(128 days)
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.
| Endpoint (Clinical Outcome) | Definition | Reported Device Performance (6 months) |
|---|---|---|
| Effectiveness Endpoints | ||
| Procedural Success | Successful creation of an endoAVF with blood flow confirmed intraoperatively with fistulography or postoperative duplex ultrasonography. | 96.7% (88/91) of the Pooled Population |
| Time to Cannulation Success | Success defined as 2-needle access and hemodialysis through the endoAVF. | Achieved in 74.2% ± 7.4% of all subjects. |
| Achieved in 86.0% ± 6.3% of subjects in the Dialysis Subset. | ||
| Median time to successful cannulation: 1.3 months. | ||
| Primary Patency | Defined according to Society of Vascular Surgery (SVS) reporting standards. | 82.3% at 6 months (K-M point estimate). |
| Assisted Primary Patency | Defined according to Society of Vascular Surgery (SVS) reporting standards. | 86.6% ± 4.5% (K-M estimate and SE) through 210 days. |
| Secondary Patency | Defined according to Society of Vascular Surgery (SVS) reporting standards. | 86.6% ± 4.5% (K-M estimate and SE) through 210 days. |
| Modified Primary Patency | Identical to Primary Patency except loss triggered by reinterventions not directly related to the access circuit (e.g., coiling or vessel ligation of venous outflow tributaries to encourage flow into superficial veins). Excludes interventions during the index procedure. | 81.0% ± 5.0% at 6 months in the Pooled Population. |
| Functional Cannulation | K-M estimates where time 0 was the date of the index procedure. | All subjects: 66.1% at 6 months. |
| Dialysis Subset: 77.2% ± 7.8% at 6 months. | ||
| Median Time to Functional Cannulation: 1.6 months. | ||
| Safety Endpoints | ||
| Significant Events | Not explicitly defined, but examples include access circuit stenosis, occlusions, thromboses, abandonment of endoAVF after cannulation-induced brachial artery injury. | 11.0% (10/91) of 4 Fr endoAVF subjects experienced a Significant Event (11 events in 10 subjects). |
| Device-related Serious Adverse Events (SAEs) | SAEs explicitly identified as related to the device. | None reported. |
| Procedure-related SAEs | SAEs explicitly identified as related to the procedure. | 3.3% (3/91) of the Pooled Population (3 SAEs). |
| Closure device-related SAEs | SAEs explicitly identified as related to closure devices. | None reported. |
| Coil-related SAEs | SAEs explicitly identified as related to coil embolizations. | None reported. |
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.
§ 870.1252 Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access.
(a)
Identification. This device is a single use percutaneous catheter system that creates an arteriovenous fistula in the arm of patients with chronic kidney disease who need hemodialysis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate:
(i) The ability to safely deliver, deploy, and remove the device;
(ii) The ability of the device to create an arteriovenous fistula;
(iii) The ability of the arteriovenous fistula to attain a blood flow rate and diameter suitable for hemodialysis;
(iv) The ability of the fistula to be used for vascular access for hemodialysis;
(v) The patency of the fistula; and
(vi) The rates and types of all adverse events.
(2) Animal testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:
(i) Delivery, deployment, and retrieval of the device;
(ii) Compatibility with other devices labeled for use with the device;
(iii) Patency of the fistula;
(iv) Characterization of blood flow at the time of the fistula creation procedure and at chronic followup; and
(v) Gross pathology and histopathology assessing vascular injury and downstream embolization.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated-use testing in a clinically relevant bench anatomic model to assess the delivery, deployment, activation, and retrieval of the device;
(ii) Tensile strengths of joints and components;
(iii) Accurate positioning and alignment of the device to achieve fistula creation; and
(iv) Characterization and verification of all dimensions.
(4) Electrical performance, electrical safety, and electromagnetic compatibility (EMC) testing must be performed for devices with electrical components.
(5) Software verification, validation, and hazard analysis must be performed for devices that use software.
(6) All patient-contacting components of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(8) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(9) Labeling for the device must include:
(i) Instructions for use;
(ii) Identification of system components and compatible devices;
(iii) Expertise needed for the safe use of the device;
(iv) A detailed summary of the clinical testing conducted and the patient population studied; and
(v) A shelf life and storage conditions.