(21 days)
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.
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.
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.
§ 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).