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Biosensors flow-directed Thermodilution catheters are designed for use in critical care patients to measure cardiac output, right atrium, pulmonary artery and pulmonary capillary wedge pressures; continuously monitor pulmonary artery temperature, sample blood, intravenously administer drugs and solution and measure cardiac output via the cardiac output computers which interface with 14 kilo-ohms catheters. Different models are available for use in pediatric and adult patients.

The tips of the catheters are mounted with a latex balloon which when inflated, protects the heart tissues from the product's tips during insertion; utilizes blood flow to direct the catheter tip through the right ventricle into the pulmonary artery.

Blosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of catheter is either of 90 or 110 cm. The extensions include a proximal, a distal, a thermistor and an inflation extension, where the distal end of the inflation extension ends with a tip mounted with a balloon.

Here's a summary of the acceptance criteria and the study details based on the provided text, formatted as requested:

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 specific sample size for the test set of the Thermodilution Catheter models with PU catheter tubing. However, it indicates "performance tests were performed on the Thermodilution Catheter models with PU catheter tubing". The provenance of the data is not specified (e.g., country of origin, retrospective or prospective), but given the applicant is Biosensors International Pte Ltd based in Singapore, the testing would likely have originated from or been managed by them.

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

The document describes performance testing against standards (ISO 10555-1, ISO 10993-1, USP 27 ), not a study requiring expert-established ground truth in the context of diagnostic accuracy. Therefore, information regarding the number and qualifications of experts for ground truth establishment is not applicable to this type of performance assessment.

4. Adjudication Method for the Test Set

Not applicable as it's not a study involving human adjudication of results. The performance was assessed against established technical and biological standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes engineering and biocompatibility testing for a medical device (thermodilution catheter), not a diagnostic algorithm where human readers would improve with AI assistance.

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

Not applicable. This is not an AI-based diagnostic algorithm but a physical medical device. The "standalone" performance refers to the device's inherent functionality and biocompatibility as tested against standards.

7. Type of Ground Truth Used

The "ground truth" for the device's performance was established by recognized international and national standards:

• ISO 10555-1: For functionality and integrity of intravascular catheters.
• ISO 10993-1 Part 1: Evaluation & Testing: For biocompatibility.
• USP 27 Biological Reactivity Tests, In Vivo: For biocompatibility.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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Biosensors Inline Sensor Assembly forms a close loop injectate system for cardiac output measurement. Inline Temperature Sensor and kits (Inline Sensor Assembly) are used in Critical Care and Surgery settings in coniunction with Thermodilution Catheters supplied by various manufacturers, including Biosensors (K911710), for measuring cardiac output of hemodynamically compromised patients by Thermodilution Technique. In this procedure, a known quantity of "room temperature" saline is injected from the Inline Sensor Assembly, and then through an internal catheter lumen to a proximal port of the catheter and into the patient's heart (right atrium). The room temperature saline mixes with the patients' blood as it is pumped by the heart through the right ventricle and into the pulmonary artery.

Biosensors Inline Sensor Assembly is designed for closed injectate delivery system use. It connects to the CVP lumen of a Thermodilution catheter to perform room temperature injections and determine a temperature reading. The inline temperature sensor housing connects to a reusable thermistor cable assembly (the Inline Temperature Assembly) that leads to a Marquette 7000 series Cardiac Output Computer. An inline check valve prevents reflux of fluid and/or blood into the system after injections. The intended use of Biosensors Inline Sensor Assembly is identical to that of Becton Dickinson's SP4572 disposable in-line injectate set.

Biosensors Cardiac Output Kit is a sterile kit of disposables which includes an in-line iniectate sensor housing along with a 10 ml syringe. 3-way stopcock, a dual one-way check valve adaptor housing and a coil of IV tubing with spike and a tubing clamp. The check valve prevents reflux of fluid and/or blood into the system following injection of saline into a Thermodilution Catheter (not a part of this application).

Here's a breakdown of the acceptance criteria and study information for the Biosensors Inline Sensor Assembly and Inline Temperature Sensor, 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 used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The assessment of performance data is described as "BSI's Inline Sensor Assembly was evaluated in accordance with ISO 10555-1. ISO 8536-4 and ANSI/AAMI ES1-1993 ISO10555." This suggests a series of standardized laboratory tests rather than clinical data from human subjects.

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

This information is not provided. The testing appears to be based on adherence to engineering and safety standards (ISO, ANSI/AAMI) rather than expert interpretation of a ground truth dataset, as might be the case for imaging or diagnostic algorithms.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided. Adjudication methods are typically relevant for studies involving subjective human assessment or labeling of data, which is not the nature of the described tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This type of study was not conducted. An MRMC study is relevant for evaluating diagnostic aids, particularly those involving human interpretation of medical images or data assisted by AI. This device is a sensor and disposable kit, not an AI-powered diagnostic tool.

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

The performance evaluation described is essentially a standalone assessment of the device's physical and functional properties, as it's not an algorithm with human-in-the-loop performance. The "algorithm" here is the functionality of the sensor and its ability to accurately measure temperature for a cardiac output computer. The tests evaluated the intrinsic performance of the sensor and assembly against established standards.

7. The Type of Ground Truth Used:

The "ground truth" for the tests appears to be:

• Engineering and Safety Standards: ISO 10555-1, ISO 8536-4, ANSI/AAMI ES1-1993, and ISO 10993.
• Predicate Device Performance: The device's performance was also assessed relative to the Becton Dickinson (B-D) SP4500 sterile In-line injectate system. The "ground truth" for its performance would be the established and acceptable performance characteristics of the predicate device.
• Physical Measurements: For parameters like temperature accuracy and response time, the ground truth would be precise physical measurements from calibrated instruments.

8. The Sample Size for the Training Set:

This information is not applicable and is not provided. This device is a mechanical/electronic medical device components, not a machine learning or AI model that requires 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 type of device.

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