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The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.

The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.

The provided text describes the 510(k) submission for the PEAK Suction Coagulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.

Therefore, the information required to populate most of the acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not available in the provided document.

Instead, the submission relies on:

• Comparison to a predicate device (Valleylab Suction Coagulator): The primary claim is that the PEAK Suction Coagulator is "substantially equivalent" due to similar output energy, delivery system, blade specifications, and the use of monopolar electrosurgery for tissue coagulation.
• Compliance with recognized standards: The device met various IEC and ISO standards related to electrical safety, electromagnetic compatibility, surgical equipment safety, sterilization, and biocompatibility.
• Histological studies: These were conducted to compare the thermal effects of the PEAK Suction Coagulator to the predicate device, aiming to show similar safety and effectiveness. The specific acceptance criteria for these histological studies are not detailed, nor are the number of samples, ground truth establishment, or expert involvement.

Here's a breakdown of what can be gathered from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified for the histological studies or laboratory/performance tests.
• Data Provenance: Implied to be laboratory tests and histological studies, conducted for this regulatory submission. No information on country of origin or whether it's retrospective/prospective.

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

• Number of Experts: Not specified.
• Qualifications: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of histological comparisons, it would typically involve expert pathologist review, but the method isn't described.

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

• MRMC Study: No, this type of study is not mentioned. The device is a surgical instrument, not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable here. The comparison is between the device and a predicate device/standards.

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

• Standalone Performance: Not applicable in the context of an electrosurgical device. The device itself is a tool used by a human surgeon. Its performance is evaluated through its physical and electrical characteristics, and its effects on tissue.

7. The Type of Ground Truth Used

• For the "Safety (Thermal Effects)" criterion, the ground truth was likely derived from histological examination by qualified personnel (e.g., pathologists) comparing tissue effects between the PEAK Suction Coagulator and the predicate device.
• For other criteria, the "ground truth" would be established by compliance with published international standards (IEC, ISO) and internal design specifications.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This document describes a medical device requiring regulatory clearance based on substantial equivalence, not an AI/ML algorithm that undergoes "training."

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

• Ground Truth Establishment: Not applicable, as there is no "training set" in this context.

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The PEAK PlasmaBlade® PLUS Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

The PEAK PlasmaBlade® PLUS consists of a single insulated bendable blade, telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip incorporates a suction lumen for the evacuation of smoke and fluids. A ball electrode attaches to the finger grip to allow a broader application of energy. The PlasmaBlade PLUS is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, PlasmaBlade EXT and PlasmaBlade 3.0S.

The provided text is a 510(k) Summary for the PEAK PlasmaBlade® PLUS, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance from a study in the format typically used for AI/ML device submissions.

Based on the content provided, here's an attempt to answer your questions, highlighting where information is absent or not applicable:

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

The document does not explicitly present a table of acceptance criteria and device performance in numerical terms for the PEAK PlasmaBlade® PLUS. Instead, it states that the device "functioned as intended and met design specifications" and "complies with" various electrical safety, sterilization, and biocompatibility standards. It also mentions "Histological studies comparing thermal effects of the device to the predicate devices demonstrated that the PlasmaBlade PLUS is substantially equivalent to the predicate devices and meets safety and effectiveness criteria."

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

The document mentions "Laboratory and performance tests were executed" and "Histological studies," but does not specify sample sizes for these tests or studies. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

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)

The document mentions "Histological studies," which implies microscopic examination, likely performed by pathologists. However, it does not specify the number of experts used, their specific qualifications, or how ground truth was established regarding the "thermal effects" in these histological studies.

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

The document does not describe any adjudication method for the tests or studies 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

No MRMC comparative effectiveness study was conducted or reported. This device is an electrosurgical tool, not an AI/ML diagnostic aid. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This question is not applicable. The PEAK PlasmaBlade® PLUS is a physical surgical device, not a standalone algorithm.

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

For the "histological studies," the ground truth was presumably based on pathology (microscopic examination of tissue samples to assess thermal effects). The exact nature of the assessment (e.g., specific measurements of thermal damage zones) is not detailed.

8. The sample size for the training set

This question is not applicable. As this is not an AI/ML device, there is no concept of a "training set" in the context of machine learning model development.

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

This question is not applicable for the same reason as above.

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The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

The PEAK Surgery System consists of the PULSAR II Generator, PEAK PlasmaBlade Tissue Dissection Devices and an optional wireless footswitch. The PULSAR II Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar RF energy for cutting and coagulation during surgery. The PULSAR II Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices which are single use, sterile handpieces for monopolar energy delivery. The PlasmaBlade Tissue Dissection Devices consist of an insulated blade electrode, rotating shaft, handle with integrated controls and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.

The provided text describes a 510(k) submission for the PEAK Surgery System, specifically the PULSAR II Generator, which is a modification of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, not on meeting specific performance acceptance criteria through a clinical study with a defined dataset.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not provide specific acceptance criteria (e.g., a certain sensitivity, specificity, accuracy, or performance metric) for the device. Instead, it states that "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications." It then concludes that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." This is a regulatory statement of equivalence, not a report of specific performance against predefined acceptance criteria from a study.

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

Not applicable. This was not a study evaluating performance against a test set with human data. The "tests" mentioned were likely engineering and functional performance tests for the device's hardware, circuitry, and output energy, comparing them to the predicate device. The context implies these were laboratory tests rather than tests on a dataset of clinical cases.

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

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

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

No. This device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant or described.

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

Yes, in the sense that the device's performance was evaluated independently. However, this was not an "algorithm only" evaluation as understood in AI/software. Rather, it refers to the engineering and functional performance of the electrosurgical unit. The "Laboratory and performance tests" assessed the device itself (PULSAR II Generator and PlasmaBlade Tissue Dissection Devices) to ensure it functioned as intended and met design specifications, and that its output energy and delivery system were similar to the predicate.

7. The Type of Ground Truth Used

Not applicable in the context of clinical ground truth (e.g., pathology, outcomes data, expert consensus). For electrosurgical devices, "ground truth" would typically refer to established engineering specifications, safety standards, and performance benchmarks for electrosurgical energy output, tissue cutting, and coagulation characteristics. The "performance data" likely referred to measurements and observations against these engineering standards.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware electrosurgical unit, not a machine learning model. There is no concept of a "training set" for such a device in the context of this submission.

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

Not applicable, as there is no training set for this type of device.

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The PEAK PlasmaBlade® 3.0S Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade. telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids. The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.

The provided text is a 510(k) summary for a medical device (PEAK PlasmaBlade® 3.0S) and largely focuses on regulatory approval based on substantial equivalence to a predicate device. It explicitly states that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

However, the document does not contain the detailed information required to fill out your request, which pertains to a specific study demonstrating the device meets acceptance criteria. This type of information is usually found in a detailed study report, not a 510(k) summary.

Here's a breakdown of what can be inferred or directly stated from the text, and what is missing:

• Acceptance Criteria/Reported Performance: The document states "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications." However, no specific acceptance criteria or quantitative performance metrics are provided. The core argument for approval is substantial equivalence to the predicate device (PEAK PlasmaBlade® 4.0), implying that if the predicate met its criteria, this device would also.
• Study Details: The document mentions "Laboratory and performance tests," but does not describe a specific study with the required details like sample size, data provenance, ground truth establishment, or expert involvement.

Therefore, most of the requested table and information cannot be directly extracted from the provided text.

In summary, based only on the provided text, here's what can be answered and what cannot:

Acceptance Criteria and Device Performance

Detailed Study Information:

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

   • Information Not Provided. The document only generally refers to "Laboratory and performance tests."

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

   • Information Not Provided. The document does not describe the establishment of ground truth for any tests, nor the involvement of experts beyond the company's internal testing.

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

   • Information Not Provided.

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, an MRMC study was not done, and this device is not an AI/imaging device. The device is an electrosurgical cutting and coagulation device.

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

   • Not applicable. This device is a surgical instrument, not an algorithm. Performance tests would be standalone in the sense they evaluate the instrument itself, but not in the context of an AI algorithm.

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

   • Information Not Provided directly. Given the nature of the device (electrosurgical instrument), "ground truth" would likely be defined by engineering specifications, material properties, and functional performance benchmarks (e.g., cutting depth, coagulation effectiveness on tissue proxies, safety parameters like temperature increase). However, the specific methodology is not described.

7. The sample size for the training set:

   • Not applicable/Information Not Provided. As this is not an AI/machine learning device, there isn't a "training set" in the conventional sense. Any internal developmental testing data would precede the performance tests mentioned.

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

   • Not applicable/Information Not Provided. (See point 7)

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The PEAK PlasmaBlade™ TnA Tonsil and Adenoid Tissue Dissection Device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device consists of a handpiece with integrated controls and cable, a shaft with a suction cannula, and two interchangeable tips. The tonsil tip consists of a curved and tapered insulated blade electrode with an opening in the center to allow for the evacuation of smoke and fluids. The adenoid tip consists of a flat, straight insulated blade electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids and smoke. Both tips connect to the suction cannula of the handpiece.

The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for bringing a new device to market.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number of experts and qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The text does mention:

• Performance Data: "Preclinical laboratory and performance tests were executed to ensure the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." However, it does not provide details about these tests, the specific criteria, or the results.
• Study Type: The device's clearance is based on proving substantial equivalence to existing predicate devices (PEAK PlasmaBlade™ Tissue Dissection Device (K073057) and ArthroCare® ENT Plasma Wands™ (K070374)). This typically involves comparing technological characteristics, intended use, and safety/effectiveness profiles rather than a new clinical efficacy or performance study against predefined quantitative acceptance criteria.

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The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

The PEAK Surgery System consists of the PULSAR Generator, PEAK PlasmaBlade Tissue Dissection Devices, and an optional wireless foot pedal. The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices, which are single use, sterile handpieces for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Devices consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.

The provided text describes a 510(k) submission for the PEAK Surgery System, an electrosurgical device. However, it does not contain detailed information about specific acceptance criteria or an explicit study proving the device meets those criteria in a quantitative manner as typically expected for imaging or AI-driven diagnostics.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is similar enough in intended use, technological characteristics, and performance to devices already approved for marketing.

Here’s a breakdown of what can be extracted or inferred based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing specific quantifiable acceptance criteria. For example, there are no reported thresholds for cutting efficiency, coagulation depth, tissue damage profiles, or specific electrical parameters and their tolerance levels that typically would be defined as acceptance criteria in a detailed engineering or performance report. The provided text only states that tests "met design specifications," without detailing those specifications.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "Preclinical laboratory and performance tests," but does not provide details on the number of tests conducted, the type of samples (e.g., in vitro tissue, animal models), or the quantity of each.
• Data Provenance: Not explicitly stated. The tests are described as "Preclinical laboratory and performance tests," implying they were conducted in a lab setting, likely by the manufacturer, PEAK Surgical, Inc. Country of origin for data is not specified, but the company is based in Palo Alto, CA, USA. The study design is not specified as retrospective or prospective.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

Given that this is a 510(k) for an electrosurgical device (not AI, imaging, or diagnostics), the concept of "ground truth" established by human experts in the context of diagnostic accuracy is not directly applicable. The "ground truth" for electrosurgical devices typically relates to objective physical or physiological measurements (e.g., tissue temperature, cut depth, coagulation size, impedance readings) rather than expert interpretation of images or clinical outcomes in the same way.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable/not mentioned. This concept is usually relevant for studies involving human interpretation or subjective assessments.

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

• MRMC Study: Not done, or at least not reported in this summary. MRMC studies are typically for evaluating diagnostic imaging devices or AI algorithms where human readers interpret cases. This device is a surgical tool.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic or interpretative device.

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

• Standalone Performance: Not applicable. This is a physical electrosurgical tool, not an algorithm. Its performance is inherent in its physical operation, not a separate algorithmic component.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated in the context of diagnostic accuracy. For this type of device, ground truth would likely refer to:
  • Engineering Specifications: Device output parameters (e.g., power, voltage, current) meeting pre-defined ranges.
  • Biophysical Effects: Objective measurements of tissue effects (e.g., measured cut depth, coagulation zone, thermal spread, histological analysis) demonstrating performance within acceptable limits or comparable to predicate devices.
  • Functional Performance: Successful operation of mechanical and electrical components (e.g., blade articulation, control responsiveness).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a conventional electrosurgical device, not a machine learning or AI algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary for the PEAK Surgery System states that "Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications" and that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." However, it does not provide the specific details regarding the acceptance criteria, the scope of the tests, the sample sizes, or the qualitative/quantitative results of these tests, which are typically contained in more in-depth sections of a 510(k) submission not included here. This summary focuses on establishing substantial equivalence based on overall performance and functional similarity to already marketed devices rather than detailed performance metrics against explicit acceptance criteria.

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The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.

The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Device, which is a single use, sterile handpiece for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Device consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpiece.

The provided text describes a 510(k) submission for the PULSAR™ Generator and PEAK PlasmaBlade™ Tissue Dissection Device. It states that preclinical laboratory and performance tests were conducted to ensure the device met design specifications and functioned as intended. However, the document does not provide explicit acceptance criteria or a detailed study report with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.) or their corresponding values.

Instead, it relies on a statement of "substantial equivalence" to predicate devices. This means the device's safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device (predicate device) that has already been cleared by the FDA.

Therefore, many of the requested details cannot be extracted directly from this document. Below is a summary of what can be inferred or explicitly stated, with clear indications where information is missing.

Acceptance Criteria and Device Performance

Additional Information

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

   • Sample size: Not specified.
   • Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Preclinical laboratory and performance tests."

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

   • Not applicable/Not specified. This type of test typically refers to a clinical study with expert interpretation of results, which is not detailed here. The tests mentioned are "preclinical laboratory and performance tests," which are likely engineering or bench tests rather than clinical studies requiring expert ground truth for interpretation.

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

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies involving multiple expert readers, which is not described.

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. This document describes an electrosurgical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.

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

   • Yes, implicitly. The "Preclinical laboratory and performance tests" would assess the standalone performance of the device against its design specifications. However, the exact methodology and metrics are not provided. The assessment is focused on the device's physical and electrical function rather than an algorithm's performance.

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

   • Not explicitly stated. For "preclinical laboratory and performance tests" of an electrosurgical device, ground truth would likely refer to objective measurements against established engineering standards, material specifications, and functional requirements (e.g., power output, temperature, tissue cutting/coagulation characteristics observed in lab settings). It would not typically involve expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic device.

7. The sample size for the training set:

   • Not applicable/Not specified. This involves an electrosurgical device, not a machine learning algorithm that requires a "training set."

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

   • Not applicable/Not specified, as this device does not involve a machine learning training set.

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