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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.

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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 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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