Search Results

Pure Impact 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.

Pure Impact device provides both training and physical therapy using Electrical Muscle Stimulation (EMS). The EMS is provided through electrodes that are controlled by the Touch Control Module.

The system includes:

• Touch Control Module
• Pure Impact™ Wireless Stimulation Modules
• Pure Impact™ Electrode Pads
• Pure Impact™ Charging Station

The Touch Control Module runs the Pure Impact™ program and displays the user interface, which provides the full range of controls to identify the patient and the required treatment. The Pure Impact™ Wireless Stimulation Modules provide EMS to selected body locations on the patient and communicate to the Touch Control Module through Bluetooth Low Energy (BLE). Each Stimulation Module contains a main stimulation unit and several stimulation subunits, each of which is attached to a Pure Impact™ Electrode Pad placed on the patient. The Pure Impact™ Electrode Pads are disposable and intended for single patient, single use only. They contain a hydrogel adhesive to attach to the selected body locations on the patient and magnetic connectors to attach to the Stimulation Modules. The Pure Impact™ Charging Station charges the Stimulation Modules.

This FDA 510(k) clearance letter pertains to the Pure Impact device, a powered muscle stimulator. The clearance is based on demonstrating substantial equivalence to a predicate device, the Pure Impact Module of the SofWave System (K250146).

The document states that the Pure Impact device is a modification of the predicate, with the only changes being related to the standalone PC, GUI, and software updates. It explicitly states that no changes were made to the Pure Impact Charging Station Unit, Pure Impact Wireless Stimulation Modules, or Pure Impact Electrode Pads. Furthermore, the change does not affect the treatment protocols, stimulation parameters, or energy delivery.

Therefore, the performance data and acceptance criteria for electrical muscle stimulators (EMS) typically revolve around safety and technical specifications, rather than clinical efficacy or diagnostic accuracy, which would involve more complex studies like MRMC or ground truth assessment from expert consensus or pathology. This is because EMS devices, particularly those for muscle conditioning, are often cleared based on demonstrating that their technical characteristics (e.g., waveform, output, safety features) are equivalent to a legally marketed predicate device, and that these characteristics do not raise new questions of safety or effectiveness.

Given the information provided, which heavily emphasizes direct technical comparison and safety testing (electrical safety, EMC, software V&V), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily framed around these technical and safety aspects, and the device's functional equivalence to its predicate. There is no mention of a clinical study assessing improvement in muscle tone or firmness with quantified metrics from human subjects, or any study involving human readers/experts for performance evaluation, as would be common for diagnostic AI/ML devices.

Here's a breakdown of the requested information based solely on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are predominantly framed as mirroring the technical specifications and safety standards met by the predicate device, and ensuring the modified device continues to meet these.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

· Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

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) console: 2) applicator: and 3) Electrical Muscle Stimulation (EMS) Module (Pure Impact). The console includes 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.

This FDA 510(k) K241685 summary describes the SofWave System, which includes an ultrasound system and an Electrical Muscle Stimulation (EMS) module (Pure Impact). The 510(k) submission is for minor changes to the existing SofWave System (K240687) and an updated software for the Pure Impact module to include the arms in its indications for use.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for performance in a quantitative sense for this 510(k) submission. Instead, it focuses on demonstrating substantial equivalence to predicate devices for the modified SofWave system and the Pure Impact module. The performance data section primarily discusses validation of the changes.

However, based on the context of a 510(k) and the information provided, we can infer the acceptance criteria were that the device performs as intended and that the changes do not raise new questions of safety or effectiveness.

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

This indicates that there was no clinical test set in the traditional sense for evaluating the device's clinical performance against an acceptance criterion in this particular 510(k) submission. The evaluation focused on engineering and software verification and validation. Therefore, information about sample size and data provenance for a "test set" in the context of clinical performance is not applicable here.

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

Since "No clinical test data was used," there was no "ground truth" establishment by experts in the context of a clinical test set. The evaluation was based on engineering and software testing against predefined specifications and comparisons to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test data was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "No clinical test data was used."

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

The device described is a physical medical device (ultrasound system and electrical muscle stimulator) with software components, not an AI/algorithm-only device. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to AI medical devices is not applicable. The software modifications were validated through software verification testing.

7. The Type of Ground Truth Used:

For the evaluation described in this summary, the "ground truth" for demonstrating substantial equivalence was effectively:

• Engineering specifications and standards: The device's electrical safety, design, and waveform output (for the Pure Impact module) were compared against established engineering principles and relevant voluntary standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971).
• Predicate device characteristics: The technological characteristics and performance of the modified SofWave module and the Pure Impact module were compared directly to already cleared predicate devices (K240687 for SofWave module and Pure Impact, and K233926 for accufit as another EMS predicate). The "ground truth" was that the subject device's performance fell within acceptable ranges or was equivalent to these legally marketed devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that involves a "training set" in the conventional sense. The software modifications mentioned were validated through verification testing, not a machine learning training process.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set was used.

Ask a specific question about this device

The SofMave 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 SofMave 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 SofMave System consists of three main functional components: 1) console; 2) applicator; and 3) Electrical Muscle Stimulation (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 text focuses on the 510(k) submission for the SofWave System, specifically for the addition of a "Smooth applicator" and its use in "short-term improvement in the appearance of cellulite." The core of the submission is to demonstrate substantial equivalence to a predicate device (K232455), which fundamentally relies on showing that the changes introduced (the Smooth applicator) do not raise new questions of safety or effectiveness.

It is important to note that the provided text does not detail specific, quantified acceptance criteria for the device's performance in terms of achieving a certain level of improvement in cellulite appearance, nor does it present a direct comparative effectiveness study (MRMC) against human readers or specify an "effect size of how much human readers improve with AI vs without AI assistance." This is because the device itself is a treatment device (Focused Ultrasound Stimulator System for Aesthetic Use), not an AI-based diagnostic tool that assists human readers.

Instead, the "performance data" section describes the studies conducted to demonstrate that the device (with the new applicator) functions safely and as expected, aligning with the predicate device's established performance. The study described is a clinical study for safety and effectiveness related to cellulite appearance, which is a clinical outcome rather than an algorithm's performance in a diagnostic task.

Given this context, I will extract and present the information as best as possible, interpreting "acceptance criteria" and "device performance" in the context of a treatment device demonstrating substantial equivalence, rather than a diagnostic AI.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a treatment device, the "acceptance criteria" are implied by the FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" (2011) and the expectation of demonstrating substantial equivalence to a predicate device. The performance is assessed in terms of safety and the expected aesthetic improvement, similar to the predicate device.

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

• Test Set Sample Size: 60 subjects were enrolled and treated in the clinical study.
• Data Provenance:
  • Country of Origin: The clinical study was conducted at 5 sites in the United States.
  • Retrospective or Prospective: The clinical study for cellulite appearance was prospective, as subjects received treatments and were followed up (baseline, 3-month follow-up). The animal model study was also prospective.

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

The text describes that "blinded independent reviewers" assessed photographs to identify pre-treatment vs. post-treatment images and grade improvement.

• Number of experts: Not specified explicitly. It states "blinded independent reviewers" (plural).
• Qualifications of experts: Not specified beyond being "independent" and "blinded." Their specific medical or aesthetic qualifications (e.g., dermatologists, plastic surgeons, radiologists) are not detailed.

4. Adjudication method for the test set

The text does not explicitly describe an adjudication method (like 2+1 or 3+1 consensus) for the "blinded independent reviewers'" assessments. It just states they "assessed" and "correctly identified" images, implying a single assessment per reviewer or the aggregate result of their assessments.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted in the traditional sense of evaluating an AI's impact on human reader diagnostic performance. The SofWave System is a treatment device, not a diagnostic AI. The clinical study aimed to demonstrate the device's safety and effectiveness in treating cellulite, not to improve human diagnostic accuracy.
• Effect Size of Human Readers with/without AI: Not applicable for this device and study.

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

• Standalone Performance: Not applicable/not performed in the context of an AI algorithm's diagnostic performance. The "device performance" was evaluated in terms of its physical outputs (acoustic parameters, thermal effects) and its clinical outcomes when used by an operator (as a therapy).

7. The type of ground truth used

The "ground truth" for the clinical study on cellulite improvement was established through:

• Expert Consensus/Blinded Reviewer Assessment: Serial clinical photographs assessed by blinded independent reviewers to identify pre-treatment vs. post-treatment images and grade improvement using established scales (Cellulite Severity Scale - CSS, Global Aesthetic Improvement Scale - GAIS, Laxity Scale - LS). This is a form of expert consensus on photographic evidence.
• Outcomes Data: Evaluation of Adverse Events (AEs) via physician examination.
• Pathology/Histology (for animal study): For the animal model, the ground truth for the efficacy of the thermal effects was histological tissue thermal effects and coagulative zones.

8. The sample size for the training set

The text relates to a 510(k) submission for a physical medical device (ultrasound system), not for an AI algorithm that requires a "training set" in the machine learning sense. Therefore, a sample size for a training set is not applicable and not mentioned.

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

As explained above, there is no "training set" in the context of an AI algorithm here. The ground truth for the device's development and validation involved engineering specifications, bench testing, animal studies, and limited human clinical data to demonstrate physical and clinical performance, but not in the format of a machine learning training dataset.

Ask a specific question about this device

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 regions 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 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, loT, 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 provided text describes the acceptance criteria and a clinical study conducted to expand the indications for use of the SofWave System to include improvement of the appearance of skin laxity on the upper arms.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: 46 subjects.
• Data Provenance: Prospective, self-controlled, multicenter study 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

• Number of experts: 3 blinded reviewers.
• Qualifications of experts: The document does not explicitly state the qualifications of the "blinded reviewers" (e.g., dermatologists, plastic surgeons, specific years of experience). It only states they were "blinded reviewers."

4. Adjudication method for the test set

• Adjudication method: The primary efficacy evaluation was based on the "correct identification of the pre- and post-treatment photographs by at least 2 of 3 blinded reviewers." This implies a form of 2 out of 3 consensus or majority vote.

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

• MRMC Comparative Effectiveness Study: No, this was not an MRMC comparative effectiveness study involving AI assistance for human readers. The study described is a clinical trial evaluating the effectiveness of the SofWave System itself, not an AI algorithm assisting human readers.

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

• Standalone (algorithm only) performance: No, this device is a physical medical device (ultrasound system) for aesthetic treatment, not an AI algorithm. The performance described is the outcome on patients.

7. The type of ground truth used

• Type of ground truth: Expert assessment/consensus. The primary efficacy was determined by the assessment of pre- and post-treatment photographs by blinded reviewers, and secondary efficacy endpoints were also assessed by these reviewers using a grading scale. Subjective reports of pain and discomfort were also used.

8. The sample size for the training set

• Sample size for training set: This information is not applicable or provided. The study described is a clinical trial for a physical device, not an AI model that requires a training set.

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

• Ground truth for training set: This information is not applicable or provided because it's not an AI model.

Ask a specific question about this device

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.

Ask a specific question about this device

Ask a specific question about this device

The SofMave 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 regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite.

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 SofMave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, the loT 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 provided FDA 510(k) summary for the SofWave System (K230820) states that this device is a modification of a previously cleared device (K230019). The modifications are described as minor hardware and software changes, specifically the addition of Internet of Things (IoT) capability via Wi-Fi. It explicitly states that these changes do not alter the fundamental scientific technology of the modified device, and specifically the energy parameters for the console or the applicators are not changed.

Therefore, this 510(k) relies on the substantial equivalence to the predicate device the original SofWave System (K230019) and does not present new clinical performance data to establish acceptance criteria or device performance related to its indications for use. Instead, it focuses on verifying that the changes made to K230820 do not negatively impact safety or effectiveness.

Based on the provided document, the following points can be inferred:

1. Acceptance Criteria and Reported Device Performance: No new performance criteria or clinical performance data are reported for the K230820 device in this document, as the changes are considered minor and not affecting the fundamental technology or energy parameters. The established performance of the predicate device (K230019) is implicitly relied upon.

2. Sample Size for Test Set and Data Provenance: Not applicable. The document does not describe a new clinical study with a test set for K230820.

3. Number of Experts and Qualifications: Not applicable.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone Performance: Not applicable as no new clinical performance data is presented for K230820 related to its intended use. However, the document does state that "Verification testing demonstrates that the modified device functions as specified and is as safe and effective as the cleared predicate device," and mentions "Software verification and validation testing was performed. The results were found acceptable for the software changes and demonstrated that the software performs as intended." This refers to internal engineering verification for the specific changes, not clinical performance for the indications for use.

7. Type of Ground Truth Used: Not applicable for K230820 in this document.

8. Sample Size for Training Set: Not applicable.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document does not contain the specific information requested regarding new acceptance criteria or a study that proves the [K230820](https://510k.innolitics.com/search/K230820) device meets acceptance criteria related to its clinical indications. This is because K230820 is presented as a modification of an already cleared device, and the submission argues that the modifications do not require new clinical performance testing. The "Performance Data" section focuses on verification and validation of the minor changes:

• Risk analysis to assess the impact of modifications.
• Verification testing to show the modified device functions as specified and is as safe and effective as the predicate.
• Electrical safety and EMC testing (repeated for the modified device).
• Biocompatibility (established based on the predicate device, as no new patient-contacting materials were introduced).
• Software verification and validation testing for the specific software changes.

To find the acceptance criteria and clinical study details for the original SofWave System (K230019), one would need to consult the 510(k) submission for that predicate device.

Ask a specific question about this device

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 regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite.

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 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 provided text describes the SofWave System, a focused ultrasound stimulator system for aesthetic use. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SofWave System, K223237) for the addition of a smaller applicator.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format as commonly seen for diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the substantial equivalence is based on demonstrating similar technological characteristics, safety, and effectiveness to its predicate. The key performance criteria evaluated relate to the functional equivalence of the new small applicator to the existing large applicator regarding thermal effects.

Study Details:

1. Test Set Sample Size and Data Provenance:

   • Sample Size: The document mentions "an animal model" (porcine model) for the in vivo study. It doesn't specify the number of animals or the number of tissue samples / treatment areas evaluated.
   • Provenance: Preclinical, acute, in vivo study using a porcine model. Country of origin is not specified.

2. Number of Experts and Qualifications for Ground Truth:

   • Number of Experts: "a third-party expert reviewer" (singular).
   • Qualifications: Not explicitly stated beyond "third-party expert reviewer."

3. Adjudication Method for Test Set:

   • The document states, "Histopathology evaluation of coagulation areas was performed by a third-party expert reviewer blinded to the treatment setting." This indicates a single blinded reviewer, so no multi-reader adjudication method (e.g., 2+1, 3+1) was used.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This device is an aesthetic treatment device, and the study presented focuses on its biophysical effects (thermal coagulation) rather than diagnostic performance requiring human interpretation with and without AI assistance.

5. Standalone Performance (Algorithm only without human-in-the-loop):

   • This question is not directly applicable in the context of this device. The SofWave System is a physical medical device (ultrasound stimulator), not an AI algorithm. The performance evaluated relates to the physical effects of the device itself. The software controls the device operation, and its performance was verified as part of functional checks, but there's no "standalone algorithm performance" in the traditional sense of an AI diagnostic.

6. Type of Ground Truth Used:

   • The ground truth for the in vivo study was "histopathology evaluation of coagulation areas" by a third-party expert.

7. Training Set Sample Size:

   • The document discusses a preclinical in vivo study to evaluate the new small applicator, but it does not describe a "training set" in the context of an algorithm's development. The study is a verification/validation study for the device's physical effects.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable as there is no mention of a training set for an algorithm. The in vivo study served as a performance evaluation, not a training phase for an AI model.

Ask a specific question about this device

The Softem 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 regions for subjects aged 22 and older. The SoftWave System is also intended for short-term improvement in the appearance of cellulite.

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 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 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; and for short-term improvement in the appearance of cellulite.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 68 subjects were treated.
• Data Provenance: Prospective clinical study conducted at 4 sites in the United States.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Number of Experts: Unspecified number of "blinded independent reviewers."
• Qualifications: "Blindness" implies they were unaware of the treatment status of the images. Specific professional qualifications (e.g., dermatologists, plastic surgeons, radiologists) are not provided in this document.

4. Adjudication Method for the Test Set

• The document states that "blinded independent reviewers" assessed photographs. It does not specify a formal adjudication method like "2+1" or "3+1" for discrepancies, implying either a single reviewer per assessment or a consensus approach without explicit detailing.

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

• No MRMC comparative effectiveness study was explicitly mentioned or detailed in this document regarding human readers improving with or without AI assistance. The study focused on the device's standalone effectiveness.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone study demonstrating the algorithm's performance (the device in this case, as it's a treatment system) was conducted. The clinical study evaluated the device's ability to improve cellulite appearance without human intervention beyond performing the treatment and assessing results.

7. Type of Ground Truth Used

• For Cellulite Improvement: Expert consensus/review of clinical photographs using the Cellulite Severity Scale (CSS) and Global Aesthetic Improvement Scale (GAIS), and Laxity Scale (LS) for blinded independent reviewers.

8. Sample Size for the Training Set

• The document does not detail a separate training set for an AI/algorithm in the traditional sense, as the device is a therapeutic system rather than a diagnostic AI. The "performance data" section focuses on the clinical study for expanding indications, which acts as the primary evidence for its effectiveness for the specified condition.

9. How Ground Truth for the Training Set Was Established

• Not applicable as there is no mention of a separate training set for an AI algorithm. The device's "training" and validation in a broader sense would be through its engineering and design processes, and its clinical performance is assessed through the described study.

Ask a specific question about this device