(29 days)
The Legend X Desktop System 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 non-invasive treatment when using RF Energy and for muscle conditioning to stimulate healthy muscles (TriPollar Applicator).
Legend X Desktop System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Legend X Desktop System is intended to be operated by a licensed health care practitioner who is present to monitor treatment.
The Legend X Desktop System ("Proposed Device") is a software-controlled capital equipment system that enables application of radiofrequency energy onto the skin for ablation, resurfacing, or noninvasive treatment or muscle activation pulses. The application of radiofrequency energy or muscle activation pulses 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.
The proposed device consists of a console with connected applicators, and applicator accessories (disposable tips) needed to perform some of Legend X Desktop dermatological and general surgical procedures. The summary descriptions of each component are outlined below.
Legend X Desktop Console: The Legend X Desktop 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 Desktop software. The monitor allows for user input during initial setup and throughout the session. The console also provides power and connectivity for the applicators.
Legend X Desktop Applicators: The Legend X Desktop Applicators (TriPollar 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 onto the skin. Each applicator is connected to the console via an applicator connector cord.
Legend X Desktop Software: The Legend X Desktop 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 subject console to compute the appropriate output via 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 Desktop Disposable Tip Accessories: The Legend X Desktop disposable tips set is part of the Legend X Desktop Applicator VO kit. The Disposable Tips Set includes:
- . gen12 disposable tip,
- gen36 disposable tip,
- . gen36L disposable tip,
- gen100 disposable tip, and
- 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 RF energy via an array of multi-electrode pins onto the skin surface.
The provided document is a 510(k) Premarket Notification for the "Legend X Desktop System," a medical device for dermatological and general surgical procedures. My task is to extract information related to acceptance criteria and the study proving the device meets these criteria.
However, the document does not contain information about studies measuring the performance of the device against specific acceptance criteria in a clinical context (e.g., accuracy, sensitivity, specificity, or effects on human readers). Instead, it focuses on demonstrating substantial equivalence to a predicate device (Legend X Platform, K232903) and compliance with various regulatory and performance standards.
The "Performance Data" section (Section 5.4) lists the types of testing performed:
- Cleaning and Sterilization Validation: Per AAMI TIR-30, ISO 11135, ISO10993-7, ASTM F1980-16, ASTM F 1929-15, ASTM F88/F88M-15, and ISO 11607.
- Biocompatibility Testing: Per ISO 10993-1 and FDA guidance.
- Electrical Safety, Performance, and EMC: Per IEC 60601 series standards.
- Software Verification and Validation (V&V): Per FDA guidance "Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- V&V Functional Testing: To verify overall functionality, safety features, and adherence to regulatory standards.
- Animal Testing: Per "General Considerations for Animal Studies Intended to Evaluate Medical Devices."
These are "performance data" in the context of demonstrating safety and fundamental functional equivalence, not clinical effectiveness studies with specific performance metrics (like sensitivity/specificity for AI, or human reader improvement). The document explicitly states: "The testing identified no new issues of safety or effectiveness." This implies the acceptance criteria are largely based on compliance with existing standards and performance comparable to the predicate device, rather than novel clinical performance endpoints.
Therefore, I cannot populate the requested table or answer most of the specific questions as the document does not contain the type of AI/diagnostic study data implied by the prompt.
Here's what can be extracted based on the provided document, addressing the prompt's implied context as best as possible:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a physical medical device (electrosurgical and muscle stimulation) and not an AI/diagnostic software, the "acceptance criteria" are primarily related to safety, functionality, and equivalence to a predicate, rather than typical AI performance metrics like accuracy.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance |
|---|---|---|
| Overall Equivalence | Device is substantially equivalent to the predicate (Legend X Platform, K232903) in terms of safety, efficacy, and performance for the requested indications for use, and raises no new questions of safety and effectiveness. | Concluded that the Legend X Desktop System "raises no new questions of safety and effectiveness as compared to the predicate and reference devices and is substantially equivalent to the predicate in terms of safety, efficacy, and performance for the requested indications for use." (Section 5.8) |
| Functional Performance | Operates as specified by the design input requirements, including applicator and controls, various functional safety features, and other general functionality. Adherence to regulatory standards. | V&V Testing: "Results of verification testing confirm that the proposed device conforms to design specifications and requirements and meets the needs of the intended user." (Section 5.4) |
| Cleaning & Sterilization | Non-disposable components' cleaning and disinfection instructions validated. Single-use disposable sterile devices and EO residual validated. Shelf life and sterile barrier packaging evaluated. | "The cleaning and disinfection instructions provided in labeling for non-disposable components were validated as per AAMI TIR-30. Single-use disposable sterile (EO) devices and EO residual were validated in accordance with ISO 11135 and ISO10993-7. The shelf life and sterile barrier packaging of the single-use disposable devices were evaluated per ASTM F1980-16, ASTM F 1929-15, ASTM F88/F88M-15, and ISO 11607." (Section 5.4) |
| Biocompatibility | Patient-contacting components evaluated and validated. | "Biocompatibility for patient contacting components has been evaluated and validated in accordance with the provision of the following FDA Guidance document... and applicable ISO 10993 standards." (Section 5.4) |
| Electrical Safety / EMC | Complies with relevant electrical safety and electromagnetic compatibility standards. | "The subject device has been fully evaluated for electrical safety and EMC compliance to IEC 60601 series standards." (Section 5.4) |
| Software | Developed, tested, and verified according to FDA guidance for software in medical devices. Design specifications are met, and needs of intended users are fulfilled. | "Software was developed, tested, and verified per the FDA guidance document: Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and results of verification and validation testing confirm that the proposed device conforms to design specifications and meets the needs of the intended users." (Section 5.4) |
| Animal Testing | Conducted according to FDA guidance for animal studies. | "Performance testing animal testing was executed according to General Considerations for Animal Studies Intended to Evaluate Medical Devices issued on March 28, 2023." (Section 5.4) |
| System Specifications | RF energy emission per pin, maximum pulses per tip, and modes of operation (Low, Medium, High) are same as predicate. Applicators and accessories, control/user interface, system weight and dimensions are within acceptable range for substantial equivalence, with differences not introducing new questions of safety or effectiveness. (Implied from Comparison Table, Section 5.6). | Reported values for these parameters are identical or appropriately justified as equivalent to the predicate, as detailed in Section 5.6. The desktop console being "miniature" and lighter is stated not to introduce any new safety/effectiveness questions. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe a "test set" in the context of a clinical performance study with human subjects (or images/data from them) to measure specific endpoints like accuracy for AI.
- The "testing" mentioned pertains to engineering verification and validation (V&V), biocompatibility, electrical safety, etc., which involve laboratory tests, material analysis, and potentially animal studies, not a "test set" of patient data for evaluating a diagnostic or AI algorithm's performance.
- No information on country of origin or retrospective/prospective nature of data for such a clinical "test set" is provided because that type of study was not conducted or reported here.
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. There is no mention of "ground truth" establishment by experts for a clinical performance test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "test set" or adjudication process 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. This device is an electrosurgical cutting and coagulation device and a powered muscle stimulator. It does not appear to be an AI-driven diagnostic or image analysis tool that would be used by "human readers" to interpret cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical system with user controls, not a standalone algorithm. The software component described manages the device's operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As noted above, there's no clinical "ground truth" as would be established for an AI or diagnostic device performance study. The "ground truth" for this device's safety and effectiveness is primarily established through compliance with recognized standards, engineering principles, and demonstration of substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This document does not describe an AI / machine learning component that requires a "training set" of data for learning. The software mentioned is for controlling the device's operation, not for diagnostic or predictive purposes based on learned patterns from large datasets.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.