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The Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-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 Datex-Ohmeda S'57M E-NSAT module is a single-width plug-in parameter module for a Datex-Ohmeda S 5 modular monitoring system. E-NSAT is used for monitoring arterial oxygen saturation of hospitalized patients. The E-NSAT module provides continuous 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 the alarm limits. The E-NSAT module is designed using the Nelleor pulse oximetry technology. The real-time pulse oximetry signal is displayed without any scale. The calculated Sp()2 value and pulse rate can be shown in a separate numberfield, or beside the pulse oximetry signal. The parameters can be trended and the trends can be printed with the Recorder module in the momitor or with a separate laser printer.

The provided text is a 510(k) Premarket Notification summary for a medical device, the Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, E-NSAT. This document focuses on demonstrating substantial equivalence to a predicate device based on technical and functional similarities, rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a novel AI device.

Therefore, most of the requested information regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, ground truth establishment for AI training/testing, and expert qualifications for ground truth cannot be extracted from this document, as it describes a traditional medical device submission and not an AI/ML device.

However, I can provide what is available or inferable:

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

The document does not detail specific acceptance criteria for performance metrics (e.g., accuracy, precision) in a tabular format, nor does it report specific performance values for the E-NSAT module against such criteria. Instead, it states that the device has been "thoroughly tested through validation and verification of specifications" and assessed against various medical device standards. The key assertion is "The Customer and parameter specifications are the same" as the predicate device, implying that the performance targets are identical to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document does not describe a clinical study with a test set of data in the context of AI/ML evaluation. The primary validation appears to be non-clinical, focusing on compliance with standards and equivalence to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document does not describe establishing ground truth for a test set in the context of an AI/ML device.

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

Not applicable. This document does not describe a test set or adjudication method.

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 document describes a pulse oximeter, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

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

Not applicable. This device is a measurement module, and its performance is inherent in its design and operation; it's not an algorithm that functions without human interaction in its use context. "Standalone performance" in the AI/ML context doesn't apply here. The device itself is "standalone" in its measurement function, but that's a different concept.

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

Not applicable. Ground truth, in the context of evaluating a diagnostic AI device, is not mentioned in this document. The device's performance is likely evaluated against established standards for pulse oximetry measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and thus there is no "training set."

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

Not applicable. There is no training set mentioned for this device.

Summary of available information related to performance/validation from the document:

While the document doesn't fit the AI/ML framework of your questions, it does describe the validation process for a traditional medical device:

• Validation Method: The device has been "thoroughly tested through validation and verification of specifications" against a comprehensive list of international and national standards, including IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 9919 (pulse oximeters for medical use safety requirements), and EN 865 (pulse oximeters particular requirements). FDA guidance documents for premarket notifications and software were also considered.
• Equivalence Basis: The primary "proof" that the device meets acceptance criteria (implicit, as being safe and effective) is its substantial equivalence to a legally marketed predicate device (Datex-Ohmeda M-NSAT Module K020479). This equivalence is based on:
  • Identical intended use and indications for use.
  • Same operating principle and fundamental scientific technology.
  • Compatibility with the same monitor software and user interface.
  • Identical customer and parameter specifications.
  • Same safety and effectiveness profile.
  • Same manufacturing processes.
• Key Change and Its Clearance: The main difference is an updated Nellcor OEM Pulse Oximetry electronic measurement board (MP100 instead of MP404). Crucially, the document states: "The MP100 is an enhanced version of the MP404, and has been previously cleared with the Sandman Express (K040113)." This prior clearance of the core measurement technology likely significantly contributes to the non-clinical validation reliance.

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