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The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, 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 B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner.

The monitor B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes.

The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI.

The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network.

The monitor B105M, B125M, B155M, B105P and B125P monitor and display: 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 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), Cardiac Output (C.O.), Entropy, neuromuscular transmission (NMT) and Bispectral Index (BIS).

The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, 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.

The proposed monitors B105M, B125M, B155M, B105P and B125P are new version of multi-parameter patient monitors developed based on the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490) to provide additional monitored parameter Bispectral Index (BIS) by supporting the additional optional E-BIS module (K052145) which used in conjunction with Covidien BISx module (K072286).

In addition to the added parameter, the proposed monitors also offer below several enhancements:

• Provided data connection with GE HealthCare anesthesia devices to display the parameters measured from anesthesia devices (Applicable for B105M, B125M and B155M).
• Modified Early Warning Score calculation provided.
• Separated low priority alarms user configurable settings from the combined High/Medium/Low priority options.
• Provided additional customized notification tool to allow clinician to configure the specific notification condition of one or more physiological parameters measured by the monitor. (Applicable for B105M, B125M and B155M).
• Enhanced User Interface in Neuromuscular Transmission (NMT), Respiration Rate and alarm overview.
• Provided Venous Stasis to assist venous catheterization with NIBP cuff inflation.
• Supported alarm light brightness adjustment.
• Supported alarm audio pause by gesture (Not applicable for B105M and B105P).
• Supported automatic screen brightness adjustment.
• Supported network laser printing.
• Continuous improvements in cybersecurity

The proposed monitors B105M, B125M, B155M, B105P and B125P retain equivalent hardware design based on the predicate monitors and removal of the device Trim-knob to better support cleaning and disinfecting while maintaining the same primary function and operation.

Same as the predicate device, the five models (B105M, B125M, B155M, B105P and B125P) share the same hardware platform and software platform to support the data acquisition and algorithm modules. The differences between them are the LCD screen size and configuration options. There is no change from the predicate in the display size.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P are multi-parameter patient monitors, utilizing an LCD display and pre-configuration basic parameters: ECG, RESP, NIBP, IBP, TEMP, SpO2, and optional parameters which include CO2 and Gas parameters provided by the E-MiniC module (K052582), CARESCAPE Respiratory modules E-sCO and E-sCAiO (K171028), Airway Gas Option module N-CAiO (K151063), Entropy parameter provided by the E-Entropy module (K150298), Cardiac Output parameter provided by the E-COP module (K052976), Neuromuscular Transmission (NMT) parameter provided by E-NMT module (K051635) and thermal recorder B1X5-REC.

The proposed monitors B105M, B125M, B155M, B105P and B125P are not Apnea monitors (i.e., do not rely on the device for detection or alarm for the cessation of breathing). These devices should not be used for life sustaining/supporting purposes. Do not attempt to use these devices to detect sleep apnea.

As with the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P also can interface with a variety of existing central station systems via a cabled or wireless network which implemented with identical integrated WiFi module. (WiFi feature is disabled in B125P/B105P).

Moreover, same as the predicate monitors B105M, B125M, B155M, B105P and B125P (K213490), the proposed monitors B105M, B125M, B155M, B105P and B125P include features and subsystems that are optional or configurable, and it 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 FDA 510(k) clearance letter and summary for K242562 (Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P) do not contain information about specific acceptance criteria, reported device performance metrics, or details of a study meeting those criteria for any of the listed physiological parameters or functionalities (e.g., ECG or arrhythmia detection).

Instead, the documentation primarily focuses on demonstrating substantial equivalence to a predicate device (K213490) by comparing features, technology, and compliance with various recognized standards and guidance documents for safety, EMC, software, human factors, and cybersecurity.

The summary explicitly states: "The subject of this premarket submission, the proposed monitors B105M/B125M/B155M/B105P/B125P did not require clinical studies to support substantial equivalence." This implies that the changes introduced in the new device versions were not considered significant enough to warrant new clinical performance studies or specific quantitative efficacy/accuracy acceptance criteria beyond what is covered by the referenced consensus standards.

Therefore, I cannot provide the requested information from the given text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists numerous standards and tests performed, but not specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not explicitly stated for performance evaluation, as clinical studies were not required. The usability testing mentioned a sample size of 16 US clinical users, but this is for human factors, not device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance studies requiring expert ground truth are not described.
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 device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "Bench testing related to software, hardware and performance including applicable consensus standards," which implies standalone testing against known specifications or simulated data. However, specific results or detailed methodologies for this type of testing are not provided beyond the list of standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated for performance assessment. For the various parameters (ECG, NIBP, SpO2, etc.), it would typically involve reference equipment or validated methods as per the relevant IEC/ISO standards mentioned.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that would require explicit training data in the context of this submission.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on demonstrating that the new monitors are substantially equivalent to their predicate through feature comparison, adherence to recognized standards, and various non-clinical bench tests (e.g., hardware, alarms, EMC, environmental, reprocessing, human factors, software, cybersecurity). It does not contain the detailed performance study results and acceptance criteria typically found for novel diagnostic algorithms or AI-driven devices.

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Mac-Lab:
The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements which may then be displayed and/or transmitted.

CardioLab:
The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements which may then be displayed and/or transmitted.

ComboLab:
The ComboLab system is indicated for use on patients of all ages when a physician determined that a patient would benefit from either a hemodynamic or electrophysiology procedure. Combol ab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements which may then be displayed and/or transmitted.

MLCL Client Software:
The MLCL Client Software is intended for recording, documenting and/or reviewing clinical data for hemodynamic and electrophysiology procedures and may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.

Mac-Lab and CardioLab are hemodynamic and electrophysiology (EP) recording systems, respectively. A third configuration, ComboLab, allows the user to access both CardioLab and Mac-Lab functions, though only one application may be accessed at a time.

These devices are used during interventional and related procedures to process, display and record hemodynamic and electrophysiology (EP) data depending on the type of procedure performed. The data is acquired and displayed real-time for multiple physiological parameters to allow the user to view the data. The data may be entered manually through the use of a dedicated keyboard/mouse/barcode scanner or acquired via procedural information devices, imaging devices and interfaced data devices, and may then be displayed, filtered, digitized, amplified, measured, and calculated.

A fourth configuration, called the MLCL Client Software, is the core Mac-Lab and CardioLab application software which is available for installation on a stand-alone workstation (i.e. outside of the Mac-Lab/CardioLab/ComboLab acquisition systems described above). The MLCL Review Software may be used to record, document, analyze, store and transmit data, including data from supported patient monitors.

Mac-Lab, CardioLab, ComboLab and the MLCL Client Software provide the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity but may also be used stand-alone (not connected to a network).

Mac-Lab, CardioLab, ComboLab and the MLCL Client Software are not intended to be used as a patient monitor and are not intended to alert the licensed health care practitioner of a change in patient status.

The provided text is a 510(k) summary for the GE Healthcare Mac-Lab, CardioLab, ComboLab, and MLCL Client Software AltiX AI.i. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of, for example, diagnostic performance metrics (sensitivity, specificity, AUROC).

The changes described in this 510(k) are related to:

• Introduction of a new version of the EP amplifier.
• Updates to signal filtering and gain.
• Inclusion of opSens/HAEMONETICS Diastolic Pressure Ratio (dPR™).
• Introduction of PruckaStream.
• Utilization of Barco Nexxis OR™ for video distribution.

These are technical modifications to existing systems that process and display physiological data, not an AI/ML algorithm that provides a diagnostic output requiring specific performance metrics like sensitivity or specificity. Therefore, the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets them (typically relevant for AI/ML diagnostic devices) is largely not applicable in the traditional sense for this submission.

However, based on the non-clinical tests and statements, we can infer the "acceptance criteria" were met through compliance with recognized standards and internal quality processes.

Here's a breakdown of the requested information based on the provided text, indicating what is applicable and what is not:

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

This document does not present quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for a diagnostic AI model, nor does it report device performance against such metrics. The "performance" described is in terms of meeting electromagnetic compatibility, safety, and functionality standards.

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

Not applicable. This device is not an AI diagnostic algorithm, so there is no "test set" of patient data in the context of evaluating diagnostic performance. The testing involved non-clinical performance and safety testing against engineering and regulatory standards.

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. As this is not an AI diagnostic algorithm, there are no medical experts establishing ground truth for a test set of patient data.

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 not an AI assistance device for human readers.

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

This device does not have a "standalone algorithm" performance as it is an integrated system for recording, displaying, and transmitting physiological data. Its function is to provide accurate data to clinicians, not to make independent diagnoses.

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

Not applicable. For this type of device, "ground truth" would relate to the accuracy of signal acquisition, processing, and display against known physical inputs or validated measurement standards, rather than medical diagnostic ground truth.

8. The sample size for the training set

Not applicable. This document describes hardware and software updates to a data acquisition and display system, not a machine learning model requiring a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) submission to demonstrate device safety and effectiveness, and thus "meet acceptance criteria" for its intended purpose, is a comprehensive set of non-clinical tests and adherence to quality assurance measures.

• Non-Clinical Tests: The device and its applications were independently tested for conformity with several voluntary standards:

  • IEC 60101-1 Ed 3.2 2020-08 CONSOLIDATED VERSION (General requirements for basic safety and essential performance)
  • IEC 60601-1-2 Ed 4.1 2020-09 CONSOLIDATED VERSION (Electromagnetic disturbances - Requirements and tests)
  • IEC 60601-2-27 Ed 3.0 2011-03 (Requirements for the safety of electrocardiographic monitoring equipment)
  • IEC 60601-2-34 Ed 3.0 2011-05 (Requirements for the safety of invasive blood pressure monitoring equipment)
  • Additionally, partial applicability of IEC 80601-2-30 Ed 2.0 (Automated sphygmomanometers), IEC 80601-2-55 Second Edition (Respiratory gas monitors), IEC 80601-2-56 Second Edition (Clinical thermometers), and IEC 80601-2-61 Second Edition (Pulse oximeter equipment) was considered for specific features and functionality.

• Quality Assurance Measures: The development process followed robust quality assurance, including:

  • Risk Analysis
  • Requirements Reviews
  • Technical Design Reviews
  • Formal Design Reviews
  • Unit-level Testing (Module verification)
  • Integration Testing (System verification)
  • Performance Testing (Verification)
  • System Testing (including Safety testing and System performance testing)

Conclusion from the Submission:

The manufacturer concluded that "The testing and results did not raise new or different questions of safety and effectiveness than those associated with the predicate device." They further determined that the proposed device is "as safe, as effective and performs as well as the legally marketed predicate device" due to these non-clinical tests, software documentation for a "Basic" level of concern, and quality system processes. No clinical studies were required to support substantial equivalence.

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The Portrait VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport.

The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.

The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.

The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients.

The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

The optional Welch Allyn® SureTemp® Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.

The optional Exergen TemporalScanner thermometer is intermittent measurement of human body temperature of patients of all ages.

The optional HeTaiDa electronic infrared non-touch thermometer is intermittent measurement of human body temperature of patients of all ages.

A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.

The portable device is designed for use in hospital-type facilities. The Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings.

The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner.

The Portrait VSM vital signs monitor is not intended for use during MRI.

"Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.

The proposed Portrait™ VSM is a vital signs monitor which is developed based on primary predicate vital signs monitor VC150(K133810) with integrated NIBP and SpO2 design from a secondary predicate monitor B105M (K213490) and provided additional non-contact infrared body temperature measurement option by supporting OEM thermometer (K171888) previously cleared by FDA.
In addition to the added non-contact infrared body thermometer, the proposed monitor Portrait™ VSM also offer several enhancements:
New hardware platform
Adopted equivalent NIBP design from B105M(K213490)
Adopted equivalent SpO2 design from B105M(K213490)
Compatible with Recorder B1X5-REC
Support Round Advisor in spot check mode
Support automatically screens brightness adjustment.
Improved Early Warning Score
Addtional alarm management enhancement.
Additional cybersecurity enhancement

The proposed monitor Portrait™ VSM adopts larger 10-inch LCD touch screen with improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate monitor VC150 (K133810) while maintaining the same primary function and operation.

As with the predicate Monitor VC150 (K133810), the proposed Portrait™ VSM is Vital Signs Monitor, utilizing an LCD display and can measure the most commonly used vital signs of patient: Non-invasive Blood Pressure (NIBP), Pulse Rate (PR), Temperature (Temp), and Pulse Oxygen Saturation (SpO2).

Same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM also has three choices for SpO2 include GE TruSignal™; Nellcor™ or Masimo SET® and temperature measurement from Exergen® TemporalScanner™, and Welch Allyn® SureTemp®.

Both the predicate monitor VC150 (K133810) and the proposed monitor Portrait™ VSM can be configured to be used for Spotchecking or for continuous morning, the device can send measured patients' data to EMR (Electronic Medical Record) system by interfacing to Hospital Information Systems (HIS) over a wired or wireless network.

Moreover, same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM can be powered by battery or AC, has a carrying handle and can be placed on a shelf or table or mounted in a variety of ways using a mounting plate located on the bottom of the monitor.

The provided document is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc. Portrait VSM vital signs monitor. It describes the device, its intended use, and a comparison to predicate devices, along with summaries of non-clinical and clinical testing.

However, the document explicitly states that "the proposed monitor Portrait™ VSM did not require clinical studies to support substantial equivalence." This means there is no detailed clinical study described in this document that proves the device meets specific acceptance criteria based on human-in-the-loop performance or expert-adjudicated ground truth, as would be expected for a complex AI/ML-driven device.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through bench testing, compliance with consensus standards, and verification of hardware/software functionality, electrical safety, usability, and environmental performance.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain a study with the specific elements you've asked for related to clinical performance verification with AI/ML and human readers.

However, I can extract the acceptance criteria (in terms of standards compliance and functional equivalence) and the reported performance from the non-clinical testing described.

Here's what can be extracted and what cannot be provided given the document's content:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Equivalence Claim)

Since no clinical study was required, the "acceptance criteria" for this device's submission are primarily based on demonstrating:

1. Functional Equivalence to legally marketed predicate devices.
2. Compliance with relevant electrical safety, EMC, usability, and performance standards for vital signs monitors.
3. Verification of hardware and software specifications through bench testing.

Therefore, the table below will reflect the claimed equivalence and standards compliance as the "performance" rather than specific accuracy metrics against a clinical ground truth from a reader study.

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The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).

Physiological parameters and waveforms supported are:

• Pulse oximetry (SpO2/pulse rate)
• Respiration rate (RR)

Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.

The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

This device is not an Apnea monitor (i.e., do not rely on the device for detection of alarm for the cessation of breathing).

This device should not be used for life sustaining/supporting purposes.

The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment.

The Portrait Mobile Monitoring Solution V1.1 is a wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages.

The Portrait Mobile Monitoring Solution V1.1 consists of the following general categories of medical devices:

Central Monitoring Devices:

• Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.
• Portrait Central Viewer Application software hosted on a Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.
• Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.

Mobile Monitoring Devices:

• Portrait Mobile Patient Monitor Hardware, a battery-powered, wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarms, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). Compared to the predicate (K230626), the Portrait Mobile Patient Monitor has been split into separate hardware and software components for serviceability. The Portrait Mobile Patient Monitor Hardware is shipped with no clinical software installed. The clinical software (i.e., Portrait Mobile Patient Monitor Software) is installed at the customer site before the device is put into use. The Portrait Mobile Patient Monitor Hardware when the Portrait Mobile Patient Monitor Software is installed (prior to patient use) is then what we will refer to as the Portrait Mobile Patient Monitor. Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly.
• Portrait Mobile Patient Monitor Software is the clinical software which gets installed at the customer site on the Portrait Mobile Patient Monitor Hardware. The Portrait Mobile Patient Monitor Software is this submission is equivalent to the software installed on the predicate Portrait Mobile Patient Monitor cleared in K230626 with minor changes as discussed in this submission.
• Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly.
• Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor.
• Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use).
• Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist
• Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria in a table format. It focuses on demonstrating substantial equivalence to a predicate device, K230626 Portrait Mobile Monitoring Solution v1.0, through non-clinical testing and updates to software and standards compliance.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in a table format in the given document. The document lists "Specifications" for the proposed device and compares them to the predicate device, stating "Identical" or "Equivalent" for most technical specifications and performance characteristics, rather than specific acceptance criteria and detailed performance results from a study.

A table comparing the proposed device specifications to the predicate device is provided on pages 19-27, with "Identical" or "Equivalent" noted for each entry. The key takeaway is that the proposed device maintains the performance characteristics of the predicate.

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

The document mentions "Bench testing related to software, hardware and performance" but does not specify sample sizes for test sets.

• Sample Size for Test Set: Not specified for individual performance tests.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective for the non-clinical tests. It focuses on compliance with FDA guidance and recognized standards.

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

This information is not provided in the document for the non-clinical performance and validation tests mentioned. The document describes compliance with standards and guidance documents but does not detail the process of establishing ground truth for testing data, nor the number or qualifications of experts involved in such a process.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This type of study is not mentioned in the document. The submission explicitly states: "The Portrait Mobile Monitoring Solution v1.1 does not contain clinical testing data."

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

The document describes "SpO2 measurement," "Pulse Rate (PR) measurement," and "Impedance Respiration" for which "no changes have been made to the algorithms since K230626, only regression testing performed." This implies that the algorithms for these measurements are operating in a standalone capacity (device only), and their performance compared to the predicate device has been affirmed through regression testing. However, no specific standalone performance metrics or studies are detailed beyond this.

7. Type of Ground Truth Used

For the SpO2 and Pulse Rate measurements, the document mentions:

• "low perfusion condition (this testing covers the full accuracy range in challenging low-perfusion conditions using a simulator, proving that there has been no system regression)"

This indicates that simulators were used to establish reference data for certain conditions (low perfusion) for SpO2 and PR. For other measurements, the ground truth methodology is not explicitly specified beyond compliance with recognized standards.

8. Sample Size for the Training Set

This information is not provided. The document states that "no changes have been made to the SpO2 algorithms since K230626, only regression testing performed" and similarly for Respiration Rate algorithms. This suggests the underlying algorithms were developed and potentially trained earlier, but details of training data are absent.

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

This information is not provided, as details about training sets are omitted.

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CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used by trained operators under direct supervision of a licensed health care practitioner on adult and pediatric patients.

The CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are designed to acquire, process, record, archive, analyze and output (12 and 15 lead) ECG data during a period of physiologic stress or during a resting ECG test, acquire data from ancillary devices (such as Spirometry and Ambulatory Blood Pressure), provide median morphology recordings and record ECG in real-time with and without arrhythmia detection.

The arrhythmia detection portion of CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms.

CASE V7.0 Cardiac Testing System and Cardiac Testing System provide the control of external devices (typically a treadmill or bicycle ergometer) and communicate with centralized electronic/digital storage system via data networks.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System provide a user selectable option for printouts of prognostic scores on selected reports. Vector loops are also available.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System can be configured in a network environment for multiple CASE and CardioSoft stations allowing the user to create a central database of patient demographics and collected patient physiological data.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are intended to be used primarily in the hospital but can also be used in clinics, physician offices, outreach centers or wherever exercise, stress testing, ECG, Spirometry or ambulatory blood pressure testing is performed.

CASE V7.0 Cardiac Testing System and Cardiac Testing System offer no diagnostic opinion to the user. Instead, it provides interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended to be used as a transport device or for home use.

CASE V7.0 Cardiac Testing System and Cardiac Testing System are not intended for use as a vital signs physiological monitor.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for intracardiac use.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use as an emergency device.

CASE V7.0 Cardiac Testing System and Cardiac Testing System will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulators.

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System are not intended for use with high frequency surgical units. Disconnect the patient from CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System before using the high frequency surgical unit.

The CASE V7.0 Cardiac Testing System and the CardioSoft V7.0 Cardiac Testing System are designed to be used for resting ECG, stress test ECG, Spirometry, Ambulatory Blood Pressure and for recording ECG in real-time with and without arrhythmia detection. The CardioSoft V7.0 Cardiac Testing System will be offered as a software only package including a front end for data acquisition. The CASE V7.0 Cardiac Testing System is a turnkey product utilizing the CardioSoft V7.0 Cardiac Testing software.

This FDA 510(k) summary provides information for the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System. However, it does not contain specific acceptance criteria, reported device performance metrics tied to those criteria, or a detailed study description with sample sizes, expert qualifications, or ground truth methods related to the device's diagnostic or analytical capabilities.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (CASE Cardiac Testing System, CS Cardiac Testing System (K103678)) by comparing features and functions. It mentions compliance with performance standards but does not detail the results of performance tests in terms of specific metrics for the device itself.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's what can be gathered, addressing the points where information is available or noting its absence:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance metrics for diagnostic accuracy, sensitivity, specificity, or other analytical capabilities. Instead, it compares the proposed device's features and technical specifications to those of the predicate device, asserting "Identical" or "Equivalent" for most technical aspects.

For example, under "ECG Signal Bandwidth", the proposed device has "0.04 to 150 Hz (CC14)" compared to the predicate's "0.01 to 150 Hz (CAM 14)". The explanation notes that the proposed device complies with IEC60601-2-25:2011 requirement of 0.67 Hz to 150 Hz, implying that 0.04 Hz is within acceptable limits for capturing useful ECG data. This is a comparison to a standard, not a specific performance metric of the device against an internal acceptance criterion.

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

This information is not provided in the document. The submission states, "The subject of this premarket submission, CASE V7.0 and CardioSoft V7.0 did not require clinical studies to support substantial equivalence." This indicates that no new clinical study was conducted for this 510(k) submission to demonstrate performance with a test set of 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)

This information is not provided as no new clinical study (test set evaluation) was detailed.

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

This information is not provided as no new clinical study (test set evaluation) was detailed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed for this submission, as it explicitly states no clinical studies were required. The device provides "interpretive statements of morphology, rhythm, and conduction for which the physician renders his/her own medical opinion," implying human-in-the-loop, but the submission doesn't detail performance with or without AI assistance.

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

A standalone performance study of the algorithm (e.g., for arrhythmia detection or ECG analysis) was not detailed as part of this submission. The "arrhythmia detection portion" is described as being "provided to the user for the convenience of automatic detection of arrhythmias but do not provide alarms." The 12SL ECG Analysis Program (V23) is mentioned, which is a previously cleared component (K141963), suggesting its performance was established in its own clearance.

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

This information is not provided as no new clinical study (test set evaluation) was detailed.

8. The sample size for the training set

This information is not provided. The document describes upgrades to existing software and hardware components and relies on compliance with voluntary standards and substantial equivalence to a predicate device. There is no mention of a new "training set" in the context of machine learning, although software development would involve internal testing.

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

This information is not provided. As above, there's no mention of a new training set or ground truth establishment. The device incorporates a "12SL ECG Analysis Program (V23) (K141963)" which would have had its own ground truth established during its prior clearance.

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The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).

Physiological parameters and waveforms supported are:
· Pulse oximetry (SpO2/pulse rate)
· Respiration rate (RR)

Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.

The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

This device is not an Apnea monitor (i.e., do not rely on the device for the cessation of breathing). This device should not be used for life sustaining/supporting purposes.

The Portrait Mobile Monitoring Solution is not in a controlled Magnetic Resonance (MR) environment.

Portrait Central Viewer Application (Portrait CVA01):
The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications.

The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Core Services (Portrait CSS01):
The Portrait Core Services are a set of software services that enable the communication of the Portrait Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Monitoring Solution.

Portrait Clinical Alarming Unit (Portrait CAU01):
The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.

The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Mobile Patient Monitor (Portrait HUB01):
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.

The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait SpO2 Attachment Accessory Band (Portrait AAB01):
The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.

The Portrait Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01):
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediativ (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait RR Electrode Patch (Portrait RRP01):
The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential signals from the patient and transmits them to the wearable respiration rate sensor.

The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait RR Electrode Patch is not in a controlled Magnetic Resonance (MR) environment.

Portrait Sensor Battery (Portrait SBT01):
The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait wearable sensors and to provide wireless communication to a host device.

The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Bedside Charger (Portrait BCH01):
The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use).

The Portrait Bedside Charger is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait Mobile Patient Monitor Pouch (Portrait MMP01):
The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Mobile Patient Monitor to be carried while the patient is ambulatory.

The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Monitoring Solution is a new wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. This device is not an Apnea monitor (i.e., do not to rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. Do not attempt to use this device to detect sleep apnea.

The Portrait Mobile Monitoring Solution consists of the following general categories of medical devices:

Central Monitoring Devices:
Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.

Portrait Central Viewer Application software hosted on a . Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.

. Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.

Mobile Monitoring Devices:
Portrait Mobile Patient Monitor, a battery-powered, . wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarming, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). . Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly. . Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly. . Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor. . Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use). . Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist. . Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the GE HealthCare Portrait Mobile Monitoring Solution.

Here's an analysis structured according to your request:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for the Portrait Mobile Monitoring Solution are primarily based on performance specifications for its physiological parameters (Respiration Rate, SpO2, Pulse Rate) and its compliance with relevant medical device standards. The document provides comparison tables indicating how the proposed device's performance aligns with or is considered equivalent to predicate devices.

Key Performance Specifications and Reported Performance:

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The blood pressure cuff is an accessory used in con-invasive blood pressure measurement systems. It is non-sterile, single-patient use. It is available in pediatric and adult sizes. The cuff is not designed, sold or intended for use except as indicated.

ONE-CUF blood pressure cuffs are accessories used in conjunction with noninvasive blood pressure (NIBP) measurement systems to obtain a blood pressure measurement. Blood pressure cuffs are non-sterile and single-patient use and may not be reprocessed for use on additional patients. They are available in pediatric and adult sizes. The devices are not designed, sold or intended for use except as indicated. Blood pressure cuffs do not include serviceable parts or components. Non-Invasive Blood Pressure Cuffs incorporate an inflatable non-distensible bladder, sized to encircle a patient's limb. The cuff includes one or two flanges for attaching flexible tubing. This allows air to flow in and out of the cuff bladder for inflation and deflation. Inflation allows for occlusion of an artery to facilitate the measurement of automated noninvasive blood pressure (NIBP). The cuff tubes are terminated with connectors that allow for attachment to a blood pressure hose. This cuff will be offered with two different connection systems, bayonet and DINACLICK.

The information provided describes the ONE-CUF blood pressure cuff and its path to substantial equivalence, primarily based on non-clinical testing and comparison to a predicate device. It explicitly states that no clinical or animal studies were required to support substantial equivalence. Therefore, there is no study described that proves the device meets specific acceptance criteria related to a model's performance in a diagnostic or predictive context (e.g., accuracy, sensitivity, specificity for an AI algorithm).

The "acceptance criteria" referred to in this document are primarily related to product performance specifications and compliance with voluntary standards for a mechanical medical device, rather than the performance metrics of an AI model.

Here's an attempt to structure the answer based on the provided text, recognizing the limitations regarding AI-specific criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The reported studies are non-clinical, focusing on device performance and safety specifications rather than a diagnostic model's performance on a test set of patient data. There is no mention of a "test set" in the context of an AI algorithm or diagnostic performance.

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

Not applicable. This device is a blood pressure cuff and does not involve AI or diagnostic interpretation requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable. There is no test set for diagnostic performance or AI algorithm output.

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 device is a non-AI blood pressure cuff. No MRMC study was performed.

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

Not applicable. This device is a non-AI blood pressure cuff. No standalone algorithm performance was evaluated.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by adherence to documented test procedures, engineering specifications, and established international standards (e.g., ISO, IEC) for medical device performance and biocompatibility.

8. The sample size for the training set

Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.

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

Not applicable. This device is a non-AI blood pressure cuff. There is no training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The “study” proving the ONE-CUF meets its acceptance criteria is a compilation of non-clinical performance testing and biocompatibility testing, along with compliance with relevant voluntary standards. The documentation states:

• Non-Clinical Testing: This included evaluations for Environmental Conditioning, Leak, Pressure Capacity, Mechanical Strength, Tensile Testing, and other performance aspects. While specific results are not detailed in the summary, these tests were submitted to support substantial equivalence.
• Biocompatibility Testing: This was performed in accordance with ISO 10993-1:2018 ("Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process") and included Chemical Characterization, Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity.
• Compliance with Voluntary Standards: The device was designed and tested for compliance with IEC 80601-2-30:2018 (for automated noninvasive sphygmomanometers) and ISO 81060-1:2007 (for non-automated sphygmomanometer test methods).
• Human Factors Validation: Summative usability testing was performed.

The conclusion is that based on these non-clinical performance data, biocompatibility results, and compliance with standards, the device is considered substantially equivalent to a legally marketed predicate device (SOFT-CUF K120125). No clinical or animal studies were required or performed to support this determination.

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Mural Clinical Viewer is a patient monitoring software application intended for the electronic collection, display, trending, annotation, measurement and export of clinical data. Data is acquired from medical devices, Electronic Health Records (EHRs) and other data sources on a hospital's network. The application is designed to accept a patient selection from a host Electronic Health Record (EHR) program and then display that particular patient's data and waveforms within the EHR. The device is intended to be used by healthcare professionals in general hospital (including ICU) or remote clinical support settings while operating within a single patient's EHR.

This product does not control or alter any of the medical devices providing data across the hospital network. All information, alerts or visual indications provided are intended to support the judgement of medical professionals. The product is not a bedside patient monitor and can only receive processed signal data from a hospital network.

Mural Clinical Viewer is a software only, information management system designed to enable viewing of patient's monitoring data. The system is accessible from the Electronic Health Record (EHR) application. Its use covers near real time and retrospective display of patient vitals, waveforms and events. The system also covers documentation of patient vitals including discrete values and waveform strips.

The software is integrated with a healthcare facility's Electronic Health Records (EHR) and Medical Gateway Interface (MGI) for electronic collection, display, trending, annotation, measurement and export of clinical data. The software accessed as an integral part of the host EHR application, provides a single place to view patient monitoring data and to record documentation in EHR system without having to switch between multiple different applications and devices.

The provided text is a 510(k) summary for the GE Medical Systems Information Technologies, Inc. "Mural Clinical Viewer". It describes the device, its intended use, and comparison to a predicate device. However, it explicitly states that no clinical studies were required or performed to support substantial equivalence.

Therefore, I cannot provide the information requested regarding acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies. The document states:

"The similarities and differences between the subject device and the predicate device, were determined not to have a significant impact on the device's performance, the clinical performance, and the actual use scenarios. Therefore, the subject of this premarket submission, Mural Clinical Viewer, did not require clinical studies to support substantial equivalence."

Instead, the submission relied on non-clinical performance testing and software evaluation:

• Summary of Non-Clinical Tests: Software was evaluated according to the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
  • Developed following GE Healthcare Quality Management System.
  • Activities successfully completed: Risk Analysis/Management, Requirements Reviews, Design Reviews, Software Verification, Software Validation, Usability Testing.
  • Subject to non-clinical V&V activities:
    • Safety classification and Performance testing in accordance with IEC 62304 Edition 1.1 2015.
    • Testing in accordance with IEC 60601-1-8 Edition 2.2 2020-07 for alarm functionality.
    • Testing in accordance with IEC 60601-2-25 Edition 2.0 for basic safety and essential performance of electrocardiographs.
    • Successful completion of design verification and validation testing to confirm that software and user requirements have been met.
• Cybersecurity: Evaluated as recommended in the 2014 FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
• Interoperability: Evaluated as recommended in the 2017 FDA guidance document "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices."

Conclusion: The performance data described above demonstrates that the Mural Clinical Viewer is as safe and effective as the Mortara Monitoring Waveform Viewer and supports a determination of substantial equivalence without the need for clinical studies.

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EK12 V2 analyzes 10 or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements.
EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnosic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG.
EK 12 V2 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or physician's office.

EK12 V2 algorithm is a software only product that provides computerized measurements from the ECG parameter data acquired by the host device. EK12 V2 analyzes ECG recordings for rhythm and measurements that is deployed as part of a host system used to generate ECG reports

Here's a breakdown of the acceptance criteria and study information for the EK12 V2 Algorithm, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics from a study. Instead, it states that "The EK12 V2 Algorithm complies with the voluntary consensus standard AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms."

This implies that the acceptance criteria are the performance requirements outlined in the AAMI/ANSI EC57: 2012 standard for cardiac rhythm and ST-segment measurement algorithms. The document then asserts that the device meets these criteria by stating its compliance. However, specific numerical performance results against these criteria are not provided within the given text.

Therefore, a direct table cannot be constructed with numerical performance. The closest interpretation based on the provided text would be:

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

The document states: "The EK12 V2 Algorithm program was designed for compliance with applicable clauses of the following voluntary standard: AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms."

However, the provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) of the data used for the "Performance testing" mentioned.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications for the test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with and without AI assistance.

6. Standalone Performance Study

The document implies that standalone performance testing was conducted. It states, "Performance testing" was a quality assurance measure applied to the development of the system and that "The EK12 V2 Algorithm program was designed... for compliance with applicable clauses of the following voluntary standard: AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms." This suggests that the algorithm itself was tested against the standard.

However, specific results of this standalone performance are not detailed beyond the statement of compliance.

7. Type of Ground Truth Used

While the standard AAMI/ANSI EC57: 2012 typically involves a precise "ground truth" derived from expert review or more invasive methods for rhythm and ST-segment identification, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the testing of EK12 V2.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set.

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

The document does not provide information on how the ground truth for the training set was established.

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The MAC 5 Resting ECG Analysis System is a non-invasive prescription device.
• The device is indicated for use to acquire, analyze, display and print electrocardiograms.
• The device is indicated for use to provide interpretation of the data for consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used in conjunction with a physician overread as well as consideration of all other relevant patient data.
• The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

The MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.
The device can capture 3, 6, or 12 lead electrocardiograms, provide interpretive analysis, and print reports.
The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.
The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.

The provided text is a 510(k) summary for the GE MAC 5 A4/MAC 5 A5/MAC 5 Lite Resting ECG Analysis System. It focuses on demonstrating substantial equivalence to a predicate device (MAC 7 Resting ECG Analysis System) and a reference device (ELI 380 - 12 Lead Resting ECG). The documentation does not contain specific acceptance criteria and performance data for the device's diagnostic capabilities, nor does it detail a study proving the device meets particular acceptance criteria related to its interpretive analysis.

The document primarily focuses on explaining that the device is substantially equivalent to existing devices based on technical specifications, intended use, indications for use, and a comparison of features. It explicitly states, "The subject of this premarket submission, MAC 5 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I describe a study that proves the device meets those criteria, as such information related to diagnostic performance is not present.

However, I can extract information related to the device's characteristics and the comparison to predicate/reference devices:

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

The document does not provide specific acceptance criteria (e.g., sensitivity, specificity, accuracy for disease detection) for the interpretive ECG analysis, nor does it report the device's performance against such criteria. The "performance" discussed is in terms of feature functionality and technical specifications being "substantially equivalent" to predicate devices.

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

This information is not provided in the document. The submission states that clinical studies were not required to support substantial equivalence.

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)

This information is not provided. Since no clinical studies were deemed necessary, there is no mention of a test set with expert-established ground truth.

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

This information is not provided.

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 mentioned. The submission states that clinical studies were not required. The device provides "interpretation of the data for consideration by a physician" and "is not intended as a sole means of diagnosis," indicating it's an assistive tool, but no study validating its impact on human reader performance is presented here.

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

No standalone performance study of the interpretive algorithm (12SLTM analysis algorithm v24) is detailed in this document. The focus is on the substantial equivalence of the overall system.

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

This information is not provided.

8. The sample size for the training set

The document does not provide information about the training set for the 12SLTM analysis algorithm. It only mentions that the proposed device uses "12SLTM analysis algorithm (v24)" (which is an updated version of the algorithm used in the predicate device, v23.1). It states "No changes to the interpretive statements of the 12SLTM analysis algorithm (v24) under K141963 and compared to the predicate device. The changes introduced with the 12SLTM (v24) do not impact the ECG analysis (measurement or accuracy) of the algorithm." This suggests the algorithm itself has been previously validated, but details are not in this document.

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

This information is not provided in this document.

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