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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) 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 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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