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ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

ACUTRON is High Frequency(=Radio Frequency, RF) includes the system main body, a handpieces with single-use micro-needle type electrodes, footswitch and an LCD touch screen control panel. The RF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the ACUTRON creates heat within the target dermal tissue via micro-needles inserted from the tip. The ACUTRON is consists of ; 1) Main unit 2) Smartcure handpiece(FDA cleared K182355) 3) Monopolar type micro-needle electrodes(FDA cleared K182355)

The provided text is a 510(k) summary for the ACUTRON device, an electrosurgical cutting and coagulation device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing details of new clinical or standalone performance studies with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, specific device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies are not available in the provided text.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary asserts substantial equivalence based on technical specifications and leveraging performance data from predicate devices, rather than presenting new acceptance criteria and a study demonstrating performance against those criteria.

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

Not applicable/Not provided. No new "test set" in the context of a clinical performance study (e.g., diagnostic accuracy) is described. The performance data is primarily "leveraged" from predicate devices and non-clinical testing.

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

Not applicable/Not provided. As no new clinical performance study with a test set requiring expert ground truth establishment is detailed, this information is absent.

4. Adjudication method for the test set

Not applicable/Not provided.

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. The device is an electrosurgical unit, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

No. The ACUTRON is a medical device (electrosurgical unit), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The document describes non-clinical testing of the device itself (electrical and mechanical safety, EMC).

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

Not applicable/Not provided for a new clinical study. For the animal testing and biocompatibility, the assumption is that established scientific methods and reference standards would be used, but specific "ground truth" for a performance endpoint is not detailed. The document mentions "Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces, the predicate device." This implies histology was used as a reference for the predicate, but specific details for ACUTRON are not given beyond leveraging.

8. The sample size for the training set

Not applicable/Not provided. This device is hardware for electrosurgery, not an AI/ML algorithm that requires a "training set."

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

Not applicable/Not provided.

Summary of available information related to performance/testing:

The document focuses on demonstrating substantial equivalence to existing predicate devices (Secret RF Smartcure applicator K182355 and Secret RF K170325). The performance data cited is primarily in the form of non-clinical testing and leveraging existing data from the predicate devices.

Non-clinical testing performed for ACUTRON:

• Biocompatibility testing: Leveraged from the predicate device as patient contact components and materials are identical.
• IEC 60601-1: 2005, AMD 1: 2012: General Requirements for basic safety and essential performance of Medical Electrical Equipment. (The requirements were fulfilled).
• IEC 60601-1-2: 2014: General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility). (The requirements were fulfilled).
• IEC 60601-2-2: 2017: Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and high-frequency surgical accessories. (The requirements were fulfilled).
• Animal testing: Ex-vivo histology testing for ACUTRON handpieces is being leveraged from the Smartcure Applicator handpieces (predicate device).

Conclusion from the document:

The manufacturer concludes that "There are no significant differences between ACUTRON and the predicate device and the reference device. The proposed device does not raise any additional questions regarding safety and effectiveness. ACUTRON has the same indication of use and shares the same technological characteristics as the predicate devices." This substantial equivalence argument is based on the shared technical specifications and leveraging the performance and safety data of the predicate devices.

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

The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA consists of the following components: Electrosurgical Unit - Main body, Two different handpieces ( motor and AC), Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products, Neutral electrode pad and neutral electrode pad cable, cleared under K092761, Handpiece stand, Foot switch, Power cord. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode.

This looks like a 510(k) summary for a medical device. Based on the provided text, the device in question is the "POTENZA," an RF electrosurgical device. However, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the way you've outlined for AI/CADe devices (i.e., sensitivity, specificity, reader studies, etc.).

This document describes the regulatory process for establishing substantial equivalence to a predicate device, which primarily relies on demonstrating that the new device has similar technological characteristics and performs comparably to devices already on the market. The performance data presented here are primarily engineering bench tests, electrical safety, biocompatibility, and software validation. These are standard tests for electrosurgical devices to ensure safety and functionality, not to evaluate diagnostic performance or AI algorithm effectiveness.

Therefore, many of the specific questions you've asked, particularly those related to AI/CADe system validation (sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance), are not applicable to the information provided in this 510(k) summary for an electrosurgical device.

Here's a breakdown of what can be extracted, and why other parts are not present:

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

The document does not explicitly state "acceptance criteria" in the format of a clinical performance metric (like sensitivity or specificity) with a target value. Instead, the acceptance criteria are implicitly met by passing various engineering and biocompatibility tests.

Regarding the specific questions about AI/CADe validation:

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. This device is an electrosurgical unit, not an AI/CADe system that analyzes data like images. The "test set" here refers to physical components and the device itself undergoing engineering and biological safety tests.

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, in the context of AI/CADe, involves expert interpretation of data. For this electrosurgical device, "ground truth" relates to objective physical and biological properties measured by standardized tests (e.g., cytotoxicity assays, electrical measurements).

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

   • Not applicable. Adjudication is for resolving discrepancies in expert interpretations of data. This is not performed for physical device testing.

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 is not an AI-assisted diagnostic device.

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

   • Not applicable. This is not an AI algorithm. Its performance is evaluated as a standalone electrosurgical unit through bench and safety tests.

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

   • The "ground truth" for the tests performed are highly standardized scientific and engineering measurements. For example, for biocompatibility, the ground truth is whether specific biological responses (e.g., cell death, irritation) occur above a predefined threshold according to the specified ISO standards. For electrical safety, the ground truth is whether the device parameters (e.g., leakage current, output power) fall within the limits set by IEC standards.

8. The sample size for the training set.

   • Not applicable. There is no AI training set for this electrosurgical device.

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

   • Not applicable. There is no AI training set or associated ground truth.

In summary, the provided document is a 510(k) summary for an electrosurgical device, detailing its regulatory pathway to market based on substantial equivalence. It focuses on safety and fundamental performance characteristics through engineering and biocompatibility testing, not on the diagnostic accuracy or AI performance metrics you've requested.

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