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The Legend X Platform and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).

It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar radiofrequency (RF) Energy and for transcutaneous electrical stimulation of periorbital, facial, and body muscles with DMSt (Dynamic Muscle Stimulation technology) for aesthetic purposes, including improvement of appearance, and for body muscle conditioning to stimulate healthy muscles. (Applicators 1-3).

The Legend X Platform ("Proposed Device") is a software-controlled capital equipment platform that enables application of radiofrequency (RF) energy onto the skin for ablation, resurfacing, or noninvasive treatment of wrinkles and rhytides or electrical stimulation of skin and muscles throughout the face and body. The application of RF or dynamic muscle stimulation only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the Console, Applicator indicators and subsequent operation of the Foot Switch and Applicators.

The proposed device consists of a Console with connected Foot Switch, Patient Controlled Manual Switch, Applicators, and Applicator accessories (disposable tips) needed to perform some of Legend X dermatological and general surgical procedures. The summary descriptions of each component are outlined below.

Legend X Console: The Legend X Console (also known as the Console or Main Control Unit) contains the graphic display interface for the user that is provided by a touchscreen monitor for viewing and a computer running the Legend X software. The monitor allows for user input during initial setup and throughout the session. The console also provides power and connectivity for the applicators, foot switch, and patient manual-controlled switch.

Legend X Foot Switch: The Legend X Foot Switch (Foot Switch) is connected to the Legend X Console via a connector cord. The Foot Switch enables or disables the energy delivery through the applicators to treatment area.

Legend X Applicators: The Legend X Applicators (1, 2, 3 and VO) are handheld handpieces which deliver energy to the treatments area. Depending on the applicator and selected user inputs, the user can utilize the applicators to deliver either muscle energy onto the muscles of the face and body or RF energy for ablation and resurfacing or noninvasive treatment of wrinkles and rhytides onto the skin throughout the face and body. Each applicator is connected to the Console via an Applicator Connector cord.

Legend X Patient Controlled Manual Switch: The Legend X Patient Controlled Manual Switch is also a handheld device that serves as the patient interface that allows the patient to stop the operation of the chosen treatment mode upon the press of a button. In this situation, the system does not allow operation to continue. A Patient Controlled Manual Switch cord connects the Patient Controlled Manual Switch to the Console. Legend X Software: The Legend X Software provides the user and patient with the ability to safely commence, drive, and stop the operation of the Applicators on the skin or muscle area of interest throughout the face and body. It receives user input from the Legend X Console, Foot Switch, and Patient Manual Controlled Switch, and computes the appropriate output to the chosen applicator connected to the Console. It provides a graphical user interface where the treatment timeline as well as status of operation is shown in real time and displays important system status information.

Legend X Disposable Tips: The Legend X Disposable Tips set is part of the Legend X Platform accessories kit. The Disposable Tips Set includes:

• gen12 disposable tip
• gen 36 disposable tip
• gen 36L disposable tip
• gen 100 disposable tip
• H7X7 disposable tip

The patient contacting portions of the disposable tips are constructed of stainless steel and gold plating. The disposable tips are connected to handheld Applicator VO for delivery of radiofrequency electrical current via an array of multi-electrode pins onto the skin surface.

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The Legend X Platform and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).

It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy and for muscle conditioning to stimulate healthy muscles (Applicators 1-3).

Legend X Platform is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend X Platform is intended to be operated by a trained professional who is present to monitor treatment.

The Legend X Platform ("Proposed Device") is a software-controlled capital equipment platform that enables application of radiofrequency onto the skin for ablation, resurfacing, or noninvasive treatment of wrinkles and rhytides or muscle activation. The application of radiofrequency or muscle activation only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the Console, Applicator indicators and subsequent operation of the Foot Switch and Applicators.

The proposed device consists of a Console with connected Foot Switch. Patient Controlled Manual Switch, Applicators, and Applicator accessories (disposable tips) needed to perform some of Legend X dermatological and general surgical procedures.

The provided text is a 510(k) summary for the Legend X Platform, a medical device. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic or screening performance.

Instead, the document details various performance data related to the device's safety and effectiveness, focusing on engineering, manufacturing, and software validation. This is typical for a 510(k) submission, which aims to demonstrate substantial equivalence to a predicate device rather than conducting a de novo clinical efficacy study.

Here's a breakdown of the performance data provided, addressing what can be inferred from your request, and indicating what is not available in this document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria with specific numerical targets and corresponding performance results for diagnostic accuracy, sensitivity, specificity, etc. This is because the device (Legend X Platform) is an electrosurgical cutting and coagulation device, and a muscle stimulator, not a diagnostic or screening tool with such performance metrics.

However, it outlines the areas of performance testing and implies that the device met the requirements of the standards and internal specifications used.

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

• Not Applicable in the traditional sense for diagnostic/screening performance. The device is not a diagnostic tool that produces "test sets" of patient data for performance evaluation like an AI algorithm for image analysis would.
• The validation activities mentioned (reprocessing, sterility, biocompatibility, electrical safety, software V&V, animal testing) would involve specific sample sizes or populations relevant to those engineering and biological tests (e.g., number of sterilization cycles, quantity of materials for biocompatibility, number of software test cases, number of animals in the animal study). However, these details are not provided in this summary.
• Data provenance is not specified for these tests.

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

• Not Applicable. This device review does not involve establishing ground truth from expert interpretations, as it's not an AI/ML-driven diagnostic device. The "ground truth" for the engineering performance tests would be defined by the technical specifications, standards, and established scientific methods (e.g., chemical analysis for residuals, physical testing for seal strength, etc.).

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert readings are resolved to establish a ground truth for a diagnostic task. This is not relevant to the performance data presented for the Legend X Platform.

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 such study was done or reported. This device is an electrosurgical and muscle stimulation platform, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with AI assistance is outside the scope of this submission.

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

• Not Applicable in the context of diagnostic/screening performance. While the device does have "Legend X Software" which was developed, tested, and verified, this software primarily controls the device's operation (energy delivery, user interface, safety features). There is no indication that this software performs a standalone diagnostic or interpretative function that would be assessed in terms of "algorithm only" performance for identifying medical conditions. The device explicitly states it "is intended to be operated by a trained professional who is present to monitor treatment."

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

• For the technical and biological performance tests, the "ground truth" is based on:
  • Validated Standards: AAMI TIR-30, ISO 11135, ISO 10993 series, ASTM F series, ISO 11607, IEC 60601 series.
  • Internal Design Specifications: As mentioned in the software V&V section, "Results of verification and validation testing confirm that the proposed device conforms to design specifications and meets the needs of the intended users."
  • FDA Guidance: "Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Considerations for Animal Studies Intended to Evaluate Medical Devices."
• There's no mention of ground truth established via expert consensus, pathology, or outcomes data for the device's operational performance, as it's not a diagnostic device.

8. The sample size for the training set:

• Not Applicable. The document describes a medical device, not an AI/ML algorithm that requires a "training set" of data for learning. The software mentioned is likely traditionally programmed and tested rather than machine learning based.

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

• Not Applicable, as there is no mention of a training set or an AI/ML algorithm that learns from data.

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