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Intended Use:

The Datex-Ohmeda Tonometry module , E-TONO is intended to be used with Datex-Ohmeda modular monitoring systems for gastrointestinal tonometry measurements.

Indications for use:

The Datex-Ohmeda Tonometry Module 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.

The Tonometry module is indicated for use by qualified medical personnel only.

The Datex-Ohmeda Tonometry module, E-TONO is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda Tonometry module, E-TONO can be used with the following Datex-Ohmeda modular monitors:

S/5TM Anesthesia Monitor (AM), S/5TM Compact Anesthesia Monitor (CAM), S/5TM Critical Care Monitor (CCM), or S/5TM Compact Critical

Care Monitor (CCCM), with monitor software versions 99 or newer.

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 min deflates the balloon, analyzes and displays the PgCO2, and inflates the balloon again.

All the calculated parameters can be selected on the display, and trended. Alarms for Tonometry are taken care of by the host monitor and follow the user interface for alarms in Datex-Ohmeda S/5 patient monitors. There are auditory and visual alarms and user adjustable limits for Tonometry variables. The accessories are the same for the E-TONO module and the predicate device, the M-TONO (K993656).

This 510(k) summary for K052167 describes a medical device, not an AI/ML powered device, and therefore does not contain the specific information requested in the prompt. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against detailed acceptance criteria through a study with ground truth data.

However, I can extract the relevant information regarding the device itself and its equivalence claim:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

This submission establishes substantial equivalence to a predicate device (Datex-Ohmeda M-TONO Module, K993656) rather than defining specific acceptance criteria for performance metrics. The underlying assumption is that if the new device is substantially equivalent to a legally marketed predicate, it meets the inherent performance standards of that predicate.

1. Table of "Acceptance Criteria" (Implied) and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not explicitly stated as numerical targets but are implied through the characteristics of the predicate device. The "reported device performance" is essentially the claim of identical characteristics to the predicate in key areas.

Study Information (Non-AI/ML Device)

The document describes a regulatory submission (510(k)) based on substantial equivalence, and not a study with the characteristics typically associated with AI/ML device validation. Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of patient data to evaluate performance metrics for an AI/ML device. The evaluation is based on engineering and design comparisons to a predicate device and adherence to safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. See point 2.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. See point 2.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. See point 2. The "ground truth" in this context is the safety and effectiveness profile of the legally marketed predicate device (K993656) and adherence to recognized standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. See point 8.

Summary of Nonclinical Testing and Conclusions:

The document states that the Datex-Ohmeda S/5™ Tonometry Module, E TONO and accessories has been assessed against the following standards:

• COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
• FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993
• IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
• EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995)
• CAN/CSA C22.2 No. 601.1-M90 + S1:1994 + S2:1998 (Canadian deviations to IEC 60601-1)
• UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1)
• IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests)

Conclusion: The device has been "thoroughly tested through validation and verification of specifications" to these standards, and there are "no new questions of safety and effectiveness" compared to the predicate device. This implies that testing demonstrated compliance with these general safety and performance standards for medical devices.

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