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Accutrans Disposable Pressure Transducer Kit provides the fluid pathway components that are intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, into electrical signals which can be displayed using separate monitoring equipment. The whole kit is fully disposable and consists of pressure monitoring lines and the Accutrans Disposable Pressure Transducer.

Accutrans Disposable Pressure Transducer: The disposable pressure transducer is provided with or without an integral 3cc/hr or 30cc/hr flush devices. Kits with Succhi flush devices are designed exclusively for use with a infusion pump for neonatal and infant applications. The disposable pressure transducer, with the integrated pressure sensor, is intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream. Accutrans Disposable Pressure Transducer Kits are available for modular assembly of an IV pole-mount transducer organizer system, or for portable on-patient mounting.

AccuTrans Pressure Monitoring Kits and AccuTrans Disposable Transducer are indirectly in contact with the blood path and hence, are supplied sterile and is intended for single use only. Pole-mounts, backplates and transducer adapter cables are accessories that are to be used externally outside the human body, and hence supplied non-sterile but hygienically clean. Between surgical cases of patient, suitable cleaning instructions should be followed to minimize cross contamination between patient and health worker.

Biosensors's Accutrans Disposable Pressure Transducer System consists of a pressure monitoring kit with pressure tubing connected to the single-use disposable transducer with an integrated pressure sensor. The transducer can come with or without an integral flush device. The complete configuration can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.

Here are the acceptance criteria and the study details for the Accutrans Disposable Pressure Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of devices) used for the functional performance and biocompatibility tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The tests seem to be performed against established technical standards (IEC, ANSI/AAMI, ISO, USP) rather than by human expert consensus or adjudication.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the evaluation relies on meeting established technical standards.

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

No MRMC comparative effectiveness study was mentioned. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical performance and biocompatibility testing. There is no information about human readers or AI assistance.

6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable as the device is a physical medical device (pressure transducer system), not an AI algorithm. Its performance is intrinsic to the device itself.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was in the form of established performance standards (IEC 60601-1-34, ANSI/AAMI BP22-1994) for functional performance and biocompatibility standards (ISO10993-1 Part 1, USP 27 ) for safety.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the same reason as point 8.

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