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.

Device Description

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.

AI/ML Overview

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.

Summary

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January 29, 2021

Soliton Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LPP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103

Re: K201801

Trade/Device Name: Rapid Acoustic Pulse Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: January 4, 2021 Received: January 4, 2021

Dear Janice Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K201801

Device Name

Rapid Acoustic Pulse Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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K201801

510(k) SUMMARY

Rapid Acoustic Pulse Device

Submitted by:	Soliton, Inc.5304 Ashbrook DriveHouston, TX 77081
Contact Person:	Leslie HondaVP, Regulatory Affairs and Quality SystemsTel: 206.375.8586
Date Prepared:
Trade Name:	Rapid Acoustic Pulse Device
Classification:	Class IILaser surgical instrument for use in general and plastic surgery and indermatology (21 CFR 878.4810)Product Code GEX
Predicate Devices:	Cynosure's Cellulaze Laser (K102541) (Primary predicatedevice)Soliton's Rapid Acoustic Pulse Device (K200331 (Reference device)

Device Description:

Intended Use / Indications for Use:

Summary of Technological Characteristics:

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Performance Data

Electrical safety and electromagnetic compatibility (EMC) testing for RAP was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

The biocompatibility of RAP is established based on the evaluation of the previous version of RAP as there is no change to the patient contacting components.

Software verification testing was conducted and the testing results were found acceptable for software release.

All performance testing demonstrated that RAP performs according to specifications and functions as intended.

Clinical Study Data

The RAP device was evaluated in a single arm, self-controlled, prospective, multi-site trial to assess the safety and effectiveness of the device for its indicated use for the temporary improvement in the appearance of cellulite. A total of 67 participants were enrolled at 4 sites in the United States and received one treatment session on the buttock and/or thigh areas. The primary analysis was conducted in 62 participants who completed a full treatment of the identified treatment areas and who completed the 12 week follow up visit. The mean age was 43 years and the majority of the participants were Caucasian.

All treatment sites were treated with multiple 1-minute doses of RAP to cover the site. Serial clinical photographs were collected under standardized conditions before treatment (baseline) and at the 12 week follow-up visits. 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). Safety assessments included evaluation of AEs via physician examination during and after the treatment.

Most participants found RAP treatment to be tolerable, with average pain during the entire treatment session rated as 2.4 using a 0 to 10 numeric pain rating scale. In addition, participants were generally satisfied with the treatment and the results.

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The safety of RAP was evaluated based on the adverse events reported during the study. All adverse events observed during the study were categorized as mild or moderate and were expected. All symptoms were transient and resolved without intervention. No adverse events were identified as serious or severe. No participants asked to stop the treatment or dropped out of the study due to any adverse event.

Based on the patient satisfaction and safety profile as documented in the pivotal clinical study, RAP was found to have a safety and effectiveness profile that is substantially equivalent to the predicate device.

Conclusions

RAP and its predicate devices have the same general intended use and similar indications for use, technological characteristics and principles of operation. Moreover, the differences in the technological characteristics do not present different questions of safety or effectiveness as compared to the predicate devices. Nonclinical testing of RAP demonstrated that the device performs as intended with a favorable safety profile. Clinical testing confirms that the differences in technology compared to the predicate do not adversely impact performance, in support of substantial equivalence. Therefore, RAP is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.