The Datex-Ohmeda Interface module, E-INT is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda S/5™ Interface module, E-INT can be used with the following Datex-Ohmeda S/5™ modular monitors:

. S/5 Anesthesia Monitor(AM) with main software S-STD93 or newer version
S/5 Compact Anesthesia Monitor (CAM), with main S-STD93 or newer version ●
S/5 Critical Care Monitor (CCM) with main software S-ICU97 or newer version .
S/5 Compact Critical Care Monitor (CCCM), with main S-ICU97 or newer version .

The E-INT integrates real time and trended parameter data from external devices for viewing on the monitor display. The E-INT can integrate alarms from the Capnomac Ultima ™ and Critikon Dinamap TM 1846SX to the Datex-Ohmeda S/5 Monitor Alarm System.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called the Datex-Ohmeda S/5™ Interface Module, E-INT. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the document does not contain the detailed information requested in the prompt regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, or adjudication methods for ground truth because such detailed studies are typically not required for 510(k) submissions.

The document primarily focuses on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (Datex-Ohmeda Interface Board B-INT, K935477) by outlining similarities and minor differences in design and function. The "study" proving the device meets acceptance criteria in this context is primarily a comparison to the predicate device and verification against relevant medical device standards.

Here's an attempt to answer the questions based only on the provided text, noting where information is explicitly absent:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it asserts that:

Acceptance Criterion (Inferred)	Reported Device Performance
Substantial Equivalence to Predicate Device (K935477)	"The Datex-Ohmeda S/5™ Interface Module, E-INT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda Interface Board B-INT (K935477)."
Identical Intended Use & Indications for Use	"identical intended use and indications for use."
Identical Fundamental Scientific Technology	"identical fundamental scientific technology."
Same Operating Principle	"use the same operating principle."
Same Customer and Parameter Specifications (with minor storage temp change)	"the Customer and parameter specifications are the same, except for the storage temperature, which has been modified to be the same for the whole S/5 Monitor system."
Same Safety and Effectiveness	"have the same safety and effectiveness."
Compliance with Medical Device Standards	Assessed against multiple standards including IEC 60601-1, EN 60601-1, CAN/CSA C22.2 No. 601.1-M90, UL 2601-1, IEC 60601-1-2.
Thorough Testing	"The device has been thoroughly tested through validation and verification of specifications."

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

This information is not provided in the document. 510(k) submissions for devices like this typically rely on engineering testing (verification and validation against specifications and standards) rather than large-scale clinical test sets with patient data.

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)

This information is not provided in the document. Ground truth as typically understood in AI/imaging studies is not relevant here. The "ground truth" for this device would be its ability to correctly integrate external device data, which is verified through engineering testing and adherence to standards.

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

This information is not provided in the document. Adjudication methods are not applicable to the type of testing described in this 510(k) submission.

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

A multi-reader multi-case (MRMC) comparative effectiveness study, and any AI assistance-related improvements, is not relevant and not performed for this device. This is an interface module for physiological monitors, not an AI-powered diagnostic or assistive tool for human readers.

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

This concept is not applicable to this device. The device is hardware/software designed to integrate external measurement devices with a monitoring system; it does not operate as a standalone algorithm in the sense of making independent clinical interpretations or decisions. Its "standalone" function would be its ability to correctly transmit data, which is part of its general verification and validation.

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

The "ground truth" for this device is the correct and accurate integration and display of data from external measurement devices as verified against engineering specifications, performance standards, and the functionality of the predicate device. This would be established through technical and functional testing, not clinical "expert consensus" or "pathology."

8. The sample size for the training set

This information is not provided and is not applicable in the context of this device. This is not an AI/machine learning device that would have a "training set" in the typical sense. Any "training" would refer to software development and testing cycles, not data on which an algorithm learns.

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

This information is not provided and is not applicable as there is no "training set" for this device in the context of AI.

Summary

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Page 1 of 3

NOV - 2 2005

K052880

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Interface Module, E-INT

GENERAL COMPANY INFORMATION as required by 807.92(a){1)

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

September 28, 2005

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Datex-Ohmeda S/5TM Interface Module, E-INT

COMMON NAME:

Interface Module

CLASSIFICATION NAME:

The following Class II classification appears applicable:

Product Code	Classification Name	CFR Section
MSX	System, network and communication, physiological monitors	870.2300

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda S/5™ Interface Module, E-INT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda Interface Board B-INT (K935477).

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DEVICE DESCRIPTION as required by 807.92(a)(4)

. S/5 Anesthesia Monitor(AM) with main software S-STD93 or newer version
S/5 Compact Anesthesia Monitor (CAM), with main S-STD93 or newer version ●
S/5 Critical Care Monitor (CCM) with main software S-ICU97 or newer version .
S/5 Compact Critical Care Monitor (CCCM), with main S-ICU97 or newer version .

INTENDED USE as required by 807.92(a)(5)

Intended Use:

The Datex-Ohmeda S/5™ E-INT module is used to enable integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.

Indications for use:

The Datex-Ohmeda S/5™ E-INT module is indicated for integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.

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

SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda S/5™ Interface Module, E-INT is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda Interface Board B-INT (K935477).

The E-INT module has the following similarities compared to the predicate B-INT board (K935477):

identical intended use and indications for use .
identical fundamental scientific technology .
the same (improved) electronic measurement board .
same (improved) module software .
use the same operating principle .
. similar accessories (modified to fit both B-INT and E-INT)
have the same user interface at the monitor (can be used with the same monitor software) .
the Customer and parameter specifications are the same, except for the storage � temperature, which has been modified to be the same for the whole S/5 Monitor system.
. have the same safety and effectiveness
. are manufactured using the same processes

The main differences between the new E-INT module and the predicate B-INT board (K935477) is primarily due to fact that the new E-INT module has the following changes:

Transformed the Interface board inserted into the rear of the Monitor frame to a plug-in . module
Minor improvements to the electronic measurement board .
. Minor improvements to the module software
The accessories have been modified for use both with the B-INT and E-INT module �

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The separate connector for interfacing G-series gas modules and two additional channels . for serial communiction have been removed as obsolete due to the evolution of the Datex-Ohmeda monitoring system since the B-INT design in 1993.
. Added interface for Dräger Julian, Cato and Cicero, for North American Dräger (NAD) ventilator models 2B & 2C, for Baxter Vigilance CCO/SvO2, Baxter Explorer CO/SvO2 and for Oximetrix 3 and Spirometry data from the Ultima monitor
The specification for storage temperature has been modified to be the same for the whole . S/5 Monitor system.

Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the Datex-Ohmeda S/STM Interface Module, E-INT are substantially equivalent to the predicate Datex-Ohmeda -Interface board B-INT (K935477).

SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda S/5™ E-INT module has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

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 (Canadian deviations to IEC 60601-1:1988 + Amdt. . 1:1991) + S2:1998 (=IEC Amdt 2:1995)
UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. . 2:1995)
IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests) .
FDA/ODE Guidance for Content of Premarket Submission for Software Contained in Medical . Devices. (May 11, 2005)

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda $/5™ Interface Module, E-INT compared to the legally marketed (predicate) Datex-Ohmeda Interface Board B-INT (K935477).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2005

Mr. Joel Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

Re: K052880

Trade/Device Name: Datex-Ohmeda S/5TM Interface Module E-INT and accessories Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: October 11, 2005 Received: October 12, 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Clurs
Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda S/5™ Interface Module, E-INT and accessories.

Indications for use:

The Datex-Ohmeda S/5™ E-INT module is indicated for integration of external measurement devices to the Datex-Ohmeda S/5 Monitors.

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

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Am Sulion

Christon Sign-Off Olvision of Anesthesiology, General Hospital,
Infection of Anesthesiology, General Hospital, and and of Aniestricsiology. Gene Infection Control. Dental Devices

510(k) Number K052886

Page _ of _

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).