment areas to appear improved compared to the pre-treatment photos, and 97.6% of participants found there was good improvement in the appearance of cellulite. |
| Safety: No significant adverse events, or only mild/moderate expected adverse events. (Implied, as safety is always a key consideration for medical devices). | All adverse events observed were categorized as mild or moderate and were expected. No adverse events were related to the device. There were no serious adverse events. |
| Long-Term Improvement: Demonstrates no significant reduction in treatment benefits up to 1 year of observation. (This is the overarching acceptance criteria for the new indication). | The reported performance data (95.2% correct identification, 1.09 mean severity reduction, high patient satisfaction, and maintained safety profile) collectively demonstrates that the treatment effect with Resonic RAP device in improving the appearance of cellulite is maintained through 1 year after the treatment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: A total of 67 participants were enrolled.
- Data Provenance:
- Country of Origin: United States (4 sites in the United States).
- Retrospective or Prospective: Prospective multi-site trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "Blinded independent reviewers" and "blinded physician panel." The exact number of individuals on the panel is not specified in this document.
- Qualifications of Experts: They were described as "blinded independent reviewers" and "blinded physician panel." While the specific medical specialty (e.g., dermatologist) or years of experience are not explicitly stated, the term "physician panel" implies qualified medical professionals.
4. Adjudication Method for the Test Set
The adjudication method is implied as "blinded independent reviewers" or a "blinded physician panel" assessing photographs. The specific scheme (e.g., 2+1, 3+1) for resolving disagreements among multiple reviewers is not explicitly stated. It just mentions they "assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study comparing human readers with vs. without AI assistance was not done.
This study focused on the effectiveness of the device itself (Resonic RAP) for improving cellulite appearance, as assessed by a blinded physician panel, not on human reader performance assisted by the device or AI. The device is not an AI diagnostic tool that "assists" human readers in making diagnoses. It's a treatment device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable in the conventional sense for an AI device. The Resonic RAP device is a physical acoustic pulse device, not an AI algorithm. Its performance is inherent in its physical operation, not an output from a standalone algorithm. The "standalone" aspect in this context refers to its use as a "standalone device to improve the appearance of cellulite" as opposed to an accessory for tattoo removal, but this is a treatment application, not a diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for effectiveness was established by:
- Expert Consensus/Assessment: Assessment of serial clinical photographs by a "blinded independent reviewers" or "blinded physician panel" to identify post-treatment images and evaluate cellulite severity reduction.
- Patient Reported Outcomes: Patient satisfaction surveys were used to assess participants' perception of improvement.
8. The Sample Size for the Training Set
Not applicable/Not provided within this document. This document describes a clinical study for a physical medical device (Resonic RAP), not the development or validation of a machine learning algorithm that requires a separate training set. The "training set" concept is typically relevant for AI/ML devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, this document does not describe the development of an AI/ML algorithm with a training set.
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(27 days)
Soliton Inc.
The Soliton Resonic™ Rapid Acoustic Pulse device is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The Resonic device is also indicated for short-term improvement in the appearance of cellulite.
The Soliton Resonic™ Rapid Acoustic Pulse device is composed of three parts: the Console, the Hand Piece and the Cable connecting the Hand Piece to the Console. 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 skin to be treated.
This document describes the Soliton Resonic™ Rapid Acoustic Pulse device, concentrating on its substantial equivalence to a previously cleared device (K201801). The information provided focuses on the modifications made and the types of testing performed to demonstrate that these changes do not alter the fundamental technology or safety/effectiveness.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the modified device functions "as specified" and is "as safe and effective as its predicate device." The performance data section focuses on ensuring the modifications did not negatively impact safety or fundamental operation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as specified | Verification testing confirmed the Resonic RAP device functions as specified. |
| As safe as predicate device | Electrical safety and EMC testing repeated an independent lab (IEC 60601-1, IEC 60601-1-2). Biocompatibility established based on predicate (no new patient-contacting materials). |
| As effective as predicate device | Verification testing demonstrated the Resonic RAP device is as effective as its predicate. |
| Software changes are acceptable | Software verification testing conducted and results found acceptable. |
| No alteration to fundamental scientific technology | Modifications did not alter the fundamental scientific technology (shape, frequency, repetition rate of acoustic waves unchanged). |
| No new questions of safety or effectiveness | Minor differences do not alter fundamental technological characteristics or present new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a separate sample size for a "test set" in the context of clinical performance. The "verification testing" mentioned would typically refer to engineering and functional tests.
- Data Provenance: The document does not provide information about the country of origin or whether data是在retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document focuses on engineering verification and equivalence to a predicate, not a clinical study involving expert assessment of ground truth.
4. Adjudication method for the test set:
This information is not provided as there is no specific mention of a clinical test set requiring adjudication in this document.
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:
This is not applicable. The device described, the Soliton Resonic™ Rapid Acoustic Pulse device, is a physical medical device (an accessory to a laser for tattoo removal and for cellulite improvement), not an AI/software device that would involve human readers or AI assistance in image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable for the same reason as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the context of demonstrating substantial equivalence for hardware modifications, "ground truth" as typically understood in clinical or AI studies (e.g., pathology for disease diagnosis) is not relevant here. The "truth" used for verification is that the device functions according to its engineering specifications and meets safety standards, and that its output (acoustic waves) remains fundamentally unchanged from the predicate device.
8. The sample size for the training set:
This is not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set mentioned.
Summary of what the document does provide regarding the study:
The document focuses on a design control and risk analysis approach to demonstrate substantial equivalence for minor hardware and software modifications to an already cleared device (K201801). The "study" isn't a traditional clinical efficacy study but rather a series of engineering and functional verification tests.
- Verification testing: Conducted using the "same methods as used for the predicate device" to show the Resonic RAP functions as specified and is as safe and effective.
- Electrical safety and EMC testing: Repeated by an independent lab in accordance with IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility: Established based on the predicate device, as "no new materials are used on the surface of the device that contacts the patient skin."
- Software verification testing: Conducted, and results were found acceptable for the software changes.
The core argument is that the "minor differences in the newer device version (the subject device) do not alter the fundamental technological characteristics or present different questions of safety or effectiveness as compared to the predicate device." Therefore, extensive new clinical studies to establish efficacy or clinical ground truth were not deemed necessary for this 510(k) submission.
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(213 days)
Soliton Inc.
The Rapid Acoustic Pulse Device (RAP) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. The RAP device is also indicated for short-term improvement in the appearance of cellulite.
The Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a standalone device to improve the appearance of cellulite. RAP uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser- induced whitening. This allows multiple laser passes in a single session, resulting in accelerated tattoo fading and fewer office visits to achieve sufficient tattoo fading. When used for improving the appearance of cellulite, the acoustic waves induce physical effects in the fibrous structures, such as the fibrous septa in the subcutaneous tissue.
RAP 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 skin to be treated.
The subject RAP device is almost identical to the previously cleared RAP device. The only hardware change to the device is the modified shape of the reflector that is part of the Hand Piece, so that the acoustic wave is less dispersed and penetrates deeper in the subcutaneous tissue where fibrous septa are located.
The provided content describes the clearance of the Rapid Acoustic Pulse Device (RAP) by the FDA, including some information about a clinical study for cellulite improvement. However, it does not contain a comprehensive table of acceptance criteria or detailed results of a study designed specifically to prove the device meets these criteria in a structured format often seen in medical device submissions. The information provided is more of a summary for a 510(k) clearance.
Based on the available text, I can extract and infer some information, but a complete answer to all your questions cannot be provided because the document focuses on regulatory clearance rather than a detailed scientific study publication with specific acceptance criteria and detailed performance metrics.
Here's an attempt to answer your questions based on the provided text:
Acceptance Criteria and Device Performance Study Summary
The document describes the RAP device's safety and effectiveness for improving the appearance of cellulite, evaluated in a prospective multi-site trial. The primary analysis was conducted on 62 participants. While specific, quantitive acceptance criteria (e.g., "X% of patients must show Y improvement") are not explicitly stated, the FDA's acceptance of the 510(k) implies that the demonstrated safety and effectiveness were deemed sufficient for substantial equivalence.
1. A table of acceptance criteria and the reported device performance
As mentioned, explicit, numerical acceptance criteria for effectiveness are not present in the document. The general acceptance criteria for FDA 510(k) clearance revolve around demonstrating substantial equivalence to a predicate device, which includes equivalent safety and effectiveness. The reported performance relates to the "temporary improvement in the appearance of cellulite" and a favorable safety profile.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (from Clinical Study) |
|---|---|
| Safety: Device must be safe for its intended use; adverse events expected to be minimal, transient, and manageable. | All adverse events categorized as mild or moderate, transient, resolved without intervention. No serious or severe AEs. No participants stopped treatment due to AEs. Average pain rating 2.4 (0-10 scale). |
| Effectiveness: Device must demonstrate temporary improvement in the appearance of cellulite. (Specific quantitative target not provided) | Effectiveness assessed by blinded independent reviewers using Cellulite Severity Scale (CSS) and Global Aesthetic Improvement Scale (GAIS) based on serial clinical photographs. (Specific outcome percentages/scores not reported in this document). |
| Tolerability: Treatment should be tolerable for patients. | Participants found RAP treatment tolerable (average pain 2.4/10). Participants generally satisfied with treatment and results. |
| Substantial Equivalence: Demonstrate technological characteristics and performance that do not raise new questions of safety or effectiveness compared to predicate devices. | Nonclinical testing demonstrated device performs to specifications and functions as intended, with a favorable safety profile. Clinical testing confirmed differences in technology from predicate do not adversely impact performance. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 62 participants (from an initial enrollment of 67) for the primary analysis.
- Data Provenance: Prospective, multi-site trial conducted at 4 sites in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "Photographs were assessed by blinded independent reviewers to identify pre-treatment images when compared to post treatment images and to grade the pre-treatment and post-treatment images using the CSS and improvement using the Global Aesthetic Improvement Scale (GAIS)."
- Number of Experts: Not specified. It mentions "independent reviewers" (plural), suggesting more than one, but the exact number is not provided.
- Qualifications of Experts: Not specified. They are simply referred to as "blinded independent reviewers." Their specific medical background (e.g., dermatologists, plastic surgeons, radiologists) and years of experience are not detailed in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The adjudication method for the reviewers is not explicitly stated in the provided text. It simply says "assessed by blinded independent reviewers."
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described. This device is a physical medical device (Rapid Acoustic Pulse Device), not an AI diagnostic algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for effectiveness in cellulite improvement was established via expert assessment of clinical photographs using validated scales (CSS and GAIS) by "blinded independent reviewers."
- For safety, it was based on adverse event reporting via physician examination and patient tolerability/satisfaction.
8. The sample size for the training set
- This question is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The study described is a clinical trial to evaluate the device's performance directly.
9. How the ground truth for the training set was established
- This question is not applicable as there is no AI algorithm training set mentioned.
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(29 days)
Soliton Inc.
The Rapid Acoustic Pulse Device (RAP) is indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
The Soliton Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments for tattoo removal. The RAP uses repeated, rapidly rising acoustic waves, releasing pigment particles from the pigment laden macrophage (PLM) and dissipating the laser-induced whitening. This allows multiple laser passes in a single session, resulting in fewer office visits.
The RAP 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 RAP is a modification to the company's Acoustic Wave Device (AWD) that has already been cleared for the same indications for use (K190542). Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device. Specifically, the shape, frequency and repetition rate of the acoustic waves are not changed.
This document describes the Rapid Acoustic Pulse Device (RAP), an accessory to specific lasers for black ink tattoo removal. However, it does not contain a detailed study proving the device meets acceptance criteria in the format of a clinical trial or performance study with specific outcome measures.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Soliton Acoustic Wave Device (K190542)).
Here's a breakdown of the information provided, and where information is missing for your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission focuses on comparing the modified device to its predicate, rather than establishing new performance criteria or reporting on a clinical study against such criteria.
2. Sample size used for the test set and data provenance
This information is not provided. The document mentions "Verification testing using the same methods as used for the predicate device" but does not detail the sample sizes, type of data, or provenance of any test sets used in this verification or for the predicate device.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
This information is not provided. As there's no described clinical performance study, there's no mention of experts or ground truth establishment.
4. Adjudication method for the test set
This information is not provided.
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
This information is not provided, and an MRMC study is not relevant here as the device is not an AI-driven image analysis tool for human readers. It's a physical device accessory for tattoo removal.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided, and a "standalone" performance study in the context of an algorithm is not applicable here as the device is a physical medical device accessory.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided.
8. The sample size for the training set
This information is not provided. No "training set" in the context of an AI/ML algorithm is mentioned or relevant to this device's description.
9. How the ground truth for the training set was established
This information is not provided.
Summary of what is provided regarding demonstration of device performance and safety (focused on substantial equivalence):
The document states that the Rapid Acoustic Pulse Device (RAP) is a modification of a previously cleared device, the Soliton Acoustic Wave Device (AWD) (K190542). The core argument for safety and effectiveness relies on the claim that:
- Minor changes: "Only minor hardware and software changes have been made. These changes do not alter the fundamental scientific technology of the modified device."
- Identical intended use/indications: Both RAP and AWD are indicated for use as an accessory to the 1064 nm Q-Switched laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.
- Similar technological characteristics and principles of operation: The shape, frequency, and repetition rate of the acoustic waves are not changed.
- Verification testing: "Verification testing using the same methods as used for the predicate device demonstrates that the RAP functions as specified and is as safe and effective as its predicate device." (No details on these methods, sample sizes, or results are provided, only the statement that it was done and considered acceptable.)
- Electrical safety and EMC: Repeated for RAP device by an independent test laboratory in accordance with IEC 60601-1 and IEC 60601-1-2. (Results are stated as acceptable, but specific data is not given.)
- Biocompatibility: Established based on the evaluation of the AWD, with no new patient-contacting materials used.
- Software verification: Conducted and testing results were found acceptable for the software changes. (Again, details are not provided.)
In essence, the submission argues that because the RAP device is fundamentally similar to its cleared predicate with only minor changes, and these minor changes were verified through established testing protocols (though not detailed here), it is substantially equivalent and thus safe and effective for its stated indications. It does not present a de novo clinical study with specific acceptance criteria and performance metrics for the RAP device itself.
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(81 days)
Soliton Inc.
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.
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