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The Microstream™ CO2 NanoPod, when connected to the host monitor, is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2-based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines.

The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/ hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.

IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SPO2 data to the NanoPod in order to calculate these parameters.

The Microstream™ CO2 NanoPod is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.

The Microstream™ CO2 NanoPod is a finished medical device that when connected to a host monitor is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, including End-tidal CO2 (EtCO2), Fractional Concentration of Inspired CO2 (FiCO2), and CO2 based respiration rate, for adult, pediatric, and neonatal patients utilizing Microstream™CO2 or Microstream™ Advance CO2 sampling lines.

The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) values. The IPI measurement is intended for use in pediatric and adult patients only, and A/hr and ODI measurements are intended for age 22 and up. Both IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SpO2 data to the NanoPod to calculate these parameters.

The Microstream™ CO2 NanoPod encloses a NanoMediCO2 capnography module, which measures inspired/expired carbon dioxide and respiration rate. The NanoPod is powered by the host monitor on a DC supply.

The Microstream™ CO2 NanoPod system includes the following sub-systems:

• . NanoPod is the medical device enclosure that encloses the NanoMediCO2 module. The NanoPod has a connected active cable that has a LEMO connector end, which connects to a host monitoring system.
• . NanoMediCO2 capnography module is enclosed in the NanoPod. The NanoMediCO2 module measures inspired and expired carbon dioxide and respiration rate. The active cable is what provides bidirectional communication between the Host monitor and the NanoMediCO2 module enclosed inside the NanoPod.
• . Interface Board is enclosed inside NanoPod which consists of an LED exposed on the outside of the NanoPod to provide the functional status of the subject device to the user.
• l Cradle is a plastic holder used to connect the NanoPod with a GCX clamp or other mounting solution, which can then be used to mount the NanoPod on a pole or bedrail. There are no sharp edges on the Microstream™ CO2 NanoPod, which enables the medical device to be held in the hand at times when it is removed from its mounting cradle.

The Microstream™ and or Microstream™ Advance CO2 sampling lines can attach to the NanoPod CO2 port on the NanoPod enclosure. Microstream™ Capnography parameters are displayed the Microstream™ and or Microstream™ Advance CO2 sampling line is connected to the NanoPod CO2 Port and the Microstream™ CO2 NanoPod is connected via LEMO connector to a host monitoring system. Please note that the Microstream™ and Microstream™ Advance sampling lines have been cleared in their own respective 510K submissions.

Due to the nature of the provided document (a 510(k) summary for a medical device), the information typically presented as "acceptance criteria" and "study proving it meets criteria" from the perspective of an AI/software device is not directly applicable. This document describes a hardware medical device (CO2 monitor) and its regulatory clearance process, which relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against a clinical ground truth via a study.

Therefore, many of the requested fields (sample size, expert qualifications, adjudication, MRMC, standalone performance, etc.) are not available in this document because they pertain to clinical studies or AI/software validation, which were explicitly stated as not required for this device's clearance.

However, I can extract the information relevant to this medical device's clearance process as best as possible, interpreting "acceptance criteria" as the performance and safety requirements it needed to meet for its 510(k) clearance, and "study" as the testing performed.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable. This was a hardware device undergoing bench and software testing, not a clinical study with patient data.
• Data Provenance: Not applicable. The testing was laboratory-based, focused on device performance according to engineering and regulatory standards.

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

• Not applicable. "Ground truth" in the clinical sense (e.g., diagnosis by experts) was not established. The "ground truth" for the device's performance would be the reference measurements from calibrated equipment against which the device was tested.

4. Adjudication method for the test set:

• Not applicable. There was no clinical test set requiring adjudication of findings.

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 measurement tool (CO2 monitor), not an AI-assisted diagnostic device, and no MRMC study was performed or required.

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

• Not applicable. This is a hardware device; the concept of a "standalone algorithm" is not relevant here. The device itself performs the measurements.

7. The type of ground truth used:

• The "ground truth" for the device's performance would be the established reference standards and calibrated instrumentation used in the bench performance testing to verify the accuracy of CO2 measurements, respiration rate, etc. This is typical for the validation of medical measurement devices.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the machine learning sense. Its operation is based on established physical principles (Non-dispersive infrared spectroscopy) and predefined algorithms.

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

• Not applicable, as there is no training set for this type of device.

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The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility.

The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.

The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. It is for prescription use in a home or healthcare facility and is used by physicians and polysomnographic (PSG) technologists as a support tool to aid in the evaluation and diagnosis of sleep disorders. A PSG tecnologist must edit, score, and review the data before sleep reports are generated.

The Cerebra Sleep System is capable of collecting data required for Level 2 PSG and Level 3 HSAT studies. A Level 3 HSAT study is a home sleep apnea test with a minimum of 4 channels that include oxygen saturation, electrocardiogram (ECG) or heart rate, airflow (e.g., nasal flow), and respiratory effort (e.g., chest band). A Level 2 PSG study is an unattended sleep test with a minimum of 7 channels that include electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG) or heart rate, chin electromyogram (EMG), and all signals from Level 3.

The Cerebra Sleep System (CSS) is comprised of three main areas:

• Prodigy: This is a PSG recorder capable of performing Level 2 and Level 3 sleep studies. It includes the Head Mounted Unit (HMU), which is worn on the patient's head, the Chest Mounted Unit (CMU), which is affixed to a chest effort belt, the Table Top Unit (TTU), which receives data wirelessly, and third party accessories including an oximeter.
• Cerebra Analytics Suite (CAS): The CAS has 4 components Web Processing (for signal processing of data), Web Scoring (for generating scoring results, which encompasses autoscoring), Cerebra Viewer (for viewing and editing PSG studies and scoring results) and Web Reporting (for generating reports). A PSG technician must edit, score, and review the data before reports are generated. These components utilize well-defined file formats to enable communication; communication with each component is done through the internet, via the Cerebra Portal.
• Cerebra Portal: All areas of the CSS product are managed by the Portal software. The Portal is used to configure a study on the TTU and allows sleep analysis service providers to manage inventory, patients, and sleep studies. It also configures Prodigy system hardware for an individual sleep study to be performed by a patient.

The Cerebra Sleep System includes an "autoscoring" module, the performance of which was evaluated against acceptance criteria.

1. Acceptance Criteria and Reported Device Performance

Note: While specific numerical acceptance criteria for the Cerebra Sleep System's autoscoring performance are not explicitly stated as strict cut-offs, the comparison tables (Table 3 and Table 5) strongly imply that the acceptance criteria were based on achieving "moderate to substantial agreement" with manual scoring and demonstrating performance similar to or better than the identified predicate devices (Michele and Alice 5 autoscoring software systems).

2. Sample Size and Data Provenance

• Test Set Sample Size: 138 randomly selected pre-existing sleep studies.
• Data Provenance: The studies were from both sleep laboratory (Level 1 sleep test) and in-home (Level 2 or 3 sleep test) use environments. The document does not specify the country of origin, but given the FDA submission, it's likely to encompass data relevant to US regulatory standards. The data was "pre-existing," indicating a retrospective study design.

3. Number of Experts and Qualifications

• Number of Experts: Three.
• Qualifications of Experts: Board-certified registered polysomnographic technologists (RPSGT) with a minimum of 13 years of experience scoring sleep studies.

4. Adjudication Method

• Method: Consensus manual scoring. The document states that the autoscoring software was compared to "the consensus manual scoring." For "No Consensus" epochs in sleep staging (1654 epochs) and respiratory events (833 epochs), it's explicitly mentioned that "all three technologists gave different scores," indicating that if the three experts did not agree, those epochs were labeled as "No Consensus" and likely excluded from the primary agreement calculations against the consensus. This suggests a form of 3-way agreement leading to "consensus."

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

• No, a direct MRMC comparative effectiveness study involving human readers improving with AI vs without AI assistance was not explicitly described in the provided text for the autoscoring module. The study focuses on evaluating the standalone performance of the autoscoring algorithm against manual scoring ("gold standard").

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The "Software Verification and Validation Testing - Autoscoring" section details the comparison of the "Cerebra Sleep System (CSS) autoscoring software" to the "consensus manual scoring," which evaluates the algorithm's performance without a human-in-the-loop.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus manual scoring. The text states: "The testing consisted of comparing the autoscoring software with the current gold standard (manual scoring) for key sleep variables." And further, "Sleep recordings were manually scored by three board-certified registered polysomnographic technologists (RPSGT)..."

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set of the autoscoring module. It only specifies the test set size of 138 studies.

9. How Ground Truth for Training Set was Established

• The document does not provide details on how the ground truth for the training set was established. It focuses solely on the validation/test set.

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Intended Use

Infinity® Acute Care System™ (IACS)

The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.

The IACS obtains the physiologic, multi-parameter data from the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.

The IACS and optional connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for use

The IACS, in connection with the M540 Patient Monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS).

Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings.

The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient information in environments where patient care is provided by trained health care professionals.

The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multiparameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.

The M540 and any connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for use

The M540 monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices: Infinity M540 Patient Monitor (Model #MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model #MK31501 - 17" screen or Model MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277).

The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without integration with the Infinity Medical Cockpits.

Associated accessories may include:

• Infinity MCable Masimo SET Model #MS20667
• Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
• Infinity MCable – Nellcor OxiMax – Model #MS20668
• Infinity MPod Quad Hemo Model #MS20725
• Infinity MCable Dual Hemo Model #MS20783
• Infinity MCable Mainstream CO2 Model #6871950
• Infinity MCable - Analog/Sync - Model #MS20662
• Infinity MCable – Nurse Call – Model #8417370
• PS120 Desktop Power Supply - Model #2606270
• Y-Adapter (for PS120) Model #MS29702

The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

The provided document is a 510(k) summary for the Draeger Infinity Acute Care System (IACS) Monitoring System. It details changes and improvements to an existing device rather than a new AI-powered diagnostic device. Therefore, it does not contain the typical acceptance criteria and study information aligned with the questions.

Specifically:

• It appears to be an update (VG4.1.1) to existing Infinity Acute Care System (IACS) Monitoring System software and associated components.
• The document indicates that clinical studies were not performed or required for the device modifications. This means there isn't a study that "proves the device meets the acceptance criteria" in the context of typical AI diagnostic device studies involving ground truth from experts or pathology.

However, based on the information provided, here's what can be extracted and inferred, addressing as many points as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, performance metric table for an AI algorithm. Instead, it focuses on compliance with standards and verification testing for functions.

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

• Test Set Sample Size: Not applicable in the context of an AI-powered diagnostic study with a discrete test set. The document indicates "Verification testing was conducted to confirm the new requirements... based on the differences between the subject and predicate devices." This implies various specific tests against functional requirements and standards, not a single patient-level test set for an algorithm's diagnostic performance.
• Data Provenance: Not applicable for this type of submission which focuses on verification of software and hardware changes against established standards, rather than analyzing patient data for a diagnostic algorithm.

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

• This information is not provided because the submission does not involve external "experts" establishing ground truth for a diagnostic algorithm's test set. The ground truth for this device's performance is based on compliance with electrical safety, EMC, and specific physiological parameter standards (e.g., EC57 for cardiac rhythm and ST segment algorithms).

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

• Not applicable, as there is no diagnostic image/signal interpretation dataset requiring expert 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

• No, an MRMC study was not done. The document explicitly states: "Clinical studies were not performed or required for the device modifications subject of this 510(k)." The device is a patient monitoring system, not an AI-assisted diagnostic tool that would typically undergo such a study.

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

• While the system has algorithms (e.g., for arrhythmia, ST segment), the submission does not detail standalone performance testing in the manner of an AI diagnostic algorithm. The "Major Level of Concern" for software indicates that the algorithms directly drive clinical decisions and thus misapplication could cause serious injury or death, suggesting the critical nature of their standalone accuracy. However, formal standalone performance metrics (e.g., sensitivity, specificity) with a defined dataset for these specific algorithms are not reported in this summary beyond compliance with standards like EC57.

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

• For the performance data mentioned (e.g., EC57 testing for cardiac rhythm and ST segment measurement algorithms), the "ground truth" would be established by reference standards or simulated physiological signals that mimic known conditions, against which the device's measurements are compared for accuracy and adherence to a recognized standard. It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm trained on a dataset of patient cases. The software updates involve improvements and corrections to existing functionalities and compliance with standards.

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

• Not applicable, as no training set for an AI algorithm is mentioned or implied.

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Intended Use

Infinity® Acute Care System™ (IACS)

The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.

The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.

The IACS and optional connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for Use

The IACS, in connection with the M540 Patient Monitor, monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS).

Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings.

The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient in environments where patient care is provided by trained health care professionals.

The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multi-parameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.

The M540 and any connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for Use

The M540 monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output - only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices Infinity M540 Patient Monitor (Model # MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model # MK31501 - 17" screen or MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277).

The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held portable patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without any integration with the Infinity Medical Cockpit.

Associated accessories may include:

• · Infinity MCable Masimo SET Model #MS20667
• •Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
• ·Infinity MCable Nellcor OxiMax Model #MS20668
• · Infinity MPod Quad Hemo Model #MS20725
• •Infinity MCable Dual Hemo Model #MS20783
• •Infinity MCable Mainstream CO2 Model #6871950
• ●Infinity MCable Analog/Sync Model #MS20662
• •Infinity MCable Nurse Call Model #8417370
• •PS120 Desktop Power Supply Model #2606270
• •Y-Adapter (for PS120) Model #MS29702

The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

Here's a breakdown of the acceptance criteria and study information for the Draeger Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring Solution, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or a direct table comparing them to reported device performance. It focuses on demonstrating equivalence to a predicate device and adherence to recognized standards. However, it does highlight areas where "verification testing was conducted to confirm the new requirements."

Based on the information, the implicit acceptance criteria are compliance with relevant safety and performance standards, and successful verification of new software requirements and algorithms.

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

The document does not specify sample sizes for test sets in relation to patient data or specific parameters. It references "verification testing" and "EC57 testing" but does not provide details on the number of cases or data points used.

The data provenance is also not explicitly stated. The studies mentioned appear to be internal performance bench testing rather than studies involving external clinical data.

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

The document does not mention the use of experts to establish a ground truth for any test set or their qualifications. The testing described appears to be technical verification against standards and internal requirements.

4. Adjudication Method

No adjudication method is described, as there is no mention of expert review of test set results.

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

No MRMC comparative effectiveness study was mentioned or conducted. The submission is for a monitoring solution, and the focus is on technical performance and equivalence to a predicate, not on human-AI assistive improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone (algorithm only) performance was indirectly assessed through the "Performance Bench Testing" and "EC57 testing conducted for performance of cardiac rhythm and ST segment measurement algorithms." This testing evaluates the device's algorithms and functions independent of human interpretation in a clinical setting.

7. Type of Ground Truth Used

The ground truth for the performance bench testing and EC57 testing would implicitly be:

• Established Standards: Compliance with the requirements of relevant IEC and ISO standards (e.g., IEC 60601 series, ISO 80601-2-55, EC57 for ECG performance).
• Engineering Specifications/Reference Values: For internal verification, ground truth would be against predetermined engineering specifications, simulated inputs, or known reference signals.

There is no mention of ground truth established via expert consensus, pathology, or direct outcomes data from human patients for the clearance of this device.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is a multi-parameter patient monitoring system, which typically involves rule-based algorithms, signal processing, and established physiological measurement techniques, rather than machine learning models that require extensive training data.

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

Since no training set is mentioned as being used for machine learning, this point is not applicable. The device's functionality is based on established medical device engineering principles and adherence to regulatory standards.

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The SOMNOscreen® plus is a non-life-supporting portable physiological signal recording device intended to be used for testing adults and children (age 2 to 12 years)/adolescents (age 12 and above) suspected of having sheep related breathing disorders.

The SOMNOscreen® plus is a modular system with the following components available .: Thermistor, Nasal Canula, Effort belts with respective sensor, SpO2-Sensor, Microphone, Headbox (EXG Channels), external body position sensor, shoulder belts, activity sensor, EMG-PLM sensor, pressure sensor, gold cup electrodes and LoFlo CO2-module (optional). The SOMNOscreen® plus device provides 13 AC channels (10 Referential and 3 Differential), 11 Respiratory and AUX Channels, and 8 Internal Channels.

The SOMNOscreen plus is available in 4 different configurations.

• . Cardio-RESP
• Home Sleep
• PSG .
• . EEG 32

The purpose of this 510(k) submission is to expand the patient population to include children and adolescents. For the use in pediatric patients the DOMINO software only allows manual (visual) scoring by qualified RPSG. There is no automated analysis or highlighting available for pediatric patients.

The provided text describes a medical device, SOMNOscreen plus, and its FDA 510(k) clearance. The submission focuses on expanding the patient population to include children and adolescents, emphasizing that for this new population, only manual scoring by qualified personnel is allowed, with no automated analysis.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner for specific diagnostic metrics (e.g., accuracy, sensitivity, specificity for detecting sleep-related breathing disorders). Instead, it discusses compliance with general safety and performance standards for electroencephalographs and polysomnographs.

However, we can infer some performance aspects based on the technical specifications and comparisons:

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

The document explicitly states: "Clinical data were not relied upon for a determination of substantial equivalence." This means no specific clinical test set was used to evaluate the device's diagnostic performance for sleep-related breathing disorders in humans for this submission. The evaluation focused on technical and safety equivalence to predicate devices and adherence to standards.

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

As no clinical data was relied upon, there was no test set requiring expert-established ground truth. The "ground truth" implicitly referred to here is compliance with technical standards and AASM recommendations for polysomnography signal acquisition. For pediatric applications, the text mentions "manual (visual) scoring by qualified RPSG" (Registered Polysomnographic Technologist), implying that human experts are crucial for interpreting the device's output, especially in the expanded pediatric population. However, this is about the use of the device, not the validation of its performance in a clinical study for this submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used or described.

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

No, an MRMC comparative effectiveness study was not done, as stated by "Clinical data were not relied upon for a determination of substantial equivalence." The document indicates that for pediatric populations, the software "only allows manual (visual) scoring by qualified RPSG. There is no automated analysis or highlighting available for pediatric patients." This suggests that any comparative effectiveness of human readers with AI assistance versus without AI assistance is not relevant to this specific clearance for the pediatric population, as AI assistance for scoring is explicitly not provided for them.

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

No standalone algorithm performance study was described. In fact, for the new pediatric population, the device explicitly does not offer automated analysis or highlighting, emphasizing human interpretation.

7. The Type of Ground Truth Used

For the purposes of this 510(k) submission, the "ground truth" used was primarily compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993, IEC 62366-1) and technical specifications, as well as adherence to minimum performance specifications recommended by the American Academy of Sleep Medicine (AASM) for signal types. No clinical ground truth (like pathology, expert consensus on diagnostic outcomes, or long-term outcomes data) was used in a specific clinical study for this submission.

8. The Sample Size for the Training Set

No training set information is provided, as the submission did not rely on clinical data or automated algorithms that would require a training set for this clearance. The "training" here refers to the design and verification process of the device itself against engineering and safety requirements.

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

Not applicable, as no training set for an AI algorithm was described. The device's "training" in an engineering sense involved verification and validation against pre-specified requirement specifications and relevant performance standards, ensuring basic safety and essential performance.

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The Infinity Delta Series Monitor (Delta/Delta XL/Kappa) are capable of

• monitoring:
• · Heart rate
• · Respiration rate
• · Invasive pressure
• · Non-invasive pressure
• · Arrhythmia
• · Temperature
• · Cardiac output
• · Arterial oxygen saturation
• · Pulse rate
• · Apnea
• · ST Segment Analysis
• 12-Lead ST Segment Analysis
• · tcp02/tcpC02
• · EEG signals
• · FiO2
• etCO2
• · Respiratory mechanics
• · Anesthetic agents
• · Neuromuscular transmission

The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians. Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Infinity Delta Series (Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arthythmia which are intended for use in the adult and pediations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.

For combination with Scio gas module:

Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors.

Infinity Delta and Kappa Series Monitors (Delta XL/ Kappa) are multi-parameter patient monitors intended for use at the patient bedside for the collection of physiological data. The intent of this 510(k) is to describe the proposed software and hardware modifications to the Infinity Delta and Kappa Series Monitors version VF9.1 which includes the integration of an alternative etCO2 solution for the Delta and Delta XL patient monitors as well as software enhancements for the Delta, Delta XL and Kappa patient monitors.

The provided text is a 510(k) summary for the Infinity Delta, Infinity Delta XL, and Infinity Kappa patient monitors. It describes software and hardware modifications to the existing devices, primarily the integration of an alternative etCO2 solution. However, it does not contain a study that proves the device meets specific acceptance criteria with detailed performance metrics, sample sizes, or ground truth establishment.

Instead, the summary states:

• "The substantial equivalence was assessed via internal verification tests, validation evaluations and external tests to FDA recognized consensus standards."
• "Performance data related to each proposed modification has been tested and evaluated."
• "High level summary reports are included in this special 510k demonstrate the changes to the monitors are substantially equivalent to the predicate devices."
• "The modified Infinity Delta and Kappa Series Monitors have been tested in accordance with applicable standards and internal design control procedures and were determined to be as safe and effective as the predicate device for its intended use."

This indicates that testing was performed, but the details of those tests, including specific acceptance criteria and detailed performance results, are not present in this document. The document focuses on demonstrating substantial equivalence to a predicate device (K070566) rather than providing a detailed performance study against specific acceptance criteria for a novel device.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, or adjudication methods from the provided text. The document asserts that testing was done to ensure substantial equivalence, but it does not present the results of such testing in the format you've requested.

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The SmartMonitor 2PS is intended for use in the continuous monitoring of respiration, heart rate and SpO2 levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.

The SmartMonitor 2PSL is intended for use in the continuous monitoring of respiration, and heart rate of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, and high or low breath rate. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment.

The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system or as an adult or pediatric vital signs monitoring system. The electromechanical design of the SmartMonitor 2PS is unchanged from the SmartMonitor 2PS (K032403) except that cleared ECG and oximetry sensor accessories have been selected for adult and pediatric use of the monitor.

The provided text describes a 510(k) summary for the SmartMonitor 2PS and 2PSL, primarily seeking to extend the existing claims to include adult and pediatric use. It does not contain specific acceptance criteria, a detailed study design with sample sizes, or the performance metrics typically associated with device efficacy.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Respironics SmartMonitor 2PS (K032403) and CAS Medical Systems 9303 Neonatal / Adult Vital Signs Monitor (K982776)) for the expanded patient population. The verification is based on design verification testing, safety standards (IEC 60601-1 and IEC 60601-1-2), and a Risk Traceability Matrix.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information. This type of information is typically found in detailed clinical study reports or validation documents, which are not present in the provided 510(k) summary.

The document states:

• "The functionality of the design of the monitor was verified through the use of design verification testing."
• "The safety of the design was assured by the completion of IEC 60601-1 and IEC 60601-1-2 testing."
• "The Risk Traceability Matrix provided in the Risk Analysis assures that all hazards identified by the risk analysis are successfully mitigated."

These statements indicate that the device's design and safety were verified through standard engineering and safety testing, not through a clinical performance study with specific acceptance criteria as you've outlined. The submission seeks to extend existing claims, implying that the fundamental performance characteristics were established in the predicate device's clearance.

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The SmartMonitor® 2 Professional Series Infant Apnea Monitor is intended for use in the continuous monitoring of respiration, heart rate, and SpO2 of infant patients in a hospital or home environment. The monitor detects and alarms for periods of central apnea, high or low heart rate, and high or low saturation.

The SmartMonitor 2PS is a microprocessor-based, software-controlled device intended for use as an infant apnea monitoring system.

The SmartMonitor 2PS is designed to analyze and record physiologic signals (ECG, respiration, SpO2 and pulse rate) acquired from infant patients during sleep. Its primary function is to analyze the physiologic signals and generate visual and audible alarm indications upon detection of physiologic events such as central apnea, bradycardia, and high or low SpO2. The portable design of the device facilitates its use in a hospital or in a home environment.

ECG and respiration signals are acquired via a single transducer set attached to the patient and directly connected to the monitor. The measurement method used to derive the respiration signal is Transthoracic Impedance. SpO2 and plethysmographic pulse rate acquired via an oximeter finger sensor. The acquired physiologic signals are classified and stored for use at a later time.

A Host PC may interface to the SmartMonitor 2PS via a direct serial connection for the purpose of downloading the monitor's previously stored data and/or retrieving the monitor's real time data.

The SmartMonitor 2PS is a compact, lightweight unit. Two front panel connectors are provided for the patient sensor input. The sensor connectors and associated sensor plugs are individually keyed to prevent improper insertion.

The SmartMonitor 2 is approximately 7.4 inches wide, 10 inches deep and 2.5 inches high. It weighs approximately 2 pounds.

The enclosure for the monitor is constructed of plastic injection molded materials. Components and assemblies are securely mounted inside. The enclosure design is resistant to the entrance of liquids and other foreign materials.

The provided text describes the SmartMonitor 2 Professional Series (SmartMonitor 2PS), an infant apnea monitor with an internal oximeter. It is a 510(k) submission seeking to extend the existing claims of the monitor to include an internal pulse oximeter.

However, the provided text does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number or qualifications of experts for ground truth, adjudication methods, or specific study designs (MRMC or standalone).
• Information on the training set or how its ground truth was established.

The text primarily focuses on:

• The product's proprietary and common name, classification, and predicate devices.
• The reason for submission (additional or expanded indications).
• Device description and its intended use (Indications for Use).
• General statements about design verification testing, IEC 60601-1 and 60601-2 testing, and a Risk Traceability Matrix to assure safety and mitigate hazards.

Based on the information available, here's what can be provided:

Acceptance Criteria and Device Performance Study Information

The document mentions that the functionality of the design was verified through "design verification testing" and safety was assured by "IEC 60601-1 and 60601-2 testing" and a "Risk Traceability Matrix." However, it does not provide specific acceptance criteria or the reported device performance from these tests. It focuses on demonstrating substantial equivalence to predicate devices (Respironics SmartMonitor 2 and Masimo SET Pulse Oximeter) rather than a detailed performance study proving specific acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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 text broadly mentions "design verification testing" but does not specify the sample size of patients or data used, nor its provenance (country, retrospective/prospective).

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 in the document. The submission focuses on device functionality and safety standards compliance, not on expert-adjudicated ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. The SmartMonitor 2PS is an apnea monitor with an internal oximeter, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's description.

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

The context suggests the device operates as a standalone monitor, analyzing physiological signals and generating alarms. The entire device essentially represents the "standalone" performance, as it directly monitors and alarms without "human-in-the-loop" performance for its primary function of detecting and alarming. However, the text does not detail specific algorithm-only performance studies with metrics; it broadly states "design verification testing."

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

This information is not explicitly provided in the document. For an apnea monitor, ground truth would typically involve independently confirmed physiological events (e.g., using polysomnography or other gold-standard monitoring) against which the device's detections are compared. The text only mentions "analyzing physiologic signals and generating visual and audible alarm indications upon detection of physiologic events."

8. The sample size for the training set

This information is not provided in the document. The device is microprocessor-based and software-controlled; while software likely involves development and testing, typical "training sets" as seen in machine learning contexts are not mentioned.

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

This information is not provided in the document.

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The SmartMonitor® 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.

The SmartMonitor 2 is a monitoring device designed to monitor respiration and heart rate. Upon detection of abnormal events, SmartMonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review.

SmartMonitor 2 acquires the electrical activity of the heart via a two or three-lead electrode configuration. The same set of electrodes is used to measure transthoracic impedance and to subsequently develop a respiration signal. Detection of heart beats and respiration breaths is accomplished via softwarebased algorithms, which analyze the ECG and respiration signals. When beats or breaths are detected, SmartMonitor 2 provides feedback by blinking the Heart and Respiration LED's and calculates apnea intervals, average heart rates, and average breath rates for the purpose for identifying ECG and respiration rates that violate preset threshold values. In addition to the alarms, when abnormal ECG and respiration rates are detected, both tabular data and associated waveforms are logged in nonvolatile memory for subsequent review by a Health Care Professional.

Here's an analysis of the provided text regarding the Respironics SmartMonitor 2, broken down by your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications for both Respiration and ECG monitoring. These specifications serve as the acceptance criteria. The document states that the SmartMonitor 2 "meets the requirements specified in the Product Specification and that it conforms to the required standards," indicating it achieved these criteria.

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

The document states: "Data were compiled from multiple sites on at least 25 patients."

• Sample size for test set: At least 25 patients.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific demographics). The study was a comparison of the SmartMonitor 2 to a predicate, and the data was "compiled from multiple sites," implying it was real-world clinical data. It's likely retrospective as it involves comparing to "predicate devices" and using "hand scoring" of data, suggesting analysis of pre-existing records rather than a forward-looking, interventional study. However, the document doesn't explicitly state retrospective or prospective.

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

The document indicates that the "gold standard" for ground truth was "hand scoring."

• Number of experts: Not specified.
• Qualifications of experts: Not specified (e.g., radiologist with 10 years of experience). It simply refers to "hand scoring," implying trained personnel who interpret the raw physiological signals.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1 or 3+1). It only mentions "hand scoring" as the "gold standard," which could imply a single scorer or an internal process not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study is mentioned. The clinical study described compares the device (SmartMonitor 2) against a "gold standard" (hand scoring) and aims to show substantial equivalence to a predicate device, not to evaluate human reader performance with or without AI assistance.

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

Yes, a standalone performance evaluation was done. The clinical protocol compared the SmartMonitor 2's performance (its algorithms for detecting apnea) "to the gold standard of hand scoring." This directly assesses the algorithm's performance without a human in the loop for the detection task itself, though a healthcare professional reviews the logged data. The device's primary function is automated detection and alarm.

7. The Type of Ground Truth Used

The type of ground truth used for the clinical study was expert consensus (implied via "hand scoring") on the physiological signals (respiration and heart rate) to identify central apnea events.

8. The Sample Size for the Training Set

The document does not specify a separate training set. The descriptions of "system qualification testing" and "software testing" refer to verification and validation activities. The clinical study described is for validation of the final device, not for training a model. Given the time period (2002) and the nature of apnea monitors, it's highly likely it was based on deterministic algorithms rather than machine learning models requiring extensive training data.

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

As no specific training set for a machine learning model is mentioned, the method for establishing ground truth for a training set is not applicable or provided. The device's performance is validated against clinical data after its algorithms are developed, implying ground truth for algorithm development would be based on physiological principles and expert-defined thresholds, not a machine learning training set in the modern sense.

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