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Invasive blood pressure function is an option for the Model 9500 Multigas monitor. This function would be used when a clinician determined the need for continuous monitoring of arterial or venous blood pressure for adult patients undergoing MRI examination.

The Invasive Blood Pressure function is an addition to a device legally marketed by MR Equipment Corporation. The device provides an additional measurement function to the Model 9500 Multigas Monitor. The existing 9500 monitor has pulse oximetry, ECG, non-invasive blood pressure (NIBP), capnograph and, optionally, oxygen and agent gas measurement functions. The Model 9500 is based on the BCI Model 9100 monitor with the same measuring functions, but the Model 9500 is specifically intended for use in the MR environment.

The provided text describes a 510(k) submission for an "Invasive Blood Pressure function for Model 9500 Multigas Monitor." However, the document does not contain specific acceptance criteria or details of a study proving the device meets those criteria in the format requested.

Instead, the document states: "The Model 9500 Multigas monitor meets IEC 601-1, IEC 601-1-2, IEC 801-2, -3, -4, -5, CISPR 11. In addition, tests were performed to establish that the Model 9500 operated in the MRI environment substantially equivalent to the predicate device." This indicates compliance with general safety and EMC standards and substantial equivalence to a predicate device regarding operation in an MRI environment.

Therefore, I cannot directly extract the detailed information requested in your prompt regarding acceptance criteria, study specifics, sample sizes, expert qualifications, or ground truth methods from the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "tests performed" without detailing the nature, size, or provenance of any specific test set for the "Invasive Blood Pressure function."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided text.

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 device is a medical monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device's compliance with standards and equivalence testing, which implies standalone performance evaluation of the device's functions. However, there's no specific "algorithm only" study described in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For the compliance tests, "ground truth" would implicitly refer to the established specifications of the standards (e.g., specific alarm thresholds, measurement accuracy within defined limits) and the performance of the predicate device for equivalence testing.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set in that context.

9. How the ground truth for the training set was established: Not applicable.

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Ask a specific question about this device