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The Datex-Ohmeda Tonometry Module, M-TONO is intended to be used with a Datex-Ohmeda Modular monitoring systems for gastrointestinal tonometry measurements.

The Datex-Ohmeda Tonometry Module, M-TONO is indicated for monitoring gastrointestinal CO2 (PgCO2) and calculation of various gastrointestinal tonometry parameters when used with a Datex-Ohmeda monitoring system.

It is indicated for use in hospital patients.

The Datex-Ohmeda Tonometry Module, M-TONO is indicated for monitoring gastrointestinal CO2 (PgCO2) and calculation of various gastrointestinal tonometry parameters (gastrointestinal - arterial PCO2 difference, gastrointestinal - end-tidal PCO2 difference and intramucosal pH) when used with a Datex-Ohmeda modular monitoring system. It is indicated for use in hospital patients.

This device is indicated for use by qualified medical personnel only.

The Datex-Ohmeda Tonometry Module, M-TONO (later referred to as M-TONO) is a module used to monitor gastrointestinal PCO2. The user interface has been implemented in the main software of the AS/3 and CS/3 monitoring systems.

The Datex-Ohmeda Tonometry Module, M-TONO is intended to be used with a Datex-Ohmeda Modular monitoring systems for gastrointestinal tonometry measurements.

The Datex-Ohmeda Tonometry Module, M-TONO is indicated for monitoring gastrointestinal CO2 (PgCO2) and calculation of various gastrointestinal tonometry parameters when used with a Datex-Ohmeda monitoring system. It is indicated for use in hospital patients.

This device is indicated for use by qualified medical personnel only.

M-TONO is a single-width plug-in parameter module including the tonometry measurement module for a modular monitoring system. This module is designed for use in the following Datex-Ohmeda modular monitors: AS/3 Anesthesia Monitor, AS/3 Compact Monitor, CS/3 Compact Monitor and CS/3 Critical Care Monitor.

The tonometry module measures the gastrointestinal PCO2 (PgCO2) every 10 minutes utilizing a tonometry catheter placed into the patient's stomach or intestine. Initially the module fills the balloon of the Tonometrics catheter with ambient air, then repeatedly every 10 minutes deflates the balloon, analyzes and displays the PgCO2, and inflates the balloon again.

The provided text is a 510(k) Premarket Notification summary for the Datex-Ohmeda Tonometry Module, M-TONO. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed studies proving the device meets specific acceptance criteria in terms of diagnostic performance (like sensitivity, specificity, accuracy).

Therefore, based only on the provided text, a comprehensive answer to your request cannot be fully generated. The document primarily discusses:

• General company and device information
• Device description and intended use
• Comparison to a predicate device (Tonocap™ Monitor, K962638), highlighting similarities in intended use and differences in form factor (module vs. standalone), ability to measure higher PgCO2, and smaller measurement volume.
• Compliance with electrical safety standards.

There is no information in the provided text regarding:

• Specific quantitative acceptance criteria for device performance (e.g., accuracy, precision for PgCO2 measurement).
• A dedicated study proving the device meets such acceptance criteria.
• Sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone performance studies related to diagnostic accuracy.
• Details on training sets or how ground truth was established for performance evaluation.

The "summary of nonclinical testing" only mentions compliance with safety standards (IEC 60601-1, CAN/CSA C22.2 No. 601-1-M90, IEC 60601-1-2, IEC 60601-1-4), electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, and software validation. It does not outline performance criteria for measuring PgCO2.

The conclusion states, "The summary above shows that there are no questions of safety and effectiveness for the Datex-Ohmeda Tonometry Module, M-TONO as compared to the predicate device," which is the standard conclusion for a 510(k) submission showing substantial equivalence, not a direct demonstration of meeting predefined performance acceptance criteria through a specific study.

To answer your request based strictly on the provided text, I must state that the requested information (acceptance criteria for performance metrics and a study proving their fulfillment) is not present in this 510(k) summary. The document focuses on substantial equivalence based on intended use, technological characteristics, and conformance to safety standards.

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