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The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE Monitor B450 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation,

· respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry)

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE Monitor B450 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

The CARESCAPE Monitor B450 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE Monitor B450 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The CARESCAPE Monitor B450 is not intended for use during MRI.

The CARESCAPE Monitor B450, including both new and existing subsystems interconnected forms a low acuity, portable multi-parameter patient monitoring system. The CARESCAPE Monitor B450 includes the monitor itself with built-in CPU and power unit, the CARESCAPE Software Platform (ESP software version 2 in this submission) and one or two batteries. The CARESCAPE Monitor B450 has a 12 inch touch screen display, mounting for a PSM/PDM hemodynamic module and a frame for one additional parameter measurement module. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader and USB remote control), and additional modules. The CARESCAPE Monitor B450 supports a variety of existing physiological parameter measurement modules and also can connect to OEM medical devices via the existing network infrastructure. The CARESCAPE Monitor B450 interfaces to a variety of other patient monitoring systems via a cabled or wireless network interface. The CARESCAPE Monitor B450 includes features and subsystems that are optional or configurable.

The provided text describes a 510(k) submission for the GE Healthcare CARESCAPE Monitor B450. However, it explicitly states, "The subject of this premarket submission, CARESCAPE Monitor B450 did not require clinical studies to support substantial equivalence."

This means that a study proving the device meets specific acceptance criteria, as typically described for a new or significantly modified device, was not conducted in the context of this 510(k) review. The device's safety and effectiveness were established primarily through non-clinical tests (compliance with standards) and by demonstrating substantial equivalence to a predicate device (CARESCAPE Monitor B650) which used an earlier version of the algorithm (EK-Pro v12 vs. EK-Pro v13).

Therefore, I cannot provide the information requested in points 1-9 as no such study is detailed in the provided document.

Here's a breakdown based on the information provided (or not provided) in the text:

1. A table of acceptance criteria and the reported device performance:

• Not provided. No specific acceptance criteria for performance were listed, nor were direct device performance results from a clinical study included. The submission focuses on compliance with general safety and performance standards for medical electrical equipment.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. No clinical test set was used or described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. No clinical test set requiring expert ground truth was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set requiring adjudication was described.

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:

• No. This type of study was not mentioned or performed. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human "readers."

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

• Not applicable in the context of clinical performance evaluation. The document mentions an "improved arrhythmia and ST analysis algorithm called EK-Pro v13," but its performance was not evaluated through a standalone clinical study for this 510(k). Its substantial equivalence was based on its predecessor (EK-Pro v12) in the predicate device and non-clinical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. As no clinical study was conducted for this submission, no ground truth was established from clinical data.

8. The sample size for the training set:

• Not provided. No information about a training set for the algorithm was included.

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

• Not provided. As no training set information was included, how ground truth might have been established is also not provided.

Summary based on given document:

The GE Healthcare CARESCAPE Monitor B450's substantial equivalence was established by:

• Demonstrating that its technology (including the new EK-Pro v13 algorithm) is "essentially the same" as the predicate device (CARESCAPE Monitor B650) which used the EK-Pro v12 algorithm.
• Mentioning that the EK-Pro v13 algorithm is "based on the previous algorithm version EK-Pro v12, which has been cleared as part of the predicate device."
• Undergoing comprehensive non-clinical testing for compliance with numerous international safety, performance, and EMC standards (e.g., IEC 60601 series, AAMI EC standards).

The crucial statement is "The subject of this premarket submission, CARESCAPE Monitor B450 did not require clinical studies to support substantial equivalence." This indicates that for this specific 510(k), the FDA did not deem a new clinical performance study necessary to prove the device met acceptance criteria, likely due to its similarity to the already cleared predicate.

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