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Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system

The Cath-Cath-Catheter is a disposable/single use, sterile pressure-volume catheter transducer that combines one or two pressure transducers and a series of electrodes mounted at various locations along the distal segment of the catheter body. It terminates in one electrical connection at the proximal end.

The medical device in question is the Millar Instruments Cardia-Cath, a Pressure-Volume (PV) Catheter Transducer. The provided text outlines the acceptance criteria and corresponding study results for this device, primarily focusing on verification testing, biocompatibility, sterility, and accelerated aging, demonstrating its substantial equivalence to a legally marketed predicate device (Millar model SPC-550).

Here's an organized breakdown of the requested information:

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 exact sample sizes for each test set (e.g., number of catheters tested for BP-22, transportation, or accelerated aging, or the number of samples for biocompatibility). It mentions:

• "Selected samples of the modified catheters were tested to the same specification..." for verification testing.
• "Samples" were tested for transportation testing.
• "Samples of the legally marketed device and the modified device were sent to Nelson Laboratories" for biocompatibility.
• The accelerated aging test was performed on "the actual modified device. Cardia-Cath."

Data Provenance: The studies appear to be prospective verification and validation tests conducted by Millar Instruments, DDL (for transportation and accelerated aging), and Nelson Labs (for biocompatibility). The testing was for a modified device (Cardia-Cath) to establish its substantial equivalence to a legally marketed predicate device (Millar model SPC-550). The country of origin of the data is implied to be primarily the United States, given the involved organizations (Millar Instruments in Houston, TX; Nelson Labs; DDL; FDA submission).

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

This type of information is generally not applicable to the non-clinical bench and lab testing described in the document. The "ground truth" here is defined by established international standards (ISO 14971, ISO 10993-1, ISO 11135, ASTM D4169-08, ASTM F1980-07) and internal specifications of the manufacturer, rather than expert consensus on clinical findings.

However, the document states:

• "The final report [for verification testing] has been reviewed and approved by qualified individuals."
• Biocompatibility testing was performed "following GLP requirements" by Nelson Labs, an accredited laboratory.

This indicates that experts with relevant qualifications (e.g., engineers for verification testing, toxicologists/biologists for biocompatibility) would have been involved in the design, execution, and review of these tests. Specific numbers and detailed qualifications are not provided.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient data by multiple human readers. This document describes non-clinical performance testing (bench testing, lab analysis, physical testing) against predefined technical specifications and standards. Therefore, an adjudication method for a test set in the conventional sense is not applicable. The "adjudication" is inherent in the objective measurements and pass/fail criteria of the specified tests.

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

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance and safety testing (bench, lab, and physical tests) of a medical device against established standards and a predicate device. It does not involve human readers interpreting cases, nor does it assess the effect of AI assistance on human reader performance.

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

The device described is a physical catheter transducer, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable here. The performance described is inherent to the physical device itself.

7. The Type of Ground Truth Used

The ground truth for the various tests is defined by:

• Industry Standards: ISO 14971:2007 (Risk Management), ISO 10993-1 (Biocompatibility), ISO 11135 (Sterilization), ASTM D4169-08 (Transportation), ASTM F1980-07 (Accelerated Aging).
• Predicate Device Specifications: The "same specification as the legally marketed device as defined in its IFU" for general performance, and specific values for parameters like Temperature Error Band and Sensitivity Error Band of the predicate device (SPC-550).
• Regulatory Limits: Maximum permissible levels for EO and Ethylene Chlorohydrin residuals per ANSI/AAMI/ISO 10993-7.
• Objective Measurements: Directly measured parameters against these standards and specifications (e.g., pressure readings, percentage errors, biological responses, SAL values).

8. The Sample Size for the Training Set

The concept of a "training set" and "training data" is applicable to machine learning or AI models. Since this document describes a physical medical device and its non-clinical verification and validation testing, there is no training set in the context of AI/ML.

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

As there is no training set for an AI/ML model, this question is not applicable.

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