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The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage:

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

EndyMed's EndyMed Contour Handpiece is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (Imagine K08346). The EndyMed Contour Handpiece combines suction module that creates vacuum energy and emits bipolar RF energy that flows between the electrodes to create thermal heating of the tissue.

The Vacuum is 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 provided document is a 510(k) premarket notification for the EndyMed Contour Handpiece. It details the device's intended use, technological characteristics, and a claim of substantial equivalence to predicate devices. However, this document does not contain the specific information requested regarding acceptance criteria for an AI/ML device study, and the detailed study description you've outlined.

The document discusses performance tests for the EndyMed Contour Handpiece itself (e.g., power output, temperature, vacuum pressure), but this is validation of a physical medical device, not a study proving an AI/ML algorithm meets acceptance criteria.

Here's why the requested information cannot be found in the provided text:

• No AI/ML Component: The EndyMed Contour Handpiece is described as an electrosurgical cutting and coagulation device accessory that uses RF energy and vacuum mechanical manipulation. There is no mention of an AI/ML component or algorithm in its description or intended use.
• Study Type: The "performance data" and "summary of clinical performance data" refer to lab performance tests, design validation, and software verification and validation for the physical device, and a claim that no clinical studies were necessary to show substantial equivalence with its predicate devices because it has the same intended use, clinical indication, and technology. This explicitly states new clinical studies were not performed for this submission.
• Ground Truth: Since no clinical studies were performed, there is no discussion of establishing ground truth, expert consensus, pathology, or outcomes data for a test set.
• Sample Sizes/Experts/Adjudication/MRMC: These are all concepts relevant to clinical or performance studies evaluating an AI/ML algorithm's effectiveness against a ground truth, which were not conducted for this submission.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study proving device meets acceptance criteria, as the provided text does not describe such a study for an AI/ML-driven medical device.

The document is a regulatory submission for a physical medical device (EndyMed Contour Handpiece), focusing on its technical specifications and substantial equivalence to existing devices, rather than the performance evaluation of a novel AI/ML algorithm.

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Noninvasive treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects.

MINNIE is a noninvasive radiofrequency device consisting of:
• Touch Screen User interface
• Programmable Microcontroller
• RF Power Module
• 4 Treatment Handpieces with following characteristics
o Bipolar Handpiece Ø 36mm
o Unipolar Handpieces Ø 36mm, 60mm and 80mm
MINNIE is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.

MINNIE Device Performance Study

This response outlines the acceptance criteria and study details for the MINNIE device, based on the provided 510(k) summary (K133405).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (Clinical Study): 52 subjects
  • Group A (Control): 8 subjects
  • Group B (Sham): 11 subjects
  • Group C (Radiofrequency Treatment): 33 subjects
• Data Provenance: Not explicitly stated, but the applicant (Elettronica Valseriana srl) is based in Italy, suggesting the study may have been conducted there. The study appears to be prospective as subjects were randomly assigned to groups and followed up.

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

• Number of Experts: 3 physicians
• Qualifications: "Blind to the randomization group," implying independence and impartiality. Specific years of experience or subspecialty (e.g., dermatologist, plastic surgeon) are not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Implicitly, consensus or strong agreement. The summary states, "There were no differences in the scoring of the evaluators," suggesting that the 3 physicians' evaluations (on clinical photographs) matched the in-vivo scores made by the investigator. If there were discrepancies, an adjudication method was not explicitly described, but their agreement eliminates the need for one.

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

• **No, a specific MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done.
• The study involved human readers (3 blinded physicians and the investigator) assessing wrinkles using a standardized scale. The device itself is an energy delivery system, not an AI-based diagnostic or assistive reader tool. Therefore, an MRMC study in the typical AI context is not applicable here.

6. Standalone Performance Study (Algorithm Only)

• **No, a standalone (algorithm only) performance study was not done.
• The MINNIE device is a medical device that delivers radiofrequency energy, not an algorithm that interprets data or provides diagnostic output. The clinical study assessed the effect of the device on human subjects.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus (for evaluations from photographs by blinded physicians that confirmed the in-vivo scores by the investigator) and clinical assessment using a standardized scale (Fitzpatrick Wrinkle Scale - FWS).

8. Sample Size for the Training Set

• Training Set Sample Size: A separate training set for an algorithm is not applicable as the MINNIE device is a hardware-based radiofrequency treatment system, not an AI software. The provided document describes a clinical study to evaluate the device's safety and effectiveness in treating wrinkles, not to train a machine learning model.

9. How Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable as there is no training set for an algorithm. The clinical study used the FWS as a measure to assess the device's effects on human subjects.

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The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation. The Intensif Applicator consists of: . Disposable treatment element (tip) . RF electrodes on a disposable tip . Operation trigger.

Here's a breakdown of the acceptance criteria and study information for the Intensif Applicator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

This device did not involve a clinical study with human subjects. The supporting studies are entirely preclinical and ex vivo.

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

• Test Set Sample Size: Not specified. The document mentions "a few Ex Vivo laboratory studies and Ex Vivo animal studies tests" but does not quantify the number of samples or animals used.
• Data Provenance: The studies were "Ex Vivo laboratory studies and Ex Vivo animal studies tests." The location where these studies were performed is not explicitly stated, but the company is based in Israel. This is a preclinical type of data.

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 the studies were preclinical (ex vivo laboratory and animal) and did not involve human interpretation or expert evaluation to establish ground truth in the context of clinical outcomes. The "ground truth" was based on measurable physical and biological effects in the lab.

4. Adjudication Method for the Test Set

• Not applicable. There was no human expert adjudication of a test set as the studies were preclinical.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This device is not an AI-assisted diagnostic tool; it's an electrosurgical applicator.

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

• While the device itself operates without human intervention post-activation, this question is typically relevant for diagnostic algorithms or AI. For this medical device, the "standalone" performance refers to its ability to achieve its intended physical effect (electrocoagulation and hemostasis) as demonstrated in the ex vivo studies. It is not an "algorithm only" type of device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance was established through measurable physical and biological effects in ex vivo laboratory settings and animal tissues. This included:
  • Evaluating thermal and biological effects.
  • Measuring power control and accuracy.
  • Testing safety features functionality.
  • Validating needle depth.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical device for electrocoagulation and hemostasis, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. Its design and performance are based on engineering principles and physical testing.

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

• Not applicable, as there was no "training set" in the context of AI/machine learning for this device.

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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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