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FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.

FUSION™ Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knitted polyester textile. These two layers are bonded together. The FUSION™ Bioline Vascular Grafts have a heparin/albumin coating on the interior surface of the graft.

Here's an analysis of the acceptance criteria and the studies that support the FUSION™ and FUSION™ Bioline Vascular Grafts, based on the provided text:

Device: FUSION™ and FUSION™ Bioline Vascular Grafts

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device (EXXCEL™ Soft ePTFE Vascular Grafts), with specific performance targets derived from clinical and bench testing.

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

• Randomized Multicenter Trial (FUSION Bioline vs. EXXCEL):
  • Sample Size: 207 subjects randomized 1:1 (105 FUSION Bioline, 101 EXXCEL).
  • Data Provenance: Retrospective analysis of prospective data. Country of origin: 18 US centers and 7 European centers.
• European Postmarketing Trial (FUSION Graft):
  • Sample Size: 117 subjects enrolled. Preliminary 12-month results reported for 92 subjects.
  • Data Provenance: Retrospective analysis of prospective data. Country of origin: 10 European study centers.

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

This information is not provided in the document. The studies are clinical trials, and ground truth (e.g., patency, MALE) would typically be established by the treating physicians and clinical investigators overseeing the subjects. The document does not specify the number or qualifications of these individuals beyond them being involved in the respective trial centers.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the document. For clinical endpoints like patency and MALE, adjudication often involves an independent clinical events committee (CEC), but the document does not detail if or how such adjudication was performed. The p-values suggest statistical analysis of collected data.

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

No, an MRMC comparative effectiveness study was not done. The studies described are clinical trials comparing the device to a predicate (or historical data for the FUSION-alone trial) in human subjects, not a study assessing human reader performance.

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 physical vascular graft, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Clinical Trials (both FUSION Bioline vs. EXXCEL and FUSION Graft European Trial):
  • Patency: Assessed by vascular imaging and ABI (Ankle-Brachial Index). This represents clinical outcome data determined through objective measurements and clinical judgment.
  • Major Adverse Limb Events (MALE): Composite endpoint including major reintervention rates, major amputation rates, and periprocedural deaths. This is based on clinical outcome data/patient outcomes.
  • Suture-hole bleeding times: Measured clinically. This is clinical outcome data.
• Animal Studies:
  • Vascular compatibility, tissue response, patency: Assessed through in vivo observation, potentially histology, and imaging. This represents animal model outcomes/pathology.
• Bench Testing:
  • Physical properties: Measured against defined engineering specifications. This is based on laboratory testing results.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical vascular graft and does not involve AI or machine learning models that require a training set.

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

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

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The HeRO vascular access device is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO vascular access device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the K/DOQI guidelines as patients who:

• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography.
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. K/DOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO device is a non-autogenous (i.e., synthetic) vascular access composed of four components: a catheter component, a pre-connected graft assembly, a crimp ring, and a sleeve. The catheter component is made of radiopaque silicone and contains reinforcing filaments that impart kink and crush resistance. The catheter is provided in two different lengths (referred to as left side and right side) to accommodate anatomical variations. During surgery, the catheter length is sized to fit the patient by peeling back the nylon filament and cutting the catheter. The pre-connected graft assembly is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The titanium crimp ring is used during surgery to secure the catheter to the graft assembly. The silicone sleeve is placed during surgery to impart kink resistance of the catheter at the connector and to cover the metal crimp ring in silicone.

Additionally, a reusable stainless steel crimp tool is provided to compress the crimp ring for securing the catheter component to the graft assembly during surgery. The crimp tool is provided non-sterile and is steam sterilized before each use.

The provided text describes the HeRO Vascular Access Device and its regulatory submission (K071778) to the FDA. It includes summaries of non-clinical (bench) and clinical performance data.

Here's the breakdown of the acceptance criteria and study information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text generally states that the device "met its acceptance criteria" for non-clinical tests and demonstrated comparable or better performance in clinical evaluation. However, specific numerical acceptance criteria for each test are not explicitly detailed in the given text. Instead, it offers a summary of the types of tests conducted and the overall outcome of meeting these criteria. For clinical performance, it compares the device's outcomes to established literature for catheters and grafts.

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

• Sample Size for Test Set:
  • 36 catheter-dependent subjects (catheter arm)
  • 50 graft subjects (graft arm)
  • Total: 86 patients
• Data Provenance: The text does not explicitly state the country of origin. It indicates it was a clinical evaluation, implying a prospective collection of data from enrolled patients.

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

The text refers to a "clinical evaluation" and "clinical performance data," and comparisons to "catheter and graft literature." It does not mention the use of a panel of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies (e.g., for image interpretation). Instead, the clinical outcomes (e.g., adverse events, bacteremia rates, patency, flow rates, dialysis adequacy) are likely direct measurements from patient follow-up, and their "truth" is established by the clinical observation and measurement process itself, then compared against established medical literature benchmarks.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method for the clinical test set outcomes. Clinical outcomes would typically be recorded based on standard medical practice and potentially reviewed by an independent clinical events committee for a larger trial, but such details are not provided here. No mention of 2+1, 3+1, or similar adjudication for establishing ground truth is made, which is consistent with a clinical outcomes study rather than a diagnostic accuracy study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a clinical evaluation of the device's safety and performance with human patients, not a study involving multiple human readers interpreting cases with and without AI assistance to measure an effect size of AI.

6. Standalone Performance Done

Yes, a standalone performance evaluation was done. The "Summary of Non-Clinical Performance Data" details in vitro performance testing and biocompatibility evaluations that were conducted on the HeRO device itself to ensure it met its engineering and safety specifications. This represents a standalone evaluation of the device's physical and functional properties. The "Summary of Clinical Performance Data" also describes the standalone clinical performance of the device in human patients, measuring outcomes directly related to the device's use.

7. Type of Ground Truth Used

For the non-clinical (bench) tests, the "ground truth" was based on engineering specifications and ISO standards for material properties and device performance. The device's ability to meet these predefined quantitative criteria served as the ground truth.

For the clinical study, the "ground truth" for evaluating safety and performance was based on observed clinical outcomes and physiological measurements from patients (e.g., actual rates of serious adverse events, measured bacteremia rates, observed patency, measured device flow rates, calculated Kt/V for dialysis adequacy). These outcomes were then compared against performance benchmarks established in published medical literature for similar vascular access methods (catheters and grafts).

8. Sample Size for the Training Set

The text does not mention a training set or how it was established. This device is a physical medical device, not an AI/ML algorithm that requires a training set of data. The "study" refers to a clinical trial/evaluation of its safety and performance in human patients, and a series of bench tests.

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

As no training set is mentioned or applicable for this type of physical medical device submission, this question is not relevant to the provided information.

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