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The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE Monitor B650 is indicated for monitoring of:

• · hemodynamic (including ECG, ST segment, arthythmia 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), spirometry, gas exchange) and
• . neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE Monitor B650 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

The CARESCAPE Monitor B650 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 B650 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 B650 is not intended for use during MRI.

The CARESCAPE Monitor B650 is a multi-parameter patient monitor including both new and existing subsystems. The CARESCAPE Monitor B650 includes the monitor itself, the CARESCAPE Software Platform (also called ESP software and for this submission ESP V2 software) and the battery. The CARESCAPE Monitor B650 itself has 15 inch touch screen display and a frame for parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader, and corded remote control), and physiological parameter measurement modules, which are existing subsystems. The CARESCAPE Monitor B650 communicates to a variety of existing OEM medical devices. The CARESCAPE Monitor B650 interfaces to a variety of other existing patient monitoring systems via a cabled or wireless network interface. The CARESCAPE Monitor B650 includes features and subsystems that are optional or configurable.

This document (K131223) describes the GE Healthcare CARESCAPE Monitor B650, a multi-parameter patient monitor. The submission primarily focuses on the update to the software platform (ESP V2) and an improved arrhythmia and ST analysis algorithm (EK-Pro V13).

Based on the provided text, the device itself (CARESCAPE Monitor B650) is deemed substantially equivalent to a predicate device (K102239 CARESCAPE Monitor B650) without requiring clinical studies to support substantial equivalence. The testing described is primarily non-clinical, focusing on compliance with voluntary standards and internal quality assurance measures.

Therefore, the requested information regarding acceptance criteria, study findings, sample sizes, expert involvement, and ground truth for a study proving the device meets acceptance criteria as a standalone AI algorithm is not explicitly present in the provided document, because a standalone performance study with these details was not conducted or required for this particular submission.

However, I can extract information related to the overall safety and effectiveness of the device as a whole system, and specifically mention the EK-Pro V13 algorithm which is an improved arrhythmia and ST analysis algorithm.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific performance acceptance criteria with corresponding reported results for the EK-Pro V13 algorithm or the device's diagnostic capabilities. Instead, it details that the device complies with a long list of voluntary standards related to safety, electromagnetic compatibility, usability, and particular requirements for various medical electrical equipment types (ECG, blood pressure, etc.).

The general acceptance criterion is that "The CARESCAPE Monitor B650 device is as safe and effective as the predicate devices." Compliance with the listed standards is the primary method used to demonstrate this.

Regarding specific AI algorithm performance (EK-Pro V13):

The document states, "The CARESCAPE Monitor B650 with ESP V2 software uses an improved arrhythmia and ST analysis algorithm called EK-Pro V13 in the Monitor Software. It is based on the previous algorithm version EK-Pro V12, which has been cleared as part of the predicate device CARESCAPE Monitor B650 with ESP V1 software (K102239)."

This implies that the improvements in EK-Pro V13 were evaluated against the performance of EK-Pro V12, which was previously cleared. However, the details of that evaluation are not provided in this specific 510(k) summary. The summary concludes that the device, with its improved algorithm, is "as safe and effective" as the predicate but doesn't provide new, specific performance metrics or an independent study for this algorithm's enhancement.

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

• Test Set Sample Size: Not specified for any performance evaluation of the EK-Pro V13 algorithm.
• Data Provenance: Not specified.

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

• Not specified. The document indicates general "Performance testing (Verification)" and "Validation" were conducted, but no details on expert adjudication for ground truth are provided for an algorithm-specific study.

4. Adjudication method for the test set

• Not specified.

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed as part of this submission. The device is a patient monitor, and its arrhythmia and ST analysis algorithm (EK-Pro V13) is a built-in feature, not a standalone AI tool for radiologists/experts to interpret, nor does the document describe a human-in-the-loop study for this algorithm.

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

• A standalone performance study specifically for the EK-Pro V13 algorithm's new improvements, with detailed metrics, is not described in this 510(k) summary. The summary states that the algorithm "is based on the previous algorithm version EK-Pro V12," implying that the validation relies on the previous clearance and general system testing.

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

• Not specified. For the system as a whole, "Performance testing (Verification)" and "Final acceptance testing (Validation)" were conducted, which would involve comparing device outputs to expected or reference values, but the methodology for establishing ground truth for algorithmic performance (like arrhythmia detection) is not detailed.

8. The sample size for the training set

• Not applicable/Not specified. The EK-Pro V13 algorithm is described as an "improved" version based on a previous cleared algorithm (EK-Pro V12). This suggests an iterative development, but details on 'training data' in the modern AI sense are not provided. Given the 2013 submission date, the development methodology might predate widespread use of "training set" terminology for deep learning models, or the algorithm may be rule-based or traditional signal processing.

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

• Not applicable/Not specified. (See point 8).

Summary of Study:

The provided 510(k) summary for the CARESCAPE Monitor B650 (K131223) focuses on demonstrating substantial equivalence to a predicate device (K102239). The core of this submission is the introduction of a new software platform (ESP V2) and an improved arrhythmia and ST analysis algorithm (EK-Pro V13).

The "study" described is a non-clinical validation process that encompassed risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, final acceptance testing, performance testing, and safety testing. The primary method of proving safety and effectiveness was demonstrating compliance with a comprehensive list of voluntary standards (e.g., IEC 60601 series, AAMI standards).

Crucially, the document explicitly states: "The subject of this premarket submission, CARESCAPE Monitor B650 did not require clinical studies to support substantial equivalence." This means that a standalone clinical study to prove the performance of the EK-Pro V13 algorithm, with specific acceptance criteria, sample sizes, expert ground truth, etc., was not conducted or presented in this 510(k) submission. The improvements in EK-Pro V13 were likely validated internally against established benchmarks and through the system-level non-clinical testing described.

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The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status.

The CARESCAPE Monitor B650 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 B650 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 B650 is not intended for use during MRI.

The CARESCAPE Monitor B650 is a multi-parameter patient monitor including both new and existing subsystems. The CARESCAPE Monitor B650 includes the monitor itself, the CARESCAPE Software Platform (also called ESP software) and the battery. The CARESCAPE Monitor B650 itself has 15 inch display (optional touch screen) with integrated keypad and a frame for parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader, and corded remote control), and physiological parameter measurement modules, which are existing subsystems. The CARESCAPE Monitor B650 communicates to a variety of existing OEM medical devices. The CARESCAPE Monitor B650 interfaces to a variety of other existing patient monitoring systems via a cabled or wireless network interface. The CARESCAPE Monitor B650 includes features and subsystems that are optional or configurable.

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

The provided text does not explicitly state specific numerical acceptance criteria for the CARESCAPE™ Monitor B650's performance or a table of its reported performance against such criteria. The submission states that the device "complies with voluntary standards" and that "The CARESCAPE Monitor B650 device is as safe and effective as the predicate devices." This suggests that the acceptance criteria are implicitly tied to demonstrating equivalence to the predicate devices and compliance with relevant standards, rather than specific performance metrics outlined in the document itself.

Therefore, I cannot generate a table with explicit acceptance criteria and corresponding performance numbers from this document.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

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

Not mentioned. The document does not describe a test set or ground truth established by experts.

4. Adjudication Method for the Test Set

Not mentioned.

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

No MRMC comparative effectiveness study was mentioned. The submission states, "The subject of this premarket submission, CARESCAPE™ Monitor B650 did not require clinical studies to support substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a multi-parameter patient monitor that includes the EK-Pro Arrhythmia Detection Algorithm, EK-Pro V12. While the algorithm is a component, the submission focuses on the overall device's substantial equivalence and does not detail specific standalone algorithm performance studies. The "Summary of Non-Clinical Tests" includes "Performance testing (Verification)", but no details are provided about the nature or results of this testing specifically for the algorithm in a standalone context.

7. The Type of Ground Truth Used

Not mentioned. Given that no clinical studies were required, there is no mention of how ground truth (e.g., expert consensus, pathology, outcomes data) was established for performance evaluation.

8. The Sample Size for the Training Set

Not mentioned.

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

Not mentioned. Given the device's substantial equivalence filing and the lack of explicit clinical studies, details about training set ground truth are not included. The algorithm (EK-Pro V12) is stated to employ the "same functional technology as the predicate device(s)" (EK-PRO ARRHYTHMIA DETECTION ALGORITHM, EK-Pro V11), implying that the underlying methodology and perhaps training data (if applicable to the original algorithm development) would be similar or derived from previous versions. However, no specific details are provided in this document.

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