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The Legend X Applicator VO and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (tips gen12, gen100, gen 36, gen36L, H7x7). The Legend X Applicator VO with genXL tip is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Applicator VO with genXL tip is limited to Skin Types I-IV.

The Legend X Applicator VO ("Proposed Device") is connected to the Legend X softwarecontrolled capital equipment platform to enable application of radiofrequency onto the skin for ablation and resurfacing or electrocoagulation and hemostasis. The proposed device applicator and applicator accessories are identical to the recently cleared Legend X Platform (K232903), with the exception of the new optional Applicator VO genXL disposable tip. The application of radiofrequency with the Applicator VO Disposable Tip only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the Legend X Console and Applicator indicators.

The proposed device consists of applicators and applicator accessories (disposable tips) needed to perform some of Legend X dermatological procedures. The summary descriptions of the proposed device are outlined below.

Legend X Applicator VO: The Legend X Applicator VO is a handheld handpiece which delivers energy to the treatment area. Depending on the selected user inputs, the user can utilize the applicator to deliver fractional RF energy for ablation and resurfacing, or electrocoagulation and hemostasis, as a means for noninvasive skin treatment throughout the face and body. The Applicator VO is connected to the cleared Legend X Console via an Applicator Connector cord.

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 Applicator on the skin area of interest throughout the face and body. It receives user input from the Legend X Console and computes the appropriate output to the Applicator VO connected to the Console. It provides a graphical user interface where the treatment parameters are adjusted as well as status of operation is shown in real time and displays important system status information.

Legend X Applicator VO Disposable Tips: The Legend X Applicator VO Disposable Tips set is part of the Legend X Applicator VO kit. The Legend X Applicator VO Disposable Tips Set includes:

• 1. gen12 disposable tip
• 2. gen36 disposable tip
• 3. gen36L disposable tip
• 4. gen100 disposable tip
• 5. H7X7 disposable tip
• 6. genXL 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 micro-electrode pins onto the skin surface.

The provided text describes the regulatory clearance for the "Legend X Applicator VO" and its accessories, not an AI or software-based medical device. Therefore, much of the requested information regarding acceptance criteria and studies for AI/software devices (such as sample size for test/training sets, expert qualifications, HR/AI assistance effect size, etc.) is not applicable and not present in the document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (an electrosurgical cutting and coagulation device and accessories) based on similar technological characteristics and performance data related to biocompatibility, electrical safety, electromagnetic compatibility, and software V&V for controlling the device.

Here's a breakdown of the relevant information from the document:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in the format typically seen for, for example, diagnostic accuracy of an AI model. Instead, it states that the device was assessed for performance in accordance with internal design specifications and applicable performance standards to demonstrate safety and effectiveness.

• Acceptance Criteria (General themes inferred from "Summary of Performance Testing"):

  • No new issues of safety or effectiveness identified.
  • Reprocessing, sterilization, and shelf life are identical to the primary predicate.
  • Biocompatibility compliance with specified ISO standards (10993-1, -5, -10, -11, -23) and FDA guidance.
  • Electrical Safety and EMC compliance with IEC 60601-1 standards.
  • Software development, testing, and verification per FDA guidance for software in medical devices.
  • Overall functionality conforms to design specifications and meets intended user needs.
  • Adherence to regulatory standards.

• Reported Device Performance (as stated in the document):

  • "The testing identified no new issues of safety or effectiveness."
  • "The reprocessing, sterilization, and shelf life for the subject device are identical to those evaluated for the primary predicate."
  • "Biocompatibility for patient-contacting components has been evaluated and validated in accordance with the provisions of the following guidance document and standards..." (lists ISO standards and FDA guidance)
  • "The subject device has been fully evaluated for electrical safety and EMC compliance and is compliant with IEC 60601-1 standards."
  • "Software was developed, tested, and verified per Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
  • "Results of verification and validation (V&V) testing confirm that the proposed device conforms to design specifications and meets the needs of the intended users."
  • "Results of verification testing confirm that the subject device conforms to design specifications and requirements and meets the needs of the intended users."

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

This information is not applicable and therefore not provided, as the submission concerns a physical medical device, not an AI/software diagnostic or predictive tool requiring a test set of patient data. The "testing" mentioned refers to engineering performance testing, biocompatibility, electrical safety, and software verification/validation against specifications.

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)

This information is not applicable and therefore not provided, as there is no "test set" in the context of patient data requiring expert ground truth for this type of device submission.

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

This information is not applicable and therefore not provided for the reasons stated above.

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 conducted or reported, as the device is not an AI assistance tool for human readers.

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

This is not applicable as the device is an electrosurgical device that requires continuous human control and direct visualization. The software mentioned controls the device's operation based on user input, it's not a standalone diagnostic algorithm.

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

This is not applicable. The "ground truth" for this device would be its adherence to design specifications and relevant safety and performance standards, established through engineering testing and regulatory compliance checks, not clinical outcomes or expert labels on patient data.

8. The sample size for the training set

This is not applicable as there is no AI/ML model being trained on a dataset. The software mentioned is a control system.

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

This is not applicable for the reasons stated above.

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