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The OptiLUV device is a handheld device intended to emit energy in the RF spectrum to provide topical heating for the purpose of elevating facial tissue temperature for a temporary relief of minor pain and the temporary increase in local blood circulation.

The OptiLUV device is a non-invasive, non-ablative device that delivers RF energy into the skin to generate heat through electrical impedance in the dermis. The device consists of the following components and accessories: the OptiLUV device, the USB Charging Cord, and the OptiLUV Preparation Balm.

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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 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.

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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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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The STOP U 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 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 device (applicator unit), the STOP U Power Supply and the STOP Preparation Gel.

The provided text describes the acceptance criteria and a clinical study conducted for the Pollogen Ltd. STOP U device (K182774), intended for non-invasive treatment of mild to moderate facial wrinkles.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size (Clinical Efficacy and Safety): 40 subjects (37 female, 3 male)
• Sample Size (Usability/Self-Selection Study): Not explicitly stated, but the text mentions "using the final STOP U packaging design produced a correct self-selection rate that met Pollogen's goal."
• Sample Size (Human Factors Validation): 61 subjects (39 female, 22 male)
• Data Provenance: The clinical trial "was conducted to support the clearance of the prescription version of the STOP U device (K140255)." This implies it was a prospective clinical study. The country of origin for the clinical study is not explicitly stated in the provided text.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three uninvolved physicians.
• Qualifications of Experts: Not explicitly stated beyond "uninvolved physicians." It is implied they are qualified to evaluate facial wrinkles and elastosis using the Fitzpatrick scale.

4. Adjudication Method for the Test Set

The adjudication method for evaluating treatment efficacy was blinded evaluation by three uninvolved physicians based on the Fitzpatrick Wrinkle and Elastosis scale using pre and post-treatment photos. A specific method like "2+1" or "3+1" is not detailed, but the use of three independent evaluators suggests a consensus-based approach would likely have been employed if there were disagreements.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a direct-to-consumer medical device, not an AI-powered diagnostic or assistive tool for clinicians.

6. Standalone Performance Study

The clinical trial described (40 subjects) assessed the standalone performance of the STOP U device regarding its safety and effectiveness in treating facial wrinkles. It measured the device's effect directly on subjects without human-in-the-loop assistance for the core treatment, though a human user operates the device. The evaluation of results, however, involved human experts (physicians) reviewing images.

7. Type of Ground Truth Used

The ground truth for effectiveness was established by expert consensus/evaluation using the Fitzpatrick Wrinkle and Elastosis scale based on pre and post-treatment photographs. Safety was assessed by monitoring adverse events.

8. Sample Size for the Training Set

The provided document describes performance testing and clinical trials for validation. It does not mention a "training set" as would be relevant for machine learning models. The studies described are for verifying the device's physical and clinical performance.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for a machine learning model, this question is not applicable based on the provided text. The studies validate the device itself, not an algorithm that would require a training set.

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The Pollogen Legend+™ System is 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 (Applicators 1-3).

Pollogen Ltd's modified Legend*™ system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of:

• Main Unit (includes the Controller); -
• Control Panel (User Interface); -
• RF Generator; -
• VO (VoluDerm) Treatment Applicator -
• Disposable tips; gen12, gen36 & gen36L -
• Treatment Applicators 1-3 (TriPollar); -
• Foot Switch; -
• Patient-Controlled Manual Switch. -
  The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.
  The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.

The provided text describes Pollogen Ltd.'s modified Legend+™ System, an electrosurgical cutting and coagulation device. The key focus of the submission for K173503 is to add a new disposable tip, gen36L, to the existing VO applicator.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of quantitative performance metrics for the device's efficacy in ablation, resurfacing, or wrinkle treatment. Instead, the acceptance criteria appear to be framed around demonstrating substantial equivalence to a predicate device (Pollogen Legend+™ System K171359) and establishing safety and effectiveness, particularly for the new gen36L tip.

The performance data primarily focuses on compliance with international standards and a pre-clinical animal study.

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

• Sample Size for Test Set:
  • Animal Study: 3 pigs.
  • Data Provenance: Not explicitly stated, but implies a controlled laboratory setting given "animal study." The manufacturer is Pollogen Ltd. in Israel, suggesting the study was likely conducted or overseen in that region or a designated test facility. This is a prospective study for the purpose of demonstrating the safety and effectiveness of the new tip.
• For other performance tests (standards compliance, biocompatibility, software V&V): The document does not specify sample sizes, as these are typically validated through engineering tests, documentation reviews, and adherence to established protocols rather than case-based test sets.

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

• Animal Study: The document states "macroscopic and histological evaluation of the tissue." This implies that veterinary pathologists or other qualified experts conducted these evaluations. However, the exact number of experts and their specific qualifications (e.g., years of experience, board certifications) are not specified in the provided text.

4. Adjudication Method for the Test Set

• Animal Study: The document does not explicitly state an adjudication method (like 2+1, 3+1, etc.) for the macroscopic and histological evaluations. It simply mentions that these evaluations were performed.

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

• No, an MRMC comparative effectiveness study was NOT done. The study's purpose was to demonstrate the safety and effectiveness of a device modification (the gen36L tip) by showing substantial equivalence to an already cleared predicate, rather than to compare human reader performance with and without AI assistance. The device in question is a medical device for skin treatment, not an AI or imaging diagnostic tool.

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

• Not applicable in the context of typical AI/diagnostic standalone studies. The Pollogen Legend+™ System is a hardware device delivering RF energy, operated by a human. Its performance is inherent to its physical operation, not an algorithm interpreted by itself. The software verification and validation are for the operational integrity of the device's control system, not for an AI diagnostic algorithm operating standalone.

7. The Type of Ground Truth Used

• Animal Study: The ground truth for the animal study was established through histological evaluation of tissue samples from the treated areas. This is a definitive biological assessment of tissue changes at a microscopic level. It also mentions "macroscopic evaluation," which represents visual assessment.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device, not an AI model that requires a training set of data. The "training" for the device would involve engineering design, component testing, and calibration.

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

• Not applicable. As stated above, this is not an AI model requiring a training set with established ground truth.

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The Pollogen Legend+™ System is 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 (Applicators 1-3).

The Pollogen Legend*™system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface.

The system consists of:

• Main Unit (includes the Controller); -
• Control Panel (User Interface); -
• RF Generator: -
• -VO (VoluDerm) Treatment Applicator;
• -Treatment Applicators 1-3 (TriPollar);
• Foot Switch; -
• Patient-Controlled Manual Switch. -

The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.

The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.

This document is a 510(k) summary for the Pollogen Legend+™ System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission does not typically include detailed clinical studies or rigorous acceptance criteria as might be found for a PMA (Premarket Approval) submission for a novel device. Instead, the focus is on demonstrating equivalence through performance testing against established standards and comparison to predicate devices.

Based on the provided text, a table of acceptance criteria and reported device performance directly related to clinical effectiveness or diagnostic accuracy is not available. The document primarily details engineering performance tests to ensure safety and functionality.

Here's an analysis of the provided information, addressing your points where data is available:

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

As mentioned, a table of acceptance criteria and reported device performance in the context of clinical efficacy (e.g., specific wrinkle reduction percentages, ablation effectiveness metrics) is not provided in this 510(k) summary. The performance data section focuses on engineering and safety verifications.

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

The document does not specify sample sizes for any of the performance tests performed. These appear to be bench tests or engineering verifications, not clinical studies involving human subjects with a "test set" in the context of diagnostic performance. There is no information on data provenance concerning geographic origin or study design (retrospective/prospective).

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

This is not applicable. The performance tests described are engineering validations of device functionality and adherence to technical specifications, not clinical assessments requiring expert ground truth establishment.

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

This is not applicable. There is no "test set" in the clinical sense, or human expert adjudication mentioned for the performance tests.

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

This is not applicable. The Pollogen Legend+™ System is an electrosurgical device for dermatological procedures, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI or MRMC studies.

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

This is not applicable. The device is a physical electrosurgical system, not an algorithm.

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

For the performance tests described, the "ground truth" would be the engineering specifications and performance standards (e.g., maximum energy per pin not higher than 62 mJ, ability to perform 800 pulses, withstand specified force, adherence to IEC/EN standards). This is a technical or engineering ground truth, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This is not applicable. The device is not an AI/machine learning system that requires a "training set."

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

This is not applicable for the same reason as point 8.

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