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

The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters.

The CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring.

The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE ONE:

The CARESCAPE ONE is not intended for use within a controlled MR environment.

CARESCAPE ONE is a new patient monitor device based on GE Healthcare predicate devices, the Patient Data Module (K071073) and the CARESCAPE B450 (K132533).

CARESCAPE ONE, with CARESCAPE Software version 3 belongs to the CARESCAPE V3 patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular parameter, including ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, or CO2. The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. The ACM's are CARESCAPE TEMP, CARESCAPE PRES, CARESCAPE ECG, CARESCAPE SpO2 (TruSignal), CARESCAPE SpO2 -Nellcor, CARESCAPE SpO2 - Masimo and CARESCAPE CO2 - LoFlo. CARESCAPE SpO2 - Nellcor, CARESCAPE SpO2 -Masimo, and CARESCAPE CO2 - LoFlo have been developed by their respective companies/manufacturers (OEM) for use with the CARESCAPE ONE. The technology from each OEM has received 510(k) clearance and is adapted to function with the CARESCAPE ONE. The OEM technologies are not new and are not a part of this submission, only their integration into the Parameters/Active Cable Modules for use with the CARESCAPE ONE is covered in this 510(k).

CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station.

Here's an analysis of the acceptance criteria and supporting studies for the CARESCAPE ONE device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a direct table of specific acceptance criteria with corresponding performance values for all features. However, it does highlight performance claims and comparisons for key components, specifically arrhythmia detection and SpO2.

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

• Arrhythmia (EK-Pro V14): The document references ANSI/AAMI EC57:1998 (R)2012. This standard specifies databases (e.g., AHA, MIT-BIH) that are used for testing arrhythmia algorithms. The specific sample size from these databases used for EK-Pro V14 testing is not explicitly stated in this 510(k) summary, but it would be derived from the standard's requirements.
  • Data Provenance: The databases mentioned in EC57 are typically retrospective, internationally recognized ECG databases. The exact country of origin for the data used for this specific EK-Pro V14 validation is not specified, but the standard's databases often compile data from various global sources.
• SpO2 (TruSignal V3): The document states a "controlled desaturation study." The sample size is not explicitly stated in this summary.
  • Data Provenance: A controlled desaturation study is a prospective clinical study designed to test pulse oximeter accuracy. The country of origin for this study is not specified.

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

• Arrhythmia (EK-Pro V14): When using standard databases like those referenced by ANSI/AAMI EC57, the ground truth (arrhythmia annotations) is typically established by multiple, highly experienced cardiologists or cardiac electrophysiologists. The exact number and qualifications for the original annotation of the standard databases are not specified in this document, as the standard itself defines these.
• SpO2 (TruSignal V3): For controlled desaturation studies, the "ground truth" for SpO2 is provided by a CO-oximeter measurement, which itself is a highly accurate laboratory method for oxygen saturation. This is an objective measurement rather than expert consensus. Therefore, "experts" in the traditional sense for establishing ground truth are not directly applicable here.

4. Adjudication Method for the Test Set

• Arrhythmia (EK-Pro V14): For standard databases, ground truth annotation often involves multiple experts reviewing and adjudicating discrepancies, sometimes with a "majority rules" or senior expert decision process. The specific adjudication method for the creation of the databases referenced by EC57 is not detailed in this summary, but would adhere to the methodologies defined by the creators of those databases.
• SpO2 (TruSignal V3): As the ground truth comes from CO-oximetry, an objective measurement, adjudication by experts is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." This indicates that human-in-the-loop performance with or without AI assistance was not assessed in this submission for primary equivalence.

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

• Yes, standalone performance was assessed for key algorithms:
  • EK-Pro V14 Arrhythmia Detection algorithm: Its performance was evaluated against the ANSI/AAMI EC57 standard, comparing it to the predicate's EK-Pro V13 algorithm. This is a standalone algorithm performance evaluation.
  • TruSignal V3 SpO2 algorithm: Its accuracy was validated in a controlled desaturation study against CO-oximetry. This is also a standalone algorithm performance evaluation.

7. The Type of Ground Truth Used

• Arrhythmia (EK-Pro V14): The ground truth would be expert consensus annotations of ECG waveforms from standard arrhythmia databases (e.g., those specified in ANSI/AAMI EC57).
• SpO2 (TruSignal V3): The ground truth was objective laboratory measurement using CO-oximetry in a controlled study. This is considered a gold standard for blood oxygen saturation.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for training the EK-Pro V14 arrhythmia detection algorithm or the TruSignal V3 SpO2 algorithm. In 510(k) submissions, training set details (especially for existing, updated algorithms) are often not required to be as extensively disclosed as test set performance, particularly when demonstrating equivalence to a predicate.

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

• The document does not explicitly state how the ground truth for the training sets of the EK-Pro V14 or TruSignal V3 SpO2 algorithms was established. For complex algorithms like these, training data is typically meticulously annotated by a combination of clinical experts (for arrhythmia) or using highly accurate reference methods (for SpO2) and then verified. Again, in a 510(k) for an updated algorithm or component, the full developmental history and training data specifics may not be detailed if the focus is on demonstrating equivalent performance post-modifications.

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The B40i is a portable multi-parameter 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 B40i is intended for use under the direct supervision of a licensed health care practitioner. The B40i is not intended for use during MRI. The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed monitor B40i is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K133576) platform. The proposed monitor B40i provides support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195). The proposed monitor B40i is also compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) but with disabled spirometry function. The proposed monitor B40i supports Airway Gas Option (N-CAiO). The proposed monitor B40i expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). This parameter feature patient population extension to cover neonatal patient population uses Patient Data Module as predicate (K071073), which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The proposed monitor B40i utilizes 12 inch LCD display panel and LED backlight with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed monitor B40i interfaces with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40, the proposed monitor B40i includes features and subsystems that are optional or configurable. The proposed monitor B40i interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40, the proposed monitor B40i has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text is a 510(k) Summary for the GE Healthcare B40i Patient Monitor. This document describes the device and its claimed substantial equivalence to predicate devices, but it does not contain a study demonstrating that the B40i device meets specific acceptance criteria based on performance data.

The document primarily focuses on:

• Device Description and Intended Use: Outlining what the B40i monitors (ECG, SpO2, NIBP, temperature, airway gases, Entropy) and for which patient populations (adult, pediatric, neonatal) and environments (hospital, intra-hospital transport).
• Comparison to Predicate Devices: A detailed table comparing the B40i to similar legally marketed devices (Monitor B40 and Patient Data Module), highlighting that most features/functions are identical or enhanced (e.g., neonatal impedance respiration expanded).
• Summary of Non-Clinical Tests: Listing the quality assurance measures and voluntary standards (IEC, AAMI, ISO) with which the device complies. This indicates that safety and performance were tested according to recognized standards.
• Statement on Clinical Tests: Explicitly stating that "No additional clinical tests were performed for proposed monitor B40i."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document. The document relies on comparison to predicate devices and compliance with standards to establish substantial equivalence, rather than presenting a novel performance study with specific acceptance criteria.

However, I can extract the acceptance criteria implied by the comparison to predicate devices and the listed standards, and present the device's reported performance as stated for the predicate devices, since the submission claims substantial equivalence and often refers to the same performance specifications.

Based on the provided K143676 510(k) Summary, here's what can be inferred and extracted, recognizing that this document does not present a new performance study with specific acceptance criteria for the B40i itself, but rather establishes equivalence to predicate devices which presumably met these criteria:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The device claims to be substantially equivalent to its predicates, which means its performance should meet or exceed the performance of the predicate if they are identical. The acceptance criteria are typically defined by recognized international standards (e.g., AAMI, IEC, ISO) and the specifications of the predicate devices. The reported device performance for the B40i is stated as identical to the predicate device's performance for most parameters.

Regarding the study that proves the device meets the acceptance criteria:

The document explicitly states: "No additional clinical tests were performed for proposed monitor B40i."
Instead of a new performance study for the B40i, the submission relies on bench testing against voluntary standards and comparison to legally marketed predicate devices (K133576 Monitor B40 and K071073 Patient Data Module) to demonstrate substantial equivalence. The argument is that the B40i's fundamental technology, performance specifications, and intended use are sufficiently similar to (or improved upon but within the same performance envelope as) the predicate devices, which were previously cleared by the FDA.

Therefore, for questions 2-9 requiring details about a study, the direct answer based on this document is that no new clinical performance study with specific acceptance criteria for the B40i was conducted or presented. The device's performance is asserted through comparison and compliance with standards.

Here's an attempt to answer the remaining points based on the understanding that no new performance study specific to the B40i is detailed here:

2. Sample size used for the test set and the data provenance: Not applicable, as no new clinical or performance test set for the B40i is described in this document. Performance claims are based on substantial equivalence to predicate devices and compliance testing to standards, but details of those predicate studies' sample sizes or data provenance are not provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance testing would typically be established during the development and clearance of the predicate devices or through standard reference methods. This document does not detail such for the B40i.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a patient monitor, not an AI-powered diagnostic imaging device involving human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as a "multi-parameter patient monitor" which inherently has a standalone monitoring function. Performance measurements like SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection (algorithms like EKPRO V12 and SuperStat DINAMAP) are implicitly standalone algorithm performances tested against specified accuracy ranges as part of standard compliance. However, details of such tests (e.g., specific test protocols, datasets) for the B40i are not provided beyond the statement of compliance to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For parameters like SpO2 and NIBP, ground truth would typically be established using invasive reference methods (e.g., co-oximetry, arterial line) for physiological signals. For ECG/arrhythmia, it would involve expert review of annotated ECG waveforms, often from standard databases. The B40i relies on algorithms (EKPRO V12, SuperStat) that were validated against such ground truths during their initial development and predicate device clearances.
8. The sample size for the training set: Not applicable to this FDA submission for the B40i. Training sets relate to algorithm development. The document refers to existing algorithms (e.g., EKPRO V12 for ECG, SuperStat DINAMAP for NIBP, Nellcor/Masimo for SpO2) from predicate devices or modules. Details of their training sets are not included here.
9. How the ground truth for the training set was established: Not applicable, for the reasons mentioned in point 8.

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The CARESCAPE V100 Vital Signs Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature.

The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac stepdown. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.

The CARESCAPE V100 Vital Signs Monitor is a small, portable monitor for use in a sub-acute hospital and non-hospital settings. The CARESCAPE V100 is for use on adult, pediatric, or neonatal patients - one at a time. The battery operated monitor provides noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature.

The CARESCAPE V100 is a multi-parameter device that provides Sp02 monitoring for use in spot-checking or continuous monitoring. The CARESCAPE V100 also measures NIBP using the oscillometric method. There are no features of CARESCAPE V100 that can be controlled by the patient.

The CARESCAPE V100 monitor is available in four standard configurations with or without an integrated printer:

• CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or . SuperSTAT), Pulse
• CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or . SuperSTAT), Pulse, and Temperature
• . CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or SuperSTAT), Pulse, and Sp02 (Ohmeda TruSignal, Nellcor, or Masimo)
• . CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or SuperSTAT), Pulse, Temperature, and Sp02 (Ohmeda TruSignal, Nellcor, or Masimo)

The provided FDA 510(k) summary for the CARESCAPE V100 Vital Signs Monitor (K073203) describes the device and its intended use, but it does not contain information regarding specific acceptance criteria, study details (like sample sizes, ground truth establishment, or expert qualifications), device performance against those criteria, or multi-reader multi-case studies.

Instead, the document states: "The subject of this 510(k) is a design modification for the ProCare V1 Vital Signs Monitor. The CARESCAPE V100 Vital Signs Monitor complies with the voluntary standards as detailed in Section 4.2 of this submission. The following quality assurance measures were applied to the development of the CARESCAPE V100 Vital Signs Monitor: Risk Analysis, Requirements Reviews, Design Reviews, Subsystem Verification, Integration testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental testing."

The conclusion provided is: "The results of these measurements demonstrated that the CARESCAPE V100 Vital Signs Monitor is as safe, as effective, and performs as well as the predicate device(s)," which is a general statement of substantial equivalence rather than a detailed report of performance against specific acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The document refers to "voluntary standards as detailed in Section 4.2 of this submission," which would presumably contain the technical performance specifications and acceptance criteria, but Section 4.2 itself is not included in the provided text.

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