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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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The AccuO2 System, which provides oxygen therapy on demand, based on continuous, non-invasive monitoring of oxygen saturation, is indicated for home use by adult Chronic Obstructive Pulmonary Disease (COPD) patients who are prescribed low-flow (0-3 L/min) supplemental oxygen via nasal cannula and USP portable oxygen.

The AccuO2 System is a portable, battery-operated system consisting of a proprietary demand oxygen delivery module combined with a commercially available pulse oximeter module. The system is used with a standard nasal cannula and USP portable oxygen. The proprietary software in the AccuO2 demand oxygen delivery module is designed to deliver oxygen on inhalation only and to maintain the patients at an oxygen saturation (SpO2) level of 90% while conserving oxygen.

Here's a breakdown of the acceptance criteria and study information for the MITI Corp. AccuO2 System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated in the provided abstract. The text only mentions "clinical testing was conducted to evaluate the ability to maintain patients at or above 90% SpO2 as designed."
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective given they are evaluating the device's performance, but this is not explicitly stated as retrospective or prospective.

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

• Not specified. The document refers to the device maintaining SpO2 levels and not increasing hypoxic states, which are physiological measurements, not interpretationsrequiring expert consensus in the same way an imaging study would.

4. Adjudication method for the test set:

• Not applicable/Not specified. The assessment criteria are objective physiological measurements (SpO2 levels, detection of breaths, valve actuation, oxygen amount calculation) rather than subjective interpretations requiring adjudication.

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

• No. This is not an AI-assisted diagnostic imaging device that would typically involve human readers. The AccuO2 system is a demand oxygen delivery system with an integrated pulse oximeter. The clinical studies compare its performance against existing devices, not human interpretation with/without AI assistance.

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

• Yes, implicitly. The functional testing and clinical studies described evaluate the device's performance directly, independent of continuous human intervention in its core functioning (e.g., detecting breaths, actuating valves, maintaining SpO2). The system's purpose is to automate oxygen delivery based on physiological inputs.

7. The type of ground truth used:

• Physiological measurements and objective device performance. The ground truth for the pulse oximeter's accuracy would likely be against a co-oximeter or arterial blood gas (ABG) analysis, though this is not explicitly detailed. For breath detection and valve actuation, the ground truth would be based on direct measurement of those events. For SpO2 maintenance, the ground truth is the patient's actual oxygen saturation as measured by the device itself (and likely validated against a reference standard during development/testing).

8. The sample size for the training set:

• Not applicable/Not specified. This device predates the widespread use of deep learning and often doesn't involve a "training set" in the modern machine learning sense, as it relies on proprietary software for control rather than a learned model from a large dataset. The software logic would be developed and verified, not "trained."

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

• Not applicable/Not specified, for the reasons mentioned above. The "ground truth" for the device's operational logic would have been established through engineering design, physiological principles, and functional testing to ensure the software correctly implements the intended control strategy.

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The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.

The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.

The device does not send any real-time alarms. The device a aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.

The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.

Using vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight, blood oxygen saturation level and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.

The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Neptec CareCompanion system.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them are primarily focused on Substantial Equivalence to a predicate device, specifically regarding the addition of a pulse oximeter. There's limited information on standalone performance metrics for each vital sign, rather the testing emphasizes functional equivalence.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not specify the sample size for any of the performance tests. It states "Testing was performed" and "The pulse oximeter was tested."
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal validation by the manufacturer, rather than a clinical study.

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

   • Not applicable. The document describes functional testing against existing specifications and predicate devices, not the establishment of ground truth by human experts for a diagnostic or interpretive task.

3. Adjudication Method for the Test Set:

   • Not applicable. The testing described focuses on functional performance and conformance to specifications, not on inter-rater agreement for a diagnostic outcome.

4. 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. This is not an AI-assisted diagnostic device, but rather a telemedicine system for vital signs collection and communication. Therefore, an MRMC study is not relevant here.

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

   • The core of the "Performance Testing" section describes standalone testing of the integrated vital signs measurement devices (e.g., "show that they operate equivalently when integrated with CareCompanion as when operated as independent devices") and the pulse oximeter against its manufacturer's specifications. This can be considered a form of standalone performance assessment for the individual measurement components within the system. The system itself is explicitly designed to be human-in-the-loop, with a "caregiver operating the Nurse Station" and clinical judgment required.

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

   • The "ground truth" for the performance testing cited appears to be:
     • Manufacturer's specifications: For the pulse oximeter.
     • Performance of independent devices: For the other integrated vital signs measurement devices. The equivalence to these "independent devices" is the reference.
     • Applicable mechanical, electrical, and environmental standards: For general system performance.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would require a "training set."

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

   • Not applicable, as there is no training set.

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Vasomedical, Inc.'s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.

The EECP® Therapy System Model TS3 with Pulse Oximetry is comprised of three major components, a Control Console, a Treatment Table, and a patient Cuff Set. The Control Console accommodates the air compressor and reservoir, a signal module panel, a power module, a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing ECG, finger plethysmograph and oxygen saturation signals. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set-point maintained by a closed-loop control system. The touch screen employs "hardware-less keys" which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system, an internal floppy disk drive is used to record data onto transferable media, and a printer is used to produce hard copy of site and patient identifiers and physiologic data. The Treatment Table accommodates a motorized lifting mechanism, mattress and the pneumatic circuit valve assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses. External pressure is applied via the patient Cuff Set to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. When the heart is in its relaxed state during the diastolic period, pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return. Immediately before the heart begins to eject blood during the next systolic phase, the cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload). Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment. The Model TS3 with Pulse Oximetry incorporates a noninvasive sensor and electronic module to acquire and process the patient's oxygen saturation. These same components functions can be used separately or simultaneously.

The provided text describes the Vasomedical EECP® Therapy System Model TS3 with Pulse Oximetry and mentions non-clinical and clinical tests. However, it does not explicitly state acceptance criteria or provide specific quantitative results of a study to demonstrate the device meets those criteria.

Instead, the documentation details:

• Non-clinical tests: Software verification and validation, including functional requirements, boundary values/stress testing, and safety requirements. It also mentions verification of system operation at both system and component levels, and biocompatibility testing. These are primarily focused on device functionality, safety, and software integrity rather than a quantitative performance metric against a defined clinical acceptance criterion.
• Clinical evaluation: A qualitative statement that "Clinical evaluation of EECP® in patients with congestive heart failure has been performed in multi-center, single center and registry-based clinical investigations. Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems. Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Given this, I cannot construct the table of acceptance criteria and reported device performance as requested, nor can I provide specific details like sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods, as these are not present in the provided text for a performance study.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not explicitly stated. The document details types of tests performed (software, safety, biocompatibility, clinical evaluation) but does not provide specific acceptance criteria or corresponding quantitative performance metrics from those tests.

Regarding the study proving the device meets criteria (based on the "Clinical Evaluation" section):

• Type of Study: Clinical evaluation (multi-center, single-center, and registry-based clinical investigations) of EECP® in patients with congestive heart failure.
• Study Purpose: To demonstrate clinical benefit in patients treated with Vasomedical EECP® Therapy Systems.
• Outcomes Measured:
  • Objective: Peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power.
  • Subjective: Quality of life, functional ability measures.
• Reported Finding: "Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems." and that "Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Missing Information (not found in the provided text):

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

• Not specified. The document mentions "multi-center, single center and registry-based clinical investigations" but provides no numbers for patient samples or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not specified. For a therapy system like EECP, the "ground truth" relates to clinical outcomes and physiological changes, which are measured directly rather than established by expert review of data/images. The document does not mention experts establishing ground truth in this context.

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

• Not applicable/Not specified. This typically applies to studies involving human interpretation (e.g., image reading), which is not the primary focus of the performance evaluation described here.

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

• No. This is not an AI-assisted diagnostic device, but a therapy system. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is not an algorithm-only device; it's a medical device used in a clinical setting by an operator.

7. The type of ground truth used:

• For the clinical evaluation, the "ground truth" would be the actual physiological measurements (peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power) and patient-reported outcomes (quality of life, functional ability measures) obtained during the investigations.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device would be its design, engineering, and software development based on medical principles and prior knowledge.

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

• Not applicable. See point 8.

In summary, while the document indicates that clinical evaluations were performed and demonstrated clinical benefits, it lacks the specific, quantifiable details regarding acceptance criteria and performance metrics that would typically be found in a robust study summary for a diagnostic or AI-powered device. The emphasis is on overall safety, functionality, and qualitative clinical benefit for a therapy delivery system.

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