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FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device named FAQ™ (102), stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements, classifications, and indications for use but does not detail performance studies or acceptance criteria.

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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 CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.

The CurrentBody Skin RF device is an OTC, home-use hand-held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of: User Interface, Programmable logic controller (PLC, microcontroller) embedded in PCBA, RF power module, Power Supply, RF electrodes. The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.

The provided text describes the regulatory clearance of the CurrentBody Skin RF device, focusing on its substantial equivalence to a predicate device. As such, it details non-clinical testing and comparisons rather than comprehensive acceptance criteria for a "study that proves the device meets the acceptance criteria" in the way one might expect for a new, AI-driven diagnostic device undergoing clinical trials.

The document emphasizes demonstrating substantial equivalence through bench tests, electrical safety, software validation, human factors, and thermal effects, rather than through a direct clinical performance study with specific effectiveness endpoints measured against acceptance criteria against a ground truth.

Therefore, many of the requested elements for a typical effectiveness study (e.g., sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this submission. The device is not an AI-driven diagnostic.

Here's an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in the traditional sense of clinical effectiveness endpoints. Instead, it demonstrates that the new device meets various safety and performance standards, and is substantially equivalent to a predicate device in its technical specifications and intended use. The "acceptance criteria" are implied by compliance with these standards and equivalence to the predicate.

• Frequency: 1 ± 0.05 MHz
• Operating RF Power (200 Ohms): $5W \pm 1$
• Total Power Density (fluence): $5 W/cm^2 \pm 1$ |
  | Temperature Control | Maintain temperature within target treatment range (e.g., maximal temperature of $40.5 \pm 0.5^\circ C$). | Two redundant thermistors constantly measure skin temperature and alter power to maintain constant temperature. |
  | Power Accuracy | Measured total power within error margin on a 200 Ω load. | Measured total power was within the error margin. |
  | Parameter Validation | Varied parameters (RF, pulse cycle, waveform, pulse duration) within acceptance criteria. | All results were within the acceptance criteria. |
  | Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-2. | The device complies with these standards. |
  | Software Verification & Validation | Compliance with FDA Guidance for Software in Medical Devices ("moderate" level of concern). | Software verification and validation testing were conducted and documentation provided as recommended. |
  | Human Factors Validation | Users can safely and effectively self-select, prepare, and perform treatment. | A Self-Selection and Human Factors validation study was performed to demonstrate this. |
  | Thermal Equivalence | Spatio-temporal heating profile comparable to predicate device. | Measurements showed comparable (near identical) spatio-temporal tissue heating in porcine belly skin. |
  | Biocompatibility | All patient-contacting parts comply with ISO 10993-1. | Compliance with ISO 10993-1 demonstrated. |

Study Details

This submission relies on non-clinical testing and comparison to a predicate device, rather than a clinical effectiveness study.

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not applicable for a clinical effectiveness study. For non-clinical tests:
     • Power Accuracy, Parameter Validation: Not specified, likely small batches of devices for bench testing.
     • Human Factors Validation: Not specified, but involved a user group for self-selection and treatment performance.
     • Thermal Effects: "Porcine belly skin samples" – number not specified.
   • Data Provenance: Not explicitly stated, but testing appears to be conducted by the manufacturer or their contracted labs (implied through the submission). The "porcine belly skin" indicates animal tissue, not human.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI studies (e.g., expert consensus on medical images, pathology results) is not relevant here. The "ground truth" for non-clinical tests would be the established performance standards or the predicate device's measured characteristics.

3. Adjudication method for the test set: Not applicable. There was no clinical effectiveness study requiring expert adjudication of results.

4. 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 not an AI-driven diagnostic and no MRMC study was conducted.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for aesthetic treatment, not a standalone algorithm. The software component, however, underwent "standalone" verification and validation to ensure its proper functioning and safety.

6. The type of ground truth used:

   • For Non-Clinical Tests: Engineering specifications, compliance with international standards (IEC, ISO), and the measured performance of the predicate device.
   • For Thermal Equivalence: Direct comparative measurements against the predicate device on porcine tissue.

7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the typical sense. Software verification and validation refer to testing the programmed logic and control, not training an AI model.

8. How the ground truth for the training set was established: Not applicable.

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The Silk'n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV.

The Silk'n Titan AllWays is a cordless, hand-held device, utilizing RF energy and low power light spectrum. The device includes an RF generator, an array of 8 LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths respectively), and a temperature stabilizer. The Silk'n Titan AllWays consists of an applicator and an adaptor. The hand-held applicator delivers energy from the treatment surface at the applicator tip which comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch (that also selects the energy level) and an indicators panel. The device can be powered by an internal rechargeable battery (cordless mode) or with the AC adaptor that connects the applicator to an electrical outlet.

The provided text describes the regulatory clearance for the Silk'n Titan AllWays device but does not present specific acceptance criteria or an explicit "study that proves the device meets the acceptance criteria" in the format typically used for performance claims. Instead, it outlines non-clinical performance testing and a clinical study to demonstrate safety and effectiveness for its intended use, which is the non-invasive treatment of mild to moderate facial wrinkles.

Here's an attempt to extract the information requested, interpreting "acceptance criteria" as general performance goals implied by the clinical study and the "study that proves the device meets the acceptance criteria" as the clinical trial described.

1. Table of Acceptance Criteria and Reported Device Performance

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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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FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.

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The provided documents are FDA 510(k) clearance letters for the device FAQ 101. These letters indicate that the device has received substantial equivalence determination, allowing it to be marketed. However, these documents do not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, ground truth establishment, or any comparative effectiveness studies (MRMC) or standalone performance studies.

The letters primarily focus on:

• Notifying the applicant (Foreo, Inc.) of the substantial equivalence determination for the FAQ 101 device.
• Listing the regulation number, regulation name, regulatory class, and product codes.
• Providing administrative updates (like adding a product code).
• Stating the general controls provisions of the Act that apply to the device.
• Listing the Indications for Use for the device: "FAQ™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI."

Therefore, I cannot provide the requested information based on the given input. To answer your questions, I would need a different type of document, such as a study report, clinical trial summary, or a more detailed section of the 510(k) submission that outlines the performance testing and acceptance criteria.

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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 sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.

The sensiLift is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:

• . User Interface
• Programmable logic controller (PLC, microcontroller) embedded in PCBA ●
• RF power module
• Power Supply ●
• RF electrodes ●

The provided document describes the SensiLift device, an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles. The document outlines the studies conducted to demonstrate its safety and effectiveness for FDA 510(k) clearance.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SensiLift device are inferred from the safety and effectiveness endpoints of the clinical study, as well as the successful completion of various non-clinical bench tests and human factors studies.

Study Details

The document primarily describes a single-arm, prospective, interventional clinical study for effectiveness and safety, along with several non-clinical studies.

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

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

   • Clinical Study (Effectiveness & Safety):

     • Enrollment: 40 female participants (ages 40-64).
     • Completed Study: 35 participants (total of 87 treatment areas) completed 8 treatments and the 3-month follow-up.
     • Provenance: Not explicitly stated, but presumable from the location of the submitting company (Israel) or where a clinical trial would be conducted. The study is described as "prospective" and "interventional."

   • Human Factors Validation Testing:

     • Labeling Comprehension/Self-Selection Study: 43 participants (2 men, 41 women), ages 18-65 (45 ± 13 years old).
     • Usability/User Interface Study: Not explicitly stated but implies a subset of the 43 participants or a similar number based on "14 out of 20" and "7 out of 20" comments. Assuming it's at least 20 participants for this part.
     • Provenance: Not specified, but likely conducted in a simulated environment.

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

   • Clinical Study (Effectiveness): 3 independent physicians (apart from the PI - Principal Investigator).
   • Qualifications: "3 board certified dermatologists or plastic surgeons."

4. Adjudication method for the test set:

   • Clinical Study (Effectiveness): Wrinkles appearance was assessed independently by the 3 physicians. There is no explicit mention of an adjudication process (e.g., 2+1 or 3+1 consensus). The percentages of improvement are reported for each reviewer separately (e.g., "89%, 95% and 95% of the study participants (as assessed by 3 reviewers, respectively)"). This implies independent assessment rather than a combined adjudicated score for each participant.

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 involving AI assistance for human readers was conducted or described. This device is a direct-to-consumer physical device for wrinkle treatment, not an AI diagnostic tool.

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

   • This question is not applicable. The device is a physical electrosurgical aesthetic device, not an algorithm. Bench tests and a clinical trial evaluated the device's standalone performance in a human-in-the-loop setting (users operating the device).

7. The type of ground truth used:

   • Clinical Study (Effectiveness): Expert assessment using the Fitzpatrick Wrinkles Severity Scale. Improvement was defined as a decrease of at least one score on this scale. This is a clinical outcome observed by qualified experts.
   • Clinical Study (Safety): Observation of adverse events.
   • Human Factors Study: Direct observation of task completion and user responses to questions.

8. The sample size for the training set:

   • The document implies that the clinical study was conducted for final validation and performance assessment. There's no separate mention of a distinct "training set" for an algorithm, as this is a physical device submission. If the device's software had any machine learning components, details about a training set would typically be provided under software V&V. The software concern level is "moderate," indicating potential harm from errors, but it's not described as an AI/ML algorithm.

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

   • Not applicable, as a discrete training set for an AI/ML algorithm is not described. The clinical study acts as the primary validation of the device's performance against ground truth established by expert consensus (dermatologists/plastic surgeons) using a recognized severity scale.

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The EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.

The Newa™ is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:

• User interface
• Programmable logic controller (PLC)
• RF power module
• Power supply
• RF electrodes

Acceptance Criteria and Device Performance Study for NEWATM

1. Table of Acceptance Criteria and Reported Device Performance

1. Preparing self for treatment (3 tasks): 100% (62/62) completed correctly.
2. Preparing device for treatment (3 tasks): 100% (62/62) completed correctly.
3. Treatment performance (8 tasks): 100% (62/62) completed correctly.
   Result: All tasks performed correctly by 100% of subjects. |
   | Clinical Performance Evaluation: Demonstrate device performs as intended for aesthetic results. | Study: 69 participants (62 completers).
   Effectiveness Criterion: At least 75% of patients show a success (≥1 score reduction on Fitzpatrick Wrinkle Severity Scale agreed by ≥2 of 3 dermatologists).
   Result (at 4-week post-treatment):

• Reviewer #1: 91.93% (57/62)
• Reviewer #2: 91.93% (57/62)
• Reviewer #3: 90.32% (56/62)
• ≥2 agree: 95.16% (59/62)
  Result (at 3-month follow-up):
• Reviewer #1: 91.93% (57/62)
• Reviewer #2: 96.77% (60/62)
• Reviewer #3: 98.39% (61/62)
• ≥2 agree: 100% (62/62)
  Conclusion: Study success criterion for treatment effectiveness was met. |
  | Biocompatibility: Patient-contacting components demonstrated to be biocompatible. | Study: Electrodes and shell (b(4)) are same as Newa™ prescription device (K130793). Tested according to ISO 10993-1 and USP Class VI tests.
  Result: Met requirements for up to 30 days contact with human tissue. |
  | Instructions for Cleaning: Cleaning instructions validated. | Study: Cleaning validation protocol and report provided.
  Result: Cleaning instructions are adequate. Device is non-sterile and reusable, for single user. |
  | Electromagnetic Compatibility (EMC) and Electrical Safety: Performance data provided. | Study: Tested against IEC 60601-1:2005/EN 60601-1:2006, IEC 60601-1-2:2007, IEC 60601-1-11:2010.
  Result: Device passed all relevant testing portions, demonstrating electrical safety for home use. |
  | Software Verification, Validation & Hazard Analysis: Performed per guidelines. | Study: Software is firmware on micro-controller, same as cleared prescription device (K130793). Considered moderate LOC. All elements for moderate LOC devices provided per FDA guidance. V&V testing conducted for system initialization, power button, power down, LEDs, vibration, temperature detection.
  Result: Satisfactory results. Software development procedures provide assurance of intended performance; all software risks adequately mitigated. |
  | Labeling: Include warnings, precautions, contraindications, and clinical summary. | Content: User Manual, Quick Reference Guide, Box Labeling. Includes: When to use (indication), What is Newa, Who can benefit, Using Newa (regimen), Who cannot use (contraindications), What to do to avoid harm (warnings, precautions), Manufacturer details.

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