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Type

Panel

Reference & Predicate Devices

K233996

Intended Use

The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.

The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to:

Lift the eyebrow
Lift lax submental (beneath the chin) and neck tissue, which can also affect the appearance of lax tissue in the submental and neck regions
Improve lines and wrinkles of the décolleté
Improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms

Ensure proper coupling of the transducer to the skin
Confirm appropriate depth of treatment such as to avoid bone

Device Description

AI/ML Overview

The provided document is a 510(k) summary for the Ulthera System, seeking clearance for expanded indications for aesthetic use on the abdomen, anterior arms, and posterior arms.

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

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

The document doesn't explicitly state quantitative acceptance criteria in a typical "numeric threshold" format. Instead, the acceptance is based on demonstrating "clinically significant skin improvement" and an acceptable safety profile, comparable to the predicate device. The performance is reported qualitatively based on the outcomes of the reviewed clinical studies.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from Document)
Safety	"From a safety perspective, there were no unexpected or severe adverse events (AEs), and all observed AEs resolved without long-term sequalae."
Effectiveness (Abdomen)	Three clinical studies (n=54 subjects) demonstrated "clinically significant skin improvement up to 180 days post-treatment via a variety of endpoints, including blinded clinician photographic assessment, physician and subject Global Aesthetic Improvement Scores (GAIS), patient satisfaction surveys, and other validated clinical endpoints."
Effectiveness (Arms)	Five clinical studies (n=113 subjects) demonstrated "clinically significant skin improvement up to 180 days post-treatment via a variety of endpoints, including blinded clinician photographic assessment, physician and subject Global Aesthetic Improvement Scores (GAIS), patient satisfaction surveys, and other validated clinical endpoints."
Functionality (Non-clinical)	"In all instances, the subject device functioned as intended." (Biocompatibility, Electrical Safety, Software V&V)
Substantial Equivalence	The device has the "same general intended use and principle of operation as the predicate device. The minor changes in device hardware and software do not raise different questions of safety or effectiveness and do not affect clinical functionality or performance specifications."

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

Test Set Sample Size: The document does not describe a traditional "test set" in the context of an AI/algorithm performance study. Instead, it references a literature search of existing clinical studies supporting the expanded indications.
- Abdomen: 54 subjects across 3 unique clinical studies.
- Arms (anterior and posterior): 113 subjects across 5 unique clinical studies.
- Total: 167 subjects across 7 unique clinical studies (some studies likely included both abdomen and arms, though this is not explicitly broken down for unique subjects per region).
Data Provenance: The document states "a comprehensive literature search was performed." This implies the data were
- Retrospective: The studies were already completed and published, not prospectively designed for this 510(k) submission.
- Country of Origin: Not specified in the provided text.

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

The concept of "experts establishing ground truth" as typically seen in AI performance studies (e.g., radiologists annotating images) is not directly applicable here. The "ground truth" for the effectiveness of the Ulthera system is based on:

Blinded clinician photographic assessment: This indicates that medical professionals (clinicians) evaluated photographic evidence, likely pre- and post-treatment, without knowing which was which. The number and qualifications of these clinicians are not specified.
Physician Global Aesthetic Improvement Scores (GAIS): Physicians assessed improvements. The number and qualifications of these physicians are not specified.
Subject Global Aesthetic Improvement Scores (GAIS): Patients themselves provided self-assessments.

4. Adjudication method for the test set

The document does not detail an adjudication method for the clinical outcomes. While "blinded clinician photographic assessment" and "physician GAIS" suggest clinical evaluation, there's no mention of how discrepancies between multiple assessors were resolved (e.g., 2+1, 3+1). If multiple clinicians assessed the same case, their consensus or a defined adjudication process is not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not conducted. This submission is for a device that delivers energy for aesthetic treatment, not an AI diagnostic algorithm that assists human readers in reading cases. The clinical data reported focuses on the device's direct effect on patients, not on how an AI component improves human interpretation.

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

The Ulthera System is a therapeutic device with an imaging component. It is not an AI algorithm, and therefore, a standalone performance study in the context of an AI system would not apply. The device's imaging function allows visualization for proper coupling and depth confirmation, but it's not a diagnostic AI system with an "algorithm only" performance metric. The "software verification and validation testing" mentioned is for the device's operational software, not an AI diagnostic algorithm.

7. The type of ground truth used

The ground truth for effectiveness was primarily clinical and subjective-to-observer:

Blinded clinician photographic assessment: Implies visual expert assessment.
Physician Global Aesthetic Improvement Scores (GAIS): Expert (physician) subjective assessment.
Subject Global Aesthetic Improvement Scores (GAIS): Patient subjective assessment.
Patient satisfaction surveys: Patient subjective assessment.
Other validated clinical endpoints: While vaguely described, this suggests other established clinical metrics were used.

No mention of pathology (biopsy) or long-term outcomes data beyond 180 days is provided as primary ground truth.

8. The sample size for the training set

The concept of a "training set" is not applicable here as the submission is for a medical device (focused ultrasound system) with new anatomical indications, not a machine learning model developed with a training set. The existing clinical studies were used as evidence to support the expanded indications, analogous to a validation set rather than a training set for an AI/ML model.

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

As there is no "training set" for an AI/ML model in this submission, this question is not applicable.

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K Number

K240687

Device Name

Manufacturer

Date Cleared

2024-05-30

(79 days)

Product Code

OHV,NGX

Regulation Number

Type

Panel

Ulthera System (UC-1 Control Unit PRIME)

Reference & Predicate Devices

K232455

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device-related adverse events are minimal and mild.	Throughout the study, there was only one device-related adverse event reported, which was mild in severity. No serious or unanticipated adverse event was reported during the study.
Effectiveness (Cellulite Appearance): Demonstrates improvement in cellulite appearance, consistent with predicate device.	Blinded Reviewer Assessment: The blinded reviewers correctly identified the post-treatment images for 92% of the subjects.
	Pain Level: The mean pain level was 4.26 (moderate pain). No subjects withdrew from the study due to discomfort or pain.
	Consistency with Predicate: Based on a literature review, the study results were consistent with the predicate device.
Functional Bench Testing: Addition of Smooth applicator does not negatively affect device performance.	Functional bench testing was conducted to verify that the addition of the Smooth applicator did not affect the device performance (reported as "demonstrated that the device performs as intended"). Acoustic mapping testing showed very similar acoustic parameters for the Smooth and Lift applicators. Thermal coagulation for each PZT is expected to be the same, demonstrated in performance testing.
Biocompatibility: Patient-contacting components are biocompatible.	Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993.
Software Verification and Validation: Software performs as intended.	Software verification and validation was performed, and demonstrated that the software performs as intended.
Electrical Safety and EMC: Complies with relevant standards.	Electrical Safety and Electromagnetic Compatibility was established in accordance with IEC 60601-1-2, IEC 60601-1, IEC 60601-1-6, IEC 60601-2-10, and IEC 60601-2-62.
In vivo (Animal) Safety & Effectiveness: Thermal effects and coagulation zones are as expected.	The preclinical, acute, in vivo study using a porcine model demonstrated that the thermal effects and the coagulation zones induced by SofWave Smooth applicator are as expected.

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.

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K Number

K233996

Device Name

Manufacturer

Ulthera, Inc.

Date Cleared

2024-02-22

(66 days)

Product Code

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K180623

Intended Use

The Ulthera System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin.

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:

· Lift the eyebrow

• Lift lax submental (beneath the chin) and neck tissue. which can also affect the appearance of lax tissue in the submental and neck regions

· Improve lines and wrinkles of the décolleté

· Ensure proper coupling of the transducer to the skin

· Confirm appropriate depth of treatment such as to avoid bone

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ulthera System (UC-1 Control Unit PRIME). The submission aims to demonstrate substantial equivalence to a predicate device (Ulthera System, K180623), primarily focusing on modifications to the console.

Based on the provided text, the device is an aesthetic device (Focused Ultrasound Stimulator System for Aesthetic Use) and NOT a diagnostic device or an AI/ML-driven device that involves human readers or complex image interpretation.

Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not applicable or not detailed in this submission.

The "study" described is a series of non-clinical performance tests validating the modified console's functionality and safety, rather than a clinical study evaluating diagnostic accuracy or reader improvement.

Here's an attempt to address the points based on the available information, noting where information is not present due to the nature of the device and submission:

Acceptance Criteria and Device Performance for Ulthera System (UC-1 Control Unit PRIME)

The 510(k) submission primarily focuses on demonstrating that modifications to the Ulthera System's console do not significantly affect its clinical functionality or performance compared to the predicate device. The acceptance criteria are essentially that the modified device functions "as intended" and remains "as safe and effective" as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a diagnostic device with specific performance metrics like sensitivity/specificity, the "acceptance criteria" relate to engineering, software, and physical performance.

Acceptance Criteria Category	Reported Device Performance/Verification
Biocompatibility	User-contacting components verified in accordance with ISO 10993-1. (Performance: Verified)
Electrical Safety and EMC	Verified in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, and IEC 60601-2-62. (Performance: Compliant)
Software Verification & Validation	Conducted as recommended by FDA Guidance, "Content of Premarket Submissions Device Software Functions." A basic documentation level was used as a failure would not present a hazardous situation with a probable risk of death or serious injury. (Performance: Conducted, Passed; Functions as intended.)
Usability	Conducted in accordance with IEC 62366-1 and FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Specific checks included console's portability, GUI visibility and layout, and display responsiveness. (Performance: Clinicians able to use device in representative environment; no new risks identified.)
Mechanical Testing	Display hinge of the console verified via mechanical cyclic testing. (Performance: Verified)
Packaging, Transit, & Environmental	Packaging and transit testing per ASTM D4169 and ASTM D4332. Environmental conditioning testing conducted to verify device functionality at defined operating and storage conditions. (Performance: Verified)
Ultrasound Output Testing	Acoustic reliability verified using simulated treatment over the device's service life. Power output and imaging were verified to be within specification. (Performance: Within specification, operates as intended)
Overall Comparison (Subject vs. Predicate)	The submission states: "These non-clinical performance tests of the Ulthera System demonstrated the modified console continues to operate as intended and that it is as safe and effective as its predicate for the proposed indications for use." (Performance: Demonstrates substantial equivalence, safety, and effectiveness compared to predicate)

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

This is not a clinical study involving a "test set" of patient data in the typical sense for AI/ML. The "testing" involves engineering and software validation on the device itself. Therefore, concepts like "sample size" for patient data and "data provenance" (country, retrospective/prospective) are not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this device's performance is established by engineering specifications, regulatory standards compliance, and direct verification of the device's physical and software functions. There are no "experts" establishing ground truth in the context of interpreting medical images or clinical outcomes for a test set.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of cases requiring adjudication by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices where human reader performance (with or without AI assistance) is being evaluated relative to a reference standard. This device is an aesthetic treatment system, and the submission is for console modifications, not a new diagnostic algorithm.

6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an AI/ML diagnostic algorithm. The device has an "imaging mode" for visualization and user guidance (proper coupling, depth avoidance) but is fundamentally an energy delivery system for aesthetic treatment. Its performance is tied to its physical and software functions (power output, imaging capabilities, safety features), which were tested directly.

7. The Type of Ground Truth Used

The "ground truth" for the various tests were:

Engineering specifications and design requirements: For mechanical, electrical, and acoustic performance.
International standards (ISO, IEC, ASTM): For biocompatibility, electrical safety, EMC, usability, packaging, and transit.
FDA Guidance: For software verification and validation, and usability/human factors.
Predicate device's established safety and effectiveness: The ultimate "ground truth" for substantial equivalence is demonstrating that the modified device performs comparably to the legally marketed predicate.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning that would require a "training set" of data.

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

Not applicable, as there is no training set for machine learning.

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K Number

K233104

Device Name

Manufacturer

Date Cleared

2023-12-22

(87 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K231537

Intended Use

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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Improvement in upper arm skin laxity	93% of treated arms showed improvement as assessed by blinded reviewers.
Safety profile/device-related adverse events	No device-related adverse events.
Patient discomfort/pain	Most subjects reported none to mild levels of pain during treatment and no discomfort afterward.

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.

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K Number

K232455

Device Name

Manufacturer

Date Cleared

2023-12-14

(122 days)

Product Code

OHV,NGX

Regulation Number

Type

Panel

Physical Medicine (PM)

Reference & Predicate Devices

K143551,K230820,K212866

Intended Use

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.

Device Description

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.

AI/ML Overview

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:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts, their qualifications, or adjudication method for ground truth.
MRMC study information or effect size.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
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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K Number

K230100

Device Name

SCIZER (SC1-M410)

Manufacturer

Classys Inc

Date Cleared

2023-11-03

(294 days)

Product Code

Regulation Number

Type

Panel

BeShape Technologies Ltd.

Reference & Predicate Devices

K112626

Intended Use

The SCIZER delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue(SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.

The SCIZER is specifically indicated for non-invasive waist circumference reduction.

Device Description

The Subject Device consists of 2 handpieces, a control unit, a Touch LCD monitor, power supply unit for irradiation and for setting parameters after the main power and key switch is turned on.

HIFU energy is irradiated based on a linear scanning method through the handpiece depending on irradiation energy that is set in advance by the user. The Cartridge D13 used with the Subject Device focuses the HIFU energy from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. The Cartridge can treat a region of tissue up to 46mm long and 46mm wide. The Cartridge can apply a maximum of 24 lines at a time. As a result, tissue temperature rises over 56°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in the destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response.

Immediately before the procedure, purified water was applied to the treatment area to promote the desired energy transmission of the ultrasound transducer. To minimize the pain from the thermal HIFU procedure, the cooling level was used through the GUI. It is recommended to use an ultrasound imaging system to visualize the sub-dermal regions of interest before treatment. It allows the physician to compile a precise view of the target treatment area.

AI/ML Overview

The provided text describes the clinical study conducted for the SCIZER (SC1-M410) device to demonstrate its safety and effectiveness for non-invasive waist circumference reduction. This is a 510(k) submission, meaning the focus is on substantial equivalence to a predicate device, LipoSonix® system model 2.

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

Acceptance Criteria and Reported Device Performance

The primary efficacy outcome serves as the key acceptance criterion.

Acceptance Criteria (Primary Efficacy Outcome)	Reported Device Performance
Waist circumference reduction above 2.45 cm after two sets of treatments/procedures.	All three analysis sets (FAS, PPS, IAS) revealed a statistically significant difference in the waist circumference between the 8th week (and 16th week) and prior to the 1st procedure, compared to the reference value of 2.45cm (δ). The null hypothesis (D

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K Number

K231628

Device Name

BeShape One Device

Manufacturer

Date Cleared

2023-09-29

(116 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K181896

Intended Use

The BeShape One™ device delivers High Intensity, Non-Focused Ultrasound energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The BeShape One™ device is specifically indicated for non-invasive waist circumference reduction.

Device Description

The BeShape One™ device is a non-invasive, high intensity, non-focused US device intended for disruption of the subcutaneous adipose tissue and indicated for noninvasive waist circumference reduction. The BeShape One™ device utilizes continuous wave (CW) ultrasonic energy applied to the adipose tissue at a temperature of 47-49ºC. A cooling system maintains the skin temperature at below 35℃. The device consists of hardware and software. These elements are integrated in the BeShape One™ console and applicator/hand piece. BeShape One™ is supplied as a console and two identical applicators. The device is portable and was specifically designed to be utilized in clinic environments.

The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems:

Power Source
Controller unit (CPU) .
Water cooling system (Chiller) ●
Vacuum System
. Block Amplifier
Touchscreen display monitor ●
Personal computer and proprietary software .
Two designated applicator cradles .
Two designated applicator connector ports .

The BeShape One™ device applicator is a mechanical handpiece with an internal rectangular bathtub-shaped chamber and consists of the following elements:

Two parallel facing US transducers Each transducer includes four piezoelectric . (PZT) ceramic elements which convert electrical energy into acoustic energy in the ultrasound frequency range. Each transducer can transmit up to 1.5W/cm2 of acoustic energy at a frequency of 2MHz.
. Vacuum - The vacuum provides effective fixation of the adipose tissue under the skin in the cup-shaped chamber of the Applicator.
The cooling system which includes thermoelectric coolers (TEC) for ultrasound ● (US) transducers (TD) and a water-cooling system for the hot side of the thermoelectric coolers (TEC). The cooling system is intended to cool the applicator and skin to below 35°C.

The Applicator uses vacuum during the procedure, which draws adipose tissue under the skin into the inner cup-shaped chamber, thereby heating the subcutaneous adipose tissue.

AI/ML Overview

The provided text is a 510(k) summary for the BeShape One™ Device, which is a medical device for non-invasive waist circumference reduction. It describes the device, its intended use, performance testing, and comparison with a predicate device (LIPOcel).

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

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

The document doesn't explicitly present a formal "acceptance criteria table" with specific numerical targets. However, it implicitly defines success by demonstrating statistical significance, clinical meaningfulness, and positive user/investigator ratings compared to baseline.

Performance Metric	Acceptance Criteria (Implicit from Study Design/Goals)	Reported Device Performance at 12 Weeks Post-Treatment
Waist Circumference Reduction	Statistically significant decrease from baseline and clinically meaningful.	Statistically significant decrease of -1.87 cm (STD=2.62). This met the performance goal.
Subject Self-Reported GAIS	Significant percentage of subjects rating improvement in waist circumference reduction.	55% of subjects rated an improvement.
Investigator Rated CGAIS	Significant percentage of subjects rating improvement in waist circumference reduction.	72.3% of subjects rated an improvement.
Subject Satisfaction Self-Rating	High level of satisfaction. (Though a decline was noted from 6 to 12 weeks, the 6-week satisfaction may be an implicit target met)	53.7% satisfaction at 6 weeks (declined at 12 weeks).
Abdominal Fat Thickness Reduction	Reduction indicated. (No specific threshold mentioned as an "acceptance criteria")	-0.20 cm (STD=0.43).
Safety (Adverse Events/LSR)	No significant or unmanageable adverse effects; acceptable Local Skin Reactions (LSRs).	Most frequent LSRs: erythema and application site bruise. No abnormal vital signs. No adverse effect mentioned.

The "performance goal" for waist circumference reduction having been met indicates an implicit acceptance criterion was defined for this key efficacy endpoint.

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

Sample Size for Test Set: The "Clinical Performance Data" section states, "The SAS comprised 72 participants." (SAS likely stands for Safety Analysis Set or Statistical Analysis Set, representing the main study cohort).
Data Provenance: The study was a "prospective, multi-center, single-arm study." The country of origin is not explicitly stated, but the applicant company is based in Israel, which suggests the study was likely conducted there or in regions accessible to them. It was a prospective study.

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

For the Clinical Global Aesthetic Improvement Scale (CGAIS), an "investigator" rated subject improvement. The number of investigators/experts is not specified. Their qualifications are also not explicitly detailed, but as it's a clinical study, they would typically be trained medical professionals (e.g., physicians, dermatologists, or clinical research staff with experience in aesthetic assessments).
For other objective measures like waist circumference and abdominal fat thickness, these are quantitative measurements, not typically requiring "expert consensus ground truth" in the same way as image interpretation or subjective aesthetic scales. The ground truth for these would be the direct measurement itself.

4. Adjudication method for the test set:

The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's assessments. For subjective scales like CGAIS, if multiple investigators were involved, it's common practice to have methods for ensuring consistency or resolving discrepancies, but this is not detailed in the summary.

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, an MRMC comparative effectiveness study was not conducted. This device is a treatment device, not an AI-assisted diagnostic device. The study described is a clinical trial assessing the direct efficacy and safety of the device on patients, not comparing human reader performance with and without AI.

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

This question is not applicable. The BeShape One™ Device is a physical medical device that delivers ultrasound energy for treatment, not a standalone AI algorithm for diagnosis or image analysis. Its "performance" is measured by its clinical effect on patients, not by an algorithm's output.

7. The type of ground truth used:

Clinical Efficacy Ground Truth:
- Objective Measurements: Waist circumference reduction (direct measurement).
- Objective Measurements: Abdominal fat thickness reduction (direct measurement).
- Subjective Clinical Assessment: Investigator-rated Clinical Global Aesthetic Improvement Scale (CGAIS). The "ground truth" here is the clinical judgment of the investigator(s).
- Subjective Patient Assessment: Subject self-reported GAIS and a 5-point Satisfaction Likert scale. The "ground truth" here is the patient's direct perception and experience.
Safety Ground Truth:
- Observation of Local Skin Reactions (LSRs) and vital signs.
- Pre-clinical (animal) study: Thermal safety, lipid profile, micro and macro-histopathology requirements.

8. The sample size for the training set:

The document describes a single-arm clinical study used for demonstrating safety and efficacy for the 510(k) submission. It does not mention a separate training set or any machine learning model training. The clinical study described served as the primary performance evaluation.

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

As no training set (in the context of machine learning) is mentioned or implied for this device's performance evaluation, this question is not applicable. The clinical trial data was primarily used for validation of the device's efficacy and safety.

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K Number

K231537

Device Name

Manufacturer

Date Cleared

2023-08-28

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Device Description

AI/ML Overview

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K Number

K230820

Device Name

Manufacturer

Sofwave Medical Ltd

Date Cleared

2023-04-18

(25 days)

Product Code

Regulation Number

Type

Special

Panel