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The Nonin® Model 7500FO 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, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

The Nonin® Model 7500FO 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, and infant patients in an MR environment. Testing was performed in MR conditional environments at 1.5T and 3T. It is indicated for spot-checking and / or continuous monitoring of patients who are well or poorly perfused.

The Model 7500FO 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 7500FO can be powered externally with a 12 VDC 1.5A AC adapter or with an integral sealed 7.2-volt rechargeable NiMH battery pack.

The Model 7500FO 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 alarm, user defined defaults, real-time data outputs, and patient security mode. Nonin's fiber optic sensors and cables contain no conductive components, they can safely be placed on the patient's finger while inside an MR (magnetic resonance) environment.

Here's an analysis of the provided text regarding the Nonin® Model 7500FO Digital Pulse Oximeter, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K071415) does not explicitly state specific numerical acceptance criteria for the device's performance in terms of accuracy (e.g., A_rms values, bias, precision for SpO2 or pulse rate). It broadly states that the device "successfully undergone both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device."

Without explicit acceptance criteria in the document, it's impossible to create a table directly comparing them to reported performance. The document focuses on establishing substantial equivalence to a predicate device (Nonin Model 8604FO Pulse Oximeter and Fiber Optic Sensor, K910001). This implies that the performance of the Model 7500FO is expected to be comparable to that of the predicate device, which would have had its own established performance characteristics.

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

• Sample Size: The document does not specify the numerical sample size (number of patients or data points) used for the clinical testing. It only states "clinical testing."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that Nonin Medical, Inc. is based in Minnesota, USA, it is likely that the clinical study was conducted in the USA and was prospective, as is typical for device approval studies. However, this is an inference, not explicitly stated.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any clinical testing. For pulse oximeters, the ground truth for SpO2 is typically established through arterial blood gas analysis (co-oximetry), which does not inherently involve expert consensus in the same way as image interpretation.

4. Adjudication Method for the Test Set

The concept of "adjudication method" (e.g., 2+1, 3+1) is primarily relevant for studies involving subjective human interpretation of data, particularly in medical imaging where multiple readers may review cases. For a device like a pulse oximeter, which provides a direct physiological measurement, adjudication methods are not applicable in the traditional sense. The comparison would be between the device's output and the objective ground truth (e.g., co-oximetry).

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. MRMC studies are used to compare the diagnostic accuracy of different methods (e.g., imaging modalities or AI algorithms) when interpreted by multiple human readers, often involving a human-in-the-loop component. This device is a standalone physiological monitor, not an interpretive diagnostic tool that involves human readers in its primary function.

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

Yes, the testing described is inherently a standalone performance study. The Model 7500FO Digital Pulse Oximeter is a device that provides measurements (SpO2 and pulse rate) directly. Its performance is evaluated by comparing its output against a reference standard (ground truth), not by how it aids a human interpreter. The "clinical testing" mentioned would assess the algorithm's ability to accurately measure SpO2 and pulse rate on patients without human intervention in the measurement process itself, beyond proper sensor placement.

7. Type of Ground Truth Used

For pulse oximeters, the universally accepted "ground truth" for oxygen saturation (SpO2) is arterial blood gas analysis (co-oximetry). This involves drawing arterial blood and analyzing it with a co-oximeter to determine the actual arterial oxygen saturation (SaO2). The pulse oximeter's readings (SpO2) are then compared to these SaO2 values. The document doesn't explicitly state "co-oximetry" but this is the standard method for establishing ground truth for oximeters. For pulse rate, the ground truth could be established via ECG or a manual pulse count.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This suggests one of two possibilities:

• The device's underlying algorithms were developed and validated internally by Nonin using proprietary data, and this information is not typically part of a 510(k) submission unless specifically requested or deemed critical to substantial equivalence beyond the predicate.
• The device's core technology and algorithms are sufficiently similar to the predicate device, or are based on established biophysical principles, such that a separate, explicitly defined "training set" for the purpose of this 510(k) submission was not deemed necessary to describe.

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

Since no training set is mentioned, no information is provided on how its ground truth was established.

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