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The Datex-Ohmeda PRESTN module , M-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients.
The Datex-Ohmeda PRESTN module (model family M-PRESTN) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure.
Impedance Respiration measurement is indicated for patient's ages 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up. The device is indicated for use by qualified medical personnel only.

The Datex-Ohmeda PRESTN module (model family M-PRESTN) and accessories is a hemodynamic multiparameter module which is able to measure ECG, two Invasive blood pressures, SpO2, two Temperatures, Non-invasive blood pressure and Impedance Respiration.

The provided text describes a 510(k) premarket notification for the Datex-Ohmeda PRESTN Module (Model family M-PRESTN) and its accessories. This submission focuses on establishing substantial equivalence to a predicate device, rather than performing a de novo study with strict acceptance criteria based on novel performance metrics. Therefore, the information provided does not align with a typical acceptance criteria and study structure for a new device's performance claims.

Here's a breakdown of why this submission differs from what your request implies, and what can be extracted from the provided text:

Lack of Traditional Acceptance Criteria and Performance Study:

The document is a 510(k) summary, aiming to demonstrate that the new device (Datex-Ohmeda PRESTN Module) is "substantially equivalent" to an already legally marketed predicate device (Datex-Ohmeda M-NE12STPR Module). This means the focus is on showing that the new device is as safe and effective as the predicate, not necessarily that it meets specific, predefined performance thresholds for a novel function.

Instead of defining explicit acceptance criteria and then proving the device meets them through a dedicated performance study, the submission relies on:

• Comparison to a Predicate Device: Stating similarities in intended use, indications for use, fundamental scientific technology, operating principles, safety and effectiveness, user interface, and manufacturing processes.
• Compliance with Standards: Listing adherence to various mandatory and voluntary safety and performance standards (e.g., IEC, ANSI/AAMI, UL).
• Validation and Verifications: General statement about thorough testing through validation and verifications, but no specific study details are provided.
• Minor Changes Justification: Explaining that changes (e.g., new boards, software modifications, new cables, NIBP cuff) do not affect safety and effectiveness.

Specific Points from your Request and their Application to the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not explicitly stated in a quantitative, measurable table as one would expect for a novel device performance study. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with relevant standards.
   • Reported Device Performance: No specific numerical performance metrics are reported from a dedicated study. Instead, the document claims "the same safety and effectiveness" as the predicate device. The only specific performance change mentioned is a "New SpO2 calibration range: 70 to 100%," which is a specification adjustment rather than a performance outcome from a study.

2. Sample Size used for the Test Set and Data Provenance:

   • Sample Size: Not specified. The document refers to "thoroughly tested through validation and verifications" but doesn't detail the subjects or cases used for these tests.
   • Data Provenance: Not specified. Given the nature of a 510(k) for a device with "no change to the basic technology from the predicate," it's highly likely that testing involved bench testing, simulated environments, and potentially limited clinical validation to confirm functionality and compliance with standards rather than a large-scale clinical trial to establish new performance. The mention of "clinical motion in the M-PRESTN module uses the same algorithm as the predicate M-OSAT module (K011670)" suggests leveraging prior evidence for that specific aspect.

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

   • Not Applicable. The context is not a diagnostic device where expert ground truth is typically established (e.g., image interpretation). This is a vital signs monitor, where "ground truth" would likely refer to direct physical measurements or comparison to established reference devices/methods, rather than subjective expert consensus.

4. Adjudication Method for the Test Set:

   • Not Applicable. See point 3. This concept is not relevant for the type of device and study described.

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

   • No. This is not a diagnostic imaging device or a device where human interpretation is a primary component being evaluated. Therefore, an MRMC study comparing human readers with and without AI assistance is not described or relevant.

6. Standalone (Algorithm Only) Performance Study:

   • Implicitly Yes, but not detailed. The device is a monitor, and its internal algorithms (e.g., for ECG, NIBP, SpO2) operate in a "standalone" fashion as part of the total system. The compliance with standards like IEC 60601-2-27 (for ECG), IEC 60601-2-30 (for NIBP), ISO 9919 (for pulse oximeters) implies that the algorithms and hardware meet predefined performance metrics, but specific study details are not provided. The phrase "The software has been modified accordingly to accommodate the new hardware" indicates algorithmic changes were part of the update.

7. Type of Ground Truth Used:

   • Objective Measurements/Reference Standards. For a physiological monitor, ground truth would be established through highly accurate reference instruments for parameters like blood pressure, SpO2, and temperature, or standardized test signals for ECG and respiration. The document states "Verification of compliance with the following mandatory and voluntary standards has been made," which implies comparison against established criteria specified within those standards.

8. Sample Size for the Training Set:

   • Not Applicable / Not Specified. This device is not presenting as an AI/Machine Learning diagnostic algorithm that requires a "training set" in the conventional sense. The "software has been modified accordingly to accommodate the new hardware," but this refers to system programming and control, not typically a data-driven model training. If any "training" occurred, it would be calibration and tuning against known physiological signals or simulated data according to the listed standards.

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

   • Not Applicable. As above, the concept of a training set and its ground truth in the context of machine learning is not discussed in this 510(k) submission for a vital signs monitor.

Summary based on the Provided Text (No formal table possible due to lack of explicit criteria and performance numbers):

The Datex-Ohmeda PRESTN Module (Model family M-PRESTN) and accessories demonstrated acceptance by achieving substantial equivalence to the predicate Datex-Ohmeda M-NE12STPR Module (K993608) and in one specific aspect (SpO2 clinical motion) to the predicate M-OSAT module (K011670).

The study that "proves" the device meets acceptance criteria primarily consists of:

• Nonclinical Verification and Validation Tests: These tests confirmed compliance with a comprehensive list of national and international safety and performance standards (e.g., IEC 60601-series, ANSI/AAMI, UL, ISO). This indicates the device's components and overall system performance were evaluated against established engineering and medical device standards.
• Risk Analysis Redo: Ensuring that none of the changes introduced in the new device adversely affected its safety and effectiveness.

Key takeaway: This document represents a regulatory submission for a device modification, focusing on upholding existing safety and effectiveness benchmarks rather than introducing and validating entirely new performance claims with dedicated clinical efficacy studies with predefined acceptance criteria.

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