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The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite and the treatment of Acne Scars. The SofWave System is indicated to improve the appearance of skin laxity on the upper arms.

The Pure Impact module is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
• The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.

The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage.

The SofWave System consists of three main functional components: 1) the console; 2) the applicator; and 3) EMS Module (Pure Impact). The console includes the power sources, cooling unit, electrical components, IoT, BLE, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console. The EMS module is wirelessly connected to and controlled by the SofWave console. It functions independently from the ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

The provided FDA 510(k) clearance letter and summary for the SofWave System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, particularly in relation to AI/software performance.

The document details the device's technological characteristics, comparison to predicate devices, and regulatory compliance (electrical safety, EMC, software V&V). However, it explicitly states under "Clinical Summary": "No clinical test data was required to support substantial equivalence." This means there was no clinical performance study conducted to demonstrate the device's effectiveness in achieving its stated indications (e.g., improvement of facial lines, muscle tone) through a study with human subjects, let alone one involving AI assistance or a standalone AI algorithm.

Therefore, many of the requested points cannot be extracted from this document because the type of study you are asking about (a performance study with acceptance criteria, human readers, ground truth establishment, etc.) was not performed or submitted for this 510(k) clearance.

Below, I will fill in the requested table and answer the questions based only on the information available in the provided text. Where information is not present, it will be explicitly stated.

Acceptance Criteria and Device Performance Study (Based on Provided Document)

Summary: The provided FDA 510(k) clearance document for the SofWave System demonstrates substantial equivalence through comparisons to predicate devices and non-clinical performance testing (software verification and validation, electrical safety, functional bench testing), but explicitly states that no clinical test data was required. Therefore, a clinical study with acceptance criteria related to device efficacy (e.g., improvement in facial lines, muscle tone) and involving a test set, expert ground truth, or AI performance metrics was not conducted and is not described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that "No clinical test data was required to support substantial equivalence," the document does not present clinical acceptance criteria for efficacy or performance in the way one might expect for a diagnostic AI device. The acceptance criteria mentioned are related to non-clinical performance and regulatory compliance.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable / Not provided. The document explicitly states, "No clinical test data was required." The functional and software testing conducted would not typically involve a "test set" in the context of patient data or clinical outcomes.
• Data Provenance: Not applicable / Not provided. No patient data or clinical data is mentioned as being used for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided. Since no clinical test data was required, there was no need for experts to establish ground truth in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No clinical test set or ground truth adjudication took place.

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

• Not applicable / Not provided. No clinical study, MRMC study, or AI assistance component (in the clinical efficacy sense) is detailed or claimed in this 510(k) summary. The "Pure Impact module" section describes the device as a "Powered Muscle Stimulator" and refers to "muscle training" but does not indicate any AI-driven diagnostic or interpretative capabilities that would necessitate an MRMC study for improved human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. The device described is a medical system with specific treatment functionalities (ultrasound for aesthetic treatments, EMS for muscle stimulation). It is not described as an AI algorithm intended for standalone diagnostic or evaluative performance. Software verification and validation were performed, but not in the context of an AI algorithm's standalone performance against a clinical ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not provided for clinical efficacy. The "ground truth" for the non-clinical testing would be the engineering specifications and established standards (e.g., IEC standards for electrical safety), which the device was verified against.

8. The sample size for the training set

• Not applicable / Not provided. If there were any machine learning components, details about a training set are not included in this 510(k) summary, as it explicitly states "No clinical test data was required."

9. How the ground truth for the training set was established

• Not applicable / Not provided. (See point 8).

Conclusion: The provided FDA 510(k) clearance document for the SofWave System focuses on demonstrating substantial equivalence to predicate devices and fulfilling non-clinical performance and safety requirements. It explicitly states that clinical test data was not required for this clearance. Therefore, the detailed information about acceptance criteria for clinical performance, test set characteristics, expert ground truth establishment, or AI performance studies (MRMC, standalone) that you requested are not present in this document.

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The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.

The Pure Impact module is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Strengthening, toning and firming of buttocks and thighs.

The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, IoT, and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console.

The subject device of this 510(k) adds an EMS module ("Pure Impact") to the previously cleared SofWave ultrasound system (K230820). The EMS module is wirelessly connected to and controlled by the SoftWave console. It functions independently from the existing ultrasound system. The user selects either the ultrasound treatment or the EMS treatment, but not both, at the beginning of the treatment.

The provided text describes the SofWave System, specifically focusing on the addition of an EMS module called "Pure Impact." The document is a 510(k) summary from the FDA, outlining the substantial equivalence of the SofWave System to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria beyond general statements about nonclinical performance testing and substantial equivalence. It primarily focuses on comparing the technological characteristics of the new Pure Impact module with existing predicate and reference devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication method for ground truth.
4. MRMC study information or effect size.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

The "Performance Data" section (page 12) only lists high-level nonclinical tests that were conducted:

• Biocompatibility (ISO 10993-1)
• Software verification and validation
• Electrical Safety and Electromagnetic Compatibility (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, IEC 60601-2-62, and IEC 62133)
• Functional bench testing
• Usability validation study

For these tests, it simply states that the "SofWave System functioned as intended" and "demonstrated that the device performs as intended." No specific metrics, acceptance thresholds, or study results are provided. The document concludes with a statement that "The minor technological differences between the subject and the predicate devices do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus is substantially equivalent to its predicates."

Without further documentation, it's impossible to detail the acceptance criteria and the study that proves the device meets them as requested.

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The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.

Indications for Use:

As an NMES device, indications are for the following conditions:

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
• Prevention of venous thrombosis of the calf muscles immediately after surgery

As a TENS device, indications are for the following conditions:

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical and post-trauma acute pain

As a pulsed mode device, indications are for the following conditions:

• Relaxation of muscle spasm
• Increasing local blood circulation
• Retardation or prevention of disuse atrophy
• Maintenance or increase of range of motion

The Chattanooga Revolution Wireless is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Chattanooga "Revolution Wireless stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles.

The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.

The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.

The Chattanooga® Revolution Wireless stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450 [mAh] battery.

The docking station is the part on which all the other components (modules, remote and accessories) are stored when the Chattanooga Revolution Wireless system is not in use. The docking is continuously connected to an AC wall socket and it allows charging simultaneously the 4 stimulation modules and the remote control. The docking main part is intended to be fixed and not for transportation purposes, but the tablet may be removed and used as a portable charging station for the remote and modules. The docking station includes a removable tray where the user can store electrodes, quick start guide, the remote and modules for transportation.

The wireless protocol of the Chattanooga® Revolution Wireless Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to

1. Send particular information from remote control to stimulation modules (stimulation settings)

2. Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status,

3. Transfer binary data to stimulation modules, and

4. Allow synchronization from stimulation modules to remote control clocks.

The provided documentation describes the Chattanooga Revolution Wireless, a powered muscle stimulator and transcutaneous electrical nerve stimulator (TENS) device. The information details the device's characteristics, indications for use, comparison to a predicate device (Vectra Neo), and performance testing conducted for its 510(k) premarket notification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table format with pass/fail values. Instead, the document discusses compliance with recognized standards and successful completion of various tests. The reported device performance is presented as a confirmation of compliance.

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

The document does not specify the sample sizes used for any of the performance tests (e.g., electrical safety, software verification, usability). There is also no mention of data provenance (e.g., country of origin, retrospective/prospective). The tests described are primarily engineering verification and validation studies rather than clinical trials with human participant data.

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

Given that the performance testing primarily involves engineering compliance with standards and functional verification, the concept of "ground truth" established by experts in the clinical sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for these tests would be the specifications outlined in the recognized standards themselves, and the expertise would lie with the engineers and testers performing the measurements and assessments against those standards. No specific number or qualifications of such experts are provided beyond implied expertise in regulatory and engineering compliance.

4. Adjudication Method for the Test Set

As the studies described are compliance-based engineering tests and not clinical studies requiring expert consensus on complex outcomes, an explicit adjudication method like "2+1" or "3+1" is not mentioned or relevant. Compliance is typically determined by whether the device's performance meets the defined parameters of the relevant standards.

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

No MRMC comparative effectiveness study is mentioned. The device is a physical therapy device (stimulator), and the evaluation focuses on its safety and performance against established standards and a predicate device, not on assessing the improvement of human readers (e.g., doctors interpreting scans) with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device itself is a physical medical device, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance studies are for the integrated device system.

7. Type of Ground Truth Used

The "ground truth" for the performance testing is implicitly defined by:

• Recognized Standards: Such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 14971.
• Design Requirements: For the software verification and usability testing, the device's own design requirements serve as the ground truth against which performance is measured.
• FCC Regulations: For radio frequency compliance.

There is no mention of pathology, clinical outcomes data, or expert consensus (in a diagnostic context) as ground truth.

8. Sample Size for the Training Set

This information is not provided. The document describes premarket notification for a physical medical device, not an AI/ML product that typically involves a "training set." The software verification mentioned refers to traditional software engineering verification, not machine learning model training.

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

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The ground truth for the device's design and functionality is established through engineering specifications, regulatory standards, and intended use definitions.

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