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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.

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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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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