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When used with the Octipolar (LB1) or Diamondpolar (LF1) applicators, the Venus Legacy Pro device is 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.

When used with the 4D Body (LB2) or 4D Face (LF2) applicators, the Venus Legacy Pro device is intended for the delivery of non-thermal RF combined with Massage and magnetic field pulses for the treatment of the following medical conditions:

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

The Venus Legacy Pro device consists of a console (main unit) and four applicators - Octipolar (LB1), Diamondpolar (LF1), 4D Body (LB2) and 4D Face (LF2). The console 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 Pro device combines two previously cleared devices (Legacy BX, K142910 and Legacy CX. K143554) into one device. The two applicators that were cleared for the Legacy BX Device - Octipolar (LB1) and Diamondpolar (LF1) and the two applicators that were cleared for the Legacy CX device - 4D Body (LB2) and 4D Face (LF2) can now be connected simultaneously to a single console, the Legacy Pro device's console.

The provided text describes the Venus Legacy Pro device, its intended uses, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size of human improvement with AI assistance.

Instead, the performance data presented focuses on engineering and regulatory compliance, not clinical outcomes.

Here's an analysis based on the information available in the text:

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

The document does not explicitly present a table of acceptance criteria for clinical performance (e.g., reduction in wrinkles by a certain percentage, pain relief score, cellulite reduction percentage). The "Performance Data" section primarily addresses engineering and regulatory compliance.

However, based on the bench tests mentioned, we can infer some performance targets for temperature control:

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

No information is provided regarding sample sizes for clinical test sets as the document focuses on technical performance and regulatory equivalence rather than clinical efficacy studies for this 510(k) submission. The "bench tests" mentioned are likely laboratory tests, not clinical studies with patients.

3. 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. The document discusses device safety, performance verification, and substantial equivalence to predicates, not the establishment of ground truth for a clinical test set.

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

Not applicable. This information is relevant for clinical studies involving human assessment, which are not detailed 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:

Not applicable. This device is not an AI-assisted diagnostic or interpretation tool for human readers. It is a physical medical device for treatment.

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

Not applicable. This device is not an algorithm for standalone performance assessment.

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

For the bench tests, the "ground truth" would be the device's design specifications for temperature output, electrical safety, and electromagnetic compatibility. For clinical efficacy (e.g., wrinkle reduction, pain relief), the document does not describe studies that would establish such ground truth for the Venus Legacy Pro device. It relies on the indications for use of its predicate devices.

8. The sample size for the training set:

Not applicable. The document does not describe a machine learning algorithm that requires a training set.

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

Not applicable.

Summary of what the document focuses on:

The entire document pertains to a 510(k) premarket notification for the Venus Legacy Pro Device. This type of submission primarily demonstrates substantial equivalence to a previously cleared predicate device, rather than performing de novo clinical efficacy trials to establish new acceptance criteria.

The "Performance Data" section discusses:

• Bench Testing: To ensure the device's outputs meet specifications (e.g., temperature ranges for applicators) and are comparable to predicate devices.
• Electrical Safety and Electromagnetic Compatibility: Compliance with international standards (IEC 60601 series).
• Software Testing: Verification and validation to confirm the software performs as intended.

The acceptance criteria are therefore implicitly tied to meeting these engineering and regulatory standards, and demonstrating that any differences from the predicate devices do not raise new safety or effectiveness concerns. The study described is a series of engineering and regulatory compliance tests, not a clinical trial with human subjects to prove clinical efficacy against specific, measurable outcomes that would typically be described with metrics like sensitivity, specificity, or reader improvement.

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The Venus Heal device is intended for the treatment of the following medical conditions; using the Large and Small 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 subject device Venus Heal system is a modification of the legally marketed Venus Legacy CX system cleared under K143554. The proposed system is a smaller and lightweight version of the previously cleared Venus Legacy CX system. The Venus Heal system consists of a console (main unit) and two applicators (Large and Small). The console design change is driven to enhance the ergonomic capabilities of the product family.

The additional changes are summarized below:
a) Ergonomics of the user interface: bigger Liquid Crystal Display (LCD) color touch screen.
c) Tissue manipulation includes manual massage only.
d) Increase of Maximal RF output power.
e) Updated software to reflect hardware changes.

The Venus Heal RF energy, pulsed magnetic fields (PMF) and tissue manipulation are utilized to trigger changes in the tissue which result in muscle spasm relief and pain relief, along with local blood circulation improvement.

Temporary reduction in the appearance of cellulite is similarly achieved by combination of these three main mechanisms: RF and Pulse Magnetic Field (PMF) delivery as well as tissue manipulation,

Consistent with the previous clearance, the system is intended to be used in professional healthcare facilities (prescription use) just as the predicate, and its major components are still the main console unit, and individual modules/hand pieces.

The Venus Heal device is intended for the treatment of minor muscle aches and pain, muscle spasm relief, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The device uses non-thermal RF, massage, and magnetic field pulses.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1 (General Requirements For Basic Safety And Essential Performance)
• IEC 60601-1-6 (General Requirements for basic safety and essential performance)
• IEC 60601-2-2 (Particular Requirements For The Basic Safety and Essential Performance Of High Frequency Surgery Equipment and High Frequency Surgical Accessories)
• IEC 60601-1-2 (Electromagnetic Compatibility Requirements and Tests). |
  | Software verification and validation. | Performed. |
  | Biocompatibility. | Confirmed using the same product material as in the predicate device. |

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

• Sample Size: Not explicitly stated for the benchmark test beyond "skin surface," but implies multiple measurements.
• Data Provenance: The study was a bench test, implying it was conducted in a laboratory setting by the manufacturer (Venus Concept USA Inc.). Country of origin is not specified, but the submission is to the U.S. FDA. It is a prospective test to verify performance.

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

• Experts: Not applicable. The ground truth for the bench test was established through direct physical measurements of temperature and functional assessment against specified engineering and regulatory standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The performance was assessed against objective physical and engineering standards, not through expert consensus on subjective outcomes.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

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

• Standalone Study: Yes, the described performance testing (bench tests, software verification) appears to be a standalone (algorithm/device only) performance evaluation. It assesses the device's inherent capability to meet technical specifications and safety standards independent of user interaction beyond basic operation. There is no AI component mentioned in the device description.

7. Type of Ground Truth Used

• Ground Truth Type: For the bench test, the ground truth was based on objective physical measurements (e.g., temperature readings) and engineering standards (e.g., compliance with IEC standards) as defined by the device's technical specifications and regulatory requirements.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not appear to involve a machine learning algorithm that would require a "training set." The testing performed was for device performance verification and validation against established standards.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm.

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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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