(95 days)
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.
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.
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.
§ 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).