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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 Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with unipolar and bipolar handpieces.

The massager component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide:
Temporary reduction in the appearance of cellulite. .

The Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
. Console
a Bipolar RF module
A Unipolar RF module (UniLarge)
A UniForm (RF and Massage) module
. Control panel
Footswitch. .
Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components:
. Handle - used for holding the module
. Trigger - activates the radiofrequency energy emission when pressed in Ready mode
Applicator tip establishes contact with the patient's skin .
. Thermoelectric cooler - integrated within the module, provides internal module cooling
. RF emission indicator - blue LED illuminates prior to- and during RF emission
Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module
. Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings.
The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application.
The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.

The provided document is a 510(k) summary for a medical device (Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite]), seeking substantial equivalence to predicate devices. It does not describe or conduct a study involving acceptance criteria and reported device performance in the way typically associated with clinical trials or AI/algorithm evaluation.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices based on technical characteristics and safety performance testing rather than clinical efficacy studies with specific performance metrics against a defined ground truth.

Therefore, many of the requested elements for describing an acceptance criteria study and the methodology behind it (like sample size, data provenance, expert ground-truthing, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the information that is present concerning the rationale for substantial equivalence and the listed safety performance testing.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance Study Information

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

The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. Instead, the "acceptance criteria" for this submission are compliance with recognized safety standards and demonstration of substantial equivalence in technical characteristics.

The results of the performance testing showed compliance with these standards. |
| Clinical Equivalence (Implicit) | Based on the above, the device is considered "safe and effective, and performs at least as safely and effectively as the predicate Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] for the intended use and indications." (This is a conclusion drawn from the technical and safety equivalence, not from a comparative clinical efficacy study provided in this summary). |

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

• Not Applicable / Not Provided. This document does not describe a clinical performance study with a test set of patient data. The "performance testing" refers to engineering and electrical safety standards compliance.

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 / Not Provided. No clinical ground truth was established for a test set in this submission.

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

• Not Applicable / Not Provided. No clinical test set or adjudication method is described.

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 / Not Provided. This device is an RF system for dermatologic/surgical procedures, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

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

• Not Applicable / Not Provided. This device does not feature an algorithm for standalone performance evaluation in the context of AI or diagnostic systems.

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

• Not Applicable / Not Provided. The "ground truth" for this submission relates to compliance with engineering safety standards and established technical specifications, not clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is not an AI/machine learning system, so there is no concept of a "training set" in this context.

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

• Not Applicable / Not Provided. No training set exists.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in this document is a regulatory submission demonstrating substantial equivalence rather than a clinical performance study measuring specific outcomes. The primary "studies" conducted were non-clinical performance testing to ensure safety and compliance:

• Type of Study: Non-clinical performance testing for electrical safety and electromagnetic compatibility.
• Purpose: To demonstrate that the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] is as safe and effective as its predicate devices, primarily through compliance with international standards (IEC 60601 series).
• Methodology: The system was tested against the requirements of IEC 60601-1-2: 2004 (electromagnetic compatibility), IEC 60601-1:1988 with amendments (general safety), and IEC 60601-2-2:2006 (particular requirements for high-frequency surgical equipment).
• Conclusion: The tests demonstrated compliance with these standards, supporting the conclusion of substantial equivalence to the predicate devices. This equivalence is based on the device sharing the same intended use, indications for use, operation principle, and similar technical and functional capabilities, alongside meeting safety criteria.

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The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.

The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.

The control unit of the device is fitted with a color touch screen, which significantly facilitates the use of the device is equipped with a stylus (touch pen) for comfortable control of the touch screen. The vertically oriented design of the device enables to see the on-screen information from various positions of the operator. In addition, the brightness of the screen can be set to match the lighting in the surgery. The on-screen information will guide you through the entire therapy by means of easy setting of parameters using touch-screen buttons and knobs/keys on the device. For easier control, the applicator is equipped with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters.

Any therapeutic parameter can be set easily by simple use of the touch-screen buttons. During the entire therapy time the device informs you about the therapeutic method, the type of the therapy applied, the set power, and other necessary data.

The EXILIS device enables to insert the patient's name and additional corresponding information in its internal memory and link these data with the pre-defined or customer protocols. At the patient's next visit simply call his/her name on the device and apply the preset therapy. The EXILIS device is placed in a specially designed cart, the shape of which provides the maximum comfort of the handling and use of the device. Four stable castors ensure easy moving of the device in the office or surgery.

The acceptance criteria and study information for the EXILIS device (K092191) are detailed below based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices." (Section 10, Clinical Testing). Therefore, there is no separately identified "test set" in the context of clinical data. The performance evaluation was based on non-clinical testing, verification, and validation of the device's hardware and software.

• Sample Size: Not applicable in the context of a clinical test set. The validation was against software design specifications and applicable voluntary standards.
• Data Provenance: The data provenance is internal, based on the manufacturer's (BTL Industries, Inc.) hardware and software development, verification, and validation processes, as well as third-party testing for safety and EMC standards. There is no mention of country of origin for a clinical dataset, nor whether it was retrospective or prospective, as no clinical study was conducted.

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

Not applicable. As no clinical testing was performed, there was no clinical "test set" requiring expert consensus for ground truth establishment. The ground truth for the non-clinical testing was based on engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used. The performance was assessed against engineering specifications and regulatory standards.

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. No MRMC study was conducted. The EXILIS device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The EXILIS is a medical device for dermatologic and general surgical procedures, not an algorithm. Its performance is inherent in its operation by a human user.

7. The Type of Ground Truth Used

For the non-clinical testing:

• Hardware and Software Performance: The ground truth was established by the Software Design Specifications and other internal engineering specifications.
• Safety and EMC: The ground truth was established by national and international safety and electromagnetic compatibility (EMC) standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development involves traditional engineering design and testing, not machine learning.

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

Not applicable. No training set was used.

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