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The Merit Manifold with Integrated Transducer is used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices. The device is also used for measurement of blood pressure.

The Merit Manifold with Integrated Transducer (referred to as M-7 in this submission) is a disposable pressure transducer bonded to a 3-port manifold. The Merit M-T device is a sterile, precalibrated, single-use device used for both a means of interconnecting tubing, catheters, or other devices, and for physiological pressure measurement. A separate reusable interface cable is used with this system to transmit the signal from the transducer to a pressure monitor. The M-T device combines two stand-alone Merit products into a single device, for ease of use and reduction of set-up time.

Here's a breakdown of the acceptance criteria and study information 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 provided text does not specify the sample sizes used for the test set in any of the verification and validation studies. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. It only states "in-house protocols" were used.

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

The provided text does not mention the use of experts to establish ground truth for any of the performance tests. The studies involved non-clinical performance testing of mechanical and material properties, rather than diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method, as the performance testing was non-clinical and did not involve human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. The device is a physical medical device (fluid manifold with integrated transducer) for physiological pressure measurement, not an AI or diagnostic imaging device that typically undergoes MRMC studies to assess human reader improvement with AI assistance.

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

No, a standalone (algorithm only) performance study was not applicable or conducted. This device is a physical instrument, not a software algorithm. The "standalone" performance here refers to the device's own functional and safety performance, which was evaluated through the non-clinical tests listed.

7. The Type of Ground Truth Used

For the non-clinical performance testing (biocompatibility, sterilization, transducer performance, device function, bond verification), the "ground truth" was established by objective measurements against recognized industry standards and internal protocols. For example, for biocompatibility, it's compliance with ISO 10993; for transducer performance, it's compliance with ANSI/AAMI BP 22.

8. The Sample Size for the Training Set

The provided text does not mention or imply the use of a "training set." This is because the device is a physical medical device, not a machine learning model that requires a training set.

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

As no training set was used, this question is not applicable.

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