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The Cheetah Reliant with NIBP and SpO2 functionalities is a portable, hemodynamic monitoring and non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a Non Invasive Blood Pressure (NIBP) function that non-invasively measures and displays blood pressure (diastolic, systolic and mean arterial pressure) and heart rate and with a SpO2 function that non-invasively measures and displays blood oxygen saturation (SpO2). The device displays associated heamodynamic parameters based on calculations with measurements incorporated into the Cheetah Reliant. These parameters are:

• Cardiac Index (CI),
• Stroke Volume (SV),
• Stroke Volume Index (SVI),
• Stroke Volume Variation (SVV),
• Heart Rate (HR),
• Ventricular Ejection Time (VET),
• Total Peripheral Resistance (TPR),
• Total Peripheral Resistance Index (TPRI),
• Cardiac Power (CP),
• Cardiac Power Index (CPI),
• Oxygen Delivery Index (DO2I),
• Electrical impedance of the chest cavity (Z0),
• Thoracic Fluid Content (TFC),
• Thoracic Fluid Content change from preset time period (TFCd) and
• Thoracic Fluid Content from baseline (TFCd0).
• Orthostatic Bioreactance (Postural changes in SV, CO and other hemodynamic parameters which are derived by Bioreactance)

The Cheetah Reliant with NIBP and SpO2 functionalities is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The Cheetah Reliant with oxygen saturation (SpO2) function is a modification of the Cheetah Reliant device cleared under K083093. The significant modification is the addition of a non invasive Oxygen Saturation (SpO2) module to the system which involved updating the user interface to allow operating the SpO2 module and for displaying the results and saving them within the device's database.

The SpO2 Module is the NELLCOR OxiMax NELL-1 Pulse Oximetry Module, manufactured by NELLCOR Pleasanton, CA ,USA, a division of Covidien. It is the same module that is in the NELLCOR OxiMax N-600x Pulse Oximeter (K060576).

The NELL-1 pulse oximeter board that is integrated into the Cheetah Reliant. uses calibration data contained in the OxiMax pulse oximetry sensor when calculating the patient's SpO2.

The NELL-1 Module connects to a OxiMax pulse oximetry sensor (DS-100A Durasensor®, the same sensor cleared with the OxiMax N-600x, K060576), through a Pulse Oximetry Cable (NELLCOR, DOC-10) that was also cleared with the OxiMax N-600x Pulse Oximeter (K060576) and provides oscillometric oxygen saturation to the Host system. The Module is controlled via software commands issued from the Host system through an asynchronous serial data port. All Module operations are initiated by the Reliant as the Host system. The Module is designed to take blood oxygen saturation measurements on demand.

The provided text describes the Cheetah Reliant with NIBP and SpO2 functionalities, comparing it to predicate devices and outlining the testing performed to demonstrate substantial equivalence. However, it does not explicitly detail specific acceptance criteria values or the results of a statistically powered clinical study for the device's performance in a quantitative manner (e.g., accuracy, sensitivity, specificity, or error rates for SpO2, NIBP, or cardiac output).

Instead, the submission focuses on demonstrating substantial equivalence primarily through:

1. Component Equivalence: The SpO2 module, cable, and sensor are identical to those in a previously cleared predicate device (NELLCOR OxiMax N-600x Pulse Oximeter, K060576).
2. Functional Verification: Testing was performed to ensure that SpO2 values calculated by the OEM SpO2 module are not corrupted during communication with the Reliant device.
3. Software Verification and Validation, Electrical Safety, and EMC testing.

Therefore, I cannot fully complete the requested table and many of the numbered points as the specific information is not present in the provided text.

Here is what can be extracted and inferred based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of a clinical performance study with human subjects for the SpO2 functionality review for this specific 510(k). The performance testing mentioned ("Performance testing to verify that SpO2 values calculated by the OEM SpO2 module are not corrupted") implies more of an engineering verification of data integrity during communication, rather than a clinical accuracy study with patient data.

The data provenance for such an engineering test would likely be simulated or internal test data, not patient data from a specific country. The original clinical data for the NELLCOR OxiMax N-600x SpO2 module (the predicate component) would have been used for its prior clearance (K060576), but that study is not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical ground truth determination is described for a test set in this submission regarding the added SpO2 functionality.

4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.

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 physiological monitor, not an AI-assisted diagnostic imaging device that involves human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The SpO2 module itself operates in a standalone (algorithm only) manner, converting sensor data to SpO2 values. The performance verification for this 510(k) focused on ensuring the integration of this pre-cleared standalone module into the Cheetah Reliant system did not corrupt its output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the SpO2 component, the original ground truth for the NELLCOR OxiMax N-600x would have been co-oximetry, but its specific details are not provided in this 510(k) summary. For the integration testing described here, the "ground truth" was the expected SpO2 values from the OEM module itself, prior to transmission to the main device display.

8. The sample size for the training set
Not applicable. This submission describes the integration of a pre-cleared COTS (Commercial Off-The-Shelf) module and system modifications, not the development of a novel algorithm that would typically require a training set.

9. How the ground truth for the training set was established
Not applicable, as no training set for a novel algorithm is described in this submission.

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The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean). In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The alternative NICOM Sensors are disposable electrodes used in conjunction with the Cheetah Medical NICOM signal processing product line.

The Cheetah Reliant non-invasive CO monitor (NICOM) is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

Cheetah Medical's alternative NICOM Sensor is a double electrode sticker. Within each sticker, one electrode is used to inject the a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. An array of such electrodes is placed at specific areas of the thorax, the impedance to the current flow calculated, and finally the electrical bio-reactance waveform constructed.

Acceptance Criteria and Device Performance Study for Cheetah NICOM System

This analysis is based on the provided 510(k) summary for the Cheetah NICOM System (K101487).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for the alternative NICOM Sensors. However, the performance is evaluated against the established performance of the predicate device. The primary acceptance criterion appears to be Substantial Equivalence to the legally marketed predicate NICOM electrodes (K071631 and K083093).

2. Sample Size and Data Provenance

• Sample Size for Test Set: 15 patients.
• Data Provenance: The study was conducted at Cheetah-Medical Ltd., suggesting it was likely conducted in Israel, where Cheetah Medical Ltd. is located. The study is prospective, as patients "underwent cardiac output evaluation."

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications for establishing ground truth in this study. The implication is that the "ground truth" for comparison was the performance of the predicate NICOM electrodes themselves, as they were the benchmark for substantial equivalence.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. The comparison was directly between the alternative sensors and the predicate sensors on the same patients.

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

No MRMC comparative effectiveness study was described. This study focused on the performance of a medical device (alternative sensors) compared to its predicate, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The study described is a standalone performance study in the sense that it evaluates the performance of the alternative NICOM sensors in measuring cardiac output, comparing its readings directly to those obtained using the predicate NICOM electrodes. It's not a human-in-the-loop study.

7. Type of Ground Truth Used

The ground truth used for the clinical testing was the measurements obtained from the legally marketed predicate device (NICOM electrodes cleared for use with the Reliant System). This approach aims to demonstrate that the new device provides comparable results to an already approved device.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" for the alternative NICOM Sensors in the context of this 510(k) summary. The clinical testing described directly serves as the "test set" for demonstrating equivalence. If a machine learning algorithm was involved, information about its training would typically be provided separately, but this document focuses on the sensor's performance.

9. How Ground Truth for the Training Set Was Established

As no specific training set is mentioned in the provided text in the context of demonstrating substantial equivalence, the method for establishing ground truth for a training set is not described.

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The Cheetah Reliant with NIBP functionality is a portable, non-invasive Cardiac Output monitoring device that monitors and displays a patient' Cardiac Output (CO) in Ltr/Min with a non-invasive blood pressure function that non-invasively measures and displays blood pressure (diastolic, systolic, and mean) and heart rate. In addition, the device measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Cheetah Reliant. These parameters are: Cardiac Index (CI), Ventricular Ejection Time (VET), Total Peripheral Resistance Index (TPRI), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), Cardiac Power (CP), Cardiac Power Index (CPI), electrical impedance of the chest cavity (Z0) and Thoracic Fluid Content (TFC). The Cheetah Reliant with NIBP functionality is intended for use within hospitals and other healthcare facilities (e.g., outpatient clinics) that provide patient care.

The Cheetah Reliant with NIPB functionality is a modification of the Cheetah Reliant device cleared under K072662. The significant modification discussed in this 510(k) submission is the addition of a Non Invasive Blood Pressure (NIBP) module to the system which involved updating the user interface to allow operating the NIBP module and for displaying the results and saving them within the device's database. The NIBP Module is the Advantage mini OEM BP™ module (Model 2 Mini), manufactured by SunTech Medical Inc. (Morrisville, NC, USA). The ADVANTAGE mini OEM BPTM Module Series is an oscillometric OEM blood pressure system. The module is controlled via software commands issued from a host system through an asynchronous serial data port (factory configurable to Logic Level or RS-232). All Module operations must be initiated by the Host system (Reliant). The module is designed to take blood pressure measurements (systolic, diastolic, and heart rate) on demand. After each blood pressure measurement, the Module discards the previous blood pressure results.

Here's a breakdown of the acceptance criteria and study information for the Cheetah Reliant with NIBP functionality, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NIBP functionality are based on compliance with ANSI/AAMI SP10:2002. This standard sets requirements for automated sphygmomanometers. While the document broadly states compliance, it does not provide specific numerical acceptance limits for parameters like accuracy and precision (e.g., mean difference and standard deviation of blood pressure readings compared to a reference) or the detailed reported device performance against those specific limits.

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

• Sample Size: The document only states "clinical testing was performed...for adult subjects." It does not specify the exact number of subjects or measurements included in the test set.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the medical device submission context, it would typically be prospective clinical data collected specifically for the regulatory submission.

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

This information is not provided in the document. For NIBP validation against ANSI/AAMI SP10, ground truth is typically established by trained observers (auscultators) using a mercury sphygmomanometer, often with a double-blinded approach. The document does not detail how many such observers were used or their specific qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document. For NIBP studies conforming to ANSI/AAMI SP10, there isn't a typical "adjudication" in the sense of expert consensus on diagnostic interpretations. Instead, the standard outlines specific procedures for simultaneous or sequential measurements by a trained observer and the device, with statistical analysis of the differences.

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

No, an MRMC comparative effectiveness study was not done for this device. The submission focuses on the performance of the non-invasive blood pressure (NIBP) module against an industry standard (ANSI/AAMI SP10:2002), not on comparing human reader performance with and without AI assistance for interpretation. The Cheetah Reliant with NIBP is a measurement device, not an AI interpretation system.

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

Yes, a standalone performance evaluation was conducted for the NIBP function. The assessment against ANSI/AAMI SP10:2002 involves comparing the device's automated measurements (algorithm only) directly against a reference standard (likely observer auscultation). There is no "human-in-the-loop" component for the NIBP measurement itself; the device automatically measures blood pressure.

7. The Type of Ground Truth Used

For the NIBP functionality, the ground truth would be established through simultaneous or sequential measurements taken by trained observers using a reference standard (e.g., mercury sphygmomanometer or an equivalent validated device), as outlined by the ANSI/AAMI SP10:2002 standard. This is not "expert consensus" in the diagnostic interpretation sense, nor is it pathology or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a training set for the NIBP module. The NIBP module (Suntech Medical Inc. Model 2 Mini) is an OEM component. While such components would have been developed and internally validated by Suntech Medical (which would involve development/training data), this information is not part of Cheetah Medical's 510(k) submission, which focuses on the integration and verification of the existing module within their system.

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

Since a training set for the NIBP module's algorithm is not discussed in this submission, the method for establishing its ground truth for training purposes is not provided. This information would typically reside with the original manufacturer of the NIBP OEM module (SunTech Medical Inc.).

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The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of Ltr/Min, and was cleared under K042144.

NICOM Electrodes are disposable electrodes used in conjunction with the NICOM signal processing product line.

The Cheetah NICOM is a portable, non-invasive, Cardiac Output detector system. The NICOM system measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

Cheetah Medical's NICOM electrode is a double electrode sticker. Within each sticker, one electrode is used to inject a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. An array of such electrodes is placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bio-reactance waveform constructed.

The provided text describes a 510(k) summary for the Cheetah NICOM System and its electrodes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for the device itself.

However, based on the information provided, we can infer and construct some of the requested elements, particularly regarding the equivalence of the NICOM electrodes.

Here's an analysis based on the supplied text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics for the Cheetah NICOM System's cardiac output measurement functionality, nor for the NICOM electrodes in isolation of their primary function.

Instead, the primary "acceptance criterion" demonstrated in the clinical testing of the NICOM electrodes is substantial equivalence to the 3M Health Care Red Dot electrodes when used with the NICOM System.

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

• Clinical Study for NICOM Electrodes Equivalence:
  • Sample Size: 10 subjects.
  • Data Provenance: Not explicitly stated, but the context of the other clinical studies (Lonestar Heart Center, Amarillo, Texas, US) suggests a prospective study conducted in the United States. The study involved measuring cardiac output in these subjects using both NICOM electrodes and the predicate 3M Red Dot electrodes.
• Clinical Safety Studies (though not performance test sets per se):
  • Sample Size:
    • 119 consecutive patients (postoperative cardiac surgery).
    • 36 patients (stress testing).
  • Data Provenance: Lonestar Heart Center, Amarillo, Texas, US for the 36 patients. The location for the 119 patients is not specified but is likely also in the US given the context of a US-based submission. These appear to be prospective studies focused on safety/adverse events.

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

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical studies. For the electrode equivalence study, "cardiac output was measured in 10 subjects." The ground truth for cardiac output itself would likely be derived from a reference method (e.g., PAC - Pulmonary Artery Catheter, mentioned in another study) or the comparative device (3M Red Dot electrodes). There is no mention of expert consensus for ground truth on the electrodes' performance.

4. Adjudication Method for the Test Set

Not specified in the provided text. The nature of the clinical "testing" for electrode equivalence ("Cardiac output was measured in 10 subjects with the NICOM System using the NICOM electrodes and using the 3M Health Care Red Dot electrodes") suggests a direct comparison, rather than an adjudication process requiring multiple reviewers for a diagnostic finding.

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 document describes a medical device (cardiac output monitor and its electrodes), not an AI algorithm intended to assist human readers in image interpretation or diagnosis. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is outside the scope of this submission.

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

• The Cheetah NICOM System is a medical device that measures physiological parameters. Its "performance" is inherent to the device's ability to measure cardiac output, not an algorithm's standalone diagnostic ability in the way an AI might operate. The system itself operates "standalone" in its measurement function, but it's a device measurement, not an algorithm interpreting data that a human would then review.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the NICOM electrodes' equivalence study, the ground truth appears to be based on the measurements obtained using the predicate device (3M Health Care Red Dot electrodes) when used with the NICOM System. The direct comparison between the new electrodes and the predicate electrodes provides the basis for demonstrating equivalence in cardiac output measurements. Another clinical study mentions "patients requiring PAC," suggesting that a Pulmonary Artery Catheter (PAC) might serve as a reference standard for cardiac output measurements in some contexts, but this isn't explicitly tied to the ground truth for electrode equivalence.

8. The Sample Size for the Training Set

• Not Applicable. This document does not mention any machine learning or AI components that would require a distinct training set. The device's operation is based on bio-impedance measurements and signal processing, not a trained algorithm in the modern AI sense.

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

• Not Applicable. As there is no mention of a training set or machine learning, this question does not apply.

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The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.

The Cheetah Reliant is a portable, non-invasive, Cardiac Output measurement system. The Cheetah Reliant measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

Here's a breakdown of the acceptance criteria and study information for the Cheetah Reliant device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set 1 (Bench Testing - Raw Data):
  • Sample Size: 44 patients
  • Data Provenance: Retrospective, Intensive Care Unit of Ambroise Pare Hospital in France.
• Test Set 2 (Human Testing):
  • Sample Size: 23 volunteers
  • Data Provenance: Prospective (implied by "testing in the Human (23 volunteers)"). Country of origin is not explicitly stated.

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

This information is not provided in the document. The "ground truth" for the comparative study was the measurements from the 1st generation NICOM System (K042144), which is the predicate device. It's not clear if human experts were involved in establishing the "truth" for either the predicate or the new device's measurements, beyond the doctors/nurses using the equipment in the ICU.

4. Adjudication Method for the Test Set

This information is not provided in the document. The study describes a "comparative study" and "Bland-Altman analysis," which is a statistical method for comparing two measurement techniques, not an adjudication method for reconciling expert opinions.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a Cardiac Output monitoring system, not an AI-based diagnostic tool that assists human readers/interpreters of medical images or data in the traditional sense of an MRMC study. The comparison was between two devices measuring the same physiological parameter.

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

• Partially, yes. The device itself is described as "standalone" in the sense that it's compact and uses an embedded processing unit, replacing an external laptop PC. The study compares the performance of this standalone device (Cheetah Reliant) against another device (1st generation NICOM System). The "algorithm only" aspect is inherent to its function as an automated measurement device. There isn't a human-in-the-loop component being evaluated in the study; it's a device-to-device comparison.

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

• The "ground truth" for this comparative study was the measurements obtained from the 1st generation Cheetah NICOM System (K042144), which served as the predicate device. The study aimed to show substantial equivalence to this established device. It's a comparison to a "standard device measurement" rather than an independent expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes testing and validation, but not the development or training of an algorithm in the machine learning sense. The device is based on existing bio-impedance measurement techniques.

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

This information is not provided in the document, as there's no mention of a "training set" or algorithm training in the context of machine learning. The device's operation is based on established bio-impedance principles, not on a trained AI model.

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The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of [Ltr/Min].

The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography.

This document is a 510(k) clearance letter for the Cheetah NICOM System. It indicates that the device has been cleared by the FDA as substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or the study that proves the device meets those criteria.

The letter itself is a regulatory approval, not a scientific study report. To find the information requested, you would typically need to refer to the original 510(k) submission documentation, which is not provided here.

Therefore, I cannot provide the requested information from the given text.

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The Cheetah Integrated Vascular Diagnostic System (I.V.D.S.) is a non-invasive tool intended to detect blood wave front (BWF) delay.

The Cheetah I.V.D.S. is a portable, non-invasive, 4-Channel Cheetah - Blood Wave Front (BWF) detector, with an additional Time Marker channel. The Cheetah channel is intended to measure the time lag between the start of the blood wave front in the peripheral vascular system and the peak of the R-wave on the time marker signal.

The Cheetah I.V.D.S. consists of 2 finger probes, 2 toe probes and time marker leads placed on the subject's wrists and legs. The probes are connected to a computer that analyses and presents a print out of the pulse wave as it reaches the periphery.

In addition, the Cheetah I.V.D.S. comprises standard Laptop computer connected to conventional analog-to-digital converter, which is used for the analysis and presentation of the acquired data.

The Cheetah I.V.D.S. is a device intended to detect blood wave front (BWF) delay. The provided text outlines its intended use, design, and a clinical study conducted for substantial equivalence.

Here's an analysis of the acceptance criteria and the study, with a focus on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative performance acceptance criteria (e.g., specific accuracy thresholds) for the Cheetah I.V.D.S. in terms of BWF delay detection. Instead, the performance evaluation primarily focuses on demonstrating substantial equivalence to a predicate device, the Autocorr® Plus (#3404) Pulse Oximeter/ECG Monitor.

The key performance criterion for the Cheetah I.V.D.S. in the context of the clinical study was:

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

The document does not specify the sample size of subjects or data points used in the clinical study that compared the Cheetah I.V.D.S. to the Autocorr device.

The data provenance (country of origin, retrospective/prospective) is also not explicitly stated for this clinical study.

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

The document does not describe the use of experts to establish a "ground truth" for the test set in the conventional sense of expert consensus on a diagnosis or measurement. Instead, the comparison was made against a legally marketed predicate device, the Autocorr Time Marker. The "ground truth" in this context is the output of the predicate device.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. Given that the comparison was between the Cheetah I.V.D.S. and a predicate device's output, it's unlikely that expert adjudication as typically applied to image or diagnostic interpretation was used.

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 Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The Cheetah I.V.D.S. is not presented as an AI-assisted device for human readers; it is a non-invasive diagnostic tool that measures BWF delay. Therefore, there's no mention of human reader improvement with or without AI assistance.

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

The clinical study described appears to be a standalone performance evaluation in the sense that the Cheetah I.V.D.S. itself, without human interpretation adding to its direct output, was compared to the predicate device. The device "analyses and presents a print out of the pulse wave" and "calculates and compares the time lags." The comparison was specifically on the "automatically calculated time lag measurements."

7. The Type of Ground Truth Used

The ground truth used for the comparative clinical study was the output of a legally marketed predicate device, the Autocorr® Plus Pulse Oximeter/ECG Monitor (specifically its time marker functionality). This falls under a form of reference standard comparison against an established and accepted device.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI development. The device is described as utilizing "currently available technology," and the software verification and validation are mentioned as ensuring performance according to specifications, but no explicit training data or its size is provided.

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

As no training set is described for machine learning or AI, the method for establishing ground truth for a training set is not applicable or provided in this document. The device's functionality is based on established physiological measurements rather than learned patterns from a large training dataset.

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