The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.

Device Description

The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party device are offered as accessories.

AI/ML Overview

The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is a data conversion device and does not involve AI or algorithms that would typically require extensive clinical studies for acceptance criteria. The information provided focuses on demonstrating substantial equivalence to a predicate device and compliance with relevant communication standards.

Here's an analysis of the provided text in relation to your requested criteria, highlighting why many aspects are not applicable to this type of device:

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

The submission does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI devices. Instead, the acceptance is based on:

Substantial Equivalence: The primary "acceptance criterion" is that the device is substantially equivalent to a legally marketed predicate device (Hewlett-Packard Model M1032A Vuelink Interface Plug In Module).
Compliance with Standards: The device's ability to comply with two specific IEEE standards related to medical device communications.

Given this, a table would look like this:

Acceptance Criterion (Type)	Criterion	Reported Device Performance/Compliance
Substantial Equivalence (Functional)	Match the intended use of the predicate device.	"Same" as predicate device (external device interface capacity).
Substantial Equivalence (Output Port)	Convert data for display on Siemens SC9000/SC9015 Bedside Monitor.	Uses IEEE 1073 (MIB Connector) output.
Standard Compliance (Communication)	Comply with IEEE 1073.3.1-1994 (Transport Profile- Connector Mode).	"complies with" this standard.
Standard Compliance (Communication)	Comply with IEEE 1073.4.1-1994 (Physical Layer Interface - Cable Connected).	"complies with" this standard.
Clinical Performance Data	Not required as per predicate device.	"Not applicable"
Biocompatibility & Sterilization	Not required as the device is not connected to patients and is not sterile.	"Not applicable"

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

This information is not applicable and therefore not provided in the submission. The device is a protocol converter; its "performance" is about correctly translating data formats and adhering to communication standards, not analyzing patient data. Testing would involve verifying correct data conversion and transmission, not analyzing or interpreting clinical 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 is not applicable. There is no "ground truth" in the clinical sense for this device. The "ground truth" would be the correct execution of the communication protocols and data conversion, which is validated through engineering and technical testing.

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

This is not applicable. Adjudication methods are used in clinical studies when there's subjective interpretation or disagreement among experts, which is not relevant for a data protocol converter.

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

This is not applicable. This device is not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

This is not applicable. This device does not contain an "algorithm" in the sense of an AI model performing analysis or interpretation. It's a hardware device with embedded software designed for data conversion and communication.

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

This is not applicable in the clinical sense. The "ground truth" for this device would be:

The specifications of the third-party devices' data output.
The specifications of the IEEE 1073 Medical Information Protocol.
The specifications required by the Siemens SC9000/SC9015 Bedside Monitor.
Verification would involve technical testing to ensure correct data mapping and protocol adherence.

8. The sample size for the training set

This is not applicable. This device does not use machine learning, so there is no "training set."

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

This is not applicable for the same reason as point 8.

Summary

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510 (K) Notification Siemens SC9000/SC9015 Medical Information Bus (MIB) Protocol Converter

K970368

MAY

-6 1997

510(k) SUMMARY

as required per 807.92(c)

2: Submitters Name, Address:

Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers. MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: David Simard, Director Quality Assurance and Regulatory Affairs Contact person for this submission: Jacqueline E. M. Emery ー Date submission was prepared: January 7, 1997

3: Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens SC9000/ SC9015 Series Medical Information Bus (MIB) Protocol Converter

B. Common Name, Classification Number, Class and Regulation Number:

Common Name	Classification Number	Class	Regulation Number
Transducer Signal amplifier andconditioner	73 DQA	II	21CFR870.2060

4: Predicate Device Identification: Hewlett-Packard Model M1032A Vuelink Interface Plug In Module cleared under 510(K) number: K923682

Device Description: The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party device are offered as accessories.
Intended Use: The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

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7. Table of device similarities and differences to predicate device

	Substantial Equivalent DeviceHewlett Packard CoModel M1032A VueLink Module	ApplicantSiemens Medical SystemsSC 9000/9015 Series Medical Information Bus (MIB)Protocol Converter
Manufacturer	Hewlett Packard	Siemens Medical Systems -Electromedical Group
510K Number	K923682	To be assigned
Intended Use	Provides an external device interfacecapability to third party devices thathave a serial RS-232 and/or analogoutput	Same
Intended Population	NANot connected to patients	Same
Intended Environment	OR or ICU	Same
Input port	RS-232, Analog, Analog/Digitalcombination	Same
Output Port	HP specific	IEEE 1073 (MIB Connector)

Assesment of non-clinical performance data for equivalence:

Substantial equivalence is claimed to the Hewlett Packard M1032A Vuelink Interface Plug-In Module cleared under 510(K) number K923682.

Assesment of clinical performance data for equivalence: Not applicable

1. Biocompatability. Not applicable
1. Sterilization Not applicable

12. Standards and Guidances:

Currently there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter complies with:

1073.3.1-1994 IEEE Standard for Medical Device Communications - Transport Profile- Connector Mode
1073.4.1-1994 IEEE Standard for Medical Device Communications - Physical Layer Interface - Cable Connected

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).