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Ask a specific question about this device

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.

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.

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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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The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

The GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.

The GENEO X ELITE device is a non-invasive, tabletop console with a graphical user interface (GUI), which supports two applicator types: the TriPollar Radiofrequency (RF) Applicator utilizing bipolar radiofrequency technology for facial wrinkles treatments and the OxyGeneo Applicator utilizing mechanical vibration for facial massage sensation.

The GENEO X ELITE device is manufactured by Pollogen Ltd. Similar to the predicate device, the STOP U Model UXV device, the GENEO X ELITE device constitutes the same underlying TriPollar technology to employ bipolar RF energy in a non-invasive manner utilizing the TriPollar RF Applicator.

In addition to the TriPollar RF applicator the GENEO X ELITE device comprises the OxyGeneo Applicator. The OxyGeneo Applicator is an electrically powered massager utilizing mechanical vibration generated by an electrically powered motor housed in the applicator.

The provided document is a 510(k) summary for the Pollogen Ltd. GENEO X ELITE device and does not contain detailed information about specific acceptance criteria or a dedicated study setup to prove device performance against those criteria in the way typically found for AI/ML devices.

However, based on the non-clinical and clinical performance data sections, and the general context of a 510(k) submission for an electrosurgical device, we can infer some "acceptance criteria" based on compliance with recognized standards and successful completion of various tests related to safety and functionality. The study described is primarily a Human Factors (Usability) study and various bench performance tests, rather than a clinical efficacy study with quantitative performance metrics.

Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and corresponding performance from a single study are not explicitly detailed for clinical efficacy in this document.

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary focused on substantial equivalence rather than a detailed clinical trial report, specific quantitative acceptance criteria for clinical effectiveness (e.g., specific reduction in wrinkle severity) and their statistically proven performance are not explicitly stated. Instead, "acceptance criteria" are inferred from compliance with recognized safety and performance standards and successful completion of bench and human factors testing.

2. Sample Sizes Used for Test Set and Data Provenance

• Human Factors Validation Testing (Phase II):
  • Sample Size: The document does not explicitly state the number of participants (users or cases) in the Human Factors Validation Testing (Phase II). It only mentions that the study involved "use of the device by the device target users (estheticians / cosmeticians) and performing device operation and knowledge tasks."
  • Data Provenance: The document states that the GENEO X Human Factors (Usability) validation test further validated the device "in a real-world environment." Phase I (formative assessment) was performed "on the GENEO X TriPollar RF device (precursor to the GENEO X) in the EU (Belgium and Switzerland) and Canada." The Phase II validation study's specific location is not detailed beyond "real-world environment." This study is prospective, as it involves testing with target users.

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

• For the Human Factors Validation Testing, "ground truth" would relate to the assessment of usability and the effectiveness of training materials. The document implies that "target users (estheticians / cosmeticians)" performed the tasks and their performance/feedback constituted the data for assessing usability. No explicit mention of independent "experts" establishing a separate "ground truth" for usability, outside of the direct user experience and observation during the study, is made.

4. Adjudication Method for the Test Set

• The document does not describe a clinical performance study with an adjudication method (like 2+1, 3+1). The Human Factors study's assessment method is not detailed in terms of adjudication.

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

• No MRMC comparative effectiveness study is described for clinical efficacy. The Human Factors study is not an MRMC study for clinical outcomes, but rather for usability. The document focuses on substantial equivalence to a predicate device based on similar technology, safety, and performance, not on demonstrating improved effectiveness over human readers or other devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This device is an electrosurgical device for aesthetic use, involving a human operator (esthetician/cosmetician). It is not an AI/ML diagnostic or predictive algorithm, so the concept of "standalone performance" for an algorithm without human-in-the-loop does not apply in the typical sense. The device's operation inherently involves a human user.

7. Type of Ground Truth Used

• For Bench Performance Data: The "ground truth" for technical specifications (e.g., RF output power, frequency, electrical safety) is established by measurements against recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• For Human Factors Validation Testing: The "ground truth" is derived from user performance, observations, and feedback from the device's target users (estheticians/cosmeticians) as they interact with the device and training materials in a simulated real-world environment.

8. Sample Size for the Training Set

• This document does not describe an AI/ML device in the context of a "training set" for an algorithm that learns from data. Therefore, the concept of a training set sample size is not applicable. The device design and safety features are based on engineering principles and compliance with standards, not machine learning training.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" in the context of an AI/ML algorithm learning.

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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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The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

The STOP U Model UXV device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.

This FDA 510(k) summary describes the Pollogen STOP U Model UXV Device, which is intended for the non-invasive treatment of mild to moderate facial wrinkles. The document details the device's technical specifications, performance tests, and comparison to a predicate device to demonstrate substantial equivalence for clearance.

Here's an analysis of the provided information, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. Instead, compliance is reported against various performance standards and general functional expectations.

• IEC/EN 60601-1 Ed 3.1 & A1:2012 (Medical Electrical Equipment: General safety)
• IEC 60601-1-6 (Usability)
• IEC 60601-1-11:2015 (Home healthcare environment)
• IEC/EN 60601-2-2 (High frequency surgical equipment)
• IEC 62304 (Software life cycle processes)
• IEC 60601-1-2 (Electromagnetic disturbances)
• ISO 15223-1:2016 (Symbols on labels)
• ISO 14971:2007 (Risk management) | The STOP U Model UXV device complies with all listed performance standards. (Implicitly, the device met the requirements of these standards). |
  | Biocompatibility (Cytotoxicity, Sensitization) | The body contact materials are biocompatible per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization). |

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

• Self-Selection Study:
  • Sample Size: Not explicitly stated for the "test set" demonstrating the correct self-selection rate, but the study "produced a correct self-selection rate that met Pollogen's goal."
  • Data Provenance: Not specified (e.g., country of origin). The study was likely prospective, conducted by Pollogen Ltd.
• Human Factors Validation:
  • Sample Size: 61 subjects.
  • Data Provenance: Not specified (e.g., country of origin). The study was prospective, conducted by Pollogen Ltd.
• Clinical Study (for TriPollar Technology):
  • Sample Size: Not specified.
  • Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective, though "a clinical study was conducted" generally implies a prospective study. It refers to a previously cleared device (K140255), suggesting this data predates the current submission.

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

• Self-Selection Study & Human Factors Validation: The document does not describe the use of experts to establish a "ground truth" in the traditional sense. These studies evaluated user interaction and self-selection by users, not by expert interpretation of clinical outcomes.
• Clinical Study (for TriPollar Technology): The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study that demonstrated the effect on wrinkles. It only states that the study "demonstrating the effect... for mild to moderate facial wrinkles and rhytides."

4. Adjudication Method for the Test Set

• Self-Selection Study & Human Factors Validation: Adjudication methods are not described as these studies focused on user performance with the device/packaging, not expert consensus on specific findings.
• Clinical Study (for TriPollar Technology): The adjudication method for assessing wrinkle reduction in the clinical study is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device in question is a medical aesthetic device, not an AI diagnostic or assistance tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical electrosurgical device for aesthetic use, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant.

7. The Type of Ground Truth Used

• Self-Selection Study & Human Factors Validation: The ground truth was based on the outcome of user tasks (e.g., correct self-selection, successful setup and treatment delivery). There wasn't a "ground truth" in terms of a clinical diagnosis or objective measurement adjudicated by experts.
• Clinical Study (for TriPollar Technology): The ground truth for this study was the effect on mild to moderate facial wrinkles and rhytides. The specific methodology for measuring and verifying this effect (e.g., blinded assessments, imaging, standardized scales) is not detailed.

8. The Sample Size for the Training Set

Not applicable. The document describes a physical medical device, not an AI algorithm that requires a training set. The clinical study mentioned would be considered for validation/performance, not for training an algorithm.

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

Not applicable, as there is no mention of a training set for an AI algorithm.

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The YandR System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Handpiece.

The YandR System, subject of this submission as well as the cleared systems of the Legend Pro RF Family of Systems (Pollogen Legend+ system (listed as Legend Pro); see K122200, K131758, K171359 and K173503) are computer-controlled RF devices connected to a treatment Handpiece/Applicators and disposable tips. The system is comprised of:

• System Console
• . VoluDerm Handpiece/Applicator and single-use sterile removable tips (present only in the Surgen, Legend Pro and YandR Systems)
  The YandR System with its VoluDerm Handpiece is a new model of the modified Legend Pro Family of RF Systems The YandR System as the cleared Pollogen Legend+ system can generate a 1MHz sinusoidal signal applied by the VoluDerm Handpiece and the same VoluDerm Tips with bi-polar electrode pins at up to 62 Joules/per pin. The proposed system relies on the same fundamental underlying technology of the cleared systems with some hardware and software modifications to meet the marketing requirements for a more compact and simple device (tabletop console instead of a floor-mounted, rolling console) with a modern interface and the support of only the VoluDerm Handpiece (removing the TriPollar Applicators), similarly to its predecessor, the Pollogen Ltd.'s Surgen U (K131758). Also, to simplify the system, the YandR system has a hand switch, integrated into the VoluDerm Handpiece (called the Handpiece Trigger), instead of a separated Footswitch.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to efficacy or clinical performance.

The document is a 510(k) summary for the YandR System, focusing on demonstrating substantial equivalence to a predicate device (Pollogen Legend+ system). It discusses hardware and software modifications and safety and performance testing for electrical, RF, electromagnetic compatibility, and software verification/validation. However, it does not include:

• A table of acceptance criteria and reported device performance related to a clinical outcome.
• Details about sample size, data provenance, ground truth establishment, or expert involvement for clinical performance evaluation.
• Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.

The "studies" mentioned (Risk analysis, Electrical, RF, EMC safety testing, Software verification/validation, System testing) are engineering and safety verification tests, not clinical performance studies demonstrating the device meets specific efficacy acceptance criteria.

The conclusion states that "Test results indicated that the YandR System performs in accordance with its requirements and specifications similarly to its predicate Pollogen Legend+ system...", but these "requirements and specifications" refer to technical performance and safety, not clinical efficacy metrics.

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Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles.

Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment.

The Legend Pro DMA generates a sequence of electrical pulses which are delivered to the skin overlaying the muscles intended to be stimulated. The Legend Pro DMA consists of a floormounted, rolling System Console that generates voltage output delivered though metal electrodes in the three different DMA Applicators. The System Console generates electrical pulses, and delivers modulated low frequency rectangular biphasic waveforms via electrodes incorporated in different Applicators connected to the System Console:

• . LP DMA Applicator No. 1 for large Areas (includes 6 stainless-steel equidistant electrodes)
• . LP DMA Applicator No. 2 for Medium areas (includes 3 stainless-steel equidistant electrodes)
• LP DMA Applicator No. 3 for Small Areas (includes 3 stainless-steel equidistant ● electrodes)

The Legend Pro DMA is controlled by a proprietary embedded SW. The system SW provides the treatment parameters. The hardware (HW) then implements the actual pulse generation according to the parameters provided by the software. Via the GUI in the System Console, the physician selects the Applicator according to the size of the area being treated and the treatment parameters (Frequency, % Height/Amplitude, pulse width and Treatment Duration). During the treatment session, the operator moves the Applicator across the skin that is lubricated with glycerine.

The provided text does not contain detailed acceptance criteria for the Legend Pro DMA device, nor does it describe a study that explicitly proves the device meets specific acceptance criteria in the format requested.

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, pre-defined acceptance criteria with a detailed study report. The "Performance Data" section lists various tests performed to establish safety and performance, which indirectly support the device's suitability for its intended use, but not against quantitative performance metrics.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds or performance targets. Instead, it compares the Legend Pro DMA's technical specifications to those of its predicate devices to demonstrate similarity and equivalence.

Study Information

The document describes non-clinical performance data to support substantial equivalence, focusing on design verification and validation processes rather than a comparative effectiveness study.

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

• Sample Size for Test Set: Not applicable in the context of device testing for substantial equivalence, as no patient-level test set data is described. The "Performance Data" section details engineering and laboratory testing on the device itself.
• Data Provenance: Not applicable. The tests are on the device's components and systems, not clinical data from patients.

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 is not applicable as there is no mention of a "test set" requiring expert ground truth in the clinical sense (e.g., image interpretation). The "ground truth" for the engineering and safety tests would be the established international standards and regulatory requirements.

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

• Not applicable as there is no clinical test set requiring adjudication.

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 MRMC comparative effectiveness study was done or reported. The device is a powered muscle stimulator, not an AI-assisted diagnostic tool that would involve human readers.

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

• Standalone performance data (algorithm only): The document mentions "Software verification and validation according to IEC 62304 and FDA Guidance 'Principles of Software Validation Guidance for Industry and FDA Staff, January 2002'." This confirms that the device's embedded software was validated as a standalone component, but it doesn't quantify its "performance" in the way one might for a diagnostic algorithm (e.g., sensitivity, specificity). Instead, it validates that the software functions as intended and meets safety requirements. There is no "human-in-the-loop" aspect to the software's direct operation regarding its core function of generating electrical pulses.

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

• The "ground truth" for the non-clinical tests is regulatory and international standards, such as:
  • Risk analysis: ISO 14971
  • Electrical, electromagnetic compatibility safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10
  • Software verification and validation: IEC 62304 and FDA Guidance "Principles of Software Validation"
  • Biocompatibility: ISO 10993-1

8. The sample size for the training set

• Not applicable. The device is a hardware and embedded software system, not a machine learning model that requires a "training set" in the conventional AI sense.

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

• Not applicable for the reasons stated above.

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The STOP U Model UXV device is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types II-IV.

The STOP U Model UXV device delivers RF current into the skin to generate heat through electrical impedance in the dermis and subcutaneous layers. The device consists of the following components and accessories: The STOP U Model UXV device (applicator unit), the STOP U Model UXV Power Supply and the STOP Preparation Gel.

This document describes a 510(k) premarket notification for the Pollogen Ltd. STOP U Model UXV device, an electrosurgical device for over-the-counter aesthetic use. The purpose of the submission is to demonstrate substantial equivalence to a predicate device (Pollogen Ltd., STOP U, K182774).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting specific acceptance criteria for a new clinical outcome. However, it does list performance standards related to safety and functionality that the device complies with.

Overall Performance Conclusion: "In all instances, the STOP U Model UXV device functioned as intended and observations were as expected."

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

The document does not describe a test set with human subjects or a clinical study that would involve a sample size for evaluating clinical effectiveness. The performance tests mentioned are verification and validation activities against technical specifications and safety standards.

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

Not applicable. The document does not describe clinical effectiveness studies requiring expert-established ground truth. The "ground truth" here refers to compliance with established engineering and safety standards, not clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable. As there is no clinical test set requiring human interpretation, no adjudication method is described.

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

No MRMC study was performed or described. This device is an electrosurgical tool for aesthetic use and does not involve AI for interpretation or diagnosis that would typically necessitate an MRMC study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance):

This device does not appear to involve an AI algorithm that would have standalone performance. The "performance data" refers to technical verification and compliance with safety standards rather than a diagnostic or interpretive algorithm. The software validation mentioned is likely for embedded control software, not an AI for clinical decision-making.

7. Type of Ground Truth Used:

The "ground truth" in this context is the adherence to engineering specifications and safety standards (e.g., maximum RF power output, safety limits, software functionality as designed). It is a technical ground truth, not a clinical ground truth like pathology or expert consensus on a medical condition.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a machine learning model that requires a training set in the way a diagnostic AI would. The software validation refers to standard software development lifecycle processes, not AI model training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for an AI model, there is no ground truth established for it.

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