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The Model 509M Pulse Oximeter is intended to provide continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused in hospital, hospital-type facilities and intra-hospital transport environments such as the operating room, emergency department and intensive care units.

The Model 509M Pulse Oximeter Module is designed for continuous, non-invasive monitoring of the functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. Oxygen saturation is measured with ratiometric technique using red and infrared absorbance of oxy- and deoxyhemoglobin and pulse rate is measured using the time between successive pulses. The O2 saturation sensors are already legally marketed as accessories to the Model 2001 monitor. The Model 509M displays digital values of SpO₂ and pulse rate and transmits these values as well as the plethysmogram to a Philips Monitoring System via the VueLink Interface. The Model 509M module consists of a dual microprocessor based data acquisition system that measures oxygen saturation data. The firmware for the primary microprocessor is responsible for handling the user interface and communications with external devices via VueLink interface. The firmware for the second microprocessor, a digital signal processor, performs the filtering, pulse rate and saturation calculations of the algorithms which analyze the incoming signals and perform noise reduction on that signal when the presence of noise is detected.

The provided 510(k) summary for the K032755 (Model 509M Pulse Oximeter) does not contain a specific table of acceptance criteria or detailed results from a study proving device performance against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device (Model 2001 Pulse Oximeter, K993979, K000794) and mentions "inter-device comparison studies" to establish accuracy and sensor compatibility.

However, based on the information provided, we can infer some aspects related to acceptance criteria and the nature of the "study."

Here's an attempt to structure the information, acknowledging the limitations of the provided document:

Acceptance Criteria and Study for K032755 (Model 509M Pulse Oximeter)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., specific SpO2 accuracy ranges with mean absolute difference (MAD) or root mean square (RMS) error). However, it implies that the device is expected to meet the accuracy specifications of its legally marketed sensors, which were previously cleared with the predicate device (Model 2001).

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

• Sample Size: The document does not specify the sample size for the "inter-device comparison studies."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It just states "inter-device comparison studies were conducted."

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

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for the "inter-device comparison studies." For pulse oximeters, ground truth for SpO2 typically involves co-oximetry of arterial blood samples, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. The document does not describe any human interpretation or adjudication process for establishing ground truth or evaluating device performance. For pulse oximetry, the ground truth is typically a direct physiological measurement, not an adjudicated expert opinion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices where human readers interpret medical images, and the AI's impact on their performance is being evaluated. The Model 509M is a physiological monitoring device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone evaluation of the device's accuracy was implicitly done through the "inter-device comparison studies." The summary states these studies were conducted "to establish the Model 509Ms accuracy" and "to ensure that the sensors meet their currently published accuracy specifications with the Model 2001." This refers to the device's ability to accurately measure SpO2 and pulse rate, independent of a human operator's interpretation of its output.

7. The type of ground truth used

The type of ground truth used for pulse oximeter accuracy studies is typically co-oximetry of arterial blood samples. While not explicitly stated in this summary, this is the standard for SpO2 accuracy validation, and it is implied that the "inter-device comparison studies" would have referred to such objective physiological measurements for establishing accuracy reference.

8. The sample size for the training set

The document states: "The Model 509M uses the identical SpO2 and pulse rate software algorithm to process the information from the sensor as the predicate device, Model 2001 Pulse Oximeter, cleared under K993979 and K000794." This implies that the algorithm itself has been previously developed and validated with the predicate device. The summary does not provide any information regarding a training set specifically for the Model 509M, as it utilizes an existing, cleared algorithm.

9. How the ground truth for the training set was established

Since the Model 509M uses an "identical" algorithm to the predicate device (Model 2001), the ground truth for any original algorithm development (what might be considered a "training set" for the algorithm itself) would have been established during the development and clearance of the Model 2001 Pulse Oximeter (K993979, K000794). This would typically involve co-oximetry of arterial blood samples across a range of oxygen saturations in human subjects, as per ISO or FDA guidance for pulse oximeters. The current submission does not describe this historical training data or its ground truth establishment, as it primarily relies on demonstrating equivalence and sensor compatibility for the new device variant.

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