(27 days)
The S/5™ FM with L-FICU04 and L-FICU04A and N-FCREC Module are intended for multiparameter patient monitoring.
The S/5 FM with L-FICU04 or L-FICU04A software is indicated for monitoring of hemodynamics (including arrhythmia and ST-segment analysis) and respiratory status of all hospital patients.
Extension module N-FCREC (option N-FCREC or N-FC) is indicated for monitoring CO2 and respiration rate of all hospital patients. CO2 measurements are indicated for patients weighing over 5kg (11lbs).
The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only.
The S/5™ FM Monitor with L-FICU04(A) software is a patient monitor, which measures and displays patient physiological parameters in hospital environments. The S/5™ FM uses two types of plug-in measurement modules: Extension module N-F(C)(REC) with CO2 or Recorder option, or both, and Patient side Module E-PSM(P), that measures ECG, impedance respiration , invasive and non-invasive blood pressures, pulse oximetry and temperature. The E-PSM(P) is the subject of a separate 510(k). The miniC unit of the N-FC(REC) Extension module, included in this 510(k) submission, is a side stream gas analyzer. It monitors the Carbon dioxide (CO2) inhaled and exhaled by the patient, by measuring the absorption of CO2 at 4.2-4.3 micrometer using narrow band IR filters. It can also monitor the respiration rate as the frequency of peak (end tidal) CO2 measurements per minute. All concentrations are measured and displayed breath by breath. The MiniC unit of the Extension module is equipped with the mini D-fend water separation system. There are two software options available for the S/5 FM: L-FICU04 and L-FICU04A. The L-FICU04A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to the L-FICU04. Commonly, the software is collectively referred to as L-FICU04(A). The E-PSM(P) and N-F(C)(REC) Modules placed in the S/5 FM are automatically recognized by the monitor. Monitoring can begin when patient cables are connected to the module plug-in jacks. The modules perform parameter measurement and minor data processing. The S/5™ FM displays measured parameters in the form of numeric values, waveforms and trends on the screen. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The L-FICU04(A) software performs some module-related tasks like arrhythmia analysis, ST value calculation, heart rate calculation, impedance and respiration rate calculation. All the module communication is also handled in the main software. The S/5™ FM is operated by command board keys. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. In addition of the standard command board there is an optional type of keyboard, a hand-held Remote controller (REMCO), which is directly connected to the S/5™ FM via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. The Recorder is a thermal array printer with which you can print from one to three traces and numerical information with a selectable speed. The S/5™ FM Monitor can be in a stand-alone or networked configuration. If networked, measurement data (parameter-associated numbers, waveforms or trends and patient care documentation) is sent to the network for central viewing of the network, monitor-to-monitor viewing, or for archiving. Software I .- FICU04 and L-FICU04A include support for wireless LAN communication between the monitor and S/5 Central station. The networking can thus be hardwired or wireless.
This document is a 510(k) Premarket Notification summary for the Datex-Ohmeda S/5™ FM monitor. It aims to demonstrate substantial equivalence to previously cleared devices, rather than proving a new device's efficacy through a comprehensive clinical study with acceptance criteria and a detailed study design. Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample size, ground truth establishment, expert qualifications, MRMC studies, standalone performance), is not provided because this type of submission focuses on regulatory compliance through comparison to existing predicates.
However, based on the provided text, we can extract the general approach to showing safety and effectiveness by demonstrating compliance with recognized standards and similarity to predicate devices.
Here's an attempt to answer your questions based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not present a table of specific quantitative acceptance criteria or device performance in the manner typically seen for a new clinical efficacy study. Instead, the acceptance criteria are implicitly compliance with established safety and performance standards and demonstration of substantial equivalence to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with mandatory and voluntary safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-27, ISO 9918, etc.) | "Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and N-FCREC Module complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made: [list of 19 standards provided]." (Page 3) |
| Substantial equivalence to predicate devices in terms of: |
- General construction
- Indications for use
- Intended use
- User interface
- Alarms
- Manufacturing processes
- Safety and effectiveness
- Specific functionalities (arrhythmia analysis, CO2 measurement, recorder option) | "The Datex-Ohmeda S/5™ FM with L- FICU04 and L- FICU04A software is substantially equivalent to the predicate Datex-Ohmeda S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software (K022740), as indicated by the similarities discussed below." (Page 2)
"The general construction, indications for use and intended use of the S/5™ FM Monitor are almost the same as for the predicate device (K022740)." (Page 2)
"The arrhythmia analysis functionality of the S/5TM FM with L-FICU04A is identical to the functionality of the predicate device..." (Page 2)
"The CO2 measurement of the N-FC(REC) is based on the CO2 measurement of the predicate M-miniC module (K023454)." (Page 2)
"The S/5™ FM Monitor and its predicate device both have the same basic user interface and alarms. They are manufactured using the same processes, and have the same safety and effectiveness, as indicated by the thorough and successful testing of the FM Monitor, documented in this submission." (Page 2) |
| No new questions of safety and effectiveness compared to the predicate device. | "The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ FM with L-FICU04 and L-FICU04A Software and N-FCREC Module as compared to the predicate device." (Page 3) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a "test set" in the context of a clinical study with patient data. The "testing" referred to is primarily nonclinical verification and validation of specifications and compliance with standards. Therefore, specific sample sizes for clinical data, country of origin, or retrospective/prospective nature are not provided.
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)
Not applicable. As this is a 510(k) submission based on substantial equivalence and compliance with engineering/safety standards, there is no mention of experts establishing ground truth for a clinical "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical "test set" requiring adjudication by experts is described.
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 is not an AI/CAD device, and no MRMC study is mentioned. The device is a patient monitor, and its safety and effectiveness are established by comparison to predicate devices and compliance with standards, not by an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a patient monitor designed for use by qualified medical personnel, continuously monitoring physiological parameters. While it performs automated measurements and calculations (like arrhythmia analysis, ST value calculation, heart rate calculation, impedance and respiration rate calculation), its "performance" is inherently tied to being used by and displaying information for a human operator. Therefore, a standalone "algorithm only" performance, isolated from the human-in-the-loop, is not described in this context. The document states: "The S/5 FM Monitor and N-F(C)(REC) Extension Module are indicated for use by qualified medical personnel only." (Page 2)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical testing and validation mentioned, the "ground truth" would be the engineering specifications and the requirements of the applicable standards. For example, the accuracy of CO2 measurement would be validated against calibrated gas mixtures, and electrical safety against the requirements of IEC 60601-1. There is no mention of clinical ground truth (like pathology or outcomes data) in this summary, as it's not a clinical efficacy study for a new therapeutic or diagnostic claim.
8. The sample size for the training set
Not applicable. This document describes a patient monitor, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable. As no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is also not applicable.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.