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

Indication for use:

The Datex-Ohmeda S/5 TM Nellcor Compatible Saturation Module, M-NSAT, and accessories are indicated for monitoring arterial oxygen saturation of hospitalized patients. The device is indicated for use by qualified medical personnel only.

The device description of the S/5 Nellcor Compatible Saturation Module M-NSAT is as follows:

[ a single width plug-in module of the S/5 multiparameter monitor

□ measuring noninvasive arterial oxygen saturation and pulse rate

□ sensor consists two light wavelenghts LEDs and photodetector

[ Nellcor OEM SpO2 measurement board MP 404 and accessories

[ an interface board for connecting the measurement board to the monitor

The modifications to the device are:

1. The Nellcor measurement board MP 203/204 is changed to Nellcor measurement board MP 404.

2. The interface board was modified to incorporate an interface for the Nellcor MP 404 board.

3. The interface software of the interface board was modified to incorporate an interface for the Nellcor MP 404 software.

4. The D-9 patient connector of the module is changed to the new pre-amplifier board circuit including the new patient connector model. These changes are determinate by Nellcor as part of the MP 404 specification.

5. Mechanics of the module bezel is redesigned for the new Nellcor patient connector and the pre-amplifier board.

6. The accessories of the new module are extended to the whole Nellcor sensor line as part of the MP 404 technology.

7. The new Nellcor trunk cable MC-10 is used.

The Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-NSAT and accessories (later referred to as M-NSAT) is a module used to monitor arterial oxygen saturation. The user interface has been implemented in the main software of the

AS/3 Anesthesia Monitor

or AS/3 Compact Monitor using S-STDxx or S-ARKxx software

or CS/3 Monitors using S-ICUxx software

or S/5 Anesthesia Monitor

or S/5 Critical Care monitor

or S/5 Compact Anesthesia Monitor

or S/5 Compact Critical Care Monitor

The M-NSAT module provides continuos non-invasive measurement of the pulse rate and oxygen saturation. Visual and auditory alarms are given for high/low pulse rate and high/low saturation values. The user can adjust alarm limits.

The M-NSAT module is designed using the Nellcor pulse oximetry technology. The user interface of the new M-NSAT module revision -04 is equivalent to the M-NSAT Nellcor Compatible Saturation Module (K943456).

The provided text is a 510(k) Premarket Notification summary for the Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-NSAT. This document focuses on demonstrating substantial equivalence to a predicate device (AS/3 Nellcor Compatible Saturation Module, M-NSAT, K943456) rather than presenting a detailed study with specific performance acceptance criteria and results in the format requested.

Therefore, many of the requested fields cannot be directly extracted or are not applicable to a substantial equivalence submission of this nature, which primarily relies on comparing technological characteristics and adherence to safety standards.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table with specific performance acceptance criteria (e.g., accuracy ranges for SpO2 or pulse rate) and corresponding reported device performance values. Instead, it states that the device "complies with the safety standards below and is therefore safe and effective for the intended use."

2. Sample sized used for the test set and the data provenance:

The document does not specify a "test set" in the context of clinical performance evaluation (e.g., a set of patient data used to evaluate accuracy). The testing mentioned is primarily non-clinical, focusing on compliance with safety standards, electrical safety, electromagnetic compatibility, mechanical, environmental tolerance, and software validation. Therefore, information on sample size and data provenance for a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The submission is not about a clinical efficacy study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for the reasons mentioned above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers.

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

The device is a standalone module for monitoring SpO2 and pulse rate. Its performance is inherent in its design and adherence to standards. The document doesn't detail a specific "standalone performance study" in the way it might for an AI algorithm. Its performance is demonstrated through its compliance with technical specifications and safety standards, as well as its substantial equivalence to the predicate device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For a pulse oximeter, the "ground truth" for SpO2 accuracy typically comes from co-oximetry (blood gas analysis, a gold standard for blood oxygen saturation). However, the document does not detail specific accuracy studies that would use this type of ground truth. The focus is on the device using a "Nellcor pulse oximetry technology" and having "no new questions of safety and effectiveness" compared to a legally marketed predicate device, which would have undergone such validation.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable for the reasons mentioned above.

In summary:

This 510(k) submission primarily leverages the concept of substantial equivalence. The acceptance criteria are implicitly met by demonstrating that the modified device has identical intended use, fundamental scientific technology, operating principle, and safety/effectiveness characteristics compared to a previously cleared predicate device (K943456), and by showing compliance with relevant electrical, mechanical, and software safety standards. The submission does not detail specific clinical performance studies with acceptance criteria for accuracy, sensitivity, or specificity, nor does it involve AI or human reader studies. The primary "study" is the non-clinical testing and comparison to the predicate device per 510(k) requirements.

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