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The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

The WavelinQ™ EndoAVF System consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter. The venous catheter contains an array of magnets positioned on either side of a radiofrequency (RF) cutting electrode contained within an isolative housing. The arterial catheter contains a matching array of magnets positioned on either side of an electrode "backstop". The backstop serves as a mechanical stop for the cutting electrode to contact following the creation of the AVF. The magnets in the two catheters serve to align and appose the arterial backstop of the arterial catheter with the RF electrode of the venous catheter when positioned in the target AVF location. Radiofrequency energy can then be delivered through the electrode for cutting tissue and AVF creation.

The arterial and venous catheters are both comprised of braid reinforced Pebax catheter shafts. These shafts provide flexibility for device delivery and torquability to aid in rotational alignment and positioning. Both catheters include a soft, radiopaque, rapid exchange style Pebax tip for atraumatic device navigation with radiographic visibility. These tips allow the catheters to track over a standard guide wire 0.014" or smaller. The catheters include a handle/hub to facilitate device delivery, positioning and alignment.

The provided text describes the WavelinQ EndoAVF System and its substantial equivalence to a predicate device (WavelinQ 4F EndoAVF System). However, it does not contain detailed information about specific acceptance criteria for a diagnostic performance study, nor does it describe a study that uses a test set, ground truth, or expert readers/adjudication in the way requested in the prompt.

The document refers to "acceptance criteria" in the context of device design verification and validation, but these appear to be related to engineering, safety, and functionality, rather than a diagnostic performance study comparing device outputs to a ground truth established by experts.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these elements are not present in the provided text.

The closest information related to testing is in the "Performance Data: Non Clinical Performance Data" section, which lists:

• Electrical Safety per IEC 60601
• Electromagnetic Compatibility (EMC) Testing
• Design Validation Cadaver Study
• Magnet Array Force Coaptation Testing
• S-Turn Tortuosity Coaptation and Alignment Comparison Testing

These tests are primarily focused on the physical and functional performance of the device's components and its ability to create the fistula, rather than assessing a diagnostic output against a clinical ground truth.

The document states: "The subject device, WavelinQ™ EndoAVF System, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This is a general statement of compliance but does not provide the specifics requested for a diagnostic performance study.

In summary, the provided text does not contain the information necessary to fulfill the request for acceptance criteria and study details related to diagnostic performance.

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The Ellipsys® System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

The device that is the subject of this 510(k) is a modified Ellipsys Vascular Access System. The Ellipsys System gained market clearance through the 510(k) Premarket Notification pathway (K183615). The specific modification subject to this submission consists of an update to the Instructions for Use to allow an additional procedural step for balloon dilation of the anastomosis junction at the radial artery and adjacent outflow vein of the AVF immediately after creation with the Ellipsys Catheter.

The Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent perforating vein using direct current (DC) thermal heating. No changes have been made to the intended use, technological characteristics, design, function, or manufacturing processes of the Ellipsys Power Controller (AMI-1001), Ellipsys Needle (AMI-3000) or the Ellipsys Catheter (AMI-6005).

The provided text describes a 510(k) premarket notification for a modified medical device, the Ellipsys Vascular Access System. The core of the modification is an update to the Instructions for Use (IFUs) to include an additional procedural step: balloon dilation of the anastomosis junction immediately after AVF creation. The submission aims to prove that this modified device is substantially equivalent to its predicate.

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

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating substantial equivalence to a predicate device, particularly that the modification (balloon dilation) does not raise new questions of safety or effectiveness. The performance data presented focuses on comparing outcomes with the modified procedure to those previously observed with the predicate device (without balloon dilation).

Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • US Study: 55 subjects
  • OUS Study: 200 subjects
  • Total: 255 subjects
• Data Provenance:
  • US Study: United States (retrospective or prospective is not explicitly stated but "prospective, IRB approved registry studies" suggests prospective.)
  • OUS Study: Outside the United States (prospective, IRB approved registry studies)

3. Number of Experts and Qualifications for Ground Truth

The text does not specify the number of experts used to establish ground truth or their qualifications. It mentions that data were collected on case report forms and reported by the "study investigators."

4. Adjudication Method for the Test Set

The text explicitly states: "although the data were not adjudicated or reviewed by independent third parties." This indicates no adjudication by independent parties was performed for the reported outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or any comparison of human readers with vs. without AI assistance. This device is a medical instrument used for creating a vascular access, not an AI-powered diagnostic tool for interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This submission pertains to a physical medical device and a modification to its procedural use, not a standalone algorithm.

7. Type of Ground Truth Used

The ground truth or clinical outcomes for the test set were established through:

• Clinical observation: Reporting of adverse events (AEs) like thrombosis/stenosis, hematomas, deaths, pseudoaneurysm.
• Procedural outcomes: Technical success, clinical success, maturation procedures, maintenance procedures, procedural success for secondary procedures.
• Objective measures: Suitability for dialysis, AVF patency as determined by ultrasound and/or physical examination.

These were collected as part of prospective registry studies.

8. Sample Size for the Training Set

The text does not provide information regarding a "training set." The studies described are clinical performance evaluations of the modified device in use, not algorithm development or training.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an algorithm.

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The WavelinQ 4F EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

The WavelinQ™ 4F EndoAVF System consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter. The venous catheter contains an array of magnets positioned on either side of a radiofrequency (RF) cutting electrode contained within an isolative housing. The arterial catheter contains a matching array of magnets positioned on either side of an electrode "backstop". The backstop serves as a mechanical stop for the cutting electrode to contact following the creation of the AVF. The magnets in the two catheters serve to align and appose the arterial backstop of the arterial catheter with the RF electrode of the venous catheter when positioned in the target AVF location. Radiofrequency energy can then be delivered through the electrode for cutting tissue and AVF creation.

The arterial and venous catheters are both comprised of braid reinforced Pebax catheter shafts. These shafts provide flexibility for device delivery and torquability to aid in rotational alignment and positioning. Both catheters include a soft, radiopaque, rapid exchange style Pebax tip for atraumatic device navigation with radiographic visibility. These tips allow the catheters to track over a standard guide wire 0.014" or smaller. The catheters include a handle/hub to facilitate device delivery, positioning and alignment.

The provided text describes the performance data for the WavelinQ™ 4F EndoAVF System, a medical device for creating arteriovenous fistulas (AVFs) for hemodialysis access. It is not an AI/ML device, so the typical AI/ML acceptance criteria and study information (like sample size for training data, number of experts for ground truth, MRMC study, or standalone performance of an algorithm) are not applicable or detailed in the document.

The document primarily focuses on demonstrating the device's substantial equivalence to a predicate device through clinical performance data, rather than showing how an algorithm meets specific acceptance criteria based on AI/ML metrics.

Therefore, I cannot extract information related to:

• A table of acceptance criteria and reported device performance specific to AI/ML metrics. The document lists clinical endpoints and their outcomes.
• Sample size used for the test set and data provenance in the context of AI/ML validation. The study uses a pooled clinical cohort.
• Number of experts used to establish ground truth or their qualifications for an AI/ML test set.
• Adjudication method for an AI/ML test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone performance of an algorithm.
• Sample size for the training set for an AI/ML algorithm.
• How ground truth for the training set was established for an AI/ML algorithm.

However, I can provide the available information regarding the clinical study and its outcomes as presented in the document:

Clinical Study for WavelinQ™ 4F EndoAVF System

The study was conducted to confirm that the WavelinQ™ 4F EndoAVF System is a substantially equivalent treatment option for patients in need of hemodialysis access.

1. Table of Acceptance Criteria (Clinical Endpoints) and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets in the same way an AI/ML study would define performance thresholds. Instead, it describes "Primary effectiveness endpoints" and "Primary safety endpoints" and reports the observed rates. While not explicitly stated as "acceptance criteria," these are the performance outcomes the device demonstrated.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Ninety-one (91) total subjects were included in the global analysis.
• Data Provenance: Data were collected from three sources: the EASE Study, the EASE-2 Study, and the EU Post-Market Study (4F cohort).
  • Countries of Origin: Paraguay (EASE and EASE-2), Germany, and the United Kingdom (EU Post-Market Study).
  • Type of Study: Clinical studies. The text states "Data from three sources... was collected and analyzed." This implies prospective collection for the original studies but analyzed retrospectively as a pooled global analysis for this submission.

3. Number of Experts and Qualifications for Ground Truth

• The document does not describe details about a "ground truth" establishment by experts in the context of an AI/ML algorithm or image interpretation.
• For clinical outcomes, procedural success was confirmed intraoperatively with fistulography or postoperative duplex ultrasonography. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC). The qualifications of these individuals are not specified beyond their roles.

4. Adjudication Method for the Test Set

• For adverse events, "Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC)." This implies a form of expert review and adjudication for adverse event reporting, but not in the context of establishing a truth standard for an AI algorithm's output.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, this was not an MRMC study and AI assistance was not involved. The study focused on the clinical performance of a medical device (WavelinQ™ 4F EndoAVF System) for creating AVFs, not on evaluating human readers' performance with or without AI assistance.

6. Standalone Performance

• Not applicable for an AI algorithm. This document describes the performance of a physical medical device. The "performance data" presented are the clinical outcomes of using the device in patients, not the performance of a standalone algorithm.

7. Type of Ground Truth Used

• The "ground truth" for the device's performance is based on clinical outcomes observed in patients, confirmed by standard medical procedures (e.g., fistulography, duplex ultrasonography for success, and independent review for safety events). It is not pathology or expert consensus on image interpretation for an AI system.

8. Sample Size for the Training Set

• Not applicable. This document describes a clinical study of a medical device, not the development or training of an AI algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable. This document describes a clinical study of a medical device, not the development or training of an AI algorithm.

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The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0 mm and less than 1.5 mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

The modified Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent vein using direct current (DC) thermal heating. The Ellipsys Power Controller (AMI-1001) is software driven and guides the user through the procedure using visual prompts via an LCD display. The Controller monitors the closure of the catheter tip, and supplies controlled DC energy to the catheter's heating element. The Ellipsys Crossing Needle (AMI-3000) and Ellipsys Catheter (AMI-6005) are sterile single-use disposable devices that are responsible for approximating (bringing together) the arterial and venous vessel walls and applying thermal energy to create an anastomosis and join the two target vessels. Both the crossing needle and catheter are designed to be compatible with .014" guidewires and 6 French introducer sheaths commonly used with vascular interventional procedures. The system is designed to be used in a surgical or radiological suite or office based procedure room.

This FDA 510(k) summary (K183615) describes a modification to the Avenu Medical, Inc. Ellipsys Vascular Access System (Ellipsys System), specifically separating the Ellipsys Crossing Needle and Catheter into individual sterile packages. The core device components (Power Controller, Crossing Needle, and Catheter) themselves, their designs, and intended use remain identical to the predicate device (K181725). Therefore, the acceptance criteria and supporting studies are largely based on the predicate device's performance, as the modification did not necessitate new comprehensive studies for the modified device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is a modification based on individual packaging, the acceptance criteria and performance are essentially the same as the predicate device (K181725) as no changes were made to the core functionality or design of the active components.

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

Direct sample sizes for test sets related to the modified device are not applicable as most performance data was adopted from the predicate device (K181725). The document explicitly states:

• Clinical Performance Testing: "Clinical data is not required in support of the special controls requirement and substantial equivalence since the intended use, technological characteristics, design and function of the Power Controller, Crossing Needle, and Catheter remain unchanged from the predicate." Therefore, no new clinical test set was used for this modification.
• Animal Testing, Non-Clinical Performance Testing, EMC and Electrical Safety Testing, Software Verification and Validation Testing, Biocompatibility, Sterilization Performance, Shelf Life Performance: For all of these, the "test data from the predicate has been adopted." This means the sample sizes and provenance would refer to the studies conducted for the predicate device (K181725), which are not detailed in this document.

The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as it refers back to the predicate submission.

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

This information is not available in the provided document. As the studies for the modified device were largely adopted from the predicate, any expert involvement would have been for the predicate device (K181725).

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

This information is not available in the provided document.

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 is not applicable. The Ellipsys Vascular Access System is a medical device for creating arteriovenous fistulas, not an AI-powered diagnostic imaging device or an AI assistant. Therefore, no MRMC study, human reader improvement with AI, or AI assistance is relevant.

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

This is not applicable for the same reasons as point 5. The device is a surgical tool, not an algorithm, and performance inherently involves a human operator (physician).

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

The document refers to various types of performance data from the predicate, which would likely have involved:

• Clinical Data: (From K181725) Likely included outcomes data (fistula patency, successful creation, adverse events) as ground truth for clinical performance.
• Animal Testing: (From K181725) In vivo observations and potentially pathology of tissues to confirm the device's effects and safety.
• Non-Clinical Performance Testing: (From K181725) Engineering benchmarks, material specifications, and functional tests (e.g., force measurements, thermal profiles) as ground truth.

Specific details for ground truth establishment for the predicate device are not available here.

8. The Sample Size for the Training Set

This is not applicable. The Ellipsys System is a hardware medical device with software control, but it is not an AI/machine learning system that requires a "training set" in the context of typical AI development. Its software undergoes verification and validation, as described, but not "training" in the AI sense.

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

This is not applicable, as there wasn't a "training set" in the AI sense. Software verification and validation (V&V) typically involve testing against predefined requirements and specifications, which serve as the "ground truth" for V&V activities.

Ask a specific question about this device

The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.

The modified Ellipsys System remains a catheter-based system that is used to percutaneously create a vascular anastomosis of the proximal radial artery and adjacent vein using direct current (DC) thermal heating. The Ellipsys Power Controller (AMI-1001) is software driven and guides the user through the procedure using visual prompts via an LCD display. The Controller monitors the closure of the catheter tip, and supplies controlled DC energy to the catheter's heating element. The Ellipsys Catheter and Crossing Needle (AMI-6005) are a sterile single-use disposable devices that are responsible for approximating (bringing together) the arterial and venous vessel walls and applying thermal energy to create an anastomosis and join the two target vessels. The catheter is designed to be compatible with .014" guidewires and 6 French introducer sheaths commonly used with vascular interventional procedures. The system is designed to be used in a surgical or radiological suite or office based procedure room.

The provided text describes a 510(k) premarket notification for the Ellipsys Vascular Access System (K181725). This submission focuses on modifications to an already cleared predicate device (DEN170004). The document indicates that clinical performance testing was not performed in support of this specific submission. Instead, the substantial equivalence determination for this modified device largely relies on non-clinical performance data and the established performance of the predicate device.

Given that no clinical study was performed for this specific 510(k) submission (K181725), most of the requested information (acceptance criteria, device performance, sample size, ground truth, experts, adjudication method, MRMC study, standalone performance, training set) typically associated with a clinical trial to prove device effectiveness is not applicable or not provided in this document for the modified device.

However, the document does mention an animal study that was conducted. Therefore, I will extract information related to that, and acknowledge the absence of clinical data for this specific submission for the modified device.

Here's a breakdown based on the provided text:

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

Since no clinical study was performed for this specific 510(k) submission, explicit quantitative acceptance criteria for clinical performance and reported device performance metrics in humans are not provided in this document. The document primarily focuses on demonstrating substantial equivalence to the predicate device based on non-clinical and animal testing.

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

• Test set sample size: Not explicitly stated as a number in the animal study section. It mentions "An acute animal study was conducted in the sheep model."
• Data provenance: Prospective animal study (sheep model). No country of origin is specified.

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

• Not specified in the document for the animal study.

4. Adjudication method for the test set

• Not specified in the document for the animal study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted based on this document. The device (Ellipsys Vascular Access System) is a medical device for creating arteriovenous fistulas, not an AI-assisted diagnostic tool for human readers.

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

• This question is not applicable as the device is a medical device for creating fistulas, not an algorithm/AI for diagnosis or interpretation. The "Power Controller" has software, but its performance is measured in terms of controlling the thermal energy for fistula creation, not in interpreting data for human users.

7. The type of ground truth used

For the animal study:

• Pathology: Gross pathology and histopathology were used to assess vascular injury and downstream embolization.
• Physiological measurements: Patency and characterization of blood flow were assessed.

8. The sample size for the training set

• Not applicable/not provided for this submission, as no clinical or algorithmic training study for a diagnostic AI product is described. The device manufacturing and control software would have undergone internal development and testing, but this is distinct from training data for an AI model.

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

• Not applicable/not provided for this submission.

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The everlinQ® endoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using the ulnar artery and ulnar vein in patients with minimum artery and yein diameters of 2.0 mm and less than 2.0 mm separation between the artery and vein at the fistula creation site who have chronic kidney disease and need hemodialysis.

The everlinQ® endoAVF System (everlinQ®) consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter, both of which are 6 Fr in diameter. The venous catheter contains an electrode for delivery of radiofrequency (RF) energy while the arterial catheter contains a ceramic backstop that serves as a mechanical stop for the electrode. The everlinQ® is used with a commercially available electrosurgical unit (ESU) and electrosurgical pencil.

The EverlinQ® endoAVF system is a percutaneous catheter system indicated for the creation of an arteriovenous fistula (AVF) in the arm of patients with chronic kidney disease who need hemodialysis. The device's performance was evaluated through a pivotal study (NEAT Study) and a supportive Global Analysis, encompassing data from multiple clinical studies and commercial use.

Acceptance Criteria and Reported Device Performance

The primary effectiveness endpoint for the device was the percentage of patients with fistula maturation/usability at 3 months post-procedure. This was defined as an endoAVF that is free of stenosis or thrombosis, with brachial artery flow of at least 500 ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR the patient was dialyzed using 2 needles. The performance goal for this endpoint was set at 57.5%, derived from historical surgical AVF failure rates.

The primary safety endpoint was the percentage of patients who experienced one or more serious study device-related adverse events during the first 3 months following AVF creation, as adjudicated by an independent Clinical Events Committee (CEC). There was no formal hypothesis test associated with this safety endpoint.

Here's a table summarizing the acceptance criteria and reported device performance from the NEAT Study:

Study Details Proving Device Meets Acceptance Criteria

The primary study used to demonstrate the device meets acceptance criteria was the Novel Endovascular Access Trial (NEAT Study), supplemented by a Global Analysis that pooled data from NEAT, FLEX, EU PMCF, and EASE studies, as well as commercial use data (COMM).

2. Sample Size and Data Provenance

• Test Set (Clinical Studies):
  • NEAT Study (Pivotal): 60 "study cohort" subjects and 20 "roll-in" subjects. The primary effectiveness and safety analyses were performed on the 60 study cohort subjects.
  • Global Analysis (Supportive):
    • Pooled Safety Analysis Population: 125 subjects (from NEAT (N=60), FLEX (N=33), EU-PMCF (N=32)).
    • Pooled Effectiveness Analysis Population: 157 subjects (from NEAT (N=60), FLEX (N=33), EU-PMCF (N=32), EASE (N=32)).
    • COMM (Commercial data set): 79 subjects (not included in pooled safety/effectiveness due to data unavailability).
• Data Provenance: The clinical studies were conducted in multiple countries:
  • NEAT: Canada, Australia, and New Zealand.
  • FLEX: Paraguay.
  • EU PMCF: Germany, England.
  • EASE: Paraguay.
  • COMM: England, Germany, Netherlands, Switzerland.
• Retrospective/Prospective: All mentioned clinical studies (FLEX, NEAT, EU PMCF, EASE) were prospective, single-arm, multi-center studies. The commercial use data (COMM) was collected retrospectively from treating physicians.

3. Number of Experts and Qualifications for Ground Truth (Clinical Test Sets)

• Clinical Events Committee (CEC): An independent CEC adjudicated all safety events (Serious Adverse Events and Significant Events).
• Number of Experts: The CEC consisted of three independent physicians.
• Qualifications of Experts: The physicians comprising the CEC had expertise in vascular surgery, interventional nephrology, and/or interventional radiology. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• CEC Adjudication: The document states that "All procedural safety data and relevant post-procedure events were adjudicated by an independent CEC." The CEC Charter describes the event definitions and the adjudication process. It also mentions that "Each event was classified with respect to: 1. Relationship to the study device, 2. Relationship to the procedure, 3. Relationship to coil embolization, if used, 4. Relationship to a brachial artery closure device, if used, 5. Whether the event was an Unanticipated Adverse Device Effect, 6. Whether the event met the definition of a Significant Event."
• The exact voting mechanism (e.g., 2+1, 3+1) is not explicitly stated beyond stating it was an "independent CEC." However, given the three-expert composition, it is highly likely that a consensus or majority vote mechanism was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was performed. This device is a medical device for creating a fistula, not an AI/imaging diagnostic tool. Therefore, a comparative effectiveness study evaluating human readers' improvement with vs. without AI assistance is not applicable to this submission.

6. Standalone Performance (Algorithm Only)

• Not Applicable. The EverlinQ® system is a physical medical device, not an algorithm or software. The document explicitly states: "The everlinQ® endoAVF System does not contain software." Therefore, standalone algorithm performance was not relevant or assessed.

7. Type of Ground Truth Used (Clinical Test Sets)

The "ground truth" for the clinical effectiveness and safety endpoints was primarily based on:

• Clinical Assessments and Measurements:
  • Duplex Ultrasound: Used for measuring brachial artery flow (ml/min) and vein diameter (mm) for the primary effectiveness endpoint.
  • Direct Observation/Confirmation: Fistulography or duplex ultrasound verification confirmed successful endoAVF creation for procedural success.
  • Clinical Usability: Patient was dialyzed using 2 needles (part of the primary effectiveness endpoint and functional cannulation assessments).
  • Adjudicated Events: Safety events (SAEs, significant events) were adjudicated by the independent CEC based on medical records and definitions.
• Outcome Data: Patency rates (primary, assisted primary, secondary, functional) and CVC exposure were tracked based on clinical outcomes.

8. Sample Size for the Training Set

• Not Applicable/Not Explicitly Defined in this Context. The device is a physical medical device, not an AI/ML model that undergoes "training" on a "training set" in the computational sense. The "training" referred to in the document relates to the training of physicians in the proper use of the device, which occurred after initial study completion and was evaluated in a smaller, subsequent cohort.

9. How Ground Truth for Training Set was Established

• Not Applicable. As noted above, there is no "training set" in the AI/ML sense to establish ground truth for. The "training" in the document refers to physician training on device usage. The impact of this physician training was observed in a small cohort, demonstrating a numerical reduction in SAEs related to brachial artery access. This outcome acted as an observed result rather than a "ground truth" derived for a training dataset.

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The Ellipsys® System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidnev disease requiring dialysis.

The Ellipsys® Vascular Access System is a catheter based system that is used to percutaneously create a vascular anastomosis between adjacent blood vessels using direct current (DC) thermal heating. The system consists of several components:

• Ellipsys Catheter ●
• Ellipsys Crossing Needle
• Ellipsys Power Controller ●

Here's a breakdown of the acceptance criteria and the study proving the Ellipsys Vascular Access System meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The primary clinical study supporting the Ellipsys Vascular Access System was a non-randomized, prospective multi-center study.

• Test Set Sample Size: The Intent-to-Treat (ITT) population, which primarily serves as the test set for the clinical endpoints, consisted of 103 patients.
• Data Provenance: The study was conducted in the United States.

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

The document does not explicitly state that experts established a "ground truth" for the test set in the traditional sense of image interpretation or diagnostic performance. Instead, the clinical study relied on direct measurements and clinical outcomes:

• Maturation definition (effectiveness endpoint): Venous diameter > 4 mm and blood flow > 500 ml/min, measured by duplex ultrasound. This is an objective measurement, not requiring expert consensus for a "ground truth" assessment of the definition itself.
• Safety endpoints: Defined as absence of specific device-related SAEs. These were adjudicated by an independent medical monitor. The qualifications of this monitor are not detailed beyond "independent medical monitor."
• Ultrasound measurements: Performed by clinical staff trained in ultrasound. No specific expert qualifications (e.g., radiologist with X years of experience) are provided for the individuals performing these measurements or interpreting them for the study.

4. Adjudication Method for the Test Set

• Adverse Events (AEs): All adverse events were adjudicated by an independent Medical Monitor. The method (e.g., single review, consensus) beyond "by an independent Medical Monitor" is not specified.
• Study Data: All study data were monitored by an independent study monitor.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The clinical study was designed to compare the device's performance against a historical performance goal for surgical AVF procedures, not against human readers with or without AI assistance in a diagnostic context.

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

This device is not an AI algorithm for diagnostic purposes. It is a medical device for creating a fistula. Therefore, a standalone (algorithm only) performance study as typically understood for AI diagnostics was not applicable or performed. The "standalone" performance here refers to the device itself performing its intended function without human intervention in the fistula creation process (beyond the physician's use of the device), which is addressed by the device success rate (99.0%).

7. The Type of Ground Truth Used

The "ground truth" for the clinical study's endpoints was based on:

• Objective Clinical Measurements:
  • Venous diameter > 4 mm and blood flow > 500 ml/min (for maturation) as measured by duplex ultrasound.
  • Direct observation of various adverse events (e.g., vessel perforation, dissection, electrical shock).
• Clinical Outcomes/Events: Patency, need for intervention (MAPs), ability to support 2-needle cannulation, CVC usage, and patient survival.
• Independent Adjudication: Safety events were adjudicated by an independent medical monitor.

8. The Sample Size for the Training Set

The document describes a clinical study to evaluate the device, not an AI system that requires a separate training set. Thus, there is no "training set" sample size for an AI algorithm in this context. The animal studies and bench testing can be considered analogous to early-stage development and testing, but not a "training set" as defined for AI.

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

As there is no AI training set, this question is not applicable. For the animal studies, the "ground truth" about the fistulae created and safety aspects was established through:

• Direct observation: Acute and post-treatment assessments, gross necropsy.
• Imaging: Ultrasound to determine fistula diameter, patency, and flow.
• Histopathological examination: To evaluate chronic safety and healing response at the fistula and downstream organs.

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