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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 generates radiofrequency (RF) energy by means of high RF at IMHz 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.

The provided text is a 510(k) Summary for the POTENZA device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (also named POTENZA, K201685) rather than presenting a study to prove acceptance criteria for a new device.

The "acceptance criteria and reported device performance" in this context refer to the performance standards and test results that show the modified device is substantially equivalent to the previously cleared predicate device.

Here's an analysis of the provided information, framed to address your request as best as the document allows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study. Instead, it details various tests performed to demonstrate that the changes made to the device (new electrode tips) do not raise new questions of safety or effectiveness and that the device continues to conform to applicable standards. The "reported device performance" are the results of these tests, which consistently show "Pass."

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., number of devices tested for electrical safety, number of tissue samples for ex vivo testing). For biocompatibility, it states "four newly added electrode tips" were tested, but not the number of samples for each biological test. For ex-vivo testing, it mentions "three types of tissue Liver, Kidney and Muscle," but not the quantity of each.
• Data Provenance: The tests were conducted by Jeisys Medical Inc., the manufacturer. The data is retrospective in the sense that it was generated for this regulatory submission. Country of origin for the data is implied to be South Korea, where Jeisys Medical Inc. is based. The tests were laboratory (bench) and ex-vivo animal tissue tests.

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

Not applicable. This submission relies on performance against recognized standards and technical specifications for electrosurgical devices, rather than human expert-established ground truth for a diagnostic AI algorithm. The device is a physical instrument, not an AI or diagnostic software.

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

Not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in diagnostic contexts. The tests described are objective, physical, electrical, and biological performance tests against defined standards.

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 tool, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.

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 through bench testing and ex-vivo studies.

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

The "ground truth" for the tests performed consists of:

• Specified limits/ranges within recognized consensus standards (e.g., ISO 10993 series, IEC 60601 series).
• The device's own predefined design specifications for parameters like output accuracy, frequency, power, impedance, needle depth, motor speed, etc.
• The expected biological responses for biocompatibility (e.g., no cytotoxicity, no sensitization).
• Expected thermal effects consistent with electrocoagulation and hemostasis in ex-vivo tissue.

8. The sample size for the training set

Not applicable. No AI/machine learning model is described, so there is no training set.

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

Not applicable. As there is no training set mentioned, the establishment of its ground truth is not relevant.

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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 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. The NEW POTENZA consists of the following components: Electrosurgical Unit - Main body, handpieces (Predicate Device have Motor, AC handpieces), electrode tips for the handpiece – Add three non-invasive tips connect to S handpiece, Neutral electrode pad and neutral electrode pad cable, cleared under K201685, Handpiece stand, Foot switch, Power cord.

This 510(k) summary describes a device (POTENZA) that is substantially equivalent to a previously cleared predicate device. The key changes are the addition of a new S handpiece and three new non-invasive electrode tips. The provided text primarily focuses on demonstrating the safety and effectiveness of these additions through non-clinical testing rather than complex AI performance studies. As such, many of the requested points regarding AI acceptance criteria, MRMC studies, and large-scale data sets are not directly applicable or available in this specific document.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets them as they relate to the changes in the device.

1. Table of Acceptance Criteria and Reported Device Performance

For the specific changes (new S handpiece and non-invasive tips), the acceptance criteria are generally focused on safety and functionality demonstrating equivalence to the predicate device.

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

• Sample Size: The document does not specify numerical sample sizes for most performance tests (e.g., number of units tested for electrical safety, number of times functions were tested). For biocompatibility, it refers to standard ISO test protocols, which imply specific sample sizes for each test type (e.g., Guinea Pig Maximization Test typically involves a certain number of animals). For Ex Vivo testing, it mentions "three types of tissue (Liver, Kidney and Muscle)," but not the quantity of each.
• Data Provenance: The tests are described as non-clinical (bench and ex vivo) and conducted by Jeisys. There is no information regarding country of origin for data samples (as it's not a clinical study involving patients), or if the testing was retrospective or prospective. It is implied to be prospective testing specifically for this 510(k) submission.

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

This information is not provided in the document as it pertains to AI/clinical ground truth establishment, which is not the focus of this 510(k) submission for an electrosurgical device modification. The "ground truth" here is based on engineering specifications and recognized consensus standards (e.g., ISO, IEC).

4. Adjudication Method for the Test Set

This information is not applicable/provided as it relates to expert review of data (e.g., medical images for AI), which is not detailed for this type of device submission. Performance is based on objective measurements against engineering specifications and standard test protocols.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was performed." MRMC studies are typically for evaluating the impact of AI on human reader performance, which is not relevant here as there is no AI component or clinical reader assessment being evaluated.

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 algorithm. There is no standalone algorithm performance described.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is based on:

• Engineering Specifications: Predefined design parameters for power output, frequency, impedance, motor speed, etc.
• Recognized Consensus Standards: International standards like ISO 10993 (biocompatibility) and IEC 60601 series (electrical safety, EMC).
• FDA Guidance Documents: Bench and thermal testing were conducted in accordance with FDA guidance for electrosurgical devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. Therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Ask a specific question about this device

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.

The provided text describes the 510(k) premarket notification for the POTENZA device, specifically for the addition of four new electrode tips. The document details the performance data collected to demonstrate that the expanded device meets acceptance criteria and is substantially equivalent to its predicate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides tables of acceptance criteria and results for biocompatibility and sterilization residual testing. Other tests mention conformance to specified standards as their acceptance criteria.

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

The document does not explicitly state sample sizes for specific tests with numerical values like "N=X". For biocompatibility testing, it mentions "the electrode tips were tested as shown in Table 1," implying a sufficient sample was used for each test type according to the standard. Similarly, for bench testing, it states "Jeisys conducted bench testing to assure that the four new electrode pins operate safely and within the predefined design specifications," suggesting testing was performed on the new electrode tips.

The data provenance is from Jeisys Medical, Inc. (South Korea), as the submitter is based in Seoul, Korea. The studies are retrospective in the sense that they are conducted by the manufacturer for the specific purpose of demonstrating substantial equivalence to a predicate device, rather than actively collecting new clinical data on human patients in a prospective manner.

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

This information is not provided in the document. The studies described are primarily in vitro (biocompatibility, sterilization), in silico (software), and benchtop engineering tests, not studies that require expert-established ground truth from clinical images or patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving expert review of data (e.g., medical images). The tests described here are technical performance tests, not clinical evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not provided and not applicable. The device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This information is not applicable. The POTENZA is a hardware device with associated software, not a standalone algorithm/AI for diagnostic interpretation. Its performance is evaluated through its physical and electrical characteristics as well as its software's functionality. The bench testing and electrical safety tests demonstrate the device's standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the various tests is based on recognized consensus standards and predefined design specifications. For example:

• Biocompatibility: Standards like ISO 10993 and USP provide the "ground truth" for acceptable biological response.
• Electrical Safety & EMC: IEC 60601 series standards define the ground truth for safe electrical operation and electromagnetic compatibility.
• Software Verification: FDA guidance provides the framework for acceptable software validation.
• Bench Testing: The device's own predefined design specifications, safety mechanisms, and performance ranges (e.g., needle depth range of the predicate device) serve as the ground truth.
• Sterilization & Shelf-life: ISO standards (e.g., 10993-7, 11135), ASTM standards (e.g., F1980-16, F1929-15), and USP standards provide the ground truth for acceptable sterilization residuals, sterility assurance level, and packaging integrity.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The described tests are for device validation and verification, not for training an AI or machine learning model.

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

This information is not provided and not applicable. No training set for an AI/ML model is mentioned or relevant to this device's submission.

Ask a specific question about this device

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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