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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.

Biosensors flow-directed Thermodilution catheter is fabricated from extruded tubing, connected to a hub carrying 4 or 5 lumens. The total length of cather 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 an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The provided document describes a Thermodilution Catheter and Accessories that has been modified to include models with a synthetic latex balloon instead of a natural latex balloon. The assessment is to demonstrate substantial equivalence to previously licensed devices (K083384).

The acceptance criteria are not explicitly detailed with numerical thresholds for performance metrics. Instead, the document states that "Functionality performance tests were performed on the synthetic latex balloon mounted on the Thermodilution catheter to evaluate the performance and integrity of the synthetic latex balloon. Based on the test results which are of the accepted criteria, the synthetic latex balloon is concluded to be safe and effective for its intended use." Similarly for biocompatibility, it states it "was proven that the Thermodilution catheter, with synthetic latex balloon, is biocompatible and safe for its intended use."

The document focuses on demonstrating that the new synthetic latex balloon material does not negatively impact the performance characteristics or safety of the device, maintaining equivalence to the predicate device.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details:

The document describes pre-clinical testing (in-vitro functionality and biocompatibility) rather than a clinical study involving human patients or a complex algorithm performance study.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document refers to "functionality performance tests" and "biocompatibility tests" being conducted on the "synthetic latex balloon mounted on the Thermodilution catheter." This implies a set of physical samples of the device and its synthetic latex balloon.
   • Data Provenance: The tests are described as "In-vitro," meaning they were conducted in a laboratory setting, not from human patients. The applicant company, Biosensors International Pte Ltd, is based in Singapore, so the testing likely occurred there or at a contract lab. Whether the data is retrospective or prospective is not applicable in the context of in-vitro bench testing; it would be prospective for the purpose of this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not applicable or not specified. For in-vitro functionality tests, the "ground truth" is typically objective measurements (e.g., pressure, volume, tensile strength, resistance to leakage), not expert consensus. For biocompatibility, the "ground truth" is determined by established assay protocols and test results interpreted by qualified toxicologists/biologists according to standard guidelines (ISO 10993-1 and USP 27 ), not a panel of clinical experts adjudicating individual cases.
   • Qualifications of Experts: Not specified for performance testing. Biocompatibility testing would be performed by personnel qualified in toxicology and biological evaluations.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. This is not a study requiring human adjudication of results in the traditional sense (e.g., 2+1, 3+1 for imaging studies). The assessment relies on objective measurements against defined standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter) and does not involve AI or human "readers" interpreting output. The study demonstrates the physical and biological performance of the device itself.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: The ground truth for functionality testing is based on objective physical and mechanical measurements (e.g., luer taper fit, catheter dimensions, balloon inflation/deflation characteristics) against pre-defined engineering and performance specifications. The ground truth for biocompatibility is established through standardized biological assays (e.g., cytotoxicity, irritation, sensitization) that yield quantifiable results, interpreted according to global standards (ISO 10993-1, USP 27 ). There is no "expert consensus," "pathology," or "outcomes data" used to establish ground truth for this type of pre-clinical submission.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in this context. The study evaluates the physical device itself.

8. How the ground truth for the training set was established:

   • Training Set Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

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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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The Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.

Not Found

I am sorry, but based on the provided document, there is no information about acceptance criteria for a device, a study proving it meets acceptance criteria, or any details related to AI, machine learning, or algorithms.

The document is a US FDA 510(k) clearance letter for the "Pulsion Pulsiocath Thermodilution Catheters and Accessories". It primarily focuses on:

• Device Name: Pulsion Pulsiocath Thermodilution Catheters and Accessories
• Regulation Number & Name: 21 CFR 870.1915, Thermodilution Probe
• Regulatory Class: Class II
• Product Code: KRB
• Date of Clearance: September 19, 2007
• Purpose: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use: For use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by thermodilution method, arterial blood pressure, and cardiac output determination by arterial pulse contour analysis. Indicated for patients requiring cardiovascular and circulatory volume status monitoring.

Therefore, I cannot provide the requested information because it is not present in the given text.

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The Balloon Thermodilution catheter is indicated for use in measuring cardiac output by the thermodilution method. In addition, this balloon thermodilution catheter can be used to measure right atrial pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary capillary wedge pressure.

Harmac Thermodilution Catheter

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Harmac Medical Products, Inc. for their Thermodilution Catheter. This document is primarily an administrative letter confirming substantial equivalence and outlining regulatory compliance.

It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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