(120 days)
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.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance / Compliance |
|---|---|---|
| Overall Safety & Effectiveness | As safe and effective as predicate devices | Demonstrated by compliance with numerous voluntary standards and non-clinical testing. |
| Risk Management | Risk Analysis | Applied to the development of the system. |
| Requirements & Design | Requirements Reviews, Design Reviews | Applied to the development of the system. |
| Software Life Cycle | IEC62304:2006 (Medical device software Software life cycle processes) | Verified through testing and development processes. |
| Usability | IEC62366:2007 (Medical Devices Application of usability engineering) | Verified through testing and development processes. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2001 + A1:2004 | Compliant |
| General Safety (Electrical) | IEC 60601-1:1988, A1:1991, A2:1995; IEC 60601-1-1:2000 | Compliant |
| Alarm Systems | IEC 60601-1-8:2006 | Compliant |
| ECG Monitoring Equpt. | IEC 60601-2-27:2005 | Compliant |
| Arrhythmia & ST Segment Measurement | AAMI EC-57:1998, A1:2003 (Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms) | Compliance with this standard is implied for the EK-Pro V13 algorithm which is an improved arrhythmia and ST analysis algorithm. The document states it is "based on the previous algorithm version EK-Pro V12, which has been cleared as part of the predicate device". |
| Non-Invasive Blood Pressure | AAMI SP10:2002 + A1:2003 + A2:2006 | Compliant |
| Respiratory Gas Monitors | ISO 21647:2004 + C1:2005 | Compliant |
| Pulse Oximeter Equipment | ISO9919:2005 | Compliant |
| Temperature Measurement | EN 12470-4:2000, A1:2009 (with exceptions) | Compliant, with noted exceptions for single-use probes and esophageal stethoscope response time. |
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.