Search Results

Type

Traditional

Panel

Reference & Predicate Devices

K171028,K150298,K052976,K052582,K123195,K171580,K151063,K191323,K143676,K162012,K122223

Intended Use

The monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport.

The monitor B125/B105 is intended for use under the direct supervision of a licensed health care practitioner.

The monitor B125/B105 is not intended for use during MRI.

The monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.

The monitor B125/B105 monitors and displays: ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement), 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 rate, airway Gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac output (C.O.) and Entropy.

The monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

Device Description

The proposed Monitor B125/B105 is a multi-parameter patient monitor that was developed based on predicate Monitor B125/B105 (K171580) to provide additional monitored parameters: Airway gases, Entropy and Cardiac output, by supporting additional optional modules previously cleared by FDA: CARESCAPE Respiratory module (K171028), Airway Ga Option N-CAiO(K151063), E-Entropy Module (K150298) (E-ENTROPY-01) and E-COP module (K052976) with extension interface rack and/or second frame(B1X5-F2).

In addition to the added parameters, the proposed Monitor B125/B105 offers several enhanced software features:

Enabled the Impedance Respiration measurement for Neonates (in addition to Ped/Adult);
Option called "Full Disclosure" to allow the display of parameter waveforms for up to 36 hours;
National Early Warning Score (NEWS) calculation provided ;
Additional printing capabilities to a remote recorder/Laser printer connected to a central station;
Adoption of EK-Pro V14 ECG algorithm (previously cleared K191323) to support enhanced arrhythmia detection performance;
Added Irregular, SV Tachy and Supra Ventricular Contraction (SVC), three more arrhythmia alarms;
Enhanced parameter alarm priority adjustment/ configuration options,
Cybersecurity enhancements.

The proposed monitor B125 and B105 is based on the previous design, and therefore shares a common software and hardware platform with its primary predicate, the Monitor B125/B105 (K171580). The primary function and operation of the monitors remain unchanged from the predicate. The difference between the two models (B125 and B105) is the LCD screen size. B125 has a 12-inch display; B105 has a 10-inch display. There is no change from the predicate in the display size.

As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 is a multi-parameter patient monitor, utilizing an LCD display with an integrated keypad and an identical pre-configuration patient parameter measurement module (Hemo module) which provides basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2. The proposed Monitor B125/B105 uses the identical E-MiniC module (K052582) and equivalent optional thermal recorder module as the predicate B125/B105 (K171580).

As with the predicate Monitor B125/B105 (K171580), the proposed Monitor B125/B105 interfaces to a variety of existing central station systems via a cabled or wireless network interface. The wireless interface is implemented with the identical integrated WIFI module (WLAN module type: B1x5-01. FCC ID: OU5B1X501) as used in the predicate Monitor B125/B105 (K171580).

As with the predicate Monitor B125/B105 (K171580), proposed Monitor B105/B125 includes features and subsystems that are optional or configurable. It can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE Medical Systems Information Technologies, Inc. Monitor B125/B105. It details the device's indications for use, its equivalence to predicate devices, and the non-clinical tests performed to support its substantial equivalence.

However, the document explicitly states in Section "14. Clinical (807.92(b)(2)): Summary of Clinical Tests:" that "the proposed Monitor B125/B105 did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide information regarding acceptance criteria and a study that proves the device meets them because:

No clinical study was conducted. The submission relies on substantial equivalence to existing predicate devices and non-clinical testing.
Acceptance criteria related to performance metrics for clinical outcomes (e.g., sensitivity, specificity for arrhythmia detection in a clinical trial setting with human readers) are not present in this document as no such clinical study was performed. The acceptance criteria for the device's performance would be related to its ability to accurately measure and display physiological parameters, which was assessed through non-clinical bench testing and comparison to predicate devices, not through a clinical trial with a test set of patient data and expert ground truth.

Because no clinical study was performed as part of this 510(k) submission, the requested information elements (1-9) which pertain to a clinical study evaluating device performance, cannot be extracted from this document. The document focuses on demonstrating substantial equivalence based on technological characteristics and non-clinical performance, rather than providing results from a new clinical efficacy or effectiveness study.

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K Number

K151063

Device Name

Monitor B40

Manufacturer

Date Cleared

2015-12-15

(239 days)

Product Code

MHX,BZQ,CBQ,CBR,CBS,CCK,CCL,DQA,DRT,DSB,DSK,DXN,FLL,GWQ,NHO,NHP,NHQ

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K052582,K123195,K061907,K150298,K133882,K032582,K102239,K053269,K060576,K133576

Intended Use

Device Description

The proposed Monitor B40V3 is still a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2.1 (K133576) and now complies with IEC60601-1 3rd edition and RoHS (Restriction of Hazardous Substances) requirements, enabled time synchronization in HL7(Health Level 7) network environment, verified compatibility with CARESCAPE Central Station (K133882) and supported OAC (Optional Activation Codes) tool used in manufacturing and service for product license control. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to interface with following optional extension modules: E-MiniC module (K052582), Airway Gas Option Module (N-CAiO) (K133576), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and Entropy module. Comparing with E-Entropy module version (E-ENTROPY-00) (K061907) supported in predicate device, the proposed Monitor B40V3 supports improved E-Entropy module version (E-ENTROPY-01) (K150298). As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to be compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) with spirometry function disabled. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 still includes features and subsystems that are optional or configurable. The proposed Monitor B40V3 will continue interfacing to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 keeps 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.

AI/ML Overview

The provided text describes the GE Medical Systems China Co., Ltd. Monitor B40 (K151063), a multi-parameter patient monitor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of analytical or clinical performance.

Instead, the document focuses on:

Substantial Equivalence: Demonstrating that the Monitor B40 (V3) is substantially equivalent to its predicate device (Monitor B40V2.1, K133576).
Design Changes and Rationale: Explaining minor design modifications (e.g., compliance with IEC60601-1 3rd edition, RoHS compliance, time synchronization, compatibility updates, component upgrades due to end-of-life parts) and asserting that these changes do not impact the device's ability to obtain patient measurements or its safety/effectiveness.
Compliance with Standards: Listing numerous voluntary and international standards the device and its applications comply with (e.g., IEC 60601-1, IEC 62304, ISO 80601-2-56).
Quality Assurance Measures: Detailing the development process, including risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety).

Therefore, many of the requested points cannot be extracted from the provided text. The document explicitly states: "The subject of this premarket submission. The proposed Monitor B40V3 did not require clinical studies to support substantial equivalence." This indicates that detailed performance metrics from a dedicated clinical study for this specific device (B40V3) are not present in this submission.

Here is what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly listed as quantitative performance metrics for a specific function (e.g., arrhythmia detection sensitivity/specificity, NIBP accuracy). Instead, acceptance criteria implicitly refer to compliance with the listed international standards and demonstrating substantial equivalence to the predicate device, implying that its performance is at least as good as the predicate.
Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for any of the monitored parameters (ECG, SpO2, NIBP, etc.) for the Monitor B40V3 itself. The document claims "no changes to the parameter measuring principle" and that "all related risks were re-evaluated and found to be unchanged," implying performance is comparable to the predicate device.

Parameter/Characteristic	Acceptance Criteria (Implicit from Standards/Equivalence to Predicate)	Reported Device Performance (Specificity to B40V3)
Overall Safety	Compliance with IEC 60601-1:2005 + A1:2012	Verified through testing (implied safe)
EMC Compatibility	Compliance with IEC60601-1-2: 2007	Verified through testing (implied compliant)
ECG Monitoring	Compliance with IEC60601-2-27: 2011+ C1: 2012	Uses identical ECG EKPRO V12 algorithm (K102239)
Alarm Systems	Compliance with IEC60601-1-8: 2006 +A1:2012	Added alarm reset feature, verified
NIBP Measurement	Compliance with IEC60601-2-34: 2011	Uses the same NIBP design
SpO2 Measurement	Compliance with ISO 80601-2-61: 2011	Uses the same GE SpO2 design; uses updated Masimo OEM SpO2 board MS-2011SB (K053269) and Nellcor SpO2 board NELL1-SR (K060576) for RoHS compliance (no performance impact claimed).
Temperature	Compliance with ISO 80601-2-56: 2009	Verified through testing
Software Life Cycle	Compliance with IEC 62304:2006	Software validation performed
Usability	Compliance with IEC 62366:2014 & IEC 60601-1-6: 2010	Verified through testing

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

Not provided. The document does not describe specific test sets for analytical or clinical performance of the device's monitoring functions. It mentions "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," and "Safety testing" as part of quality assurance, but no details on size, provenance, or type of data are given.

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/Not provided. Since no specific clinical or analytical performance study with a 'test set' requiring expert ground truth is described, this information is absent. The submission focuses on technical compliance and substantial equivalence rather than de novo performance validation.

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

Not applicable/Not provided. As no performance study with a test set requiring adjudication is 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

Not applicable/Not provided. This device is a physiological monitor, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or described.

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

Not explicitly described as a standalone performance study. The device itself functions in a "standalone" mode as a monitor, and its algorithms (e.g., ECG EKPRO V12, NIBP) operate without human intervention in their core function. However, no specific "standalone study" with performance metrics for these algorithms is described in this document for the B40V3. The document states that the Monitor B40 can be a stand-alone monitor or interfaced to other devices.

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

Not applicable/Not provided. For a physiological monitor, ground truth would typically be established against highly accurate reference devices or established clinical standards. However, since no specific clinical performance study is detailed, the method for establishing ground truth for performance metrics is not mentioned. Compliance testing for standards (e.g., IEC, ISO) would rely on defined test methodologies and reference values.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" for AI or machine learning algorithms within this submission. The device uses established algorithms for physiological parameter monitoring.

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

Not applicable/Not provided. As there is no mention of a training set.

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K Number

K143676

Device Name

B40i Patient Monitor

Manufacturer

GE HEALTHCARE FINLAND OY

Date Cleared

2015-07-31

(219 days)

Product Code

MHX,BZQ,CBQ,CBR,CBS,CCK,CCL,DQA,DRT,DSB,DSK,DXN,FLL,GWQ,NHO,NHP,NHQ

Regulation Number

Type

Traditional

Panel

ENGSTROM CARESTATION, ENGSTROM PRO

Reference & Predicate Devices

K061907,K123195,K042642,K052582,K022834,K133576,K071073

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Parameter / Feature	Implied Acceptance Criteria (from Predicate/Standards)	Reported Device Performance (B40i, stated as identical to predicate unless noted)
ECG - Arrhythmia Algorithm	Fulfils AAMI EC57-1998 standard for EKPRO V12 algorithm.	EKPRO V12 (Fulfils AAMI EC57-1998 standard), Identical
SpO2 Accuracy (GE Trusignal, Adult/Pediatric)	Without motion: 70-100% ±2 digits (±3 digits with ear sensor); With motion: 70-100% ±3 digits; Low perfusion: 70-100% ±3 digits. 1-69%: unspecified.	Identical
SpO2 Accuracy (GE Trusignal, Neonatal)	Without motion: 100-70% ±3 digits; With motion: 100-70% ±3 digits. 1-69%: unspecified.	Identical
Pulse Rate Accuracy (GE Trusignal, No Motion)	30-250 bpm ±2 bpm (Adult/Pediatric/Neonatal)	Identical
Pulse Rate Accuracy (GE Trusignal, With Motion)	30-250 bpm ±3 bpm (Adult/Pediatric/Neonatal)	Identical
Pulse Rate Accuracy (GE Trusignal, Low Perfusion)	±5 bpm (Adult/Pediatric)	Identical
Invasive Blood Pressure Accuracy (Systolic, Diastolic, Mean)	±5% or ±2mmHg (whichever is greater)	Identical
Invasive Blood Pressure Pulse Rate Accuracy	±5% or ±5 bpm (whichever is greater)	Identical
Temperature Accuracy	±0.1°C (Note: EN 12470-4:2000, A1:2009. Clause 6.3 b) Temperature measurement error with single use probes exceeded maximum permissible error for predicate).	Identical (Note: Same exception for single use probes as predicate).
Impedance Respiration Rate Accuracy	±5% or ±5 bpm (whichever is greater)	Identical
NIBP Measurement Accuracy	Clinical evaluation for SuperStat (DINAMAP) K022834 algorithm to ensure compliance per applicable standards (e.g., AAMI SP10). Implicitly, the accuracy for systolic, diastolic, and mean pressures would need to fall within specified ranges for adult/pediatric/neonate populations.	Identical to predicate which uses SuperStat (DINAMAP) K022834 algorithm. Measurement ranges for systolic, diastolic, and MAP are identical to predicate for adult/pediatric/neonate. (E.g., Adult/Pediatric Systolic: 30-290 mmHg; Neonate Systolic: 30-140 mmHg)
Environmental & Safety Standards	Compliance with multiple IEC and ISO standards (e.g., IEC 60601-1 for basic safety, IEC 60601-1-2 for EMC, IEC 60601-2-27 for ECG, IEC 60601-2-30 for NIBP, etc.) and AAMI standards (e.g., AAMI / ANSI EC13).	The B40i was designed and tested for compliance to these listed standards.

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:

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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
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.
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.
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.
How the ground truth for the training set was established: Not applicable, for the reasons mentioned in point 8.

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K Number

K142679

Device Name

CARESCAPE R860

Manufacturer

Datex-Ohmeda, Inc.

Date Cleared

2015-06-12

(266 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K050597,K051092,K052582,K123195,K111116,K123149

Intended Use

The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.
Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules.
Not all features are available for all patient types or product configurations.
The CARESCAPE R860 ventilator is not a pulmonary function calculation device.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

Device Description

The CARESCAPE R860 is a flexible, adaptable, intuitive critical care ventilator. Touchscreen capability allows the user to quickly and easily access patient information and procedures. A wide selection of performance options gives the user full control of the system configuration. The CARESCAPE R860 features patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.
The CARESCAPE R860 is designed to provide mechanical ventilation for adult, pediatric and neonatal patient types weighing 0.25 kg and above, and having degrees of pulmonary impairment varying from minor to severe.
The CARESCAPE R860 introduces a new user interface with touch screen capabilities. Icons represent configurable views of past (historical trends), present (patient status), and possible future patient needs through clinical decision support, including Spontaneous Breathing Trial to evaluate a patient's ability to breath spontaneously for a limited, specified duration of time.
This ventilator comes with standard ventilation modes as well as purchasable ventilation modes and clinical decision support features.
Standard ventilation modes:

A/C VC (Assist Control Volume Control) .
A/C PC (Assist Control Pressure Control) .
A/C PRVC (Assist Control Pressure Regulated Volume Control)
SIMV VC (Synchronized Intermittent Mandatory Ventilation Volume Control) ●
SIMV PC (Synchronized Intermittent Mandatory Ventilation Pressure Control)
CPAP/PS (Continuous Positive Airway Pressure/Pressure Support)
SBT (Spontaneous Breathing Trial) .
Purchasable ventilation modes:
. nCPAP (nasal Continuous Positive Airway Pressure)
. SIMV PRVC (Synchronized Intermittent Mandatory Ventilation Pressure Regulated Volume Control)
. BiLevel
. BiLevel VG (BiLevel airway pressure ventilation Volume Guaranteed)
VS (Volume Support) ●
NIV (Non-Invasive Ventilation) .
. APRV (Airway Pressure Release Ventilation)
Additional features:
. FRC (Functional Residual Capacity)
. SpiroDynamics
The CARESCAPE R860 is based on the Engström Carestation feature set and contains similar performance characteristics to the Engström family of ventilators.
The CARESCAPE R860 is a microprocessor-based, pneumatically controlled, data driven ventilator which includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb nebulizer control board. The ventilator consists of two main components: the display and the ventilator unit. The display allows the user to interface with the system through a resistive touch screen and Trim Knob with keys. The CARESCAPE R860 also includes an optional module bay which allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.
The user interface for control of nebulization is provided via the ventilator display unit. The standard nebulizer board is provided with the CARESCAPE R860. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.
Optional accessories common to the CARESCAPE R860 and the predicate Engström family of ventilators include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets. Additional optional accessories include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, adjustable mounting rail, nebulizer and components, and module bay.
The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to ventilator equipped with the optional compressor. The use of an integrated air compressor was first cleared on the predicate Engström Carestation and Engström Pro in K050597.
Optional functionality includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), E-MiniC module (K052582), or E-sCO, E-sCOV, E-sCAiO, E-sCAiOV (K123195) which are physically integrated into the CARESCAPE R860, receive electronic power from the CARESCAPE R860 and communicate measured values to the CARESCAPE R860 for display on the system display unit.

AI/ML Overview

This document, a 510(k) Pre-market Notification, describes the CARESCAPE R860 ventilator and asserts its substantial equivalence to a predicate device, the Engström Carestation.

Based on the provided text, the CARESCAPE R860 device is a ventilator, not an AI/ML powered device designed to meet specific performance criteria based on an AI model's output. Therefore, many of the requested criteria regarding AI model evaluation (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or type of ground truth) are not applicable (N/A) in this context.

The document primarily focuses on demonstrating the device's adherence to regulatory standards and its functional equivalence to a previously cleared device through non-clinical testing.

Here's the information extracted and filled out based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a ventilator and not an AI/ML diagnostic or predictive device, the "acceptance criteria" are related to compliance with medical device standards and functional equivalence to a predicate, rather than specific performance metrics like sensitivity or specificity for an AI model.

Acceptance Criteria Category	Reported Device Performance/Compliance
Safety and Essential Performance	Compliant with ANSI/AAMI ES60601-1:2005 (R 2012), Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, and relevant collateral standards (IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, ISO 80601-2-12, IEC 62366, ISO 5356-1, IEC 62304).
Functional Equivalence	Demonstrated to have similar performance characteristics to the predicate Engström Carestation family of ventilators. Thoroughly tested through verification of specifications and validation.
Software Validation	Software validation completed.
Risk Management	Risk Analysis performed.
Requirements/Specifications	Requirements/Specification Reviews completed.
Design Development	Design Reviews completed.
Testing Levels	Testing performed on unit level, integration testing, performance testing (verification), safety testing (verification), simulated use/user requirements testing (validation).
Clinical Performance	No clinical testing required as modifications did not warrant it; modifications evaluated by non-clinical tests to verify and validate substantial equivalence.
Intended Use	Functions as a mechanical ventilator for neonatal, pediatric, and adult patients weighing 0.25 kg and above, with integrated monitoring of FiO2, airway pressure, flow, and volume.

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

Sample Size for Test Set: N/A (No specific "test set" in the context of AI/ML evaluation is mentioned. The testing involved functional verification and validation of a medical device against engineering specifications and regulatory standards.)
Data Provenance: N/A (The testing performed is non-clinical, involving the device itself rather than patient data.)

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)

Number of Experts: N/A
Qualifications of Experts: N/A
- Explanation: Ground truth in this context refers to the correct functioning of the ventilator according to engineering specifications and regulatory standards. This is typically established through engineering and quality assurance processes, not by expert medical review of output data.

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

Adjudication Method: N/A

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

MRMC Study Done: No.
Effect Size: N/A
- Explanation: This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.

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

Standalone Performance: N/A
- Explanation: This device is a ventilator, performing mechanical functions. While it has software, it's not an AI algorithm in the sense of making diagnostic or treatment recommendations that would have a standalone performance evaluated against a ground truth. Its "performance" is its ability to deliver ventilation parameters accurately and safely.

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

Type of Ground Truth: Engineering specifications, regulatory standards (e.g., ISO 80601-2-12 for medical ventilators), and performance characteristics of the predicate device (Engström Carestation). The "ground truth" is the established correct mechanical and software operation within specified tolerances.

8. The sample size for the training set

Sample Size for Training Set: N/A (No AI model training involved.)

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

How Ground Truth Established: N/A (No AI model training involved.)

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K Number

K140575

Device Name

Manufacturer

DATEX-OHMEDA, INC.

Date Cleared

2015-02-03

(334 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K050597,K001814,K051092,K023454,K052582,K111116

Intended Use

The GE Datex-Ohmeda Engström Carestation and Engström Pro are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities on Engström Carestation and Engström Pro expand the patient range to 0.25 kg.

The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway pressure, spirometry, and volume monitoring. Options include an Aerogen Aeroneb nebulizer, data capture accessory, and an integrated air compressor. Options available on Engström Carestation only include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling, capabilities to measure SpiroDynamics via an intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method.

Not all features are available with all patient populations.

The Engström Carestation is not a pulmonary function calculation device.

The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

Device Description

The GE Datex-Ohmeda Engström Carestation and Engström Pro are flexible, and intuitive, critical care ventilators. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation and Engström Pro feature patient monitoring, patient ventilation, and the capability of interfacing with central information management systems.

Both the GE Datex-Ohmeda Engström Carestation and Engström Pro are designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. Optional Neonatal capabilities allow the Engström Carestation and Engström Pro to be used with patients weighing 0.25 kg and above.

The modes of ventilation currently available include:

Volume Controlled (VCV)
Pressure Controlled (PCV)
Pressure Controlled, Volume Guaranteed (PCV-VG)
Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC)
Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
Bi-level Airway Pressure Ventilation
Constant Positive Airway Pressure Support Ventilation (CPAP/PSV)
Apnea backup (available in SIMV-VC, SIMV-PC, SIMV-PCVG/BiLevel-VG, BiLevel, CPAP/PSV, and VG-PS)
Non-invasive ventilation (NIV), not available in neonatal mode
Infant Nasal CPAP (nCPAP), only available in neonatal mode
Volume Guarantee. Pressure Support (VG-PS), only available in neonatal mode

The ventilator consists of two main components: a display and a ventilator unit. The display allows the user to interface with the system and control settings through use of soft keys on the display, a com wheel, and a resistive touch screen. The Engström Carestation also includes a module bay that allows the integration of various Datex-Ohmeda patient monitoring modules with the ventilator.

The user interface for control of nebulization is provided via the ventilator display unit. The standard nebulizer board is provided with both the Engström Carestation and Engström Pro variants. Users have the option to configure the system to use an external pneumatic nebulizer in place of the standard nebulizer.

The optional medical air compressor is intended for use as an accessory to provide a dry, filtered, breathable compressed air supply. The compressor is installed in the base of the ventilator cart. The compressor is powered from AC mains only. A source of compressed oxygen is required to be connected to Engström Carestation/Engström Pro equipped with the optional compressor. The use of an integrated air compressor was first cleared in K050597.

Optional accessories common to both Engström Carestation and Engström Pro include a trolley/cart, integrated air compressor, support arm, humidifier and water trap mounting brackets, and a data capture accessory. Additional optional accessories specific to the Engström Carestation include airway modules, intratracheal pressure sensor, auxiliary electrical outlets, and module bay. Optional functionality specific to the Engström Carestation includes integrated respiratory gas monitoring, capabilities to measure SpiroDynamics via a GE supplied intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/Wash Out method. The integrated respiratory gas monitoring is provided via the Datex-Ohmeda Gas Modules, M-C. M-COV. M-COVX, M-CaiO, M-CAiOV, M-CAiOVX, rev 3.2 software and higher (K001814), E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV, E-CAiOVX (K051092), or M-Mini-CO2 Module (K023454) or E-MiniC module (K052582) which are physically integrated into the Engström Carestation, receive electronic power from the Engström Carestation and communicate measured values to the Engström Carestation for display on the system display unit.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators.

This 510(k) submission (K140575) is primarily for the addition of an alternate integrated air compressor (EVair) to the existing GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators, which were previously cleared under K111116. The submission states "There have been no changes to the intended use or fundamental scientific technology." and "The addition of the alternate compressor, EVair, does not affect the safe or effective use of the ventilator as the compressor interfaces with the ventilator in the same manner, and performs in an equivalent manner. There is no change to the Engstrom performance as a result of this change." Consequently, the acceptance criteria and studies focus specifically on the new compressor and its functional equivalence, rather than a broad re-evaluation of the entire ventilator system.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) (adding an alternate component), the acceptance criteria are framed around functional equivalence and safety of the new EVair compressor compared to the predicate EVair03.

Acceptance Criteria Category	Specific Criteria (Expected Performance)	Reported Device Performance (Engström Carestation and Engström Pro with EVair)
Intended Use	Identical to the predicate device (Engstrom 7.x - K111116): Mechanical ventilation for adults and pediatrics (5kg+), optional neonatal (0.25kg+). Microprocessor-based, electronically controlled, pneumatically driven. Integrated FiO2, airway pressure, spirometry, volume monitoring, Aerogen Aeroneb nebulizer, data capture accessory, integrated air compressor. Integrated respiratory gas monitoring (Carestation only), SpiroDynamics, FRC calculation (Carestation only). For facility use.	Confirmed to be identical to the predicate Engstrom 7.x (K111116) Indications for Use, with only a textual change in reference to the product name. No change to the intended use.
Ventilation Modes	Identical to the predicate device (Engstrom 7.x - K111116) list of 12 ventilation modes, including VCV, PCV, PCV-VG, SIMV-VC, SIMV-PC, SIMV-PCVG, Bi-level, CPAP/PSV, Apnea backup, NIV, Infant Nasal CPAP, and Volume Guarantee/PS.	Confirmed to be identical to the predicate Engstrom 7.x (K111116). No change to the ventilation modes.
Ventilator System Software	Minor software updates only, with no change to the features or function of the ventilator. (Version 7.X)	Version 7.X. Minor software updates only have been made with no change to the features or function of the ventilator. Considered substantially equivalent.
Optional Integrated Air Compressor Functionality	Functionally equivalent to the predicate (EVair03) such that it does not affect the safe or effective use of the ventilator.	Verification has demonstrated that the EVair compressor is functionally equivalent to the predicate EVair03 compressor. The compressor interfaces with the ventilator in the same manner. This results in no change to the Engstrom performance.
Air Compressor: Transition to Backup Air Supply	Pneumatic control to switch from standby to reserve air supply. Backup operation begins when pipeline pressure drops below 250 kPa (36.3 psi) [for predicate EVair03]. Pressure values should fall within the Engstrom ventilator specifications.	Software control to switch from standby to reserve air supply. Backup operation begins when pipeline pressure drops below 280 kPa (40.6 psi), which is a factory set-point but can be adjusted by trained service personnel. The backup operation of the EVair is substantially equivalent to the predicate EVair03. Pressure values still fall within the Engstrom ventilator specifications. No functional change to the Engstrom Ventilator; the EVair has been verified to be functionally equivalent to the EVair03 compressor.
Safety and Performance (New Compressor)	Compliance with applicable standards (e.g., electrical safety, EMC, performance standards for ventilators), risk analysis, software validation. The compressor should exhibit improvements in acoustics, vibration, and thermal dissipation compared to the predicate.	Thoroughly tested through verifications and validation, including software validation. Verification of compliance with applicable standards has been completed. Risk Analysis, Requirements/Specification Reviews, Design Reviews, Testing on unit level, Integration testing, Performance Testing (Verification), and Safety Testing (Verification) were applied. The EVair compressor contains improvements in acoustics, vibration, and thermal dissipation.

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

The provided document describes nonclinical testing only.

Sample Size: The document does not specify a quantitative "sample size" in terms of units tested for the compressor, nor does it refer to patient data. Testing appears to be on developmental units of the EVair compressor integrated with the Engström ventilators.
Data Provenance: The testing was "nonclinical," meaning it did not involve human patients. It was conducted by the manufacturer, Datex-Ohmeda, Inc. (GE Healthcare). There is no mention of country of origin for specific test data, but the company is based in Madison, WI, USA. The testing is prospective in the sense that it evaluates a newly designed component (EVair compressor) before its market release.

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

The concept of "ground truth established by experts" is not directly applicable here as this is a nonclinical engineering and functional equivalence study for a medical device component.
The ground truth for this type of evaluation is typically defined by engineering specifications, regulatory standards (e.g., ISO, IEC for medical electrical equipment), and the performance characteristics of the legally marketed predicate device.
The "experts" involved would be the manufacturer's engineers, quality assurance personnel, and regulatory specialists who designed, tested, and evaluated the device against these objective criteria. Their qualifications would stem from their professional expertise in medical device development, testing, and regulatory requirements.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where consensus or a tie-breaking mechanism is needed to establish a "true" label.
This submission describes nonclinical engineering testing. Therefore, such adjudication methods are not applicable. The results of the tests (e.g., pressure measurements, acoustic levels, vibration, thermal performance, software function) are objective, quantitative data compared against predefined specifications and predicate performance.

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

No, an MRMC comparative effectiveness study was not done.
MRMC studies are clinical studies designed to evaluate the diagnostic performance of human readers, often comparing performance with and without an AI-assisted device.
This 510(k) submission is for an alternate component (air compressor) of a ventilator, not a diagnostic AI device. The submission explicitly states: "The modifications made to the Engström ventilator did not require clinical testing."

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

This question is framed for AI/algorithm-based devices. The Engström Carestation and Engström Pro are physical medical devices (ventilators) with microprocessor control, not standalone AI algorithms.
The "standalone performance" of the EVair compressor itself was evaluated during its design and verification to meet engineering specifications (acoustics, vibration, thermal dissipation) and then its integrated performance with the ventilator system was verified. This can be considered the equivalent of a "standalone" functional test for the component.

7. The Type of Ground Truth Used

For this nonclinical submission, the ground truth is based on:
- Engineering Specifications: Detailed technical requirements for component performance (e.g., pressure ranges, flow rates, alarm thresholds, acoustic limits, vibration levels, thermal profiles).
- Regulatory Standards: Compliance with relevant national and international standards for medical devices, particularly continuous ventilators (e.g., 21 CFR 868.5895, ISO, IEC standards).
- Predicate Device Performance: The demonstrated safe and effective performance of the previously cleared predicate device (Engstrom Ventilator K111116 and its EVair03 compressor). The new EVair compressor was evaluated against the functional performance of the EVair03.

8. The Sample Size for the Training Set

This question is relevant for machine learning or AI models.
Not applicable. This submission is for a physical medical device and its component, not an AI model requiring a training set.

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

Not applicable, as there is no training set for an AI model in this submission.

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K Number

K133576

Device Name

MONITOR B40

Manufacturer

Date Cleared

2014-02-21

(93 days)

Product Code

MHX,BZQ,CBQ,CBR,CBS,CCK,CCL,DQA,DRT,DSB,DSK,DXN,FLL,GWQ,NHO,NHP,NHQ

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K052582,K123195,K061907

Intended Use

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

The Monitor B40 is not intended for use during MRI.

The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network.

The Monitor B40 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 during 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 rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

Device Description

The proposed Monitor B40V2.1 still is a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2 (K130584) and now includes supporting for an additional optional extension module Airway Gas Option (N-CAiO), and few software improvements by adding alarm breakthrough, extending the upper limit of ECG PVC (Premature Ventricular Contraction) alarm and providing four waveform scale options for Masimo SpO2 and Nellcor SpO2. Same as the predicate Monitor B40V2 (K130584), the proposed Monitor B40V2.1 continues interfacing with following optional extension modules: E-MiniC module (K052582), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and E-Entropy module (K061907). The compatibility with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) is also provided but with spirometry function disabled.

The proposed Monitor B40V2.1 still has a 12.1 inch LCD display but is from different LCD manufacturer and LCD backlight is changed from CCFL to LED due to RoHS compliance.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 still includes features and subsystems that are optional or configurable. The proposed Patient Monitor B40V2.1 will continue interfacing to a variety of existing central station systems via a cabled network interface.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 keeps 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a multi-parameter patient monitor (Monitor B40V2.1) and its substantial equivalence to a predicate device, the Monitor B40V2 (K130584).

Here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics for an AI/algorithm. Instead, the "acceptance criteria" are implied by the determination of "substantial equivalence" to a predicate device. The performance is assessed based on whether the changes made to the device have a significant impact on its ability to obtain patient measurements.

Acceptance Criteria (Implied)	Reported Device Performance
No significant impact of design changes on the device's ability to obtain patient measurements.	"The design changes made to the proposed Monitor B40V2.1 have no effect on the device's ability to obtain patient measurements as there are no changes to the parameter measuring hardware."
Related risks re-evaluated and found to be unchanged.	"To assess if the changes had any significant impact to the device, all related risks were re-evaluated and found to be unchanged."
Device is as safe and effective as the predicate device.	"GE Healthcare considers the proposed Monitor B40V2.1 to be as safe, as effective, and performance is substantially equivalent to the predicate device."

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

The document explicitly states: "The proposed Monitor B40V2.1 did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size and no data provenance mentioned for a clinical study related to this specific device (B40V2.1). The evaluation was based on non-clinical tests and a comparison to the predicate device.

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

Since no clinical studies were performed for the B40V2.1, there were no experts used to establish ground truth for a test set. The evaluation relies on the established safety and efficacy of the predicate device and the non-clinical assessment of the changes.

4. Adjudication method for the test set:

As no clinical test set was used, there was no adjudication method employed.

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 MRMC comparative effectiveness study was done as this device is a multi-parameter patient monitor, not an AI or imaging diagnostic tool that would typically involve human "readers" in the context of AI assistance. The focus is on the device's ability to continuously monitor physiological parameters.

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

The device is a standalone multi-parameter patient monitor, meaning it operates to collect and display physiological data. However, the evaluation described is not a "standalone algorithm performance" study in the typical sense of AI, but rather a demonstration of the device's inherent functionality as a medical instrument. No specific algorithm-only performance study details are provided beyond the statement that "there are no changes to the parameter measuring hardware."

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

For the specific device (Monitor B40V2.1), no explicit ground truth based on expert consensus, pathology, or outcomes data was used because clinical studies were not required. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety of the predicate device (Monitor B40V2) and the assessment that the changes introduced did not alter these fundamental aspects. The non-clinical tests (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) are intended to ensure the device performs as intended and meets relevant standards.

8. The sample size for the training set:

Not applicable. This document describes a traditional medical device (patient monitor) and its modifications, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable for the same reason as above.

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K Number

K130584

Device Name

MONITOR B40

Manufacturer

Date Cleared

2013-06-26

(113 days)

Product Code

MHX,BZQ,CBQ,CBR,CBS,CCK,CCL,DQA,DRT,DSB,DSK,DXN,FLL,GWQ,NHO,NHP,NHQ

Regulation Number

Type

Traditional

Panel

Reference & Predicate Devices

K061907,K123195,K052582,K120598,K102239

Intended Use

The Monitor B40 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 Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 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 during 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.

Device Description

The proposed Monitor B40V2 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40V1 (K120598) platform. The proposed Monitor B40V2 provides additional support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) compared with predicate Monitor B40V1 (K120598). The proposed Monitor B40V2 is also compatible with CARESCAPE Respiratory modules (E-sCOV and EsCAiOV)(K123195) but with disabled spirometry function. The proposed Monitor B40V2 utilizes the existing 12 inch LCD display with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed Monitor B40V2 will continue to interface with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40V1, the proposed Monitor B40V2 includes features and subsystems that are optional or configurable. The proposed Monitor B40V2 interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V1, the proposed Monitor B40V2 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.

AI/ML Overview

This document describes the GE Monitor B40V2, a multi-parameter patient monitor. The primary focus of the provided text regarding acceptance criteria and studies is on the SpO2 accuracy performance for the neonatal patient population.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifically mentions an SpO2 accuracy performance study for the neonatal population. However, it does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges or statistical thresholds) within the provided text. It only reports that the study "demonstrated SpO2 accuracy performance."

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance
(Specific SpO2 accuracy threshold for neonates, e.g., ±X% saturation)	SpO2 accuracy performance of the TruSignal V2 technology was demonstrated on the neonate population.

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

Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Neonatal patient population" for the clinical study.
Data Provenance: Not explicitly stated in the provided text regarding country of origin. The study was a "Clinical study of the GE SpO2 TruSignalV2 on Neonatal patient population." It is described as a prospective study since it was a "clinical study" performed "in accordance to ISO 14155-1, ISO14155-2, ISO9919 and FDA Guidance."

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

Not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

Not explicitly stated in the provided text.

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

No, an MRMC comparative effectiveness study was not done. The study described is a clinical study for SpO2 accuracy in neonates, not a comparison of human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done. The clinical study was performed to demonstrate the "SpO2 accuracy performance of the TruSignal V2 technology on the neonate population," which implies an evaluation of the algorithm's performance independent of human interpretation.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy study would typically be established by a co-oximeter or a reference device known to precisely measure arterial oxygen saturation (SaO2) from blood samples. While not explicitly stated as "co-oximetry," clinical studies for SpO2 accuracy universally rely on such reference measurements.

8. The Sample Size for the Training Set

Not applicable/Not stated. The document refers to a clinical study for performance demonstration, not the training of an AI algorithm. The device primarily consists of a "TruSignal V2 algorithm" which is likely a fixed, developed algorithm, not one that undergoes continuous training in the context described.

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

Not applicable/Not stated. As above, this document describes performance testing of a developed algorithm, not the training phase.

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K Number

K122253

Device Name

PROCARE MONITOR B20

Manufacturer