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The Paragon 8F Balloon Guide Catheter is in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Paragon 8F Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.

The Paragon™ 8F Balloon Guide Catheter (BGC) is a multi-lumen, braid-reinforced, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon inflation can be facilitated through the side port of the bifurcated luer hub. The 10 mm long balloon can be inflated up to a maximum volume of 0.6 mL. At this volume, the balloon diameter is 10 mm. The through-lumen extends from the center port of the bifurcated luer hub to the distal tip. The external distal segment of the catheter shaft has hydrophilic coating to reduce friction during use. The coating starts from the proximal balloon bond and extends proximally for 19 cm in length. There are two Paragon 8F BGC configurations which have working lengths of 85 cm. The difference in device length resides in the proximal shaft segment only. The 16 cm distal flexible segment and the balloon are identical for both configurations.

The Paragon 8F Balloon Guide Catheter is compatible with minimum 0.110 inch inner diameter (ID) introducer sheaths, guidewires up to 0.038 inch outer diameter (OD), and 6F catheters up to 0.085 inch OD. The Paragon 8F Balloon Guide Catheter is sterile, non-pyrogenic, and intended for single use only.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Wallaby Medical Paragon 8F Balloon Guide Catheter (K232437). However, it focuses on the physical and biological performance of the catheter, not on an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance) are not applicable to this submission.

Here's a breakdown of the available information based on the provided text, adapted to the context of a physical medical device.

Acceptance Criteria and Device Performance (for a Physical Medical Device)

Since this is for a physical medical device (catheter) and not an AI/ML software, the following sections are either not applicable ("N/A") or cannot be extracted from the provided text, as they pertain specifically to AI/ML software validation.

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

• Sample Size for Test Set: The exact number of samples for each bench test is not explicitly stated in the summary, other than "all samples" met the criteria. For biocompatibility, it refers to standard GLP (Good Laboratory Practice) animal and in vitro studies, which have their own sample size guidelines.
• Data Provenance: N/A. This applies to clinical data for AI/ML. The "data" here is the physical performance and biocompatibility of the device, typically conducted in a laboratory setting.
• Retrospective or Prospective: N/A. (Applies to AI/ML clinical data).

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

• N/A. Ground truth in this context refers to established standards (e.g., ISO, ASTM), specified design requirements, and GLP guidelines for testing. Expert interpretation of images or other data to establish a "truth" is not relevant here.

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

• N/A. This is relevant for AI/ML where multiple human readers interpret data. For physical device testing, results are objective measurements against predefined criteria.

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:

• N/A. This is a physical device, not an AI/ML algorithm.

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

• N/A. This is a physical device, not an AI/ML algorithm.

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

• For bench testing: Pre-defined engineering specifications, industry standards (ISO, ASTM), and design requirements.
• For biocompatibility: Standardized biological evaluation methods and acceptance criteria defined in ISO 10993 series. Animal studies (e.g., guinea pig, rabbit) are the "ground truth" for assessing biological responses.

8. The Sample Size for the Training Set:

• N/A. This applies to AI/ML software. This device does not have a "training set."

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

• N/A. This applies to AI/ML software.

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The Paragon 28 External Ring Fixation System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and closed fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis, infected union, non-union, or malunion of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures
• Bone transport

The Paragon 28 External Ring Fixation System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
• Lisfranc dislocations
• Ankle distraction (arthrodiastasis)
• Septic fusion

The Paragon 28 External Ring Fixation System is a modular, ring-based, external fixation system designed for the treatment and fixation of a variety of conditions in pediatric and adult patients. The Paragon 28 External Ring Fixation System utilizes wires, pins, struts, rods, bolts, fasteners, clamps, and plates that connect to rings statically placed or gradually manipulated in order to fixate or correct the bone. The modular design of the system allows for a customized treatment for the patient.

Components of the Paragon 28 External Ring Fixation System may be used in conjunction with all Paragon 28 legally marketed devices.

The components of the device are offered in a variety of sizes, which allow for a truly customized external fixation device.

This document is a 510(k) Summary for the Paragon 28 External Ring Fixation System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study or for evaluating AI performance. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in the provided text.

The document focuses on:

• Indications for Use: Listing the medical conditions the device is intended to treat.
• Device Description: Describing the components and modular nature of the system.
• Predicate Devices: Identifying legally marketed devices to which the Paragon 28 system claims substantial equivalence.
• Performance Testing Summary: Stating that non-clinical testing was performed according to ASTM F1541, which is a standard for external fixation devices. This is mechanical performance testing, not clinical performance for diagnostic accuracy or effectiveness with human intervention.
• Comparison of Technological Characteristics: Arguing that the subject device shares material, design, and operating principles with the predicate devices.
• Conclusion: Stating that the device is substantially equivalent based on the provided information.

In summary, the provided FDA 510(k) clearance letter and summary are for a traditional medical device (an external ring fixation system) and do not contain information related to AI or a study designed to evaluate its clinical performance against specific acceptance criteria as you've outlined.

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The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.

The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) with Tubing Pack is a hollow fiber membrane oxygenator with an integrated heat exchanger pre-connected to blood line and gas line tubing. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the requlation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces.

The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.

The Tubing Pack is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.

The document provided is a 510(k) summary for a medical device (Paragon Adult Maxi PMP Oxygenator with Tubing Pack) and does not contain information about an AI/ML powered device or study that determines acceptance criteria based on AI/ML performance.

The provided text details the regulatory review of a conventional medical device (oxygenator and tubing pack) and focuses on its substantial equivalence to predicate devices, in vitro and non-clinical test results. There is no mention of acceptance criteria related to a study proving an AI/ML device meets them. Therefore, I cannot extract the requested information from the provided document.

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The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.

The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.

The provided FDA 510(k) summary for the Paragon 28 APEX 3D Total Ankle Replacement System does not contain information related to AI/ML device performance or clinical studies using AI/ML. The document describes a traditional medical device (an ankle replacement system) and focuses on its mechanical performance testing and substantial equivalence to predicate devices based on physical properties, materials, and design.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements are specific to the evaluation of AI/ML-driven medical devices, not the type of device described in this document.

The document details:

• Device Type: Total Ankle Replacement System (mechanical implant).
• Performance Testing: Focuses on mechanical characteristics like range of motion, contact stress, fatigue strength, polyethylene wear, etc.
• Substantial Equivalence: Based on intended use, indications, design, materials, and size range compared to predicate mechanical devices.

Thus, all specific questions regarding AI/ML device evaluation (e.g., test set, ground truth, experts, MRMC, standalone performance, training set) are not applicable to the content provided.

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The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours.

The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.

The provided text describes information for a K191246 submission regarding a Cardiopulmonary Bypass Oxygenator, not an AI/ML medical device. Therefore, it does not contain the specific details requested for an AI/ML device, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), nor does it describe studies involving human readers, training/test sets, or ground truth established by experts.

The document focuses on the Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP), a physical medical device. The "acceptance criteria" and "study that proves the device meets acceptance criteria" are discussed in terms of the device's physical and functional performance, rather than AI model performance.

However, I can extract and present the physical device's performance evaluation in a table format as requested, interpreting "acceptance criteria" in the context of this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a physical medical device (Cardiopulmonary Bypass Oxygenator) and not an AI/ML-driven diagnostic or assistive technology, the following requested details are not applicable to the provided document:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical testing of the device, not a data set for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is established by experts, but for a physical device, performance is measured against engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to expert review for AI ground truth.
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 for AI-assisted human reading studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as this is not an AI/ML device. The "ground truth" for this device's performance is based on established engineering and biological standards (e.g., ISO standards, FDA guidance).
8. The sample size for the training set: Not applicable. This is only relevant for AI/ML models.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the testing and performance evaluation of a traditional medical device against established industry standards and a predicate device, rather than the performance of an AI/ML algorithm.

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The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.

The Paragon XHD Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Paragon XHD Diagnostic Ultrasound System consists of the main unit, an ultrasound probe, power adapter, connecting cable.

The provided document is a 510(k) summary for the Shenzhen Wisonic Medical Technology Co., Ltd. Paragon XHD Diagnostic Ultrasound System. This document outlines the device's characteristics and its substantial equivalence to predicate devices, focusing on safety and performance.

However, the document does NOT contain information about acceptance criteria and the study that proves the device meets the acceptance criteria from an AI/algorithm performance perspective. Instead, it discusses the device's compliance with electrical safety, EMC, biocompatibility, and general performance standards for an ultrasound system.

Therefore, I cannot extract the requested information regarding AI/algorithm performance acceptance criteria, test set details, expert consensus, MRMC studies, or standalone algorithm performance, as these are not discussed in the provided text.

The information given pertains to the ultrasound system itself, not an AI component within it. The closest approximation to "performance testing" in the document describes evaluating "clinic measurement accuracy and system sensitivity," which are general ultrasound system performance metrics, not related to an AI algorithm that would have specific acceptance criteria like sensitivity, specificity, or AUC.

Without further information describing an AI component and its validation, I cannot fulfill your request in full detail. If there was an AI component, the provided document does not elaborate on its specific validation.

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The SherpaPak™ Pancreas Transport System is intended to be used for the static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

Not Found

This looks like a 510(k) clearance letter for the Paragonix SherpaPak Pancreas Transport System. As such, the information you've requested about acceptance criteria and study details (like sample size, number of experts, ground truth, etc.) is typically not found directly within the clearance letter itself.

A 510(k) clearance is about demonstrating substantial equivalence to a predicate device, not necessarily extensive clinical performance studies like those required for a PMA (Premarket Approval). The FDA reviews the provided data (which might include bench testing, engineering reports, and sometimes limited clinical data or literature reviews) to determine if the new device is as safe and effective as a legally marketed predicate device.

Therefore, based solely on the provided text, I cannot extract the specific details you've asked for. The document primarily outlines the FDA's regulatory decision and standard disclaimers.

However, I can tell you the stated "Indications for Use" which implicitly sets the performance envelope for the device:

• Intended Use: Static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ.
• Performance Claim: The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

To get the detailed information you're looking for (acceptance criteria, study design, sample sizes, ground truth establishment, etc.), you would typically need to refer to:

• The original 510(k) submission document: This is a comprehensive package submitted by the manufacturer to the FDA. It contains all the bench testing, performance data, and other information used to support the substantial equivalence claim. This is usually not publicly available in full detail.
• Any associated clinical trial publications: If the manufacturer performed any studies (even limited ones for 510(k), or more extensive ones for other regulatory purposes or marketing), they might be published in scientific journals.
• The manufacturer's official documentation: User manuals, technical specifications, and marketing materials might provide some of this performance data.

In summary, the provided FDA letter does not contain the detailed study information you're seeking. It confirms the clearance of the device and its intended use and a key performance parameter (temperature range and duration).

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The SherpaPak Cardiac Transport System is intended to be used for the station of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the SherpaPak Cardiac Transport System. It indicates that the device has been found substantially equivalent to predicate devices for its intended use. However, the document does not contain any information about acceptance criteria for device performance, nor does it describe any study demonstrating that the device meets such criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided input. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance metrics or clinical trial results.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (which may be part of a 510(k) submission but is not included in this clearance letter), a clinical study report, or a descriptive document of the device's validation.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.

This document describes a 510(k) premarket notification for the Paragon 2, a mobile x-ray system, and states that no clinical study was required for its clearance. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed in the typical manner of a clinical trial.

Instead, the submission relies on bench and laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. The key aspects of the device's performance are evaluated against established safety and performance standards for x-ray equipment.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical clinical acceptance criteria are defined in this document (due to the nature of the 510(k) submission for substantial equivalence based on bench testing), the "acceptance criteria" are implied by compliance with safety and performance standards, and the "reported device performance" is its demonstrated adherence to these standards and equivalence to predicate devices.

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The ArthroCare ArthroWands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures:

The ArthroCare ArthroWands are bipolar, single use, sterile, high frequency electrosurgical devices designed for specific indications in arthroscopic and orthopedic procedures.

The Paragon T2 Wand with Integrated Cable is a part of the family of ArthroCare ArthroWands and is specifically indicated for resection, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures of the knee.

Consistent with the predicate device, the Paragon T2 Wand with Integrated Cable is compatible with the System 2000, Quantum, Quantum 2, or Atlas System Controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. The Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired.

The wand consists of an active electrode, temperature indicator epoxy, a return electrode, a spacer, insulation, a connector block, a bent bead blasted shaft, nylon tubing, and a handle that connects via an integrated cable to the controller. The cable consists of wires that communicate with the active and return electrodes as well as the controller.

The Paragon T2 Wand with Integrated Cable is a Coblation wand designed to effectively ablate articular cartilage with minimal thermal effect on surrounding tissue. This Wand incorporates a Temperature Indicating Marker (TIM) as a visual indicator to the user that the temperature around the tip has reached 43°C-57°C degrees.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in relation to a diagnostic or AI-driven medical device.

The document is a 510(k) premarket notification for the ArthroCare Corporation's Paragon T2 Wand with Integrated Cable. This device is an electrosurgical cutting and coagulation device, not a diagnostic imaging or AI product.

The relevant sections discuss:

• Performance Data: States that "Performance bench testing, including functional testing, ablation life, and biocompatibility testing were performed on the proposed Paragon T2 Wand with Integrated Cable, which demonstrated the modified temperature sensitive dye met the required specifications."
• Verification Testing: Lists various electrical and mechanical tests performed, such as "Visual Inspection," "TIM Color Change," "Ablation 1X/2X/3X Life Testing," "Coagulation Testing," and "Dielectric Withstand / HiPot Testing." The reported result is that "Both the Paragon T2 Wand with Integrated Cable and predicate device have substantially equivalent testing specifications and both performed within acceptance criteria. These results support that the Paragon T2 Wand with Integrated Cable and predicate device are substantially equivalent."
• Biocompatibility Testing: Confirms that "all testing demonstrates that the Paragon T2 Wand with Integrated Cable performs as intended and has acceptable mechanical properties when used in accordance with its labeling."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them in the context of AI or diagnostic performance, as this document pertains to a surgical instrument's mechanical and electrical performance.

However, based on the provided text, I can infer a general structure for how such criteria and studies are presented for this specific electrosurgical device:

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

The remaining points (2-9) are not applicable or cannot be answered from the provided text, as they relate to AI/diagnostic studies, which this document does not cover. Specifically:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices undergoing bench testing, not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for electrosurgical device performance is established through engineering and material science standards, not expert consensus on medical images or patient outcomes.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not relevant for this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For this device, the "ground truth" is defined by engineering specifications, material properties, and functional performance standards (e.g., specific thresholds for electrical safety, validated ablation capabilities, and biocompatibility standards).
8. The sample size for the training set: Not applicable. There is no AI model or "training set."
9. How the ground truth for the training set was established: Not applicable.

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