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The Nonin ® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO 2 ) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.

The Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The Model 7500 display uses light-emitting diodes (LED) components to present patient's SpO2 and pulse rate values, as well as alarm limit and volume settings. The Model 7500 can be powered internally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack. The Model 7500 includes adjustable audible and visual pulse rate, oxygen saturation, and perfusion alarms. It also includes a variety of advanced features, including low battery alarms, sensor fault, user defined defaults, real-time data outputs, and patient security mode.

Nonin Medical, Inc. Model 7500 Digital Pulse Oximeter

Here's an analysis of the provided information regarding the acceptance criteria and study for the Nonin Medical, Inc. Model 7500 Digital Pulse Oximeter:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary is for the addition of the Model 8000Q2 Ear Clip Sensor to an existing device (Nonin's Model 7500 Digital Pulse Oximeter, cleared under K071285). The summary for K080255 primarily focuses on demonstrating that the new sensor, when used with the existing device, does not introduce new concerns regarding accuracy or risks. Therefore, specific numerical acceptance criteria and a detailed breakdown of device performance for this particular 510(k) are not explicitly listed in the typical format you might expect for a primary device clearance.

However, the summary states:

Important Note: The precise numerical accuracy (e.g., RMS difference between SpO2 readings and CO-Oximeter) for the Model 7500 itself would have been established during its original clearance (K071285) in alignment with ISO 9919, which specifies accuracy requirements for pulse oximeters. This current 510(k) relies on that prior demonstration and confirms that the new sensor maintains that performance.

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

The provided document for K080255 does not explicitly state the sample size for the clinical testing conducted for the 8000Q2 Ear Clip Sensor. It only mentions "clinical testing."

• Data Provenance: Not specified, but generally, clinical studies for medical devices intended for the US market are expected to be conducted in a manner compliant with FDA regulations, often involving US-based patient populations or studies with robust ethical oversight. The summary does not specify if it was retrospective or prospective.

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

The document does not provide this information. For pulse oximetry, the ground truth for SpO2 accuracy is typically established using a reference CO-Oximeter, not primarily through human expert consensus on readings alone. If physician assessment of patient condition was part of the study (e.g., for perfusion), the qualifications of those physicians are not listed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. In the context of pulse oximetry accuracy studies, adjudication is less about expert review of images/readings and more about the rigorous methodology of blood sampling and CO-Oximeter measurements to establish arterial oxygen saturation (SaO2) as the reference standard against which the device's SpO2 is compared.

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

No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret images, and the AI's role is often assistive. For a pulse oximeter, the device provides a direct numerical measurement, and human interpretation of the measurement itself (as opposed to interpreting images from which the measurement is derived) is not the focus of such a study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the testing for the pulse oximeter's accuracy is inherently a standalone performance evaluation. The device generates SpO2 and pulse rate values directly. The "clinical testing" mentioned in the summary would involve comparing the device's readings against a gold standard (CO-Oximeter for SpO2) without human intervention in the device's calculation or display.

7. Type of Ground Truth Used

While not explicitly detailed in this summary, for pulse oximeters, the established ground truth for oxygen saturation (SpO2) accuracy studies is:

• Reference Oximetry (e.g., CO-Oximetry): Arterial blood samples are drawn and analyzed by a calibrated reference CO-Oximeter to determine the actual arterial oxygen saturation (SaO2). The pulse oximeter's SpO2 readings are then compared to these SaO2 values. This is the industry standard for establishing SpO2 accuracy.

8. Sample Size for the Training Set

The document does not provide information on the training set sample size. Pulse oximeters, particularly those from 2008, typically rely on physiological models and empirical calibration curves rather than "training sets" in the machine learning sense. While algorithms are involved, they are generally fixed based on extensive physiological research and empirical data collected during development, not necessarily a 'training set' in the modern AI iteration/re-training paradigm. Therefore, the concept of a training set as understood in current AI/ML might not directly apply or be documented in this type of 510(k).

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

As explained above, the concept of a "training set" with ground truth in the typical AI/ML sense is likely not applicable or detailed for this device. The underlying physiological models and calibration would have been developed based on extensive physiological research and empirical data (likely including human volunteer studies with reference CO-Oximetry), but this process isn't typically categorized as establishing "ground truth for a training set" in the context of a 510(k) for a pulse oximeter from this era.

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