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The Datex-Ohmeda S/5™ Oxygen Saturation Module, M-OSAT is intended for use with The Datex-Ohmeda modular multiparameter patient monitors for monitoring arterial oxygen saturation of hospitalized patients.

The Datex-Ohmeda S/5™ Oxygen Saturation Module, M-OSAT, and accessories are indicated for monitoring arterial oxygen saturation of hospitalized patients including monitoring during conditions of clinical patient motion. The device is indicated for use by qualified medical personnel only.

The Datex-Ohmeda Oxygen Saturation Module, M-OSAT and accessories with TruTrak+ motion correction performance (later referred to as M-OSAT) is a module used to monitor arterial oxygen saturation. The user interface has been implemented in the main software of the following:

• · AS/3 Anesthesia Monitor (K933285)
• · AS/3 Compact Monitor (K933156) using S-STDxx or S-ARKxx software
• · CS/3 Monitors (K974792) using S-ICUxx software
• · AS/3 Anesthesia Monitor (K000815) using S-ANE99(A), L-ARK99(A)
• · S/5 Compact Anesthesia Monitor (K002478) using S-00A05, S-00A06, L-00A07, L-00A08 software
• · S/5 Compact Critical Care Monitor (K002158) using S-00C03, S-00C04 software.

M-OSAT is single-width plug-in parameter module including the arterial oxygen saturation and pulse rate measurements for a modular monitoring system. This module is designed with the following characteristics:

• a single width plug-in module for the S/5 multiparameter monitor .
• measuring noninvasive arterial oxygen saturation and pulse rate .
• sensor consists of two light wavelengths LEDs and photodetector .
• Datex-Ohmeda proprietary SpO2 measurement board Prologue .
• an interface board for connecting the measurement board to the monitor .
• uses TruTrak+ with motion performance correction technology for measuring . noninvasive arterial oxygen saturation during clinical motion

This 510(k) summary does not contain a detailed study report with specific acceptance criteria and performance data in the format typically required for novel device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device, primarily by highlighting that the new device (M-OSAT with TruTrak+ motion correction) maintains the same accuracy and measuring range with an additional specification for motion conditions.

However, based on the provided text, we can infer the acceptance criteria and reported performance related to the new feature in this submission (motion correction).

Here's an attempt to extract the information as requested, though it will be limited by the detail presented in the 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size for any clinical or non-clinical test sets.
The document does not specify the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide any information regarding experts or ground truth establishment for a test set. The focus is on demonstrating compliance with standards and equivalence.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method as it does not detail a study involving expert review for ground truth.

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

The document does not mention or present a multi-reader multi-case (MRMC) comparative effectiveness study. The submission is for a device, not an AI-based interpretation tool for human readers.

6. Standalone Performance Study

The accuracy of the device (specifically the +/- 3 digits under motion conditions) is a measure of its standalone performance. However, the document does not provide details of a dedicated standalone study with methodology, exact sample sizes, or a comprehensive report. It states this as an "additional specification," implying testing was performed to establish this.

7. Type of Ground Truth Used

For oxygen saturation devices, the "ground truth" for accuracy is typically established through controlled desaturation studies where arterial blood gas samples are taken and analyzed by a co-oximeter or similar reference method. While the document doesn't explicitly state "co-oximetry," this is the industry standard for validating SpO2 accuracy. The document does not explicitly state the type of ground truth used but implies that the device's accuracy was verified.

8. Sample Size for the Training Set

This submission is for an oxygen saturation module, which typically relies on signal processing algorithms rather than machine learning models that require a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable in the context presented in this document. The "TruTrak+" technology likely refers to advanced signal processing for motion artifact reduction, which would be developed through engineering and signal processing techniques rather than a large labeled training dataset.

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

As explained above, the concept of a training set and its ground truth in the machine learning sense is not applicable to this device as described. The "TruTrak+" likely refers to internal algorithmic development and testing against known motion artifacts and reference oxygen saturation values, rather than a labeled training dataset.

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