(88 days)
The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transfering data from external devices.
The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx is indicated for data transfer from ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines to Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The devices are indicated for use by qualified medical personnel only.
The Device Interfacing Solution (DIS) has the following key components: Device specific converter module, device specific cable, bus cable to another DIS converter module, if needed, and Datex-Ohmeda monitor bus cable.
External devices are connected to the monitoring system by using converter modules that handle the communication between the device and S/5 monitoring system. These DIS converter modules convert the data coming from the connected device to a format that can be utilized in the S/5 Anesthesia Monitor, S/5 Critical Care Monitor, S/5 Compact Anesthesia Monitor, or S/5 Compact Critical Care Monitor.
The DIS converter module is connected to to the socket at the rear of the Datex-Ohmeda monitor with a bus cable. The bus cable is also used for connecting DIS converter modules to each other. Specific modules can be connected to the different type of external devices. Up to ten DIS converter modules can be connected in series. Each external device has its own specific DIS converter module that can be used only with that device. One DIS converter module is needed for interfacing one external device.
The use of a DIS system consists of making physical connections: connecting external devices to DIS and linking DIS modules together to make a complete bus, and sending the converted data to the S/5 monitoring system. The user can then select the source of measurement data for physiologic parameters displayed in the Datex-Ohmeda monitor.
The Device Interfacing Solution supports interfacing of the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines.
The Device Interfacing Solution can interface numerical, waveform and event type of data from the external device. Alarms are not transferred.
Interfaced data can be displayed on the monitor screen, trended, printed and used for record keeping purposes. Also, interfaced physiologic data is sent to the network to be viewed at the Central station monitor.
The provided text describes a medical device, the "Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx," and its regulatory clearance process (510(k)). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data (e.g., accuracy, sensitivity, specificity studies).
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that the device is substantially equivalent to a predicate device (AS/3 Interface Board, B-INT (K935477)).
- Compliance with Standards: The study mentioned is a nonclinical one demonstrating compliance with various electrical safety, electromagnetic compatibility, mechanical, environmental tolerance, and software validation standards.
- Functional Description: Details about what the device does (e.g., converts data, interfaces with external devices) and what it does not do (e.g., perform physiological measurements itself, transfer alarms).
Therefore, I cannot populate the requested table or answer most of the questions directly from the provided text. The document is a regulatory submission demonstrating safety and effectiveness based on equivalence and adherence to general engineering and safety standards, not a performance study as typically understood in the context of diagnostic or AI-driven medical devices.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance metrics (e.g., accuracy, latency of data transfer, error rate for data conversion) | NOT PROVIDED in the document. The document states "Verification of compliance with the following mandatory and voluntary standards has been made" and lists several electrical and safety standards. It also mentions "software validation and verification of specifications," but no quantifiable performance specifications are given. |
| Compliance with EN 60601-1:1990 + Amdt 1:1993 + Amdt 2:1995 + Amdt 3:1996 (Medical electrical equipment Part 1: General requirements for safety) | Verified |
| Compliance with IEC 60601-1:1988 +Amdt 1:1991 + Amdt 2:1995 | Verified |
| Compliance with CAN/CSA C22.2 No. 601.1-M90 + S1:1994 + Amdt 2:1998 | Verified |
| Compliance with UL 2601-1, October 24, 1997 | Verified |
| Compliance with IEC 60601-1-2:1993 | Verified |
| Compliance with EN 980: 1996 | Verified |
| Compliance with EN 1041 1998 | Verified |
| Compliance with EN 60529 | Verified |
| Electrical Safety | Compliant |
| Electromagnetic Compatibility | Compliant |
| Mechanical and Environmental Tolerance | Compliant |
| Software Validation | Verified |
| Verification of specifications | Verified (but no specific performance specifications are detailed) |
2. Sample size used for the test set and the data provenance: Not applicable. The "study" refers to compliance testing against engineering standards, not a clinical or performance validation study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study involving expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a data converter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "nonclinical testing" including "software validation and verification of specifications." This suggests some form of standalone testing was done for the software's functionality, but no specific performance metrics (like accuracy of data conversion, latency, error rates) are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the nonclinical testing, the "ground truth" would be the expected output or behavior of the device as defined by its specifications and the requirements of the standards (e.g., correct data format conversion, adherence to electrical safety limits). There's no biological or clinical "ground truth" in this context.
8. The sample size for the training set: Not applicable. This device does not use machine learning or AI that would involve a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).