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Model X-100: Nonin's SenSmart™ Model X-100 Universal Oximetry System is a modular system and is indicated for use in simultaneously measuring, displaying, monitoring, and recording up to six (6) channels of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate or cerebral or somatic hemoglobin oxygen saturation (rSO2) of blood underneath the sensor. Patient populations include adult, pediatric, infant, and neonate through the use of SenSmart compatible sensors. The SenSmart system is intended for use in hospitals, long-term care, medical facilities, sleep laboratories, sub-acute environments, and Emergency Medical Services (EMS), including patient transport. The X-100 SenSmart system may be used for spot-checking and continuous monitoring with patient alarms. The SenSmart pulse oximetry (SpO2) functionality is suitable for use in both motion and non-motion conditions, including patients who are well or poorly perfused.

Model 8100S(x): Nonin's Model 8100S(X) reusable soft sensor is indicated for non-invasive spot checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.

SenSmart Download Software: The SenSmart Download Software is an optional accessory for use with Nonin's X-100M SenSmart Monitor only. It is intended for use by healthcare professionals when 1) transferring data from the X-100M to a computer in order to maintain individual records of oximetry data, 2) reviewing data according to user-selected parameters, and 3) generating reports.

The SenSmart X-100 Oximetry System performs both pulse oximetry and regional oximetry measurements. The SenSmart X-100 Oximetry System works with all Nonin Equanox regional oximetry sensors (Model 8004CA, Model 8003CA, Model 8004CB and Model 8004CB-NA). The SenSmart compatible pulse oximetry Soft Sensor Model 8100S(x) is used with the Model X-100 System. The system consists of the sensor, the X-100SP signal processor (up to 6), extensions cables, the X-100H hub for multiple channels, the X-100M SenSmart Monitor which includes display, alarms, and memory. The SenSmart Download software is included for data storage review and reporting on a Windows PC.

The Nonin Medical, Inc. Model X-100 Universal Oximetry System is designed to measure and monitor arterial hemoglobin oxygen saturation (SpO2), pulse rate, and cerebral or somatic hemoglobin oxygen saturation (rSO2). The device underwent several tests to ensure its performance and safety, including functional and safety testing, rSO2 accuracy testing, SpO2 accuracy testing, and a usability study.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• SpO2 Accuracy Testing:

  • Sample Size: 13 healthy, non-smoking, light-to-dark-skinned subjects.
  • Data Provenance: Prospective, conducted in an independent research laboratory. The document does not specify the country of origin, but "Nonin Medical, Inc." is based in Plymouth, MN, USA.

• Usability / Human Factors Study:

  • Sample Size: 20 healthcare professionals.
  • Data Provenance: Prospective, likely conducted within a controlled environment to simulate clinical use. Country of origin not specified, but implied to be in the same geographic region as the manufacturer.

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

• SpO2 Accuracy Testing:

  • The ground truth for SpO2 was established by comparing the device's SpO2 measurements to arterial hemoglobin oxygen (SaO2) values determined from blood samples using four (4) laboratory co-oximeters. The final SpO2 values were paired with the average of three Radiometer CO-oximeters (ALB80Flex OSM). While these are not "experts" in the human sense, the co-oximeters serve as a highly accurate, standardized ground truth instrument for SaO2 measurement. No human experts are mentioned for establishing this specific ground truth.

• Usability Study:

  • The "ground truth" for usability was established through the observations of the study personnel and user feedback captured via questionnaires. No specific number or qualifications of "experts" are provided to establish the ground truth for usability, beyond the general conduct by "Nonin personnel" who provided in-service training and an "observer" during task performance.

4. Adjudication Method for the Test Set

• SpO2 Accuracy Testing: The method involved taking multiple arterial blood samples at different plateaued SpO2 levels and running them on four co-oximeters. The average of three Radiometer co-oximeters was used as the reference against which the device's SpO2 readings were compared. This isn't a traditional "adjudication" in the sense of multiple human readers resolving discrepancies, but rather a robust method of establishing a highly accurate instrumental ground truth.

• Usability Study: An observer was present to document whether tasks were performed appropriately and if the user had difficulty. User responses and body language were also documented. Task effectiveness was the primary objective, suggesting a pass/fail assessment based on predefined criteria, but no formal adjudication process by multiple individuals 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

• No, an MRMC comparative effectiveness study was not done. This device is an oximetry system and does not involve AI for interpretation or human-in-the-loop performance improvement. The studies described focus on the device's accuracy in measuring physiological parameters and its usability without, or as a replacement for, human interpretation of raw data.

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

• Yes, a standalone performance study was clearly the primary focus for SpO2 and rSO2 accuracy. The SpO2 accuracy testing directly compared the device's measured SpO2 values to the co-oximeter reference, operating independently of human interpretation of the measurement output. The rSO2 accuracy was demonstrated through direct device comparison and testing with the predicate system. The Usability study evaluated human interaction with the device, but the core accuracy measurements were standalone.

7. The Type of Ground Truth Used

• SpO2 Accuracy Testing: Instrumental Ground Truth (Laboratory Co-oximetry for SaO2 values).
• rSO2 Accuracy Testing: Comparison to a predicate device's measured rSO2 values, which would have been established with similar instrumental ground truth methods.
• Usability Study: User feedback and observation of task completion against predefined usability criteria.

8. The Sample Size for the Training Set

• The provided document describes pre-market testing for substantial equivalence. It does not mention a "training set" as would be relevant for machine learning algorithms. The device is hardware-based with embedded software, and its performance is verified through testing, not developed through machine learning. Therefore, this question is not applicable in the context of this device.

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

• As the concept of a "training set" is not applicable to this pre-market submission for a hardware medical device, this question is also not applicable.

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