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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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