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The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.

The MX960 reusable pressure transducer is a non-fluid pathway device. A pressure waveform is conveyed through a disposable dome which is coupled to the reusable pressure transducer during pressure monitoring. Both the transducer and dome have mutually exclusive diaphragms. Accordingly, fluid contact is limited to the dome portion of the system. The materials which comprise the MX960 have been aggressively tested per the ANSVAAMI/ISO 10993 "Biological Evaluation of Medical Devices" and the "Tripartite Biocompatibility Guidance for Medical Devices". All materials have successfully met these standards.

The Medex, Inc. MX960 Reusable Pressure Transducer underwent performance testing against the ANSI/AAMI BP22-1994 standard for blood pressure transducers.

Here's a breakdown of the acceptance criteria and the study details:

1. Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample size used for the test set in terms of the number of individual devices or the duration/number of tests performed for each parameter. It indicates that the MX960 was "aggressively tested."
• The data provenance is not specified (e.g., country of origin, retrospective or prospective). It is an in-house performance test against a recognized standard.

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

• This device is a physical transducer, not an AI or diagnostic imaging device that requires expert interpretation for ground truth. The "ground truth" for its performance is established by standardized measurements against the ANSI/AAMI BP22-1994 specifications using calibrated testing equipment. Therefore, no human experts are directly involved in establishing "ground truth" in the way they would be for image analysis or disease diagnosis.

4. Adjudication method for the test set:

• Not applicable, as this is a performance test against objective engineering specifications, not a diagnostic task requiring adjudication.

5. 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:

• Not applicable. This is a performance test for a reusable pressure transducer, not a device involving AI or human interpretation in a diagnostic context.

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

• Not applicable. This is a standalone performance test of a physical medical device. The "algorithm" here is the transducer's internal mechanism, and its performance is measured directly.

7. The type of ground truth used:

• The ground truth is based on the ANSI/AAMI BP22-1994 standard specifications for blood pressure transducers. This standard defines the acceptable ranges and limits for various operational and performance parameters.

8. The sample size for the training set:

• Not applicable. This is a physical device performance test, not a machine learning model that requires a training set.

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

• Not applicable for the reasons mentioned above.

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