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The Venus Velocity is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:

• Hair removal;
• o Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and
• . Treatment of pseudofolliculitis barbae.

The Venus Velocity consists of a console, a detachable diode laser applicator, and three interchangeable sapphire light quides/tips (small, medium, and large sizes). A water system and pump in the console distribute water to cool the handpiece and tips during device use, decreasing the likelihood of burns, discomfort, or pain during treatment. The system is also provided with a water filling kit.

The device incorporates several safety features, including an emergency laser stop button, user login and password protection, and other software and hardware settings to mitigate the risk of improper energy release and ensure that system outputs are within specifications. The device also comes with goggles and patient eye protectors.

This document is a 510(k) Summary for the Venus Velocity device. It describes the device's technical characteristics, intended use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, this document does not contain a detailed study proving the device meets acceptance criteria in the way typically expected for a clinical performance study. Instead, it relies on demonstrating that the device's technical specifications and safety profile are similar to existing, cleared devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of "acceptance criteria" for clinical performance. Instead, it implicitly defines acceptance by demonstrating that the device's technical parameters are within the ranges of predicate devices and that various safety and engineering tests passed.

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

The document does not describe a clinical test set with human subjects. The "performance data" refers to engineering, safety, and software verification tests. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.

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

This information is not applicable as no clinical test set with ground truth established by experts is described in this document. The "tests" described are primarily engineering and technical validations against standards.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set requiring expert adjudication is described in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The Venus Velocity is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device that would involve human readers or AI assistance in that context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The Venus Velocity is a physical medical device (laser system) and does not involve AI algorithms in the sense of a standalone diagnostic or interpretative tool.

7. The Type of Ground Truth Used

For the engineering and safety tests, the "ground truth" was adherence to established international standards (e.g., IEC 60601 series, ISO 10993 series) and the specified technical parameters of the device. For software, it was "demonstrating that the software is appropriate for release."

8. The Sample Size for the Training Set

This information is not applicable. The Venus Velocity is a physical medical device, not an AI/machine learning model that requires a training set of data.

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

This information is not applicable for the same reason as point 8.

In summary:

This 510(k) summary focuses on demonstrating "substantial equivalence" to legally marketed predicate devices through a comparison of technological characteristics, intended use, and by showing the device meets relevant engineering, electrical safety, biocompatibility, and software validation standards. It does not present a clinical study with human subjects to establish specific performance metrics like sensitivity, specificity, or permanent hair reduction rates against predefined acceptance criteria for a new clinical claim. Instead, the claim of "permanent hair reduction" is tied to the predicate devices and general understanding of "laser surgical instrument" performance, and the device's technical specifications are verified to be safe and effective within those established ranges.

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The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:

Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.

The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.

The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:

• Intense Pulsed Light (IPL); ●
• Radiofrequency (RF); .
• Magnetic Pulse (MP2). .

The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.

The provided document is a 510(k) summary for the Venus Versa System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific clinical acceptance criteria through a standalone study with a predefined ground truth and expert adjudication. Therefore, much of the requested information (like specific acceptance criteria based on clinical efficacy, sample sizes for training/test sets, expert qualifications, or MRMC comparative effectiveness studies) is not typically found or required in a 510(k) summary for this class of device and type of submission.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and bench testing (system verification testing) rather than clinical performance data against specific endpoints.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described are largely related to technical specifications and safety, not clinical efficacy. The reported performance refers to the device meeting these technical specifications.

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

The document does not describe "test sets" in the context of clinical data for performance evaluation. The "testing" mentioned refers to engineering and safety verification on the device itself. Therefore, specific sample sizes for clinical test sets or data provenance (country, retrospective/prospective) are not applicable to the information provided for this 510(k) submission.

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

This information is not applicable as the document describes technical verification and safety testing, not clinical studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a clinical test set requiring adjudication.

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

No MRMC comparative effectiveness study is mentioned. The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (bench testing), not comparative clinical efficacy with human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

This information is not applicable as the Venus Versa System is a physical device (multi-application aesthetic system), not an AI algorithm. Its performance is inherent in its operation, not an "algorithm only" in the sense of AI.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation described would be engineering and manufacturing specifications/standards. For example, the "truth" for fluence measurement is the expected fluence value, and the "truth" for biocompatibility is conformance to ISO 10993-5. There is no clinical or pathological "ground truth" established from patient data mentioned in this submission for proving performance.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is a physical system, not a machine learning model.

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

This information is not applicable for the reasons stated above.

Summary of Device Acceptance and Study:

The Venus Versa System gained acceptance (clearance) through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices. The "study" proving this involves:

• Comparison of Technical Characteristics: Showing that the Venus Versa System's intended use, indications for use, technological characteristics (energy type, IPL spectrum, frequency, spot size, pulse duration, energy density), and principles of operation are similar to its predicate devices, with minor differences that do not raise new safety or effectiveness concerns.
• Bench Testing / System Verification: Conducting a series of engineering, safety, and performance evaluations on the device itself. This included:
  • Electromagnetic Compatibility (EMC) testing.
  • Electrical Safety testing.
  • Biocompatibility testing of patient-contacting materials.
  • Validation of cleaning, disinfection, and sterilization parameters.
  • Software validation.
  • Specific system verification for each applicator type (IPL, Bipolar RF & PMF, Fractional RF) to ensure measured outputs (e.g., fluence, RF voltage, output power, temperature) met predefined technical specifications and expected values.

In essence, the "acceptance criteria" were regulatory requirements for safety and performance equivalence to predicate devices, and the "study" was a combination of documentation outlining feature similarity and rigorous engineering verification testing. Clinical efficacy for specific indications, while implied by equivalence to predicates, was not proven through new clinical trials with patient cohorts described in this document.

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The Venus Versa System is a multi-application device intended to be used in aesthetic procedures.

The SR515 and SR580 IPL applicators are indicated for the following:

· Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

· Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650 and HR690 IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Versa System is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy to the treatment area. Four IPL handpieces (SR515, SR580, HR650, HR690) are included with the device system. The Versa device provides individual adjustment of light fluency and pulse duration, and has integrated skin cooling features. Using the IPL applicators, the light energy delivered to the patient's skin is used to treat various conditions via the mechanism of selective photothermolysis.

The provided text is related to a 510(k) premarket notification for the "Venus Versa System", an Intense Pulsed Light (IPL) device used in aesthetic procedures. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance metrics for a specific AI/ML medical device.

Therefore, I cannot fully address your request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document does not contain that type of information. Specifically, it does not include:

• A table of acceptance criteria and reported device performance for an AI/ML model.
• Sample sizes for test sets used for AI/ML model validation.
• Information about data provenance (e.g., country of origin, retrospective/prospective) for AI/ML data.
• Number of experts and their qualifications for establishing ground truth for AI/ML test sets.
• Adjudication methods for AI/ML test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI+human vs. human-only.
• Standalone (algorithm only) performance metrics for AI/ML.
• Type of ground truth used for AI/ML (e.g., pathology, outcomes data).
• Sample size for training sets for an AI/ML model.
• How ground truth for a training set was established for an AI/ML model.

However, based on the provided text, I can infer some aspects related to general device performance and regulatory acceptance for a non-AI/ML device.

The document describes the regulatory review for the Venus Versa System, focusing on its substantial equivalence to predicate IPL devices. The "performance data" mentioned is primarily related to engineering and safety standards, rather than clinical efficacy studies with specific acceptance criteria for diagnostic or therapeutic accuracy in the way an AI/ML device would be evaluated.

Here's what can be extracted from the document regarding performance and "acceptance":

General Device Performance and Acceptance (as presented in this document for a non-AI/ML device):

The acceptance criteria are implicitly defined by compliance with recognized standards and the demonstration that the device's technological characteristics and performance are "substantially equivalent" to legally marketed predicate devices, and that it "performs as intended for the indicated uses."

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for this non-AI/ML device):

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

• Not Applicable / Not provided for clinical performance: This document does not describe a clinical study with a "test set" in the context of an AI/ML model for accuracy evaluation. The "testing" mentioned refers to engineering and safety compliance tests, and the "sample size" for such tests is typically governed by engineering standards (e.g., number of units tested for electrical safety or energy output consistency).
• Data Provenance: Not applicable.

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

• Not Applicable: This document does not describe the establishment of ground truth for a clinical test set as would be done for an AI/ML device.

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

• Not Applicable: This document does not describe this type of clinical adjudication process.

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: This device is an IPL system, not an AI-powered diagnostic or assistive tool.

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

• Not Applicable: There is no AI algorithm being evaluated for standalone performance.

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

• Not Applicable: As there is no AI/ML model here, there is no need for this type of clinical "ground truth." The "ground truth" for the engineering tests would be the established specifications and regulatory standards.

8. The sample size for the training set:

• Not Applicable: This is not an AI/ML device, so there is no training set mentioned.

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

• Not Applicable: This is not an AI/ML device, so there is no training set ground truth to establish.

In summary, the provided document is a 510(k) clearance letter and summary for a non-AI/ML medical device (IPL system). It focuses on demonstrating substantial equivalence through technological comparison and compliance with engineering and safety standards, rather than clinical performance based on AI model evaluation and ground truth establishment.

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The Venus Legacy CX device is intended for the treatment of the following medical conditions; using the LB2 and LF2 applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:

• Relief of minor muscle aches and pain, relief of muscle spasm .
• Temporary improvement of local blood circulation .
• Temporary reduction in the appearance of cellulite

The Venus Legacy CX device consists of a console (main unit) and two applicators (LB2, LF2). The console in the Venus Legacy CX device contains a power supply unit, an RF generator (power module, on main board), a suction module (vacuum), a controller unit (on main board) and a touchscreen user interface and display panel. The Venus Legacy CX device provides RF treatments combined with emitted magnetic fields and vacuum massaging. The Vacuum is mainly used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the sub-dermal and adipose tissues shrinkage and improves the contact surface between electrodes and tissue. The RF currents heat the adipose and muscular tissues to trigger tissue level changes leading to temporary reduction in the appearance of cellulite and temporary relief of muscle pain and muscle spasm. The RF heating effect also improves local blood circulation in the sub dermal layers. The PMF assists in achieving treatment effect.

This document, a 510(k) summary for the Venus Legacy CX device, primarily focuses on demonstrating substantial equivalence to a predicate device (Viora Reaction System) rather than proving the device meets specific performance acceptance criteria through clinical studies with human participants. Therefore, many of the requested categories related to clinical study design, sample sizes, expert adjudication, and comparative effectiveness studies are not applicable or cannot be extracted from this document directly.

The document emphasizes performance bench testing to show similarity to the predicate device.

Here's the information that can be extracted, and an explanation for the areas where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary demonstrating substantial equivalence, explicit "acceptance criteria" for clinical performance (e.g., specific percentages of cellulite reduction in a defined population) are not provided. Instead, the "performance" discussed is related to engineering and bench testing comparisons to the predicate.

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

• Test Set (Clinical): Not applicable. This document does not describe a clinical test set with human participants.
• Test Set (Bench/Pre-clinical):
  • Porcine Tissue for Thermal Profile: The document mentions "porcine tissue" but does not specify the sample size (e.g., number of tissue samples or animals).
  • Other Bench Tests: No specific sample sizes for components or systems tested are provided, other than "several performance tests" and "validation study."
• Data Provenance: Not specified, but generally, bench testing data would be generated in a lab setting, likely in the country of manufacture (e.g., USA or where Venus Concept operates). The testing is prospective for the purpose of this 510(k).

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

• Not applicable. No clinical ground truth established by experts is mentioned as this is a 510(k) based on substantial equivalence using bench testing.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set with expert adjudication is described in this document.

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

• No. This document does not mention an MRMC comparative effectiveness study, as it relies on substantial equivalence through bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical device (electrosurgical unit) and not an AI algorithm. Its performance is inherent to the device's physical operation, not an algorithm's standalone output.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" for the bench testing would be established by objective measurements and comparisons against the specifications of the predicate device and relevant international standards (e.g., RF output, thermal profiles, electrical safety standards).
• For Biocompatibility: Ground truth involved established ISO standards for cytotoxicity, intracutaneous testing, and sensitization, along with previous clearance of an equivalent device.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a training set.

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

• Not applicable. This device is not an AI algorithm that requires a training set.

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The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Viva SR device is designed for non-invasive dermatological procedures requiring ablation and resurfacing of the skin. The system is designed to deliver RF energy to the skin in a fractional manner. The device is comprised of a console and an applicator. The applicator is connected to the system via a cable. The applicator (hand piece) includes a detachable electrode tip that is comprised of an array of small electrode pins. The radiofrequency energy is delivered from each of the tissue, heating the dermal layers beneath the pin with minimal injury to the epidermis layer.

This document is a 510(k) Summary for the Venus Viva SR Device, indicating that it has been determined to be substantially equivalent to a predicate device. As such, it does not contain the detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the way one might expect for a novel device or a clinical trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

However, I can extract information related to performance evaluations and the animal study that supports the device's safety and effectiveness.

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

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome. Instead, it describes various tests and their "passing" or "as expected" results, demonstrating compliance with recognized standards and expected performance in a pre-clinical setting.

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

• Test Set Sample Size: The document mentions a "porcine study" (animal study). The specific number of animals or treatment sites is not specified.
• Data Provenance: The study was an animal study (porcine), which is a pre-clinical setting. The country of origin is not specified. It is implicitly a prospective study in the context of controlled experimental animal research.

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

• The document states "Skin biopsies were submitted for pathologic review to assess the healing profile at sites following treatment."
• Number of experts: Not specified.
• Qualifications of experts: The experts are implicitly pathologists, but their specific qualifications (e.g., years of experience) are not detailed.

4. Adjudication method for the test set

• The document mentions "gross necropsy findings" and "pathologic review." It does not specify an explicit adjudication method like "2+1" or "3+1" for interpreting these findings. It implies a standard pathological review process.

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 done. This document describes a medical device (Venus Viva SR Device) for dermatological procedures, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the information provided.

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

• This question is not applicable. The Venus Viva SR Device is an energy-based medical device, not an algorithm. The performance evaluation focuses on the device's physical and biological effects, not on an algorithm's diagnostic accuracy.

7. The type of ground truth used

• For the animal study:
  • Direct observation: For erythema, edema, and microneedle pattern at specified time points (Day 0, Day 4, Day 14).
  • Histopathology: For assessing the healing profile of skin biopsies.
  • Gross necropsy: For evaluating overall findings.

8. The sample size for the training set

• This document describes a 510(k) submission for a medical device, not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The device's design and parameters are based on engineering principles and comparisons to predicate devices, not on training data.

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

• As there is no "training set" for this type of device, this question is not applicable.

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The Venus Swan (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

The Venus Swan (MP)2 TM System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes together with Pulsed Magnetic Field (PMF). The Venus Swan(MP)2 TM is a modification to the previously cleared Venus Concept's Venus Swan system (K100586). The Venus Swan (MP)2 is a noninvasive, non-ablative device consisting of Main Unit (console) - Touch Screen user interface, RF Power module, Controller unit, and Two optional treatment applicators: Octipolar-MTM applicator for medium sized treatment areas, composed of 8 (1) RF electrodes, 8 electrode coils assembled over the electrodes and a central coil (the RF is emitted through the electrodes. The PMF is generated by the coils), and (2) Diamondpolar™ applicator for small treatment areas, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).

Here's the breakdown of the acceptance criteria and the study that supports the Venus Swan (MP)2 System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical Study): 31 subjects
• Data Provenance: Not explicitly stated, but clinical studies for FDA clearance are typically prospective. The country of origin for the data is not specified in the document, but the applicant is based in Israel, so it could potentially be an international study or a study conducted in Israel.

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

• Number of Experts: "Uninvolved reviewers" performed the photographic analysis. The exact number of reviewers is not specified.
• Qualifications: Not specified. It only states they were "uninvolved reviewers."

4. Adjudication Method for the Test Set

• The document mentions "Photographic analysis of pre-and post treatment of the digital images was conducted by uninvolved reviewers." This indicates that reviewers were used to assess improvement, but it does not specify an adjudication method like 2+1 or 3+1 for conflicting assessments.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a clinical study focused on the safety and effectiveness of the device itself, not comparing human readers with and without AI assistance. The device in question is not an AI-assisted diagnostic tool but a therapeutic medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable as the Venus Swan (MP)2 is a physical medical device (RF and PMF system), not an algorithm or AI system. Its performance is measured directly through its physical output and clinical outcomes, not as a standalone algorithm.

7. The Type of Ground Truth Used

• Clinical Efficacy: Photographic analysis by uninvolved reviewers (likely a visual assessment of wrinkle and rhytide improvement).
• Patient Experience: Subject reporting (for pain and expectation fulfillment).
• Safety: Direct observation for adverse events.

8. The Sample Size for the Training Set

• Not applicable. As this is a physical medical device, there isn't a "training set" in the context of machine learning or AI. Performance is based on engineering specifications and clinical trials.

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

• Not applicable. See point 8.

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The Venus Freeze (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

The Venus Freeze (MP)2 is a noninvasive, non-ablative device consisting of:

• Main Unit (console)
• Touch Screen user interface
• RF Power module
• Controller unit
• Two treatment applicators:
  (1) Octipolar™ applicator - for large area treatments, composed of 8 RF electrodes, 8 electrode coils assembled over electrodes and 1 central coil (the RF is emitted through the electrodes. The PMF is generated by the coils).
  (2) Diamondpolar™ applicator - for small area treatments, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).
  Touch screen user interface provides:
• Applicator selection (Octipolar™ / Diamondpolar™)
• RF Power Output and Treatment Time parameter adjustments to fit individual patient's skin condition and anatomical site treated.
• Current treatment parameters display.
  The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

The provided text describes the Venus Freeze (MP)2 System, a non-invasive device for treating moderate to severe facial wrinkles and rhytides. While it mentions regulatory compliance and a clinical study, it does not provide detailed acceptance criteria or the comprehensive study breakdown as requested.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information for this table:

• Specific, quantitative acceptance criteria for effectiveness. For example, a percentage reduction in wrinkle severity as measured by a specific scale, or a certain percentage of patients achieving a predefined improvement. The document only states "clearly indicate" effectiveness without defining measurable criteria.

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

• Sample size for test set: Not explicitly stated. The document refers to "Patients were treated with the Venus Freeze (MP)2 System for face wrinkle reduction" but does not give a number for the study population.
• Data provenance: Not explicitly stated. It's a clinical study conducted to support a 510(k) submission, suggesting it's prospective, but the geographical origin of the data (country) is not mentioned.

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

• This information is not provided. The document makes no mention of expert evaluation, subjective grading, or the qualifications of any such experts.

4. Adjudication method for the test set

• This information is not provided. Given the lack of expert involvement details, adjudication methods are not discussed.

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 done. This device is an aesthetic medical device, not an AI-powered diagnostic tool, so such a study would not be applicable. The text describes a system that uses RF and PMF technology directly on patients, not an AI that assists human readers.

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

• Not applicable. This is a medical device for direct patient treatment, not an algorithm, so "standalone performance" in the context of an algorithm is irrelevant.

7. The type of ground truth used

• The "ground truth" for the device's effectiveness appears to be based on clinical observation of wrinkle reduction and the absence of unexpected adverse side effects. However, the specific method of measuring wrinkle reduction (e.g., a standardized scale, physician assessment, patient satisfaction) is not detailed.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that undergoes training. It's a hardware device with specific energy delivery mechanisms.

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

• Not applicable. See point 8.

In summary:

The provided 510(k) summary focuses on the device description, intended use, predicate devices, and general safety and regulatory compliance. While it mentions a clinical study to demonstrate effectiveness ("face wrinkle reduction") and safety, it lacks the granular detail requested for acceptance criteria, study design (especially sample sizes and expert involvement for ground truth), and performance metrics typically found in efficacy studies for AI or diagnostic devices. The closest the document comes to performance is the statement that "No unexpected adverse side effects were detected or reported" and that the data "clearly indicate" effectiveness, but without quantitative measures or specific acceptance thresholds for that effectiveness.

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The Venus Swan™ is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The Venus Swan™ System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes. The Venus Swan™ is a modification to the previously cleared Venus Concept's Venus Freeze system (K100586). The Venus Swan™ is a non-invasive system consisting of: - Main Unit (console) - Touch Screen user interface - RF Power module Controller unit Three optional treatment applicators: (1) Octipolar-LTM applicator - for large treatment areas, composed of 8 RF electrodes (2) Octipolar-M™ applicator - for medium sized treatment areas, composed of 8 RF electrodes (3) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes The system can be connected to two applicators only at a time. The user can choose which applicator to use according to the size of the treatment area. The Touch screen user interface provides: - Applicator selection - RF Power Output and Treatment Time parameter adjustments - Current treatment parameters display. The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for the Venus Swan System, which focuses on device description, intended use, and substantial equivalence to a predicate device (Venus Freeze) rather than detailed clinical study results with specific performance metrics and acceptance thresholds.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, ground truth, or comparative effectiveness studies.

The document primarily states:

• Intended Use: Non-invasive treatment of mild to moderate facial wrinkles and rhytides.
• Performance Standards: Compliance with general electrical and medical device safety standards (EN 60601-1, IEC 60601-1-2, ANSI AAMI 60601-2-2).
• Substantial Equivalence: Claims substantial equivalence to the Venus Freeze (K100586). This typically means that the manufacturer asserts the new device is as safe and effective as a legally marketed predicate device, and often relies on similar technological characteristics and performance rather than new, extensive clinical studies for standalone performance claims against specific clinical acceptance criteria.

To answer your request, a different type of document, such as a full clinical study report, would be needed.

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The Venus Freeze is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The Venus Freeze is a noninvasive, non-ablative device consisting of:

• Main Unit (console)
• Touch Screen user interface
• RF Power module
• Controller unit
• Two treatment applicators:
  (1) Octipolar M applicator - for large treatment areas, composed of 8 RF electrodes
  (2) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes.
  The Touch Screen user interface allows the selection of treatment parameters (time and power) by pressing on the treatment buttons and displays the current treatments settings.
  The Controller Unit provides the operational and safety function of the system.
  Treatment applicators transmit Bi-Polar RF energy in a method that creates an organized Bi-Polar RF energy matrix which produces homogeneous heating in the entire treatment area for maximum safety and efficacy, eliminating the need for pre/post cooling mechanisms.
  The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

The provided text states that for the Venus Freeze device, "Venus-Concept believes that animal and clinical studies are not required to determine the safety and efficacy of the device" due to previously published scientific research and clinical studies on similar radiofrequency devices. Therefore, a specific study proving the device meets acceptance criteria as typically outlined in an FDA submission with performance data, sample sizes, and ground truth establishment was not conducted for this 510(k) submission.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards for safety.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is explicitly stated as not required or not applicable:

Acceptance Criteria and Device Performance

Study Details (As per the provided document, studies were not conducted for this specific device's 510(k) submission to establish safety and efficacy directly.)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable. No new test set data from a clinical or animal study was generated for this 510(k) submission. The safety and efficacy relied on existing literature for similar devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. No new ground truth was established for a test set specific to the Venus Freeze device in this submission.

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

   • Not applicable. No new test set requiring adjudication was used.

4. 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. This device is a non-AI electrosurgical device for dermatologic procedures; therefore, an MRMC study related to readers and AI assistance is not relevant.

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

   • Not applicable. This is a hardware device, not an AI algorithm. Its performance is inherent in its operation and not separate from human-in-the-loop (operator) performance.

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

   • For the purpose of this 510(k) submission, the "ground truth" for safety and efficacy for the device type (radiofrequency devices for wrinkle treatment) was established through "comprehensive animal and clinical study performed in scientific research and published in the literature" of similar devices, rather than new evidence for the Venus Freeze itself.

7. The sample size for the training set:

   • Not applicable. No training set for an algorithm was used or mentioned. The device's design implicitly relies on established engineering principles and prior research of similar devices.

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

   • Not applicable. No training set was used.

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