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The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused. The monitoring system is intended for use in hospital-type facilties, and during intra-hospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ Respiration Rate parameter, when used in conjunction with the Nellcor™ Bedside Respiratory Patient Monitoring System and Nellcor™ Adult Respiratory Sensor, is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

The subject device is the Nellcor™ Bedside Respiratory Patient Monitoring System (oximeter) which contains the Nellcor™ Respiration Rate Parameter (RR Version 2.0 Application device). The oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and respiratory rate by use of one of compatible Nellcor OxiMax oxygen transducers (sensors). The oximeter displays digital values of SpO2 and pulse and respiratory rate. The oximeter device features the same technological characteristics as the predicate, which is the exact same system featuring a system software upgrade.

The oximeter features the optional Nellcor™ Respiration Rate (RR) Software Application for use on the finished oximeter device. Covidien is submitting this traditional 510(k) submission as the result of a design change to the RR software device residing on the oximeter. The design change to the RR Software Application involves a modification to the principles of operation of the RR software algorithm.

The RR software application is intended for continuous non-invasive monitoring of respiration rate in adult patients, and it is calculated by an RR algorithm residing on the monitor which derives patient respiratory rate in breaths per minute based upon oximetry photoplethysmography data that is received from the oximetry sensor on the patient. The software parameter was cleared by the FDA through traditional 510(k) premarket notification (K111933) as the Nellcor Respiration Rate Software, Version 1.0 on March 15, 2012. Version 2.0 (V2.0) of the Respiration Rate (RR) software is an upgraded design of the original cleared software.

This document describes the regulatory submission for the Nellcor™ Bedside Respiratory Patient Monitoring System, specifically focusing on the Nellcor™ Respiration Rate (RR) Software Version 2.0. The device is a pulse oximeter that non-invasively monitors arterial oxygen saturation (SpO2), pulse rate, and respiration rate.

Here's a breakdown of the requested information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-clinical Testing (Simulated Motion Data for Respiration Rate): The document states this data was "collected from monitored patients on the general care floor which represents the intended populations and includes extreme boundaries of patient characteristics and artifact."
  • Sample Size: Not explicitly stated as a number but described qualitatively (patients on general care floor).
  • Data Provenance: Retrospective, derived from monitored patients on a general care floor. The country of origin is not specified.
• Clinical Validation Studies (for Respiration Rate Software):
  • Sample Size: Not explicitly stated as a number, but conducted on "healthy adult volunteers and on subjects from the hospital general care floor."
  • Data Provenance: Prospective, as these were conducted as part of the clinical validation. The country of origin is not specified.

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

This information is not provided in the document. The document refers to "ground truth" implicitly through expert-defined standards (e.g., ±1 breath per minute accuracy) and clinical assessment, but does not detail how the true respiration rates or SpO2 values for the test sets were established by experts, nor their specific qualifications.

4. Adjudication Method

The document does not explicitly mention an adjudication method for establishing ground truth in either the non-clinical or clinical studies.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study focuses on the standalone performance of the device.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm and device. The document describes several tests:

• Non-clinical performance data summary: This includes verification and validation reports for pulse oximetry, ISO and IEC test reports, Human Factors Summative Usability validation, and simulated motion testing for both pulse rate and respiration rate accuracy. This demonstrates the algorithm's performance under various simulated conditions.
• Clinical Summary: Clinical validation studies were conducted on healthy adult volunteers and hospital subjects to assess the accuracy of the Respiration Rate Software algorithm. The results demonstrated the algorithm's ability to calculate respiration rate within a stated accuracy.

7. Type of Ground Truth Used

• For Pulse Oximetry: Implied to be established against reference methods as per FDA Guidance, ISO, and IEC standards, which typically involve co-oximetry for SpO2 and ECG for heart rate.
• For Respiration Rate: For the non-clinical simulated motion data, the ground truth was based on measurements under controlled conditions simulating motion, low pulse rate, low perfusion, and low respiratory variations. For the clinical validation studies, the ground truth for respiration rate would typically be established by a reference method such as capnography or direct observation by trained personnel, though this is not explicitly stated. The document refers to "the Respiration Rate Software algorithm calculates respiration rate within a stated accuracy of +1 breath per minute over a range of 4-32 breaths per minute" implying a comparative measurement to a gold standard.

8. Sample Size for the Training Set

The document does not specify a separate sample size for a training set. The submission focuses on validating the performance of an upgraded algorithm (Version 2.0) against established criteria and its predicate. It is likely that development and initial tuning of the algorithm occurred on separate datasets, but these are not detailed in this regulatory summary.

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

As no training set is explicitly discussed, information on how its ground truth was established is not provided. The document details acceptance criteria and performance against those criteria, but not the developmental process of the algorithm in terms of training data and ground truth creation.

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The Nellcor OxiMAX N-600X Pulse Oximetry System with N-600X Pulse Oximeter and OxiMAX Sensors and Cables is indicated for prescription use only for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The N-600X Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospital-type facilities, intra hospital transport, and home environments.

The N-600X with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and into the lungs.

For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software: The Nellcor Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpOz) and pulse rate of adult, pediatric, and neonatal patients during both no motion conditions and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hosport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in aifflow through the upper airway and into the lungs.

The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

The Nellcor Bedside SpOz Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.

The OxiMAX family of pulse oximeters (including the N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside SpO2 Patient Monitoring System) provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate.

The N-600X, Nellcor Bedside Respiratory Patient Monitoring System, and Nellcor Bedside Sp02 Patient Monitoring System are designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMAX pulse oximetry sensors and the DOC-10 cable.

The Nellcor Bedside Respiratory Patient Monitoring System, Bedside SpO₂ Patient Monitoring System and the OxiMAX N-600X Pulse Oximetry System, the Nell-1 family of pulse oximeters, are technologically identical. They have the same oximetry PCBA and software.

Here's a breakdown of the acceptance criteria and study details for the Covidien pulse oximeters, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here is for the pulse oximeter's accuracy in measuring SpO2 (functional oxygen saturation of arterial hemoglobin) and pulse rate under both no-motion and motion conditions. The study implicitly aims to demonstrate that the device's accuracy remains within acceptable clinical ranges despite motion. The specific numerical acceptance criteria (e.g., standard deviation or RMS error) are not explicitly stated in the provided text as a table of criteria values. However, the study results confirm that the device was "validated for accuracy."

Study Details

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: The exact number of healthy adult volunteers for the invasive hypoxia study is not specified, but the study was conducted on "healthy, well-perfused adults."
   • Data Provenance: The study was a prospective, induced hypoxia study conducted by Covidien. The country of origin of the data is not specified, but the device manufacturer (Covidien) has addresses in Boulder, CO (USA) and Galway, IRELAND. The study description implies it was performed under medical supervision.

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

   • The document does not mention the use of human experts to establish ground truth for this medical device study. Instead, the ground truth was established by objective medical measurements:
     • SpO2 ground truth: SaO2 values from a CO-Oximeter (a laboratory instrument).
     • Pulse Rate ground truth: ECG values.

3. Adjudication method for the test set:

   • No adjudication method (like 2+1 or 3+1 consensus) was used, as the ground truth was established by direct instrumental measurements (CO-Oximeter and ECG) rather than subjective expert interpretation.

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 MRMC study was done, as this is a pulse oximetry device, not an AI-assisted diagnostic imaging or interpretation tool. The study focuses on the device's accuracy against objective measurements, not human reader performance.

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

   • Yes, the primary study detailed is essentially a standalone performance evaluation of the pulse oximeter's algorithm. The device measures SpO2 and pulse rate independently and then these measurements are compared to the ground truth from the CO-Oximeter and ECG. Human interpretation is not part of the measurement process being tested.

6. The type of ground truth used:

   • Objective Instrumental Measurements:
     • For SpO2: SaO2 values obtained from a laboratory CO-Oximeter.
     • For Pulse Rate: ECG values.

7. The sample size for the training set:

   • This document describes a clinical validation study for a medical device trying to expand its indications for use. It does not mention a "training set" in the context of machine learning, as this is not an AI/ML device that requires explicit training data for its core functionality. The device's algorithms for SpO2 and pulse rate measurement would have been developed and refined during its initial design process, but the details of that development (including any "training" data for the algorithms themselves) are not part of this 510(k) submission summary. The "training" in this context would implicitly refer to the data used during the initial development and validation of the N-600X and Nell-1 family of oximeters prior to this specific K-K123581 submission.

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

   • Not applicable, as this submission does not detail a machine learning model's training process. The ground truth for the validation study was established using a CO-Oximeter for SpO2 and ECG for pulse rate, as mentioned above.

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