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The NONIN® Model 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients. Its functions may be used separately or simultaneously.

Pulse Oximeter Intended Use:
The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. It may also be used for spot-checking and / or continuous monitoring of patients.

Blood Pressure Monitor Intended Use:
The blood pressure monitor is intended for noninvasively monitoring the blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The blood pressure monitor is not intended for use with neonates. It is intended for attended care and may be used for spot-checking.

The Model 2120 should be used for patients with arm circumferences of 18-42 cm.

The Model 2120 combines Pulse Oximetry and NIBP, utilizing the same fundamental scientific technology and intended use as the predicate devices.

Pulse Oximetry:
The NONIN® Model 2120 Finger Pulse Oximeter passes red and infrared light through perfused tissue and detects the fluctuating signals caused by arterial blood pressure pulses. Well-oxygenated blood is bright red, while poorly oxygenated blood is dark red. The pulse oximeter determines functional oxygen saturation of arterial hemoglobin from this color difference by measuring the ratio of absorbed red and infrared light as the blood volume fluctuates with each heart beat.

Blood Pressure Measurement:
The NONIN® Model 2120 NIBP uses an oscillometric step deflate technique to determine blood pressure. An internal electric pump is used to inflate the cuff, and deflation is controlled by two valves. During cuff deflation, small cuff pressure changes (resulting from arterial blood pressure pulses) are analyzed by the microprocessor, in order to determine the blood pressure. The Model 2120 has the ability to make blood pressure measurements at predetermined intervals or on demand. The Model 2120 has a Memory playback feature, allowing stored data to be transferred to a computer through data acquisition software for analysis.

The Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (NIBP) Monitor combines pulse oximetry and NIBP functionalities.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set (NIBP): Not explicitly stated, but the NIBP module supplier (SunTech Medical Instruments) performed clinical testing according to AAMI SP10 section 4.4.2. AAMI SP10 generally recommends a minimum of 85 subjects for clinical validation.
• Data Provenance (NIBP): Not explicitly stated (e.g., country of origin), but it was a clinical test. The summary does not specify if it was retrospective or prospective, but clinical validation studies are typically prospective.

3. Number of Experts and Qualifications for Ground Truth

• NIBP: The NIBP clinical testing, performed according to AAMI SP10 section 4.4.2, compared the device to manual readings. This implies that human observers (likely trained medical professionals) established the ground truth through auscultation (listening with a stethoscope) and a sphygmomanometer. The summary does not specify the number of these "experts" or their qualifications (e.g., years of experience), but AAMI SP10 requires a minimum number of trained observers (usually at least two) whose readings are then averaged or compared.

4. Adjudication Method for the Test Set

• NIBP: For the NIBP clinical testing against manual readings, AAMI SP10 dictates a specific protocol for how manual readings are taken and compared to the device readings. This usually involves multiple observers, and the reference standard might be the average of their readings or a comparison against a more invasive, simultaneously obtained reference (though manual readings are often considered the reference in oscillometric device validation). The summary does not explicitly detail the adjudication method beyond "compared to manual readings on patients according to section 4.4.2 of AAMI SP10."

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

• No, a MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported in this 510(k) summary. The device in question is a monitoring device, not an AI diagnostic tool that assists human interpretation of images or other complex data.

6. Standalone Performance

• Yes, a standalone performance assessment was effectively done for the NIBP component through the clinical testing according to AAMI SP10. This standard assesses the algorithm's performance against a reference standard (manual blood pressure measurements) without human intervention in the interpretation of the device's output.
• For the Pulse Oximeter, while no specific clinical study details are provided, the claim of "same fundamental scientific technology and intended use as predicate devices" implies that its standalone performance would be similar to established oximeters.

7. Type of Ground Truth Used

• NIBP: The ground truth used was expert consensus/manual readings. Specifically, it was comparison against manual sphygmomanometer readings, which are the established clinical standard for non-invasive blood pressure measurement and the standard required by AAMI SP10.
• Pulse Oximetry: Not explicitly stated, but for pulse oximeters, the ground truth is typically assessed against invasive arterial blood gas (ABG) measurements (co-oximetry) under controlled hypoxia studies, or by demonstrating substantial equivalence to devices that have been validated in such a manner. Given the brevity and focus on NIBP, these details for the oximeter are omitted.

8. Sample Size for the Training Set

• The 510(k) summary does not mention a separate training set or its sample size. This is typical for medical devices that are based on established physiological principles and signal processing without explicit machine learning or AI models that require distinct training and test sets in the modern sense. While the core algorithms for NIBP (oscillometric processing) and pulse oximetry were developed and refined, the concept of a "training set" as understood in current AI/ML development is not applicable here.

9. How Ground Truth for the Training Set Was Established

• As no explicit "training set" is mentioned in the context of this 510(k), there is no information provided on how ground truth for such a set would have been established. The underlying physiological models and signal processing algorithms would have been developed and refined through general engineering principles and possibly internal testing data, but not a formally described "training set" as submitted for an AI/ML device.

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