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The intended use of the BEACON Caresystem is to provide

• respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU)
• on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician

Patients should be hemodynamically stable.

The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.

BEACON Caresystem is an Intensive Care Unit (ICU) ventilation assist system. BEACON Caresystem will provide ICU clinicians with on-demand ventilator-dependent open-loop advice for ventilating adult patients.

BEACON Caresystem uses inputs measured by BEACON Caresystem and data inputs from the ventilator and manual data entry by the clinician into a computer program that has been designed to provide advice for changes to the ventilator settings for the individual patient undergoing mechanical ventilation.

BEACON Caresystem is an adjunct to third party legally marketed ICU mechanical ventilators.

BEACON Caresystem consists of the following components:

• BEACON Display Unit
• BEACON Gas Module
• BEACON Power Adaptor
• NONIN XPOD SpO2 Analyzer

BEACON Caresystem utilizes the following cleared accessories:

• BEACON Flow Sensor (Adult) private label version of Metaphor E-Z Flow Sensor, Size Adult [K093080]
• BEACON Water Trap (Adult) [K182075 & K171292]
• NONIN Finger Clip SpO2 sensor NONIN 8000AA1 [K071285]
• NONIN Ear Clip SpO2 sensor- NONIN 8000Q2 [K080255]
• NONIN Forehead Reflectance SpO2 sensor NONIN 8000R [K071285]

The BEACON Display Unit is a standard off-the-shelf tablet touch-screen computer. The BEACON display unit connects through a USB port to the NONIN XPOD SpO2 analyzer for pulse oximetry measurements and serial data ports for connection to the BEACON Gas Module and the connected ICU ventilator. The BEACON Display unit includes the BEACON Caresystem Software. The BEACON Gas Module performs measurement of patient airway flow and inspired and expired fractions of CO2 and O2 in the airway.

As described above, BEACON Caresystem combines the functionalities of a spirometric monitor, respiratory gas monitor, and pulse oximeter. Each of these functions, respectively, is intended for:

• Respiratory mechanics monitoring (i.e. airway flow/volume)
• Measurement of expired and inspired breathing gases (CO2, O2) and respiration rate
• Non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The BEACON Caresystem Software utilizes the monitored parameters above with data from the connected ICU ventilator and clinician entered values to generate on demand, open-loop advice for changes to the ventilator settings for an adult patient undergoing mechanical ventilation.

The BEACON Caresystem is intended to provide respiratory mechanics monitoring and on-demand ventilator-dependent open-loop advice for mechanically ventilated adult patients in the Intensive Care Unit (ICU).

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantifiable table with specific thresholds (e.g., accuracy > 90%). Instead, it describes a comparative approach where the BEACON Caresystem's performance is deemed "comparable" to a legally marketed predicate device.

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

The document states that five clinical studies were submitted, and these appear to form the basis of the test set for the advice generation. However, it does not explicitly state the sample size (number of patients or cases) for any of these clinical studies or for the bench tests.

The provenance of the data (country of origin, retrospective or prospective) is not explicitly stated in the provided text.

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

The information provided does not specify the number of experts used to establish ground truth for the clinical studies. For the study evaluating BEACON Caresystem advice and active clinicians, it mentions "active clinicians" but does not detail their number or specific qualifications. For the study on spontaneous breathing patients, it mentions using an "esophageal catheter" as a reference technique, implying a technical measurement rather than expert consensus for that specific ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical studies. For the study evaluating BEACON Caresystem advice and active clinicians, it states it was evaluated "blindly," but further details on adjudication are missing.

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 provided text does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was performed to assess how much human readers improve with AI vs. without AI assistance. The clinical studies primarily focus on the agreement and appropriateness of the BEACON Caresystem's advice, not on human reader performance with or without the device. The fifth study did "evaluate blindly the BEACON Caresystem advice and active clinicians in patient cases," but it's not described as an MRMC comparative effectiveness study to measure improvement from AI assistance.

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

Yes, a standalone evaluation of the algorithm's performance (advice generation and measurement accuracy) appears to have been a significant part of the testing.

• Bench Tests: Gas and flow measurements (EtCO2, VA, RR, VO2, VCO2, EE) were evaluated in "bench test comparisons with predicate and reference devices." This suggests a standalone evaluation of the device's measurement accuracy against established standards without direct human-in-the-loop influence on the measurement results.
• Patient Simulator Test: A "head-to-head test comparing the advice presented by BEACON and the predicate device was performed on a patient simulator." This is a standalone evaluation of the advice generation algorithm.
• Clinical Studies: The clinical studies primarily assessed the advice generated by the BEACON Caresystem ("agreement of BEACON Caresystem advice," "effect of the applied advice," "ability of BEACON Caresystem advice to find appropriate breathing effort levels"), implying an evaluation of the device's output.

7. The Type of Ground Truth Used

The ground truth for different aspects of the device's performance appears to vary:

• Advice Generation: Ground truth appears to be established through:
  • Comparison with the predicate device's advice on a patient simulator.
  • "Clinical practice agreement" in three clinical studies, suggesting agreement with established medical best practices or expert clinical judgment (though details on how this was established are scarce).
  • Reference technique (esophageal catheter) for breathing effort levels in one study.
  • Comparison with "active clinicians" in patient cases in the fifth study.
• Gas and Flow Measurements: Ground truth was established by comparison with predicate and reference devices in bench tests.

8. The Sample Size for the Training Set

The provided text does not contain any information about the training set for the BEACON Caresystem software or algorithm. This document focuses on the S510(k) submission, which typically emphasizes testing of the final product rather than describing the development and training phases.

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

Since no information is provided about the training set (see point 8), there is no information on how its ground truth was established.

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ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least 1 - year of age.

ExSpiron 2Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:

• Minute Ventilation (MV)

• Tidal volume (TV)

• Respiratory Rate (RR)

ExSpiron 2Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 2Xi Respiratory Monitor System consists of:
Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC.
Computer: A tablet PC performs signal processing and calibration and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.
Patient Cables and Electrode Padsets that are also included in the system but were cleared in previous 510(k)s: K130170, K162131, K173181
ExSpiron Patient Cable: A reusable cable that connects the ExSpiron 2Xi Monitor to the Electrode PadSet.
Single patient use ExSpiron Electrode PadSet: A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin.

The provided document describes the ExSpiron 2Xi Respiratory Monitor System, focusing on its substantial equivalence to a predicate device (ExSpiron 1Xi).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ExSpiron 2Xi are based on demonstrating substantial equivalence to its predicate (ExSpiron 1Xi). The key performance metric highlighted is Bench Accuracy for Minute Ventilation (MV), Tidal Volume (TV), and Respiratory Rate (RR), which serves as a surrogate for demonstrating equivalent performance.

The document states, "The accuracy of the proposed device is substantially equivalent to the predicate." This implies that the ExSpiron 2Xi's performance falling within a comparable range to the predicate's established performance fulfills the accuracy acceptance criterion.

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

The document does not specify a sample size for a particular "test set" in the context of clinical data for accuracy. Instead, it refers to "Bench Accuracy" testing. This suggests the primary testing for equivalence was done in a controlled, non-human, benchtop environment, rather than a clinical dataset of patients.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as the clinical testing was deemed "not required" for this Special 510(k). The "large historical cohort" mentioned for algorithm training is not further detailed.

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

This information is not provided as the primary performance evaluation relied on "Bench Accuracy" testing, not clinical studies requiring expert ground truth for medical imaging/diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation did not involve human readers interpreting a test set requiring adjudication.

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

An MRMC study was not conducted for this submission. The submission is a "Special 510(k)" which typically relies on design control changes and verification/validation testing to demonstrate substantial equivalence, rather than new clinical trials or comparative effectiveness studies with human readers. The document explicitly states, "Clinical testing was not required."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The accuracy values provided for MV, TV, and RR are implied to be standalone performance metrics of the device itself, as they are derived from "Bench Accuracy" testing. There is no mention of human interaction influencing these reported accuracy percentages in the context of the device's output.

7. Type of Ground Truth Used

For the "Bench Accuracy" testing, the ground truth would likely be established through controlled measurements using calibrated testing equipment or simulated physiological models, where the true values of Minute Ventilation, Tidal Volume, and Respiratory Rate are known or precisely controlled. The document does not specify the exact nature of this "ground truth" for bench accuracy, but it would not be expert consensus, pathology, or outcomes data in this context.

8. Sample Size for the Training Set

The document states that the software algorithm was trained with "a dataset containing respiratory data from a large historical cohort." A specific sample size for this training cohort is not provided.

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

The document mentions that the algorithm uses a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort." It does not explicitly state how the ground truth for this training data was established. It can be inferred that for the "respiratory data," ground truth would likely involve highly accurate reference measurements from other established monitoring methods (e.g., spirometry, capnography, or other gold standard methods) when the historical data was collected. However, this is conjecture based on typical medical device development, and not explicitly stated in the document.

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The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

The Gas Module 3 is an independently powered unit capable of interfacing with Mindray DS USA, Inc. (hereafter MRDS) Patient Monitors using a proprietary communications protocol. The system connects to the patient monitor via a RS232 connector. All Gas Module 3 data display on the monitor screen. And all user commands are entered on the monitor and then electronically transmitted to the Gas Module 3.

The Gas Module 3 measures in real-time, breath-by-breath CO2, O2, N2O gases. Additionally, the Gas Module 3 monitors the anesthetic agents Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Desflurane (DES) and Enflurane (ENF).

The Gas Module 3 consists of AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board and Communication Board.

The subject device is a modified version of a previously cleared model, the Gas Module SE. The Gas Module SE was cleared under K062754, on September 13, 2006.

The provided text is a 510(k) summary for the "Gas Module 3" device (K180788). This document primarily focuses on establishing substantial equivalence to a predicate device (Gas Module SE, K062754) based on non-clinical testing. It does not describe an acceptance criteria study in the conventional sense of establishing performance against a predefined clinical or statistical threshold.

Instead, the study outlined is a series of non-clinical bench tests and EMC/Electrical Safety tests designed to demonstrate that modifications to the predicate device still meet existing specifications and standards, and that its performance is equivalent to the predicate. There is no mention of a human-in-the-loop study, expert ground truth establishment, or specific sample sizes for clinical data because this is a non-clinical performance evaluation for a monitoring spirometer, not an AI/software-as-a-medical-device (SaMD) study involving ground truth or human reader performance.

Therefore, many of the requested fields cannot be directly populated from the provided text as they are not applicable to the type of device and study described.

Here's the information that can be extracted or deduced from the provided document:

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

The document details performance changes and states they meet relevant standards. It frames the "acceptance criteria" not as novel thresholds, but as continued adherence to existing specifications and consensus standards.

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ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least one year of age.

ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:

• Minute Ventilation (MV)
• Tidal volume (TV)
• Respiratory rate (RR)
  ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate.

The ExSpiron 1Xi system consists of:
• Monitor:
The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
o Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC.

o Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.

There are no hardware changes included in this submission.

Single-Patient Use ExSpiron Electrode PadSet:
• A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.

The acceptance criteria and study proving the device meets them are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the equivalence tests rejected the null hypothesis that the ExSpiron 1Xi and NM3 have different mean values and concluded with 90% power that the measurements of MV, TV, and RR from the ExSpiron 1Xi and NM3 are equivalent within +/-10%. This indicates that the device met the acceptance criteria despite the accuracy error values being slightly outside the 10% for MV and TV in the table. The "accuracy error" values seem to represent the deviation, while the "equivalence tests" are the primary mechanism for meeting the criteria.

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

• Sample Size: 72 pediatric patients.
• Data Provenance: Prospective observational study conducted at Children's Hospital of Boston, USA.

3. Number of Experts and Qualifications for Ground Truth:

• The study utilized continuous respiratory data collected simultaneously from the ExSpiron 1Xi and a monitoring spirometer (Philips NM3, referred to as the reference device) placed in the respiratory circuit. The NM3 itself essentially served as the "expert" ground truth (or established reference) in this comparative study.
• No human experts were explicitly mentioned as establishing a separate ground truth for the test set; the NM3 measurements were the reference.
• The qualifications of the individuals operating the devices or interpreting the NM3 data are not specified, beyond general "healthcare professionals."

4. Adjudication Method:

• No explicit adjudication method (like 2+1, 3+1) was mentioned. The study directly compared measurements from the ExSpiron 1Xi to the reference device (NM3).

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

• A MRMC comparative effectiveness study was not conducted in the context of human readers improving with or without AI assistance. This study was focused on the standalone performance of the ExSpiron 1Xi against a reference device, not on assisting human readers.

6. Standalone (Algorithm Only) Performance:

• Yes, a standalone study was performed. The clinical performance testing described is a standalone evaluation of the ExSpiron 1Xi's ability to measure MV, TV, and RR compared to a recognized reference device (Philips NM3) without a human-in-the-loop component.

7. Type of Ground Truth Used:

• The ground truth used was a reference device comparison. Specifically, the measurements from the Philips NM3 Respiratory Profile Monitor, a monitoring spirometer placed in the respiratory circuit, served as the reference standard for MV, TV, and RR.

8. Sample Size for the Training Set:

• The device's algorithm uses a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort."
• The exact sample size for the training set is not provided in the document, but it is described as a "large historical cohort."

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

• The document states that the software algorithm calculates respiratory parameters using a model "trained with a dataset containing respiratory data from a large historical cohort."
• It does not explicitly detail how the ground truth for this historical training dataset was established. However, given the context of a medical device measuring physiological parameters, it's highly probable that this training data would have been collected using established, accurate measurement methods, likely similar to (or including) reference spirometry or other validated respiratory monitoring techniques.

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ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients.

ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:

• Minute Ventilation (MV)

• Tidal volume (TV)

• Respiratory rate (RR)

ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate.

The ExSpiron 1Xi system consists of:
Monitor:
The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC. Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.
A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.

Acceptance Criteria and Device Performance for ExSpiron™ 1Xi

1. Table of Acceptance Criteria and Reported Device Performance

The provided document compares the proposed device (ExSpiron 1Xi) to a predicate device (ExSpiron™ 1Xi, K130170). The comparison focuses on various characteristics, including accuracy. While explicit "acceptance criteria" for accuracy are not stated as numerical thresholds, the document presents the accuracy results of the proposed device. The implied acceptance is that the proposed device performs at least as well as, or better than, the predicate device.

The document notes that the "algorithm was refined for the ExSpiron 1Xi using thousands of additional data points collected over the last 3 years in a wide variety of patient populations," leading to "more accurate respiratory volumes than the predicate." However, the accuracy percentages show a slight decrease in accuracy (higher percentage value) for MV and TV compared to the predicate in this summary document. This might be due to presenting overall clinical study results for the proposed device, while the predicate's numbers might be from a specific lab setting or a different calculation method for its initial clearance. The conclusion explicitly states the proposed device "is as safe and as effective as the predicate."

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 20 subjects
  • Age range: 22-80
  • BMI range: 19-42
  • Gender: 9 female, 11 male
• Data Provenance:
  • Country of Origin: Waltham, MA, USA (clinical study conducted there)
  • Retrospective or Prospective: Prospective. The study was conducted specifically to compare simultaneous measurements from the ExSpiron 1Xi and the predicate device.

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

The document does not explicitly state the number of experts used to establish the ground truth for this clinical study, nor does it specify their qualifications. The study focused on comparing the performance of the proposed device against a predicate device through simultaneous measurements. This implies the predicate device's measurements or another recognized standard served as the comparative reference, rather than a separate "ground truth" established by experts for each breath.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. It states that simultaneous measurements were taken from both the proposed device and the predicate device, implying a direct comparison rather than a need for expert adjudication of independent measurements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical study comparing simultaneous measurements of the proposed device and a predicate device on patients, not a study evaluating human reader performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance aspect is implied. The "Accuracy" section of the comparison table and the clinical study results (Bias, Precision, Accuracy) directly assess the performance of the device's algorithms in measuring respiratory parameters (MV, TV, RR) without explicitly mentioning human intervention in the real-time measurement process. The device provides "approximate values" of these parameters.

7. Type of Ground Truth Used

The ground truth for the clinical study was established by simultaneous measurements from a legally marketed predicate device (ExSpiron™ 1Xi, K130170). The study aimed to show equivalence or improvement compared to an already cleared device.

8. Sample Size for the Training Set

• The predicate device's algorithm was "trained with a dataset containing respiratory data from a large historical cohort."
• The proposed device's algorithm was "refined for the ExSpiron 1Xi using thousands of additional data points collected over the last 3 years in a wide variety of patient populations." The exact numerical sample size ("thousands") is not specified beyond this qualitative description.

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

The document does not explicitly detail how the ground truth for the "large historical cohort" or the "thousands of additional data points" used for algorithm training/refinement was established. However, given the nature of a spirometer, it is highly probable that the ground truth for training data would have been established using:

• Reference Spirometry: Directly measured, highly accurate respiratory volumes and rates from calibrated gold-standard spirometry equipment.
• Other established physiological measurement techniques that provide accurate respiratory parameters.

The purpose of the training data is to allow the device's proprietary, non-linear, regressive model to accurately calculate respiratory parameters "without patient-specific calibration" for the proposed device.

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ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients.
ExSpiron 1xi is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:
Tidal volume,
Respiratory rate, and
Minute ventilation
ExSpiron 1xi measurements are used as an adjunct to other clinical information sources.

The ExSpiron 1xi system consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Computer: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ 1xi Electrode PadSet: An electrode assembly containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode PadSet is also used to perform subsystem checks prior to patient measurements.

The ExSpiron™ 1xi respiratory monitor is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in adult (at least 21 years old) patients. It is a non-invasive system that graphically displays lung volume against time and reports approximate values for Tidal Volume, Respiratory Rate, and Minute Ventilation. The measurements are used as an adjunct to other clinical information sources.

The provided documentation does not contain a table of acceptance criteria or reported device performance for this specific 510(k) submission (K130170). The submission is a Special 510(k) where the manufacturer states that "No clinical testing was performed for this 510(k). The measurement algorithm and software are unchanged from the predicate. Measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087." This means that the device's performance relies on the data submitted for its predecessor, the ExSpiron Respiratory Monitor (K120087).

However, based on the information provided for K130170:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, no specific acceptance criteria or reported performance for the ExSpiron™ 1xi is provided in this document as it references the predicate device. For the predicate device, K120087, the performance statistics would have been determined through clinical trials. Without access to K120087, these specific details cannot be provided here.

The document states that changes for K130170 were related to:

• Software Verification & Validation
• Safety Testing - IEC 60601-1 2nd Edition
• Electromagnetic Compatibility - IEC 60601-1-2
• ExSpiron 1Xi System Test Plan
• Patient Cable Design Verification (AAMI / ANSI EC53:1995/(R) 2008)
• Electrode PadSet Design Verification (AAMI / ANSI EC12:2000/(R)2010, AAMI / ANSI EC53:1995/(R) 2008)
• Electrode - Biocompatibility - ANSI/AAMI/ISO 10993-1

All performance testing for these modifications was reported as successful, raising no new safety or efficacy concerns and demonstrating substantial equivalence to the predicate device.

2. Sample Size for Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087.
• Data Provenance: Not applicable for this specific 510(k). For the predicate device (K120087), this information would be detailed in its submission. It's likely that the data would be prospective, given the nature of clinical trials for device performance. Country of origin not specified in the current document.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

• Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The ground truth for the predicate device's clinical trials (K120087) would have been established through a reference standard method, but the number and qualifications of experts are not described in this document.

4. Adjudication Method for the Test Set:

• Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed.

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

• No MRMC comparative effectiveness study was done for this specific 510(k) (K130170). The device is a monitor that reports values, not an AI for interpretation requiring human readers.

6. Standalone (Algorithm Only) Performance Study:

• Yes, implicitly. The statement that "The measurement algorithm and software are unchanged from the predicate" implies that the core algorithm's performance was evaluated in a standalone manner during the clinical trials for the predicate device (K120087). This 510(k) (K130170) focuses on modifications to hardware components and software updates that do not alter the fundamental measurement algorithm.

7. Type of Ground Truth Used:

• For the performance statistics referenced from the predicate K120087, the ground truth for respiratory measurements (Tidal Volume, Respiratory Rate, Minute Ventilation) would typically be established using a gold standard reference measurement system (e.g., highly accurate spirometry, capnography, or volumetric respirators) rather than expert consensus on images or pathology. The document does not specify the exact ground truth method used in the predicate study.

8. Sample Size for the Training Set:

• Not applicable for this 510(k) (K130170). The clinical trials for the predicate device (K120087) would have involved a patient sample. The document does not provide this information.

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

• Not applicable for this 510(k) (K130170). For the predicate device's clinical trials, the ground truth would have been established using a gold standard reference measurement system, as mentioned in point 7.

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ExSpiron is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years of age) patients.

ExSpiron is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:

• Tidal volume, .
• . Respiratory rate, and
• Minute ventilation. ●

ExSpiron measurements are used as an adjunct to other clinical information sources.

The ExSpiron™ consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Panel PC: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ Electrode Lead Set: An electrode lead set containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode lead set is also used to perform subsystem checks prior to patient measurements.

The provided 510(k) summary for the ExSpiron™ device includes information about its acceptance criteria and the study performed to demonstrate its performance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the calculation of bias and accuracy. The specific pass/fail thresholds for these metrics are not explicitly stated as "acceptance criteria" but are presented as the device's performance against a reference.

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

• Sample Size for ExSpiron-Wright study: 20 subjects
• Sample Size for Wright-Morgan study: 20 subjects (a different set of subjects)
• Data Provenance: The document does not explicitly state the country of origin, but it is a 510(k) submission to the FDA, suggesting the study was conducted to support US market approval. The study design (clinical comparison) implies prospective data collection for the purpose of the submission.

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

Not applicable. This device is a measurement device, and its performance is compared directly against existing medical devices (Wright spirometer and Morgan SpiroAir LT diagnostic spirometer), which are considered the reference or "ground truth" for these measurements. There is no mention of human experts establishing ground truth for individual measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth was established by direct measurement from predicate devices, not by 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

Not applicable. The ExSpiron™ is a medical device for monitoring physiological parameters (tidal volume, minute ventilation, respiratory rate), not an AI-powered diagnostic tool for interpretation by human readers. Therefore, an MRMC study or AI assistance effect size is not relevant to this submission.

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

Yes, the clinical performance testing describes a standalone assessment of the ExSpiron™ device. Its measurements were compared directly and simultaneously with those from the predicate devices (Wright spirometer and, indirectly, Morgan diagnostic spirometer). The output of the ExSpiron (tidal volume, minute ventilation, respiratory rate) is generated solely by the device based on its bioimpedance measurements and internal algorithms, without human intervention in the measurement process itself.

7. The Type of Ground Truth Used

The ground truth used was measurement from predicate medical devices:

• Wright spirometer: for tidal volume, minute ventilation, and respiratory rate. Respiratory rate was calculated using a stopwatch in conjunction with the Wright spirometer.
• Morgan SpiroAir LT diagnostic spirometer: for tidal volume and minute ventilation in a separate comparative study with the Wright spirometer. This allowed for an indirect comparison between the ExSpiron and the Morgan device.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The ExSpiron™ uses a "Bioimpedance measurement system" with "Firmware performs signal acquisition and relays data to the panel PC. Panel PC: A Windows 7 PC performs signal processing and calibration." It also states "the ExSpiron was calibrated to the individual" in the clinical study. This suggests a traditional signal processing approach with individual calibration, rather than a large dataset-based machine learning training paradigm. Therefore, a specific "training set sample size" as understood in AI development is not provided or likely applicable in the conventional sense for this device.

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

Similar to the point above, a traditional "training set ground truth" is not explicitly described. Instead, the device undergoes individual calibration for each subject against known physiological signals or reference measurements at the time of use. The clinical study details that "electrodes were applied, the ExSpiron was calibrated to the individual, and each subject performed ten 60-second breathing tests." This initial calibration likely establishes the individual's baseline and correlation for the bioimpedance measurements before subsequent monitoring.

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The intended use of the Philips NM3 Respiratory Profile Monitor, Model 7900, is to provide:

• cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU).
• spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.
• continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED).
  The intended use of the VentAssist software option is to provide:
• non-invasive monitoring of work of breathing per minute in adult patients receiving pressure support mechanical ventilation.
• on-demand advice in mechanically ventilated adult patients as prescribed by the caregiver regarding (a) modifications to the current pressure support settings in order to assess the work of breathing and breathing pattern and (b) modifications to ventilation in order to maintain end-tidal CO2 in a range determined by the physician. The patients should be hemodynamically stable and must be breathing spontaneously.

The NM3 monitor with VentAssist is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography and pulse oximetry in all of these clinical settings. It is intended to serve all of the same purposes as the flow, carbon dioxide, pulse oximetry, and cardiac output monitoring components of the predicate NM3 monitor with the addition of the optional VentAssist software.
Combination CO2 adapter/flow sensors (neonatal, pediatric, adult), combination adult CO2 adapter/flow sensors with a partial rebreathing valve and flow sensors (infant/neonatal, pediatric/adult) are connected with a male pneumatic connector to the NM3 monitor. Sidestream airway adapters and nasal cannulas are available which are connected with a sample cell connector to a receptacle on the LoFlo Module which can be interfaced to the NM3 monitor. All of these sensors are already legally marketed as accessories of 510(k) cleared Respironics-Novametrix NM3 monitor. The pulse oximetry sensors are connected to the NM3 monitor via a connector on the front panel of the monitor. All of the pulse oximetry sensors are already legally marketed as accessories of the 510(k) cleared NM3 monitor and Masimo predicate devices.
The principal function of the flow portion of combination sensors and flow sensors is to provide a differential pressure signal related to flow and airway pressure relative to atmospheric pressure. These sensors are often placed in the breathing circuit between the endotracheal tube and the ventilator circuit Y piece and may also be used in conjunction with a face mask or mouthpiece. The flow measurement portion of the NM3 monitor consists of a microprocessor-based data acquisition system that measures flow, and pressure and interfaces with a Capnostat 5 CO2 sensor. The CO2 airway adapter portion of the combination sensors, allow the Respironics-Novametrix CO2 mainstream gas sensor, the Capnostal® 5, to attach to it and measure the concentration of CO2 in the airway using infrared technology. When CO2 measurements are combined with airway flow and volume measurements, other parameters such as CO2 production and dead space can be calculated in all patient populations. The Capnostat 5 sensor as a mainstream gas analyzer includes a sample cell positioned in the breathing circuit through which a patient's inspiratory and expiratory gases flow. The LoFlo module, a sidestream type of gas analyzer, samples gases at 50 ml/min from a sampling port in an adapter placed in a breathing circuit or from a nasal or oral cannula. The gas then passes through a sampling tube to the sample cell, where the gas components are measured. The combination adult CO2 adapter/flow sensors with a partial rebreathing valve with periodic activation of the rebreathing valve allow pulmonary capillary blood flow and cardiac output to be calculated using the differential Fick method.
The VentAssist software option comprises a new screen with a soft key that provides ondemand ventilator-independent open-loop advice with respect to the level of pressure support and ventilation. As an advisory system, the clinician can choose to accept or reject the advice, alleviating any issues of safety and effectiveness. Additionally, an improved method for the calculation of plateau pressure has been included, as well as a new calculated parameter for work of breathing (WOB). The WOB parameter facilitates the goal of reducing excessive work of breathing per minute, or power of breathing (WOB/min), for mechanical ventilatory support in patients with respiratory failure. The WOB/min parameter is implemented using an Artificial Neural Net (ANN) and is used by the PSV Advisor software. The VentAssist PS/V Advisor is a rule based system which provides on-demand advice for the setting of the PSV level and ventilator support levels, based upon WOB/min, breathing frequency, tidal volume, ideal body weight, and end-tidal CO2. The advice is based upon a set of logic rules developed and refined in conjunction with experienced critical care clinicians at teaching University hospitals. Decision support advice offered by the VentAssist software is available during monitoring of adult patients. The monitor uses the sensor-type (adult, pediatric, or neonate), as well as patient data entered into the monitor, to enable appropriate features.

Here's a breakdown of the acceptance criteria and study information for the Philips NM3 Respiratory Profile Monitor with VentAssist, Model 7900, based on the provided text:

Important Note: The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and describes the validation of the Work of Breathing (WOB/min) parameter and the PS/V Advisor. It does not provide a detailed table of specific acceptance criteria with numerical thresholds for performance, nor does it present the study results in a quantitative manner against those thresholds. Most of the information below is extracted from the "Validation" section and related descriptions.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit numerical acceptance criteria are not provided in the document. The validation focuses on the accuracy of WOB/min and the agreement with PS Advisor recommendations.

• Agreement with esophageal pressure measurement (cleared device: Bicore CP-100)
• Bias and precision of invasive vs. noninvasive WOB/min |
• "Validating the front end for esophageal pressure measurement with a cleared device, Bicore CP-100 Cardiopulmonary Monitor"
• "Comparing invasive measurements of WOB/min using the esophageal balloon to noninvasive measures of WOB/min derived from proximal flow and airway pressure data... (bias and precision of 0.84 ±2.2 J/min)" |
  | VentAssist PS/V Advisor (Clinician Agreement) |
• Clinician agreement with recommendations (implicit: high degree of agreement expected) |
• Two clinical studies conducted. One study: "clinicians agreed with the PS Advisor recommendations." (Published in Banner et al, Chest, 133(3):697-703, 2008)
• Second study: "similar but done blinded so the clinician was unable to see the recommendations of the PS Advisor." (No specific results provided in this document for the second study) |
  | VentAssist PS/V Advisor (Safety & Effectiveness) |
• As an advisory system, safety and effectiveness are supported by the clinician's ability to reject advice |
• "clinician can choose to accept or reject the advice, alleviating any issues of safety and effectiveness." |
  | WOB/min Algorithm Implementation |
• Proper implementation in the embedded system |
• "Validating that the WOB/min algorithm was properly implemented in the embedded system, the Philips NM3 Monitor." |

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

• WOB/min Validation: "ventilated adults in the ICU (MICU, CICU, SICU, burn unit, step-down unit) who were breathing spontaneously on pressure support ventilation."

  • Sample Size: Not explicitly stated.
  • Data Provenance: Prospective, collected from various ICU settings (MICU, CICU, SICU, burn unit, step-down unit). Country of origin is not specified but the context of "teaching University hospitals" for rule development suggests US-based.

• PS/V Advisor Clinical Studies:

  • Sample Size: Not explicitly stated for either study.
  • Data Provenance: Prospective, clinical studies. Country of origin not specified, but the context of "teaching University hospitals" for rule development suggests US-based. One study's results were published in "Banner et al, Chest, 133(3):697-703, 2008."

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

• WOB/min Validation:

  • Number of Experts: Not applicable in the context of ground truth for this parameter. Ground truth was established by invasive esophageal balloon measurements.
  • Qualifications: "experienced critical care clinicians at teaching University hospitals" were involved in the development and refinement of the logic rules, not in establishing ground truth for the WOB/min measurement itself.

• PS/V Advisor Clinical Studies:

  • Number of Experts: Not explicitly stated for the test set evaluation. The text indicates that the advice was based on "logic rules developed and refined in conjunction with experienced critical care clinicians at teaching University hospitals." These clinicians likely acted as the "experts" whose judgment was compared against the device's advice.
  • Qualifications: "experienced critical care clinicians at teaching University hospitals." No specific years of experience are listed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for either the WOB/min validation or the PS/V Advisor studies.

• For WOB/min, the comparison was directly between the device's measurement and invasive (esophageal balloon) measurements.
• For the PS/V Advisor, the first study involved clinicians agreeing or disagreeing with the recommendations. The second study was blinded. This implies a direct comparison of the device's advice to clinical judgment.

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

• No, a formal MRMC comparative effectiveness study, as typically understood in medical imaging or diagnostic contexts, was not described.
• The clinical studies for the PS/V Advisor involved clinicians evaluating the device's recommendations, which could be seen as a form of human-in-the-loop assessment. However, the document does not quantify an "effect size of how much human readers improve with AI vs without AI assistance" in terms of specific performance metrics. It rather indicates that clinicians "agreed with the PS Advisor recommendations."

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

• Yes, for WOB/min calculation: The "noninvasive work of breathing per minute parameter" was validated by comparing its autonomously calculated values to invasive measurements (bias and precision of 0.84 ±2.2 J/min). This represents the standalone performance of the WOB/min module.
• No, for PS/V Advisor: The VentAssist PS/V Advisor is explicitly an "advisory system" where the "clinician can choose to accept or reject the advice." Its validation inherently involves human interaction (clinician agreement).

7. The Type of Ground Truth Used

• Work of Breathing Per Minute (WOB/min): The ground truth was invasive measurements of WOB/min using the esophageal balloon.
• VentAssist PS/V Advisor: The ground truth for evaluating the advice was the judgment/agreement of experienced critical care clinicians. The logic rules themselves were developed in conjunction with these experts.

8. The Sample Size for the Training Set

• WOB/min Artificial Neural Net (ANN): The sample size for training the ANN is not mentioned.
• VentAssist PS/V Advisor (Fuzzy Logic Rules): The document states the rules were "developed and refined in conjunction with experienced critical care clinicians." It does not specify a distinct "training set" of patients or cases used solely for this development, but rather implies an iterative process with clinical expert input.

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

• WOB/min Artificial Neural Net (ANN): How the ground truth for training the ANN was established is not provided. It's common for such ANNs to be trained on data where the output (WOB/min) is derived from invasive measurements using standard physiological models.
• VentAssist PS/V Advisor (Fuzzy Logic Rules): The ground truth for developing and refining the fuzzy logic rules was established through collaboration and consensus with experienced critical care clinicians at teaching University hospitals. This involved their expertise in defining appropriate PSV levels and ventilation adjustments based on various patient parameters (WOB/min, breathing frequency, tidal volume, ideal body weight, and end-tidal CO2).

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The intended use of the Wright/Haloscale Respirometer is the measurement and monitoring of the level of lung ventilation achieved by intensive care patients, during anesthesia and post operative recovery.

It measures expired volumes and thus indicates whether adequate ventilation is being achieved, whether in open or closed circuit or spontaneously breathing or mechanically ventilated patients.

The Respirometer is a mechanically driven dial, where the dial indicates gas volume passed, and the mechanism is driven by the kinetic energy in the flowing gas. The device measures expirate gas flow and measurements are unaffected by inspirate gas flow. It has an on/off button to lock the pointer and a reset button to return the pointer to zero when it approaches full scale

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wright/Haloscale Respirometer:

This document is a 510(k) summary for a medical device that measures lung ventilation, and as such, it focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a novel clinical study to establish new acceptance criteria and prove its performance.

Therefore, many of the typical acceptance criteria and study elements you requested (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance with ground truth, etc.) are not applicable or not explicitly detailed in this type of submission. The "study" here is primarily a bench-testing and technical comparison to the predicate device and established technical standards.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

   The "acceptance criteria" for a 510(k) are typically derived from the performance specifications of the predicate device and relevant industry standards. The device's reported performance is then compared to these.

   Acceptance Criteria (from Predicate/Standards)	Reported Device Performance (Wright/Haloscale Respirometer)
   Accuracy
   Tidal Volumes: ± 3% for minute volumes > 5 LPM	Achieved: ± 3% for minute volumes exceeding 5 LPM
   Continuous Flow: ± 4% for minute volumes > 4 LPM	Achieved: ± 4% for minute volumes exceeding 4 LPM
   Continuous Flow: ± 2% @ 16 LPM	Achieved: ± 2% @ 16 LPM
   Continuous Flow: ± 5% to + 10% @ 60 LPM	Achieved: ± 5% to + 10% @ 60 LPM
   Sensitivity
   Starts volume registration at not more than 2.5 LPM	Achieved: Starts volume registration at not more than 2.5 LPM
   Resistance
   Proportional to square of flow rate, not more than 2cm H2O @ 100 LPM	Achieved: Proportional to square of the flow rate and not more than 2cm H2O @ 100 LPM
   Dead Space
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 22 ml
   Permissible Gases
   Not specified (implied to be similar to predicate if not mentioned)	Reported: All respirable gases
   Maximum Temperature
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 55°C (131°F)
   Maximum internal to external pressure
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 30cm H2O
   Maximum Leakage
   60ml/min at 30cm H2O (to ASTM F1208-89)	Achieved: 60ml/min at 30cm H2O (to ASTM F1208-89)
   Maximum Recommended Flow Rate
   Not specified (implied to be similar to predicate if not mentioned)	Reported: 60 LPM (300 LPM continuous flow for short periods)

   Note: "Not specified" for criteria where only the device's reported performance is given means the document doesn't explicitly state the predicate's equivalent spec, but the FDA's acceptance implies it met an unstated or inferred standard.

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

   • Sample Size: Not specified. This would typically involve a series of bench tests using controlled gas flow measurements. The number of repetitions or specific test conditions is not detailed in this summary.
   • Data Provenance: The data provenance is laboratory/bench testing conducted by nSpire Health, Inc. This is not clinical data from patients (retrospective or prospective). The location is implied to be at the manufacturer's facility (Longmont, CO).

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

   • Not Applicable. For a device of this type undergoing a 510(k) for substantial equivalence, clinical expert ground truth is typically not required for the technical characteristics comparison. The "ground truth" for the technical specifications is established by calibrated flow meters and pressure sensors used during bench testing.

4. Adjudication method for the test set

   • Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert opinions, typically in clinical studies or evaluations of subjective interpretations (e.g., image analysis). This is a technical performance assessment, not an expert review.

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 mechanical respirometer, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was done, and there is no AI component.

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

   • Yes, in essence. The performance data presented (accuracy, sensitivity, resistance, etc.) are inherent characteristics of the device itself, determined through direct measurement during laboratory testing. It operates as a standalone mechanical device without human-in-the-loop performance in the sense of interpretative assistance.

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

   • The "ground truth" for the technical characteristics is based on calibrated physical measurements from standard laboratory equipment (e.g., reference flow meters, pressure gauges) and adherence to established industry standards like ASTM F1208-89.

8. The sample size for the training set

   • Not Applicable. This is a mechanical device, not a machine learning or AI model, so there is no concept of a "training set."

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

   • Not Applicable. Since there is no training set, this question is not relevant.

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The intended use of the Mercury module with Capnostat 5 is to provide:

• spirometric, and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination CO2/flow sensors are provided for adult, pediatric and neonatal use.

The Mercury module with Capnostat 5 is intended for non-invasive monitoring of the inspired and expired airflow and airway pressure of intensive care unit (ICU), anesthesia and emergency room (ER) patients, as well as capnography in all of these clinical settings. It is intended to serve the same purposes as the Mercury module with Capnostat 5. The submitted Mercury module with Capnostat 5 is identical to the cleared Mercury Module with Capnostat 5 CO2 sensor. except the nominal upper limit for the specification for the neonatal flow and neonatal CO2/flow sensors used with the Mercury module has been increased from 25 to 30 LPM to align with the specification for maximum inspiratory flow for ventilators cleared for use with neonates. The Mercury module with Capnostat 5 is intended to provide continuous monitoring of respiratory flow and pressure, and CO2 during anesthesia and intensive care and in the emergency department. The flow sensors connect to a patient airway circuit and provide physiological information to the Mercury module. The parameters directly measured and computed by the module (when connected to a Capnostat 5 sensor) include airway flow and pressure, volume, and CO2. The monitor calculates flow by measuring the pressure drop across a known resistance placed in the breathing circuit. CO2 is measured as the absorption of a known intensity of infrared light by CO2 molecules in the airway.

This document describes a Special 510(k) for a device modification, specifically an increase in the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM on the Mercury Module with Capnostat 5 CO2 sensor. The submission asserts that the device is "identical" to the predicate device except for this specification change, which was made to align with maximum inspiratory flow for ventilators cleared for use with neonates.

Because this is a Special 510(k) for a minor modification, the typical structure of a comprehensive de novo submission with detailed performance studies and acceptance criteria as outlined in your prompt is not present. Special 510(k)s often rely on demonstrating that the change does not significantly affect safety or effectiveness, often by showing that the modified device still meets existing performance standards or by providing limited testing related only to the change.

Therefore, many of the specific details you requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for a full-scale AI/ML device validation are not available in this type of submission.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for an AI/ML context:

Acceptance Criteria and Device Performance Study (K092217)

This submission is a Special 510(k) for a minor modification to an existing device (Mercury Module with Capnostat 5 CO2 sensor). The modification involves increasing the nominal upper limit for the specification for neonatal flow and neonatal CO2/flow sensors from 25 to 30 LPM. This type of submission relies on demonstrating substantial equivalence to a predicate device and that the change does not significantly affect safety or effectiveness.

Due to the nature of this submission (a device modification rather than a new device), the provided text does not contain explicit performance acceptance criteria or detailed study results in the manner one would expect for a novel AI/ML device. Instead, the focus is on the equivalence to the predicate device and the justification for the specification change.

The primary "acceptance criterion" for this Special 510(k) appears to be that the modified device remains substantially equivalent to the cleared predicate device (K080652) and that the change aligns with existing standards for neonatal ventilators.

Based on the provided text, a formal "study" with specific performance metrics and statistical analyses (as would be typical for an AI/ML product) is not described. The manufacturer states that the device is "identical" except for the changed specification.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this Special 510(k), explicit performance acceptance criteria are not detailed in the provided text. The "acceptance" is implied by the FDA's decision of substantial equivalence.

The following points cannot be answered definitively from the provided text as it pertains to a hardware device modification, not an AI/ML algorithm requiring such specific validation details.

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

• Not Applicable/Not Provided: For a hardware modification like this, a "test set" in the context of AI/ML validation (e.g., a dataset of images or patient records) is not relevant. The testing would involve verifying the hardware's performance characteristics. Details on such testing (e.g., number of units tested, conditions) are not in this summary.

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

• Not Applicable/Not Provided: Ground truth in the AI/ML sense (e.g., expert labels for clinical conditions) is not relevant for this hardware modification. The "ground truth" for the modified specification would likely be established through engineering design, material specifications, and performance verification against known physical standards, rather than expert clinical consensus.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable/Not Provided: This method is used in AI/ML studies to resolve discrepancies in expert annotations. It is not relevant to the validation of a hardware device's technical specifications.

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

• Not Applicable/Not Provided: MRMC studies are specific to evaluating clinical performance of AI/ML tools used by human readers. This submission concerns a physical sensor's performance.

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

• Not Applicable/Not Provided: This pertains to AI/ML algorithm performance independent of human interpretation. It is not relevant for a hardware sensor.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Not Applicable/Not Provided: The "ground truth" for this device's performance would likely be based on physical measurements against calibrated standards, engineering specifications, and established physiological ranges for neonatal respiration, rather than clinical consensus, pathology, or outcomes data in the AI/ML context.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: "Training set" refers to data used to train an AI/ML model. This device is a hardware sensor, not an AI/ML algorithm.

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

• Not Applicable/Not Provided: As above, this concept refers to AI/ML model development and is not applicable to this hardware device modification.

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