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The LCI Option for Innocor is intended to measure the Lung Clearance Index (LCI), which is the cumulative expired volume required to clear an inert gas from the lungs during normal breathing in a multiple-breath washout (MBW) test divided by the Functional Residual Capacity (FRC).

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method, c) spirometry parameters by means of forced respiratory maneuvers, and d) peripheral airway function by means of multiple-breath inert gas washout.

The basic Innocor provides cardiac output (CO) as the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations. The disappearance curve for the blood soluble gas is used to calculate pulmonary blood flow (PBF), which in the absence of a significant intrapulmonary shunt is equal to cardiac output. The functional residual capacity (FRC) is determined from the dilution of the relatively insoluble gas during the same maneuver.

The LCI Option for Innocor, used alone or in conjunction with the entire Innocor system, provides information on lung volume and peripheral airway function.

The LCI is calculated as the cumulative expired volume (VcE) required to clear the inert tracer gas from the lungs during normal breathing, minus the product of the number of wash-out breaths and the external dead space outside the lips. divided by the subject's Functional Residual Capacity (FRC). FRC is the amount of air that stays in the lungs (up to the lips) after a normal expiration. In other words, LCI represents the number of lung volume turnovers (i.e. FRCs) that the subject must breathe to clear the inert tracer gas from the lungs (by convention, to an end-tidal concentration of 1/40th of the starting concentration over three subsequent breaths).

Innocor uses a combination of two techniques to determine the LCI, using SF6 as the inert tracer gas:

Inert gas rebreathing (IGR) is used for rapid wash-in of a very small amount of SF% until an even concentration is obtained in the lungs before the wash-out can start. This allows accurate determination of the functional residual capacity (FRC) by gas analysis alone.

This is followed by multiple-breath wash-out (MBW) for determination of the cumulative expired volume (VCF) required to clear the SF6 from the lungs. The Innocor device is a compact and portable point-of-care device. The hardware in the LCI Option for Innocor is identical to that used in the Innocor Diagnostic Programmable Computer (K051907) and the Cardiopulmonary Exercise Testing Option to Innocor (K071911). The combined rebreathing/multiple breath wash-out test performed with the LCI Option for Innocor requires accurate measurements of the respiratory flow and the concentration of SF6 at the mouth during inspiration (inhalation) and expiration (exhalation). The Innocor device measures the flow and SF6 concentration by means of of a pneumotachometer and a photoacoustic infrared gas analyzer, respectively, while the patient takes multiple breaths over a period of time through a pneumatically activated respiratory valve unit (RVU). The rebreathing gas mixture for wash-in of SF6 is filled into a rubber bag prior to testing.

Here's an analysis of the acceptance criteria and study information for the LCI Option for Innocor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for LCI or FRC measurements, nor does it present a direct comparison of the device's performance against such criteria. Instead, the performance evaluation is framed as demonstrating "substantial equivalence" to predicate devices and adherence to relevant guidelines.

The performance data described focuses on:

• FRC determination: Evaluated against a calibration syringe.
• LCI determination: Evaluated using data from a simulation model.

The summary states: "Performance data demonstrates that the hardware and software of the LCI Option for Innocor is as safe, as effective, and performs as well as or better than the predicate devices and thus that the device is substantially equivalent to the predicate devices."

Since specific numerical acceptance criteria and a detailed breakdown of the device's measured performance against them are not provided, I cannot create a table with specific numbers. The document relies on a qualitative statement of substantial equivalence.

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

• Sample Size: The document does not specify a sample size for the test set. It mentions evaluation against a "calibration syringe" for FRC and "data from simulation" for LCI. This implies bench testing rather than human subject testing for primary performance evaluation for equivalence.
• Data Provenance: The data provenance is from "bench testing" using a "calibration syringe" and "simulation." This suggests laboratory-based data, not human patient data, and therefore no country of origin or retrospective/prospective designation in the conventional sense for clinical studies.

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

There is no mention of experts being used to establish ground truth for the test set. The ground truth for FRC assessment appears to be the known volume of the calibration syringe, and for LCI, it's derived from a simulation model. This is typical for bench testing where the 'ground truth' is a controlled, known quantity.

4. Adjudication Method for the Test Set

No adjudication method is mentioned or relevant, as the testing described is bench testing against known physical or simulated values, not human expert interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done.
• This device is a measurement instrument for physiological parameters (LCI, FRC), not an AI-assisted diagnostic tool that would involve human readers or AI assistance for interpretation. Therefore, human reader improvement with/without AI assistance is not applicable.

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

Yes, a standalone performance evaluation was done. The device, which functions as a "Pulmonary function data calculator," directly measures and calculates LCI and FRC. Its performance was evaluated on its own ("against a calibration syringe for FRC determination and data from simulation for LCI determination") without human operators interpreting results to determine its accuracy. The "software is different from previous models," indicating that the algorithm's performance is primary.

7. The Type of Ground Truth Used

• FRC: Calibration syringe (known, controlled volume).
• LCI: Data from a simulation model.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is consistent with a device that is essentially a physiological measurement calculator, where the calculations are based on established scientific principles rather than a machine learning model that requires a "training set" in the typical sense. The "software is different from previous models" but this likely refers to implemented algorithms for calculation, not machine learning.

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

As no training set is mentioned in the context of machine learning, there is no discussion of how ground truth for a training set was established.

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The Spirometry Option for Innocor is intended to be used as a diagnostic spirometer, used in pulmonary function testing, to measure the flow of gas moving into and out of a patient's lungs.

In order to produce data regarding the maximum performance with respect to tidal volume and ventilation, the specific parameters measured by the Innocor Spirometry Option are:
FEV1: Forced expiratory volume in one second
FVC: Forced vital capacity
FEV1%: FEV1/FVC
PEF: Peak expiratory flow
MEF 75*: Maximum instantaneous forced expiratory flow where 75% of the FVC remains to be expired
MEF 50*: Maximum instantaneous forced expiratory flow where 50% of the FVC remains to be expired
MEF 25*: Maximum instantaneous forced expiratory flow where 25% of the FVC remains to be expired
FET: Forced expiratory time
MVV: Maximum voluntary ventilation

• MEF 75 is equal to FEF 25 (maximal instantaneous forced expiratory flow where 25% of the FVC has been expired); MEF 50 is equal to FEF 50; MEF 25 is equal to FEF 75.

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, and b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method. The Cardiopulmonary Exercise Testing Option to Innocor provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (Vr) and end-tidal gas concentrations plus a number of derived parameters. These parameters are determined by simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests, providing the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time.

Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. Spirometry is recognized as a valuable screening test of general respiratory health.

The Spirometry Option for Innocor measures the subset of spirometric variables of a patient during a forced expiration testing procedure. These measured variables include FEV1 (forced expiratory volume in 1 second), FVC (forced vital capacity), FEV . PEF (peak expiratory flow), MEF 75 (Maximal instantaneous forced expiratory flow where 75% of the FVC remains to be expired), MEF 50, MEF 25, FET (Forced expiratory time) and MVV (Maximum voluntary ventilation). These parameters are determined by measurements of the respiratory flow when breathing ambient air during a spirometry test of a patient (tidal breathing followed by a full inspiration and then finally a maximal forced expiration). The respiratory flow is measured by means of a pneumotachometer.

The Spirometry Option for Innocor device was evaluated against the "Standardisation of Spirometry" document in the series "ATS/ERS Task Force: Standardisation of Lung Function Testing," issued by The American Thoracic Society (ATS) and the European Respiratory Society (ERS). The performance data demonstrates that its hardware and software meet the ATS/ERS standards.

1. Table of Acceptance Criteria and Reported Device Performance:

*Note: MEF 75 is equal to FEF 25; MEF 50 is equal to FEF 50; MEF 25 is equal to FEF 75.

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

• The document does not specify the sample size for the test set or the data provenance (country of origin, retrospective or prospective nature). It generally states that "Performance data demonstrates that the hardware and software meet the ATS/ERS standards."

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 in the document.

4. Adjudication method for the test set:

• This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• The document does not mention an MRMC comparative effectiveness study. This device is a diagnostic spirometer for measuring pulmonary function, not an AI-assisted diagnostic tool for human readers.

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

• The study described is a standalone performance evaluation of the Spirometry Option for Innocor against established spirometry standards (ATS/ERS), without involving human-in-the-loop performance testing.

7. The type of ground truth used:

• The ground truth used is the ATS/ERS Standards for spirometry. These standards define the accepted physiological measurements for various spirometric parameters.

8. The sample size for the training set:

• The document does not specify a training set sample size, as the evaluation focuses on comparing the device's measurements to established standards rather than a machine learning model's training.

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

• The concept of a "training set" and associated ground truth establishment is not applicable in the context described. The device's performance is validated against pre-existing, widely accepted ATS/ERS Standards, which serve as the reference for accuracy and reliability in spirometry. These standards are established by expert medical societies (American Thoracic Society and European Respiratory Society) based on scientific consensus and extensive research in pulmonary function testing.

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A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for: Main metabolic parameters: Oxygen uptake, Carbon dioxide excretion, Expiratory minute ventilation. Calculated/derived parameters: Oxygen uptake per kg, Respiratory exchange ratio, Alveolar ventilation, Anatomical dead space (Fowler dead space), Tidal volume, Respiratory rate, End-tidal concentration of oxygen, End-tidal concentration of carbon dioxide, Expiratory quotient / ventilatory equivalent for oxygen, Expiratory quotient / ventilatory equivalent for carbon dioxide. And the following calculated parameters after an incremental exercise test: Anaerobic threshold, Respiratory compensation, Rest values, Values at AT point, Values at max exercise.

Innocor is a compact point-of-care device intended to be used for non-invasive measurement of a) cardiac output (CO) and other hemodynamic parameters utilizing inert gas rebreathing (IGR) technology, and b) metabolic parameters including oxygen uptake by means of a breath-by-breath gas exchange method. The Breath-by-Breath option provides measurements of gas exchange parameters including oxygen uptake (VO2), carbon dioxide excretion (VCO2), ventilation (VE) and end-tidal gas concentrations plus a number of derived parameters. These parameters are determined by simultaneous measurements of the respiratory flow and gas concentrations when breathing ambient air. The respiratory flow is measured by means of a differential pressure type flowmeter (pneumotachometer) placed between the respiratory valve unit and the patient. The gas exchange calculations are carried out online for each breath between the rebreathing tests. This gives the opportunity to perform an incremental exercise test on a bicycle ergometer or treadmill and measure the progress of cardiac function, pulmonary function and gas exchange at the same time.

The provided text describes the Cardiopulmonary Exercise Testing Option to Innocor. Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that the device has been shown through bench testing to be substantially equivalent to the predicate device. However, specific numerical acceptance criteria for performance metrics (such as accuracy, precision, or deviation) and the exact reported device performance metrics are not detailed in the provided text. The statement is a general claim of equivalence.

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

The document mentions "bench testing" but does not specify a sample size for the test set. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature of data).

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

The document does not mention the involvement of experts or provide details about their number or qualifications in establishing ground truth for the bench testing. The comparison is made against a legally marketed predicate device.

4. Adjudication Method for the Test Set

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

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

An MRMC comparative effectiveness study was not conducted as per the provided information. The study described is a bench test for device equivalence, not a study involving human readers or AI assistance.

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

The study was described as "bench testing" to demonstrate substantial equivalence to a predicate device. This implies a standalone (algorithm/device only) performance evaluation against the predicate, rather than an evaluation with human interaction.

7. The Type of Ground Truth Used

The ground truth for the bench testing appears to be the measurements provided by the legally marketed predicate device, the Medical Graphics Ultima System (K061731). The new device's performance was compared to this established device.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This submission focuses on the performance of a medical device rather than an AI/machine learning algorithm that typically requires a training set.

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

Since no training set is mentioned, no information is provided on how its ground truth was established.

Summary of Study Information:

The study described is a bench testing comparison of the Cardiopulmonary Exercise Testing Option to Innocor against a legally marketed predicate device (Medical Graphics Ultima System, K061731). The primary goal was to demonstrate substantial equivalence in the measurement of metabolic parameters on a breath-by-breath basis. The document lacks specific details regarding quantitative performance metrics, sample sizes, data provenance, expert involvement, or adjudication methods typically associated with clinical or AI algorithm validation studies. The ground truth for this comparison was established by the measurements of the predicate device.

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Innocor is indicated for the determination of a number of hemodynamic parameters. Cardiac Output (CO) is the principal measured parameter. Utilizing inert gas rebreathing, Innocor measures the relative levels of two inhaled gases of differing blood solubility over approximately 3-4 respirations and calculates pulmonary blood flow (PBF). In the absence of a significant intrapulmonary shunt (arterial oxygen saturation ≤ 95% as measured by a pulse oximeter incorporated in the Innocor), PBF is equal to CC. As an optional accessory, Innocor includes a noninvasive Blood Pressure (NIBP) monitoring system. This option provides systolic, diastolic and mean arterial pressures. With the NIBP option, Innocor provides values for the following measured and calculated hemodynamic parameters: Cardiac Output, Arterial Oxygen Saturation, Heart Rate, Stroke Volume, Lung Volume, Cardiac Index, troke Index, Blood Pressures (Systolic, Diastolic, Mean Arterial), ystemic Vascular Resistance, Systemic Vascular Resistance Index.

Innocor is a compact point-of-care device intended to be used for measurement of a) cardiac output (CO) utilizing inert gas rebreathing (IGR) technology and b) other hemodynamic parameters. Two Models will be made available initially in the U.S: Innocor, Innocor with NIBP option. With the NIBP module option, the device will provide values for the hemodynamic parameters included in the Indications for Use below.

The provided text for K051907 describes the Innocor device and its substantial equivalence to predicate devices, focusing on its ability to measure cardiac output and other hemodynamic parameters. However, it does not contain the detailed information required to fill out the table and answer the study-related questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a clinical study for the Innocor device itself.

The document primarily focuses on establishing substantial equivalence for regulatory purposes by comparing the Innocor's intended use and components (inert gas rebreathing for cardiac output, pulse oximeter, NIBP) to already cleared predicate devices. It lists the predicate devices and the parameters Innocor measures but does not include a specific study design with acceptance criteria and performance metrics for the Innocor.

Therefore, I cannot provide the requested table and detailed study information based solely on the provided text. The output below reflects the information that is not present in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth Establishment

• Number of Experts: Not specified in the provided text.
• Qualifications of Experts: Not specified in the provided text.

4. Adjudication Method for Test Set

• Adjudication Method: Not specified in the provided text.

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

• Was an MRMC study done? Not specified in the provided text. The document focuses on device equivalence, not human reader performance with or without AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as an MRMC study is not mentioned.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? The document describes the device's functionality for measuring various parameters. While it performs these measurements, a formal "standalone study" with specific performance metrics against an established ground truth (as typically reported for AI/algorithm performance) is not detailed. The text implies a comparison to methods like Thermodilution and Direct Fick for cardiac output, but not in the format of a standalone performance study with defined criteria and results.

7. Type of Ground Truth Used

• Type of Ground Truth: For the cardiac output measurement, the document mentions substantial equivalence to "Thermodilution Cardiac Output Computers" and the "Direct Fick Method preamendment calculation method." These predicate methods serve as a comparative basis for the Innocor's measurements, implying they represent the "truth" against which the new device is compared. However, a specific ground truth dataset and its source (e.g., pathology, outcomes data, expert consensus on a test set) for Innocor's own validation is not described.

8. Sample Size for Training Set

• Sample Size: Not applicable. The Innocor is described as a device utilizing inert gas rebreathing technology and other measurement components, not an AI/machine learning algorithm that requires a training set in the conventional sense.

9. How Ground Truth for Training Set Was Established

• How Established: Not applicable, as there is no mention of a training set for an AI/machine learning component.

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