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The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) is intended for measuring of the blood and/or intra-abdominal pressure of the critically ill patients.

The blood pressure sensing is carried out by converting of the hemodynamic waves from a patient's intravasular catheter, through the integrated pressure transducer/sensor, into electrical signals which can be displayed on a monitoring equipment. The intra-abdominal pressure sensing is carried out in the same manner, however by converting of the physiological waves from the patient's inflated bladder.

The device is for single and short term use.

The Art-Line™ Disposable Pressure Transducer (Art-Line™ DPT ) set is a disposable pressure transducer device that interfaces between a catheter and a monitoring equipment by converting changes in pressure into electrical signals. The Art-Line™ DPT (see Table 1.) is offered in different configurations to fit physicians' needs: with one, two or three channel lines. Also it may be offered as a closed system which assist to prevent blood loss and minimize a cross contamination risk. The complete configuration may be pole or patient mounted. The set is sterile and non-pyrogenic.

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

Disclaimer: The provided text is a 510(k) summary for a medical device submitted to the FDA. It details a determination of substantial equivalence, not a standalone clinical study report. Therefore, some information typically found in a detailed study report (e.g., highly granular acceptance criteria, specific effect sizes for human improvement with AI) may not be present or directly applicable.

Acceptance Criteria and Device Performance Study

The Art-Line™ Disposable Pressure Transducer Set (Art-Line™ DPT) aims to measure blood pressure and/or intra-abdominal pressure. The demonstration of its performance relies on functional performance tests and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "functional performance tests" and "biocompatibility tests" performed on the Art-Line™ DPT. However, it does not specify the sample size (e.g., number of devices tested, number of patients, number of data points) for these tests.

The data provenance is implicitly from laboratory/bench testing and potentially in-vitro biocompatibility testing, given the standards cited. There is no mention of human clinical data or patient data (retrospective or prospective) being used to assess the functional performance against the cited standards.

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

This information is not applicable or not provided in the context of this 510(k) summary. The acceptance criteria are based on established international and national standards for medical devices (IEC 60601-2-34, ANSI/AAMI BP22-1994, ISO 10993-1), which define objective performance benchmarks. These standards themselves are developed by expert committees, but the document does not detail individual expert involvement in establishing ground truth for this specific device's test set.

4. Adjudication Method for the Test Set:

This information is not applicable or not provided. Since the performance assessment is against objective standards set for devices (functional and biocompatibility), typical clinical adjudication methods (like 2+1 or 3+1 expert consensus) are not relevant.

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

No MrMC study was mentioned or performed. This device is an extravascular blood pressure transducer, a physical measurement device, not an AI/software-based interpretive tool that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is not an algorithm or AI system. Its performance evaluation is based on its physical properties and ability to accurately convert pressure into electrical signals according to established medical device standards.

7. Type of Ground Truth Used:

The ground truth for assessing performance was based on established industry standards and objective measurements prescribed by:

• IEC 60601-2-34: Specifies performance requirements for invasive blood pressure monitoring equipment.
• ANSI/AAMI BP22-1994: Standard for blood pressure transducers.
• ISO 10993-1: Standard for biological evaluation of medical devices.

These standards define the acceptable range of physical and biological characteristics, which serve as the "ground truth" for evaluating the device's compliance.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware component and does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable for the same reason as in point 8.

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