Search Results

ACENT™ Central Venous Catheter is an intravascular catheter, designed for infusion of fluid to the central venous system and/or for pressure measurements.

• for short-term (less than 30 days) infusion therapy or parenteral nutrition
• for continuous or intermittent monitoring of the central venous pressure,
• for blood sampling.

ACENT™ catheters are polyurethane, radiopaque single, double, or triple lumen catheters. The catheter is available in sizes that vary from 4 French through 8 French and lengths 8 cm through 20 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches via the connector into dedicated extension tubes for infusion of fluids. Each of the extension line has a slide clamp and are labeled to provide identification of the lumen size and location. The catheter body has depth markings, measured in cm from the catheter tips. The extension line marked "distal" is used for device placement with a compatible guide wire. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system.

The ACENT™ Central Venous Catheter is a medical device designed for infusion of fluids to the central venous system, pressure measurements, short-term infusion therapy or parenteral nutrition (less than 30 days), continuous or intermittent monitoring of central venous pressure, and blood sampling.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document describes bench performance testing, biocompatibility testing, sterilization validation, and packaging & shelf life studies. It does not specify a "test set" in the context of clinical data with human subjects or a comparison to expert ground truth.

• For bench performance tests, the document states "sterilized production lot" was used, but the specific number of units tested is not provided.
• For biocompatibility tests, the document lists various tests performed, which would involve in vitro and in vivo (animal) models, but does not specify sample sizes for these tests.
• For sterilization validation and packaging/shelf life studies, standard industrial validation protocols were followed, which involve specific sample sizes per the respective standards. However, the exact sample sizes are not explicitly stated in this summary.

Data Provenance: The studies are described as bench performance, biocompatibility, sterilization, and packaging & shelf life studies, which are laboratory-based and generally not associated with country of origin in the same way as human clinical data. They are not retrospective or prospective clinical studies.

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

This information is not applicable to the provided document. The studies described are technical performance tests, biocompatibility assessments, and sterilization validations, which rely on established scientific and engineering standards and validated methods, rather than expert consensus on clinical diagnoses or interpretations of images/data for a "test set" in the context of AI or advanced diagnostic devices.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no "test set" requiring adjudication by experts in the context of this device's performance data. The studies performed are based on predefined standards and objective measurements.

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. This type of study is typically conducted for diagnostic imaging devices or AI-assisted diagnostic tools to evaluate how a device impacts human reader performance. The ACENT™ Central Venous Catheter is a hardware device for infusion and measurement, not a diagnostic tool requiring human interpretation of output.

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

No, a standalone (algorithm-only) performance study was not done. This type of study is relevant for AI or algorithmic devices. The ACENT™ Central Venous Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the ACENT™ Central Venous Catheter is based on adherence to international and national standards (e.g., ISO, USP, ASTM, AAMI/ANSI) for medical devices. This includes:

• Engineering specifications and standards for physical performance (e.g., strength, flow rates, connection integrity).
• Biological evaluation standards for biocompatibility (e.g., absence of cytotoxicity, irritation, systemic toxicity).
• Sterilization validation standards to ensure a specified sterility assurance level.
• Packaging integrity standards to maintain sterility and function over the shelf life.

This is distinct from clinical "expert consensus," "pathology," or "outcomes data" which would be used for diagnostic devices or clinical trials.

8. The Sample Size for the Training Set:

This information is not applicable. The ACENT™ Central Venous Catheter is a hardware medical device, not an AI or machine learning algorithm, and therefore does not have a "training set."

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

This information is not applicable, as there is no training set for this device.

Ask a specific question about this device