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The PROCARE Monitor B40 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The PROCARE Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.

The PROCARE Monitor B40 is not intended for use during MRI.

The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The PROCARE Monitor B40 is a multi-parameter patient monitor including both new and existing subsystems. The PROCARE Monitor B40 has a12 inch display with integrated keypad and a fixed pre-configuration patient parameter measurement module (Hemo module). The PROCARE Monitor B40 also supports a thermal recorder and Airway gas module (E-MiniC, K052582) with an extension rack.

The PROCARE Monitor B40 includes features and subsystems that are optional or configurable. The PROCARE Monitor B40 interfaces to a variety of existing central station systems via a cabled network interface.

The provided text does not contain specific acceptance criteria or details about a study designed to prove the device's performance against such criteria. Instead, it refers to summaries of non-clinical tests and states that clinical studies were not required to support substantial equivalence.

Here's a breakdown of the information that is available and what is missing:

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

   • Missing. No specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are listed for the PROCARE Monitor B40's performance. The document focuses on regulatory compliance and substantial equivalence to predicate devices rather than direct performance metrics against pre-defined criteria.

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

   • Missing. Since no clinical studies were performed, there is no test set or associated sample size discussed.

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

   • Missing. No expert-established ground truth is mentioned, as no clinical tests were conducted for this submission.

4. Adjudication method for the test set

   • Missing. Not applicable, as no test set requiring adjudication was used.

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

   • Missing. No MRMC study was done, as clinical studies were explicitly stated as "not required." The device is a patient monitor, not an AI-assisted diagnostic tool for human readers.

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

   • Missing. While the device contains algorithms (e.g., "identical arrhythmia algorithm, EK-Pro V12," and "identical NIBP hardware and SuperStat algorithm" to predicate devices), the document does not describe standalone performance studies for these algorithms. Performance is implied through substantial equivalence to predicate devices.

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

   • Missing. Not applicable, as no clinical studies requiring a ground truth were performed.

8. The sample size for the training set

   • Missing. The document mentions the device has "identical arrhythmia algorithm, EK-Pro V12" and "identical NIBP...SuperStat algorithm" as predicate devices, implying these algorithms were developed previously. However, details about the training sets for these algorithms are not provided in this submission for the PROCARE Monitor B40.

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

   • Missing. Similar to item 8, details on how the ground truth for the training sets of the existing algorithms (EK-Pro V12 and SuperStat) were established are not provided in this document.

Summary of Device Performance (based on provided text):

The PROCARE Monitor B40's performance is not evaluated directly against novel acceptance criteria in this submission. Instead, the submission argues for substantial equivalence based on the following:

• Technology: "The PROCARE Monitor B40 is a new monitor that essentially is a combination of the features and parameters of three existing predicate monitor platforms."
• Algorithms: It uses "identical arrhythmia algorithm, EK-Pro V12, as the CARESCAPE Monitor B650 (K102239)" and "identical NIBP hardware and SuperStat algorithm with CARESCAPE V100 Vital Signs Monitor (K073203)."
• Non-Clinical Tests: The device claims compliance with voluntary standards and underwent internal quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, module verification, system verification, validation, performance testing, safety testing).
• Conclusion: "GE Healthcare considers the PROCARE Monitor B40 to be as safe, as effective, and performance is substantially equivalent to the predicate devices."

In essence, the "study" proving the device meets its acceptance criteria (which is substantial equivalence) is the comparison to predicate devices and adherence to design control and quality assurance processes, rather than a clinical trial with specific performance metrics.

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