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The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:

· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),

· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.

The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Contraindications for using CARESCAPE B650:

The CARESCAPE B650 is not intended for use in a controlled MR environment.

CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 includes features and subsystems that are optional or configurable.

The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE B650 patient monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance. Therefore, the information requested in your prompt is largely not available within this document.

Here's a breakdown of what can and cannot be extracted based on the provided text:

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the format you requested. It states: "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications." This is a general statement about testing without specific criteria or performance metrics.

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 document mentions "Bench testing related to software, hardware and performance," but does not detail the nature of the test sets, their size, or their origin.

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 this is a 510(k) submission for a patient monitor, the primary evidence relies on engineering and performance testing against established standards, not typically on expert consensus for "ground truth" in the way it might be for an AI diagnostic device.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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 done, and it is not applicable to this submission. The device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence."

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" and "Software testing included software design, development, verification, validation and traceability." This implies standalone testing of the device's algorithms and functionality. However, specific details about the results of such standalone performance are not provided in a quantifiable manner against acceptance criteria.

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

Given the nature of the device (a multi-parameter patient monitor), "ground truth" would likely be established through:

• Reference measurement devices/standards: For parameters like ECG, blood pressure, oxygen saturation, temperature, etc., the device's measurements would be compared against validated reference devices or established physical standards.
• Simulated physiological signals: For arrhythmia detection, the device would be tested with simulated ECG waveforms containing known arrhythmias.

However, the specific types of "ground truth" used are not explicitly elaborated beyond "bench testing" and "applicable consensus standards."

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of a patient monitor's 510(k) submission unless specific machine learning algorithms requiring training data were a novel aspect of the submission, which is not indicated here. The document describes modifications to software and hardware, implying updates to existing functionalities rather than the introduction of new, data-trained AI models.

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

This information is not provided and is not applicable for the reasons stated in point 8.

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The CARESCAPE B850 is a multi-parameter patient monitor intended for use in multiple areas within a professional healthcare facility.

The CARESCAPE B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B850 is indicated for monitoring of:

• · hemodynamic (including ECG, ST segment, arthythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
• · respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
• · neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.

The CARESCAPE B850 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B850 also shows alarms from other ECG sources.

The CARESCAPE B850 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.

The CARESCAPE B850 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.

Contraindications for using the monitor

The CARESCAPE B850 is not intended for use in a controlled MR environment.

CARESCAPE B850 is a new version of a modular multi- parameter patient monitoring system. The monitor includes a separate 19-inch touchscreen display, the central processing unit (also called CPU), the CARESCAPE Software, and a module frame F5 or F7. CARESCAPE B850 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition modules for patient monitoring. In addition, the F5 module frame has five module slots, and the F7 module frame has seven module slots where patient data acquisition modules (E-Module type), can be connected to perform patient monitoring. The CARESCAPE B850 includes features and subsystems that are optional or configurable.

This looks like a 510(k) summary for the GE Healthcare CARESCAPE B850 patient monitor. I will extract information related to the acceptance criteria and study that proves the device meets them.

Based on the provided text, the CARESCAPE B850 is a multi-parameter patient monitor. The 510(k) submission is for a new version with updated software and minor hardware modifications. The submission refers to a primary predicate device, also named CARESCAPE B850 (K191323), and additional predicate/reference devices for specific parameters (INVOS PM7100 and MASIMO RADICAL Y PULSE CO-OXIMETER).

The key takeaway is that the device did not require clinical studies to support substantial equivalence because it is a modified version of an already cleared device and incorporates previously cleared parameters. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical bench testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the new CARESCAPE B850 compared to a specific threshold. Instead, it relies on the concept of substantial equivalence to a predicate device.

The "acceptance criteria" are implied to be that the performance of the new device is "as safe, as effective, and the performance to be substantially equivalent to the predicate device." The reported "device performance" is primarily that it passed various non-clinical tests.

Implied Acceptance Criteria (based on substantial equivalence concept):

Note: The document states that the fundamental function and operation of the proposed CARESCAPE B850 monitor are unchanged compared to its predicate (K191323), except for the addition of an E-musb Interface module and the capability to display previously cleared hemodynamic parameters from OEM devices (regional oxygen saturation and total hemoglobin concentration).

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "bench testing related to software, hardware and performance." This typically involves testing prototypes or production units, but a "sample size" in the context of patient data is not applicable here as no clinical studies were performed for this submission.
• Data Provenance: Not applicable, as no external data (e.g., patient data from a specific country, retrospective or prospective) was used for this 510(k) submission to demonstrate substantial equivalence. The testing was internal bench testing.

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

• Number of Experts: Not applicable. For bench testing of hardware and software, "ground truth" is typically established by engineering specifications, validated test protocols, and adherence to consensus standards, rather than expert clinical consensus on patient data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept applies to clinical studies where discrepancies in observations or diagnoses need to be resolved. For bench testing, test results are typically compared against predefined specifications.

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: No. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers. The new version mostly focuses on software updates, minor hardware changes, and display of previously cleared parameters from other OEM devices.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The core functionality of the device (e.g., ECG, arrhythmia detection, various physiological measurements) operates in a "standalone" fashion in that the algorithms process patient data collected by the sensors. The document doesn't detail specific "algorithm-only" performance metrics as would be seen for a novel AI algorithm. Instead, it relies on the previous clearance of the predicate device and the fact that the algorithms (like EK-Pro arrhythmia detection algorithm V14) are identical. The newly added parameters (regional oxygen saturation and total hemoglobin concentration) are sourced from OEM devices that would have their own standalone performance data from their original clearances.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical bench testing, the ground truth would be the engineering specifications of the device and adherence to relevant consensus standards (e.g., for electromagnetic compatibility, electrical safety, environmental performance). For the physiological parameters, the "ground truth" for the algorithms (e.g., arrhythmia detection) was established during the development and clearance of the predicate device (K191323) and the OEM devices for rSO2 and SpHb.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As this is not an AI/ML device that requires a distinct "training set" for model development for this 510(k) submission, this information is not relevant here. The update involves existing algorithms and integration of existing cleared parameters.

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

• How Ground Truth for Training Set Was Established: Not applicable, for the same reason as point 8.

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CARESCAPE ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. CARESCAPE ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the CARESCAPE ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, functional oxygen saturation [SpO2]) - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, it provides the following physiological parameters to the host monitor: - · ECG (heart rate, ST segment, and arrhythmia detection) - · Pulse oximetry (pulse rate, function [SpO2], and total hemoglobin concentration [SpHB]] - · Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) - · Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) - · Regional oxygen saturation (rSO2) - · Temperature - · Respiratory carbon dioxide (EtCO2, FiCO2, and respiration rate) - · Impedance respiration When the CARESCAPE ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on CARESCAPE ONE. CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for nonitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the proper use of the equipment in a professional healthcare facility. Contraindications for using CARESCAPE ONE: The CARESCAPE ONE is not intended for use within a controlled MR environment.

CARESCAPE ONE belongs to the CARESCAPE patient monitor family. The concept of the CARESCAPE ONE is to provide a flexible bedside monitor that can also be used during intra-hospital transport. The flexibility of the CARESCAPE ONE allows the user to configure the monitor's vital sign acquisition for only the parameters they require. This is achieved using plug and play Active Cable Modules (ACM) that connect via medical grade USB ports on the CARESCAPE ONE monitor. Note that the USB ports are not compatible with commercial USB items on the market due to a custom connector design. Each ACM is dedicated to measuring a particular vital sign, currently there are ECG/Respiration, Invasive Blood Pressure, Temperature, SpO2, CO2, and rSO2 (rSO2 monitoring is only supported when CARESCAPE ONE is operating as an acquisition device. rSO2 values are not displayed on CARESCAPE ONE). The only exception is the Non-Invasive Blood Pressure (NIBP) measurement which does not require a separate ACM since the capability to measure NIBP is built-in to the CARESCAPE ONE monitor itself. CARESCAPE ONE provides the users the acquired display values, waveforms, alarms and status messages in compact footprint monitor that runs on an internal battery as well as AC power when connected to the docking station. When connected to a compatible host monitor, CARESCAPE ONE operates as an acquisition device. In this mode, CARESCAPE ONE screen and user interface is effectively disabled and it transmits data received form the Active Cable Modules to the host monitor, which is responsible for managing clinical configuration settings, and displaying values, waveforms, alarms, and status messages.

The provided text is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc.'s CARESCAPE ONE device. It outlines the device's characteristics, intended use, and a comparison to a predicate device (K200494). However, it explicitly states that clinical studies were not required to establish substantial equivalence for this submission.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, specifically in the context of human reader performance or ground truth established by experts beyond what is implied by general device performance testing. The focus of this 510(k) submission is on demonstrating substantial equivalence to a previously cleared device through non-clinical bench testing, not through a clinical study involving human readers and a robust ground truth determination process.

Here's what can be extracted from the document regarding "acceptance criteria" and "device performance" in a general sense, based on the non-clinical tests performed:

Summary of Non-Clinical Tests and Implied Acceptance Criteria:

The non-clinical tests performed demonstrate that the device meets its own specifications and relevant consensus standards. The "acceptance criteria" implicitly refer to compliance with these standards and the device's design specifications.

Implied Acceptance Criteria and Reported Device Performance (based on Non-Clinical Tests):

Here's why the other requested information cannot be provided from this document:

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

  • This document focuses on non-clinical bench testing and compliance with standards. It does not mention clinical test sets, patient data, country of origin, or retrospective/prospective study design.

• 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)

  • No clinical user studies are mentioned that would require ground truth established by experts.

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

  • Not applicable as there are no clinical test sets or expert reviews mentioned for adjudication.

• 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

  • The document explicitly states: "Clinical studies of the CARESCAPE ONE device performance were not required to establish substantial equivalence." Therefore, no MRMC study or AI assistance effect size is discussed.

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

  • While the device has algorithms (e.g., EK-Pro arrhythmia algorithm), the document focuses on the device's performance in meeting safety and compatibility standards, not on a standalone algorithm's performance where "human-in-the-loop" is a distinct variable to be tested. The algorithms themselves are "identical" to the predicate, implying their performance was previously accepted.

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

  • Not relevant to the non-clinical bench testing described. Ground truth is not established in the context of clinical accuracy for this submission.

• 8. The sample size for the training set

  • The document does not describe the development or training of any AI/ML components or algorithms. It states that the measurement algorithms are "identical" to the predicate, suggesting they were already developed and validated.

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

  • Not applicable as there is no mention of a training set or its associated ground truth.

In summary, this 510(k) submission for the CARESCAPE ONE device relies on demonstrating "substantial equivalence" to a previously cleared predicate device (K200494) through non-clinical bench testing and adherence to recognized standards, rather than new clinical studies involving human performance or ground truth established by experts.

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The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals > 2.5 kg at risk for reduced-flow or no-flow ischemic states. For patients ≤ 2.5kg, the INVOS™ Patient Monitor, model PM7100 is only intended for adjunct trend monitoring of regional hemoglobin oxygen saturation of blood tissue beneath the sensor.

It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood tissue beneath the sensor in any individual.

The INVOS™ Pediatric rSO2 sensor is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing greater than 4 kg and less than 40 kilograms. This sensor is only intended to be used with INVOS™ PM7100 system with INVOS™ Near Infrared Spectroscopy (NIRS) technology. For additional information regarding setup and use of the INVOS™ PM7100 System including indications for use, contraindications, warnings and cautions, consult the Monitoring System Operator's Manual.

The INVOS™ OxyAlert NIRSensor disposable sensor Model IS is indicated for single patient use when cerebrallsomatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing > 2.5 kilograms and

The INVOS™ PM7100 Patient Monitor is a cerebral/somatic tissue oximeter intended for use as an adjunct trend monitor of regional hemoglobin and oxygen saturation monitoring. The monitor utilizes a near infrared diffuse reflectance spectroscopy system employing near infrared light at four wavelengths for the adult and pediatric system configurations. One pair of wavelengths is used to estimate the percentage of hemoqlobin saturated with oxygen in tissue beneath the sensor; another pair of wavelengths is used for the sensor on/off detection algorithm. The infant system configuration currently only employs the two wavelengths needed to estimate regional oxygenated hemoglobin.

The subject device is non-sterile and consists of a multi-channel touch screen display, preamplifier, cables, and three single use sensor types for use in the adult (PMSENS71-A; cleared in K182868), pediatric (PMSENS71-P; new to subject device), and infant (IS; new to subject device) populations.

The subject device utilizes up to four detachable sensors to collect signals, and up to two preamplifiers receive signals from the sensors, digitize the signals, process the data and then periodically estimate the rSQ2 at each sensor site. The preamplifiers then transmit the measured and calculated parameter data to the monitor where the information is displayed. The oximeter is powered primarily by AC power at 100 VAC to 240 VAC ±10% and is equipped with an internal rechargeable lithium-ion battery for intra hospital transport and back-up purposes. The INVOS™ PM7100 Patient Monitor is intended for use in hospitals, and is not intended for home use or out-of-hospital transport.

The PM7100 Monitor configures the PMPAMP71 preamplifier modules for monitoring and allows the user to configure sensor placements on a patient's body as well as establish baseline rSQ2 values. Device features include a user configurable rSO2 baseline, alarms, signal strength indicator and area under the curve thresholds. The monitor measures and displays an rSO2 trend line in a graph for the estimated regional oxygen saturation value unique to the specific area under each sensor. the baseline rSQ2 value, the current estimated rSQztrend accuracy value and percent change from patient rSO2 baseline. The PM7100 Monitor also displays alarm information and indicates connected sensor type. The Monitor is equipped with technical (system status) and physiological (patient status) alarms. Alarm conditions are detected via the sensor, the physiological and technical information are then processed in the preamplifier/processor, which then communicates this information to the monitor then provides a visual and audio alarm notification. The device permits the user to silence alarms, mark events, and manage case history data.

The PMPAMP71 preamplifier interfaces with the PM7100 monitor via a cable for communications and power, and with one or two sensors via reusable sensor cables to receive optical signals. The optical signal flows from the sensor into the PMPAMP71 which in turn generates saturation (rSO2) for tissue under the sensor that is communicated to the PM7100 monitor.

The INVOS™ Adult SpO2Sensor, PMSENS71-A, is a non-sterile, non-invasive, disposable sensor intended for application on cerebral and somatic sites. The PMSENS71-A was designed for use with the INVOS™ PM7100 and 5100C cerebral/somatic monitoring systems for monitoring of site-specific regional oxygen saturation (rSO2) in adult patients weighing >40 kilograms. There have been no significant changes to this sensor since clearance under K182868.

The INVOS™ Pediatric rSO2 Sensor, PMSENS71-P, is a new non-sterile, non-invasive, disposable sensor intended for application on cerebral and somatic sites in pediatric patients greater than 4 kg and less than 40 kilograms. The PMSENS71-P was designed to support the existing two wavelength rSO2algorithm along with a new two wavelength sensor on/off detection algorithm. Accordingly, the PMSENS71-P sensor is designed to emit and collect sensor data with a total of four wavelengths.

The INVOS™ Infant Regional Saturation Sensor, model IS, is a non-sterile, non-invasive, disposable sensor intended for application on cerebral and somatic sites in the infant and neonate patient population. The IS sensor configuration currently only employs the two wavelength m. Accordingly, the IS sensor is designed to emit and collect sensor data with a total of two wavelengths. The INVOS™ Reusable Infant Sensor Adapter Cable (PMAC71RIC) is a new non-sterile, non-invasive reusable cable intended for adapting the infant sensor connection to the PM7100 preamplifier.

The INVOS™ Docking Station connects to the INVOS™ PM7100 Patient Monitor and is designed with a mounting surface on the back of the docking station which can connect to the Patient Monitor Stand or any other compatible mounting service. The docking station is equipped with inputs for AC power, USB, serial port and VGA port. The docking station also facilitates recharging of the back-up battery. There have been no significant changes to the docking station since clearance in K182868.

The INVOS™ Patient Monitor Stand is an accessory that connects to the INVOS™ Docking Station. The monitor stand has not changed since clearance in K 182868.

The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the INVOS™ PM7100 Patient Monitor, INVOS™ Pediatric rSO2 Sensor, and INVOS™ Infant Regional Saturation Sensor.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Device: INVOS™ PM7100 System (with Infant/Neonatal IS sensor)

Device: INVOS™ PM7100 System (with Pediatric rSO2 sensor, PMSENS71-P)

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

Infant/Neonatal Sensor Study (Hypoxia Study):

• Sample Size: 24 subjects
• Data Provenance: Not explicitly stated regarding country of origin, but described as a non-invasive hypoxia study conducted on healthy, non-smoking adults and adolescent volunteers. Given the FDA submission context, it's highly likely to be conducted in the US. This was a prospective clinical study.

Pediatric Sensor Feasibility Study (Room Air Study):

• Sample Size: 28 subjects
• Data Provenance: Not explicitly stated regarding country of origin. This was a prospective clinical feasibility study.

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

The document does not explicitly mention the use of experts to establish a "ground truth" in the traditional sense of image annotation or disease diagnosis for the clinical studies.

• For the Infant/Neonatal sensor study, the "ground truth" or reference for the rSO2 trend precision appears to be the cleared INVOS™ 5100C system in conjunction with the Infant/Neonatal Sensor (predicate system).
• For the Pediatric sensor feasibility study, the "ground truth" or reference for rSO2 performance was the predicate INVOS™ 5100C system in conjunction with the Pediatric sensor, SPFB. Sensor on/off detection accuracy was evaluated against observed physical states.

Therefore, this aspect of ground truth establishment by human experts, as typically seen in AI/ML performance studies, is not applicable in the context of this device's testing.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., radiology reads). As the studies described here involve direct physiological measurements and comparisons to a predicate device, or assessment of a sensor's physical state detection, an adjudication method in this sense is not applicable. The "ground truth" was established by the measurements from the predicate device or the direct observation of sensor states.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is an oximeter, and the studies focused on its measurement accuracy and trend precision compared to a predicate device, and the functionality of new features like sensor on/off detection. It is not an AI/ML-based diagnostic device that assists human readers.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, the "Performance Data Summary" describes standalone performance for the specific algorithms and hardware of the device.

• Non-clinical Performance Testing: This section details bench-top optical phantom testing to verify static rSO2 calculation, confirming the subject device's rSO2 algorithm performs within acceptable limits compared to the predicate system. This is a standalone performance test.
• Clinical Studies: The clinical studies evaluated the direct output of the device (rSO2 measurements, trend precision, sensor on/off detection) against a reference (predicate device or physical observation), without direct human-in-the-loop interpretation impacting the device's output. While a human uses the device, the performance metrics are about the device's intrinsic measurement capabilities.

7. The Type of Ground Truth Used

• Infant/Neonatal Sensor Study: Comparative "ground truth" was established based on measurements from the cleared INVOS™ 5100C system in conjunction with the Infant/Neonatal Sensor (predicate system) during induced hypoxia. This is a form of comparative reference device data.
• Pediatric Sensor Feasibility Study (rSO2 performance): Comparative "ground truth" was established based on measurements from the cleared INVOS™ 5100C system in conjunction with the Pediatric sensor, SPFB (predicate system) at room air. This is also a form of comparative reference device data.
• Pediatric Sensor Feasibility Study (sensor on/off detection): The ground truth was based on direct observation of the sensor's physical state (on subject, off subject, face up/down on sheet, hanging).

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" in the context of machine learning. The studies described are verification and validation studies (test sets) for the device's performance, not for training a model. The algorithms are based on Near Infrared Spectroscopy (NIRS) technology, not on machine learning that requires a specific training phase with a dedicated dataset.

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

Not applicable, as no machine learning training set is described or utilized in the regulatory submission for this device. The device's operation is based on established NIRS principles and algorithms, rather than data-driven machine learning models requiring large labeled training sets.

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