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The Sunny RF Handpiece (6.78MHz) is indicated for Dermatologic procedures for electrocoagulation and hemostasis.

The Pulsar handpiece (1MHz and 2MHz RF) is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The Sunny device is a high frequency electrosurgical unit that conveys current to the human body through non-invasive electrodes. The device includes three different high frequencies: 6.78MHz (RF), 1MHz (RF), and 2 MHz (RF). It is composed of the main body, Sunny handpiece, Pulsar handpiece, treatment tips, neutral electrode pad, refrigerant gas, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.

Based on the provided text, the device in question is an electrosurgical unit (Sunny™) and not an AI-powered diagnostic device. Therefore, a significant portion of the requested information, such as multi-reader multi-case (MRMC) comparative effectiveness studies, ground truth establishment by experts, and sample sizes for training/test sets related to AI model validation, are not applicable.

The acceptance criteria and study that proves the device meets them are focused on hardware performance, safety, and substantial equivalence to a predicate device.

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

Device: Sunny™ (Electrosurgical Cutting and Coagulation Device and Accessories)

1. Table of Acceptance Criteria and Reported Device Performance

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The VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Microneedle Array Handpiece (1MHz): The Microneedle Array Handpiece with 1 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At power less than 36W, the Microneedle Array Handpiece with 1 MHz functionality is intended for the percutaneous treatment of facial winkles in Skin Types I-V.

Microneedle Array Handpiece (2MHz): The Microneedle Array Handpiece with 2 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Microneedle Array handpiece with 2MHz functionality is not intended to treat wrinkles.

One Pin Exact Handpiece: The One Pin Exact handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The One Pin Exact Handpiece is not intended to treat wrinkles.

VYBE RF II is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The device consists of the device console, Microneedle Array Handpiece, One Pin Exact Handpiece, RF plate, Foot Switch, and Power Cord. VYBE RF II is operated through an intuitive user interface (UI) on a 10.4- inch wide touch LCD screen. This product delivers high-frequency energy to the human body through the needle tip cartridge connected to the Microneedle Array Handpiece (1MHz, 2MHz) and One Pin Exact Handpiece (1MHz).

The provided text is a 510(k) Summary for the Vybe RF II electrocoagulation and hemostasis device. It details the device's intended use, comparison with predicate devices, and performance testing, but it does NOT contain an acceptance criteria table or information related to AI or clinical studies for facial wrinkles. The information provided heavily focuses on electrical safety, EMC, software lifecycle, risk management, and the device's ability to achieve consistent thermal damage profiles in ex vivo tissue, which are not directly about the performance against acceptance criteria for clinical efficacy for wrinkle treatment.

Therefore, many of the requested sections about acceptance criteria, clinical studies, sample sizes, expert ground truth, adjudication methods, and AI performance cannot be extracted from this document in the context of clinical efficacy for facial wrinkles as it states "No clinical studies were conducted as part of this submission."

However, I can extract information related to the technical performance testing conducted to support substantial equivalence.

Here's a breakdown of the available information based on your request:

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance for clinical use, especially for wrinkle treatment. It describes technical performance testing conducted for safety and verification of RF energy output.

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

• Sample Size for Histopathology (Test Set):
  • Ex vivo bovine kidney (unspecified number of samples/sections).
  • Ex vivo Yucatan mini-pig skin (abdomen site) (unspecified number of samples/sections).
• Data Provenance: In vitro/ex vivo lab testing. The country of origin is not specified but the applicant is from Republic of Korea. The testing itself is not clinical trial data.

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. The histopathology testing involves objective measurements of thermal damage profiles, which are typically assessed by pathologists or histologists. However, the document does not specify the number or qualifications of any experts involved in reviewing the histopathology slides.

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

Not applicable. This type of adjudication method is used in clinical studies for diagnostic accuracy, where multiple readers evaluate medical images. The testing described is bench and histopathology.

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. There is no mention of an MRMC study, human readers, or AI assistance in this submission.

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

Not applicable. This device is an electrosurgical unit, not an AI software algorithm.

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

For the histopathology testing, the "ground truth" was established by histological analysis of the thermal damage profiles observed in the ex vivo tissues after treatment with the device. This is a form of pathology assessment.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The testing described does not involve a training set for an algorithm.

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

Not applicable. There is no training set for an algorithm.

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The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.

The PlaDuo System is an electro-surgical device for use in dermatological applications. The device utilizes nitrogen and argon gas to be used separately to generate the desired power level to patients. The effect of the device is achieved by heating the outer layer of the skin so that part or all of it becomes non-viable and there is controlled damage to the underlying skin.

The PlaDuo system consists of a system console with wells for 2 gas tanks, footswitch, 2 handpieces, and tip with 3 interchangeable guides.

This document describes the FDA's 510(k) clearance for the ShenB Co Ltd's PlaDuo System. The system is an electrosurgical device that uses nitrogen and argon gas to generate plasma for dermatological and general surgical procedures.

Based on the provided text, the device meets acceptance criteria through various performance tests, including:

1. IEC 60601-1:2005 + A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
2. IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests.
3. IEC 60601-2-2:2017: Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories.
4. IEC 62304:2006+A1:2015: Medical Device Software Life Cycle Processes.
5. EN ISO 14971:2012: Medical Devices - Application Of Risk Management To Medical Devices.
6. Biocompatibility testing (cytotoxicity, irritation, and sensitization) per ISO 10993-1:2018 for patient-contacting materials (space guides).
7. Software verification and validation testing in accordance with FDA's guidance.
8. Thermal testing on ex vivo tissue specimens to verify the performance of the argon gas.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

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

   • The document mentions "thermal testing on ex vivo tissue specimens." It specifies "skin and in liver models" and "muscle" as the tissue types. However, the exact sample size (number of specimens or tests) is not provided.
   • Data provenance: "ex vivo tissue specimens." The country of origin is not specified. The study's nature is likely prospective as it involves new testing for the modified device.

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

   • The document does not specify the number of experts or their qualifications used to establish ground truth or interpret the thermal testing results. The conclusion about "desirable clinical treatment effect" based on thermal damage profiles implies expert assessment, but details are absent.

3. Adjudication method for the test set:

   • Since the thermal testing is described as direct measurement of physical effects ("measurable thermal damage," "traceable thermal effect"), a human adjudication method in the sense of consensus reading (2+1, 3+1) is not applicable in the same way it would be for image interpretation. The method of assessing "consistent thermal damage profiles" and comparability to predicate devices would likely rely on quantitative measurements and engineering/biomedical expertise, but no specific adjudication method is mentioned.

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:

   • No MRMC study was done. This device is an electrosurgical tool, not an AI interpreting medical images. The evaluation focuses on the safety and performance of the electrosurgical function itself, particularly its thermal effects, rather than how it assists human interpretation or decision-making in a diagnostic context.

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

   • This question is not applicable as the device is a piece of hardware with integrated software for control, not an AI algorithm to be evaluated in a standalone diagnostic capacity. The "software verification and validation testing" confirms the software's functional performance, which is a component of the device's overall standalone performance.

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

   • For the thermal testing, the ground truth was observed thermal damage profiles on ex vivo tissue, measured directly. The comparison was made against profiles produced by predicate and reference devices, implying their established effectiveness provides a benchmark. It's a physical/biophysical ground truth.

7. The sample size for the training set:

   • The document describes a 510(k) submission for a physical medical device, not an AI/machine learning model that typically has a "training set." Therefore, the concept of a training set sample size does not apply in this context.

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

   • As this is not an AI/ML device, the question of establishing ground truth for a training set is not applicable.

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The VYBE RF Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The VYBE RF Electrosurgical System is comprised of the following components:

• . The system main body, consisting of:
  • o LCD touch screen control panel
  • High-frequency generating output section (main P.C.B board or RF Generator) O
  • Power supply component Switch Mode Power Supply (SMPS) O
• The accessories to the device include:
  • Handpiece with Handpiece Connector O
  • Disposable micro-needle cartridge (electrode) for insertion into Handpiece o
  • Foot switch O
    Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.

The document provided describes the VYBE RF Electrosurgical System and its substantial equivalence to a predicate device, the VIVACE Electrosurgical System. It includes performance data, but does not describe an acceptance criteria and study proving the device meets the acceptance criteria in the manner requested by the prompt for a typical AI/ML medical device submission.

Specifically, the document focuses on regulatory compliance through electrical, biocompatibility, sterility, software verification and validation, and thermal testing. These are standard tests for medical devices to ensure safety and fundamental functionality, not necessarily performance benchmarks against clinical criteria in the same way an AI/ML diagnostic or prognostic tool would be evaluated.

Therefore, many of the requested categories in the prompt regarding acceptance criteria, human reader studies, and ground truth establishment are not applicable or not explicitly detailed in the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

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

The document lists various tests and states that "All acceptance criteria were met." However, it does not provide a table with specific acceptance criteria values (e.g., a specific thermal threshold) or the quantitative reported performance for each of these tests. It only lists the standards followed.

2. Sample size used for the test set and the data provenance

Not applicable for the types of tests conducted. These are primarily engineering, laboratory, and compliance tests, not clinical studies with patient data.

3. 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 understood in AI/ML clinical studies (e.g., expert consensus on image interpretation) is not relevant to these engineering and compliance tests.

4. Adjudication method for the test set

Not applicable for the types of tests conducted.

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 system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an electrosurgical system.

7. The type of ground truth used

For the sterility testing, the ground truth is the established Sterility Assurance Level (SAL) of 10^-6 and adherence to the listed ISO standards.
For other tests, the "ground truth" is adherence to the specified engineering and biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable.

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The AF Laser device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The AF Laser is a medical laser used to treat nail fungus (onychomycosis) and promote the growth of healthy nails. The operating mechanism of this device is photochemical reaction that uses two wavelengths -- 635nm and 405nm. The AF laser is a compact, all-in-one device that is intended to be used on the floor and is operated by an intuitive 10.2 inch's wide LCD screen for ease of use. An LCD monitor incorporated into the deck of the device helps the operator check the exact location of treatment area during a procedure.

This document describes the FDA's 510(k) clearance for the AF Laser, a device intended for the temporary increase of clear nail in patients with onychomycosis.

Based on the provided text, the acceptance criteria and study proving the device meets these criteria can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the AF Laser is "substantially equivalent" to its predicate device, the LunulaLaser (K153164). The acceptance criteria appear to be met by demonstrating this substantial equivalence, rather than through specific performance metrics outlined in a dedicated clinical study against a predefined threshold.

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

The document explicitly states: "No Clinical testing was conducted as part of this submission." Therefore, there is no test set of clinical data from human subjects in the traditional sense for evaluating device performance against acceptance criteria for clinical efficacy. The submission relies on a comparison to a predicate device and engineering/bench testing.

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

Since no clinical testing was performed, there was no clinical test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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 a laser for direct treatment, not an AI-assisted diagnostic tool for human readers.

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

Not applicable, as this is not a diagnostic algorithm. Performance was assessed through engineering and safety standards compliance, and comparison to the predicate device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission appears to be the established safety and efficacy profile of the legally marketed predicate device (LunulaLaser K153164) and compliance with international safety and performance standards for laser devices.

8. The Sample Size for the Training Set:

Not applicable. As this is not a machine learning or AI device, there is no "training set."

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

Not applicable.

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The Virtue RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Smart RF Handpiece:
The Smart RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types I-V.
The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles.

Exact RF Handpiece:
The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles.

Deep RF Handpiece:
The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.

The VirtueRF device is a radio frequency output device using 0.5MHz, 1MHz & 2Mhz to deliver radio frequency energy to the human body with 3 applicators that attach to the connecting cable. The energy is applied to the human body using sterile disposable needle arrays consisting of 36 needles, 12 needles, o 1 needle. This product consists of main body, SmartRF Bipolar handpiece, DeepRF Bipolar handpiece, ExactRF Monopolar handpiece, connector cable, grounding plate for ExactRF, cooling plate for the DeepRF, foot switch and power cord.

The provided text is a 510(k) summary for the Virtue RF device, an electrosurgical cutting and coagulation device. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial to prove de novo effectiveness or meeting specific performance acceptance criteria for a novel device. As such, the document does not contain information typically found in a study demonstrating a device meets acceptance criteria involving human or animal subjects, ground truth, or statistical measures of performance like AUC, sensitivity, or specificity.

Instead, the submission demonstrates substantial equivalence primarily through:

1. Bench testing: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) and biological compatibility (ISO 10993-1).
2. Thermal effect tests: Performed on four types of tissues (liver, kidney, muscle, and skin) as guided by FDA for electrosurgical devices.
3. Direct comparison of technological characteristics: Side-by-side tables comparing the proposed device's various handpieces (Smart RF, Exact RF, Deep RF) with its own predicate device (Virtue RF K202415) and other reference devices (Primaeva Medical Miratone System K082391, Agnes K192728, and Agnes K160469, though K160469 is not explicitly listed as a reference device, it appears in a comparison table for Exact RF).

Therefore, I cannot provide the detailed acceptance criteria and study information requested in the prompt, as these elements are not part of this specific type of regulatory submission. The document concludes that "Substantial equivalence is supported by the performance testing and there are no new questions of safety or effectiveness."

To explicitly address your points:

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

• Acceptance Criteria for Bench Testing: Adherence to the listed IEC standards (e.g., meeting specific safety thresholds for electrical current, electromagnetic emissions, and biological compatibility). The "reported device performance" is that it passed these tests.
• Acceptance Criteria for Thermal Effect Tests: The criteria would be to demonstrate substantial equivalence to the predicate device in terms of thermal effects on tissues. The "reported device performance" is that the "Test shows that the VirtueRF is substantially equivalent to the predicate device."
• Acceptance Criteria for Technological Characteristics: The criteria are for the proposed device's features (Source of energy/Modality, Radiofrequency, Output energy type, Electrode type, Max Power, RF Duration, Number of Needles, Grounding Mechanism, Cooling Modality) to be "Same" or "Similar" to the predicate/reference devices, with justifications where there are differences (e.g., "Similar; same as reference device" or "Same as reference; similar to predicate device"). The "reported device performance" is detailed in the comparison tables provided in the document (pages 6-8).

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

• Not applicable for this type of submission. The "tests" here are bench tests on the device's hardware and thermal effects on tissues, not clinical trials on human subjects. The tissue tests would likely use an ex vivo or in vivo animal model, but details on sample size or provenance are not provided.

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. Ground truth from human experts is not used for this type of technical and bench testing-focused submission.

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

• Not applicable. No expert adjudication is involved.

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 not an AI-assisted diagnostic device, and no MRMC study was conducted.

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

• Not applicable. This is not a software algorithm; it's an electrosurgical device.

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

• For the thermal effect tests, the "ground truth" would be objective measurements of tissue coagulation or heating, compared to measurements from the predicate device. For technical standards, the "ground truth" is adherence to the specified parameters in the IEC and ISO standards.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning device.

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

• Not applicable.

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The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The VIVACE Electrosurgical System is comprised of the following components:

• . The system main body, consisting of:
  • LCD touch screen control panel O
  • High-frequency generating output section (main P.C.B board or RF Generator) O
  • Power supply component Switch Mode Power Supply (SMPS) O
• The accessories to the device include: ●
  • Handpiece with Handpiece Connector o
  • Disposable micro-needle cartridge (electrode) for insertion into Handpiece O
  • Foot switch O
    Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.

The provided text is a 510(k) Summary for the VIVACE Electrosurgical System. It outlines the device's technical specifications and the performance data submitted to the FDA to establish its safety and efficacy and demonstrate substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML medical device, which is what your request implies.

The "Performance Data" section (Page 6 of the input) lists various tests that were conducted (electrical testing, biocompatibility testing, sterility testing, shelf life/packaging, software verification/validation, and thermal testing) and states that "All acceptance criteria were met." However, it does not define these acceptance criteria, nor does it provide detailed results or specific studies that you've requested (e.g., MRMC studies, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for AI/ML performance studies).

The "Thermal Testing" section briefly mentions:

• An ex vivo animal study using a porcine tissue model.
• Standardized H&E staining techniques to visualize and measure thermally damaged profile data through Nitro Blue Tetra Chlorine (NBTC) and H&E histological evaluation.
• The finding that the vivace microneedling device showed consistent formation of measurable thermal lesions for highest energy level settings in the treatment porcine tissue at a temperature close to physiological.

This is a performance test, not a study to establish clinical effectiveness or compare AI performance against a human or a human-assisted AI.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study proving the device meets them as described in your prompt (which is structured for an AI/ML device performance study) because this regulatory document for the VIVACE Electrosurgical System does not contain such information. It focuses on demonstrating substantial equivalence through engineering and biological performance testing, not AI model performance.

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The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz.

1MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V.

2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.

The VirtueRF device is a radio frequency output device using 1MHz & 2Mhz to deliver radio frequency energy to the human body with an applicator attached to the connecting cable. The energy is applied to the human body using a sterile disposable needle array consisting of 36 needles. This product consists of main body, Needle Bipolar RF (Smart RF) handpiece cable, foot switch and power cord.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VirtueRF device:

Based on the provided K202415 510(k) Summary for the VirtueRF device, the submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and standard performance testing. This type of submission generally does not include extensive clinical studies with specified acceptance criteria regarding diagnostic performance or human-AI comparative effectiveness, as it's not a diagnostic AI device.

Therefore, many of your requested points regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable in this context. The acceptance criteria here are related to meeting safety, electrical, biological, and thermal performance standards to demonstrate equivalence to existing devices.

Nonetheless, I will extract what information is present or clearly implied.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not present for the efficacy or diagnostic performance as those types of studies were not conducted or described. The "test set" in this context refers to the samples used for the engineering and bench testing (e.g., tissue samples for thermal effect tests, electrical testing setup), not a clinical trial test set for diagnostic performance. The document does not specify the number of tissue samples or the specifics of the electrical test configurations used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the submission is not for a diagnostic device or an AI algorithm requiring expert-established ground truth for performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, which the VirtueRF electrosurgical system is not.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone algorithm performance study was not done. The VirtueRF is a medical device, not a standalone AI algorithm for diagnostic purposes. Its performance is evaluated through engineering, electrical, biocompatibility, and thermal tests, and comparison to predicates, not through AI-specific performance metrics.

7. The Type of Ground Truth Used

For the thermal effect tests, the "ground truth" would be established by direct physical measurements of temperature changes and tissue effects, validated against established scientific principles and comparison to the predicate device's known effects. This is a scientific and engineering ground truth rather than a clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable. The VirtueRF is a hardware device, not an AI model that requires a "training set."

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

This information is not applicable for the reasons stated above.

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The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The ShenB Co Ltd PlaDuo is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis.

The PlaDuo system consists of a system console, footswitch, handpiece, and tip with 3 interchangeable guides.

The provided text is a 510(k) summary for the PlaDuo System, an electrosurgical device. It outlines non-clinical tests conducted to support its substantial equivalence to predicate devices, but no clinical studies or acceptance criteria based on clinical performance are mentioned. Therefore, I cannot provide details on acceptance criteria or studies that prove the device meets them in the context of clinical performance.

However, based on the non-clinical tests performed, I can infer acceptance criteria for those tests and describe the study that proves the device met them.

Here's a summary of the non-clinical acceptance criteria and the studies performed:

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

Important Note: The document explicitly states "No Clinical study was conducted as part of this submission." Therefore, the following points address the questions in the context of the available non-clinical information.

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

• Biocompatibility: The sample sizes for these tests are specific to the biological assay standards (e.g., number of cells for cytotoxicity, number of guinea pigs for sensitization, number of animals for intracutaneous reactivity). These specific numbers are not detailed in the provided summary, but the tests were performed in accordance with international ISO standards.
• Electrical Safety & EMC: These are typically laboratory tests performed on a single or a few units of the device. The specific number of units tested is not stated.
• Software Verification & Validation: This involves reviewing and testing the software, often through simulated scenarios or on development units. Sample size for actual "test cases" within software testing is not specified.
• Bench Testing: This involved testing of the device and its components (e.g., tips). The specific number of devices or tips tested is not provided.

The provenance of this non-clinical data is from the manufacturer, ShenB Co. Ltd., which is based in South Korea (Seongdong-Gu, Seoul). These were prospective tests conducted to demonstrate compliance with the relevant standards.

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 question is not directly applicable as the studies were non-clinical, involving engineering, materials science, and software experts.

• Biocompatibility: The "ground truth" (i.e., whether a material is biocompatible) is established by the results of standardized laboratory tests interpreted by trained toxicologists/biocompatibility specialists.
• Electrical Safety & EMC: The "ground truth" (i.e., whether the device meets electrical safety and EMC standards) is established by measurements against predefined limits by qualified electrical engineers and testing laboratories.
• Software Verification & Validation: The "ground truth" (i.e., whether the software functions as intended and is safe) is established by software engineers and quality assurance specialists comparing software behavior against its requirements and design specifications.
• Bench Testing: The "ground truth" (i.e., performance against specifications) is established by engineers performing measurements and observations against design requirements.

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

This concept is primarily relevant for clinical studies involving human interpretation or subjective endpoints. For these non-clinical tests, adjudication methods like 2+1 or 3+1 are not typically used. The results of these tests are objectively measured against established standards and specifications. If there were any ambiguous results, internal quality processes or re-testing would be employed.

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 study was performed as no clinical studies were conducted, and the device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system.

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

This question is not applicable as the PlaDuo System is an electrosurgical device, not an algorithm. The "standalone" performance relates to the device's functional integrity as an electrosurgical unit, which was assessed through bench testing and compliance with electrical safety standards.

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

For the non-clinical tests:

• Biocompatibility: The ground truth is established by standardized laboratory test results (e.g., cell viability, immune response observed in animal models) compared against established safety thresholds defined by ISO standards.
• Electrical Safety & EMC: The ground truth is established by objective measurements of electrical characteristics (e.g., leakage current, electromagnetic emissions) against the limits defined in IEC standards.
• Software Verification & Validation: The ground truth is established by the software requirements specification and design documents, against which the functionality and performance of the software are tested.
• Bench Testing: The ground truth is established by the device's predefined design specifications and engineering requirements for parameters like output energy, tip durability, and thermal effects.

8. The sample size for the training set

This question is not applicable as there is no mention of an algorithm or AI model in the submission that would require a training set.

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

Not applicable, as no training set for an AI/algorithm was mentioned.

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