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The Advanced NIBP Module is designed for use with the DINAMAP MPS Select Family of Monitors, including the DINAMAP MPS Select Portable Monitor and the DINAMAP MPS Select Multiparameter System. The Advanced NIBP Module is intended to obtain a single patient's systolic, diastolic and mean arterial blood pressures and pulse rate in the same intended use environment as the DINAMAP MPS Select Family of Monitors: hospital, outpatient surgery and healthcare practitioner facilities. The Advanced NIBP Module optimizes performance in the presence of artifact. The Module combines Advanced NIBP for use with small adult, adult, large adult and thigh cuffs with standard NIBP for use with neonatal cuffs. The device is intended for use by qualified healthcare personnel trained in its use.

Used with the DINAMAP MPS Select Family of Monitors, the Advanced NIBP Module obtains systolic, diastolic and mean arterial pressures and pulse rate via the oscillometric method. The Advanced NIBP Module optimizes performance in the presence of artifact due to vibration and patient motion. Reduced measurement time, a message for values that may be affected by artifact and greater patient comfort differentiate Advanced NIBP Module performance.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Advanced NIBP Module:

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 clinical test set. It mentions "Clinical studies...were conducted," but the number of patients or measurements is not provided. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical studies. Given the nature of blood pressure measurement, the "ground truth" would typically refer to a referent measurement method (like intra-arterial) rather than expert consensus on readings.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a non-invasive blood pressure module, not an imaging or diagnostic device requiring human reader interpretation in the same way.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was done for the algorithm. The "Advanced NIBP Module Software Algorithm" was the subject of the clinical and bench studies. The clinical studies demonstrated its accuracy against the ANSI/AAMI SP10 standard, and bench testing focused on its performance in terms of measurement time and artifact management.

7. Type of Ground Truth Used

The ground truth used for the clinical accuracy study was presumably a reference blood pressure measurement method consistent with the ANSI/AAMI SP10 standard. This standard typically involves either direct intra-arterial blood pressure measurements or a simultaneous auscultatory method performed by trained observers using mercury sphygmomanometers, often with specific protocols for observer blinding and averaging to reduce bias.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is a software modification of an existing device, and the focus of the submission is on testing the performance of the modified algorithm rather than describing its development.

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

The document does not provide information on how ground truth was established for any training set. As mentioned, the focus is on performance testing of a modified algorithm.

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