(267 days)
Intended use:
The Datex-Ohmeda PRESTN model family E-PRESTN is intended to be used with Datex-Ohmeda modular monitors for monitoring hemodynamic parameters of hospitalized patients.
Indications for use:
The Datex-Ohmeda E-PRESTN module family (including E-PRESTN, E-RESTN, E-PRETN, E-PP, E-PT,a nd E-P modules) and accessories is indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including ST-segment and arrhythmia), Impedance respiration, NIBP, Temperature, SpO2 (including monitoring during conditions of clinical patient motion), and invasive blood pressure. Impedance Respiration measurement is indicated for patient's ages 3 and up. The NIBP measurement is indicated for patients who weigh 5kg (11 lb.) and up.
The device is indicated for use by qualified medical personnel only.
The Datex-Ohmeda E-PRESTN module family and accessories is a hemodynamic multiparameter module which is able to measure ECG, two Invasive blood pressures, SpO2, two Temperatures, Non-invasive blood pressure and Impedance Respiration.
The Datex-Ohmeda E-PRESTN module can be used with the following Datex-Ohmeda modular monitors.
S/5 Anesthesia Monitor(AM) with main software L-ANE05(A)..00 or newer version
S/5 Compact Anesthesia Monitor (CAM), with main software L-CANE05(A) or newer version
S/5 Critical Care Monitor (CCM) with main software L-ICU05(A) or newer version
S/5 Compact Critical Care Monitor (CCCM), with main software L-CICU05(A) or newer version
There are 6 different model variants of the module:
E-PRESTN: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp
E-RESTN: (does not include invasive pressures) NIBP, ECG, SpO2, 2*T, Resp
E-PRETN: (does not include SpO2) NIBP, ECG, 2T, 2inv. press.,Resp.
E-PP: Two invasive pressure measurement channels
E-PT: One invasive pressure measurement channel, dual temperature measurement channel One invasive pressure measurement channel E-P:
The letters in the module name stand for:
P= Invasive Pressure
R= Impedance Respiration
E= 12-Lead ECG
S= Pulse Oximetry
T= Temperature
N=NIBP, Non-Invasive Blood Pressure
In the remainder of this document," E-PRESTN module family" is used to denote all six modules, "E-PRESTN" is used as a collective name for the double-width E-PRESTN, E RESTN, and E-PRETN modules, and the respecitve module names "E-PP", "E-PT" or "E-P" (or "E-PT/E-P") are used for the single-width modules.
The provided document is a 510(k) Premarket Notification for a physiological patient monitor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data with acceptance criteria for device performance. Therefore, the document does not contain the detailed information necessary to fully answer all aspects of your request as typically found in a clinical study report for new device performance claims.
Specifically, there is no mention of:
- A table of acceptance criteria and reported device performance in the format requested. The document references compliance with various IEC, ANSI, CSA, and ISO standards as part of non-clinical testing for validation and verification of specifications. However, specific performance metrics and acceptance thresholds are not detailed in this summary.
- Sample sizes used for a test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, or details on ground truth establishment for a test set. This is because the submission emphasizes technological equivalence and compliance with established standards rather than new clinical performance claims requiring such detailed validation.
- Training set sample size or how ground truth for a training set was established.
Instead, the document states:
"The Datex-Ohmeda PRESTN Module (Model family E-PRESTN, including E-PRESTN, E-RESTN, E-PRETN, E-PP and E-PT/E-P) and accessories have been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications."
The standards listed are primarily for electrical safety, electromagnetic compatibility, and specific medical device functionalities (e.g., ECG, patient monitors, blood pressure, oximeters, thermometers). Compliance with these standards implies that the device meets their specified performance and safety requirements.
However, based on the information provided, here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document primarily refers to compliance with various international and national standards for medical devices. Compliance with these standards serves as the "acceptance criteria" for the non-clinical performance and safety aspects. No specific performance metrics (e.g., accuracy, sensitivity, specificity) with associated acceptance thresholds are reported for comparison in this summary.
2. Sample size used for the test set and the data provenance
Not explicitly stated for a clinical test set. The submission focuses on non-clinical testing (validation and verification of specifications) against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/mentioned. Ground truth establishment for a test set is not described as part of this 510(k) submission.
4. Adjudication method for the test set
Not applicable/mentioned.
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 physiological monitor, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies for human reader improvement. The "arrhythmia and ST detection and analysis algorithm" is described as having identical functionality to the predicate, implying no new AI-driven improvement study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone monitor. Its performance is assessed through compliance with standards. The summary does not detail specific "algorithm-only" performance metrics in the way one might expect for a new diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for a clinical performance study. For hardware and software components, ground truth would typically refer to calibrated reference instruments or established physical/electrical benchmarks used during validation and verification processes.
8. The sample size for the training set
Not applicable/mentioned. This is a physiological monitor, not a machine learning model that requires a "training set" in the typical sense of AI development.
9. How the ground truth for the training set was established
Not applicable/mentioned.
Summary of Nonclinical Testing and Conclusion from the Document:
- Study: The device underwent "thorough testing through validation and verification of specifications" against a list of international and national standards. These standards cover aspects such as electrical safety, electromagnetic compatibility, and performance requirements for specific physiological measurements (ECG, blood pressure, SpO2, temperature).
- Acceptance Criteria (Implied): Compliance with the following standards:
- FDA regulation 21 CFR 898.12
- IEC 60601-1:1988 + Amendments: A1:1991, A2:1995
- IEC 60601-1-2:2001
- IEC 60601-1-4:1996 + AI 1999
- ANSI/AAMI ES1 (1993)
- CAN/CSA C22.2 No. 601-1-M90 + S1 (1994)+Amdt2:1998
- IEC 60601-2-27 (1994) (Electrocardiographic monitoring equipment)
- IEC 60601-2-30 (1999) (Automated non-invasive sphygmomanometers)
- IEC 60601-2-34 (2000) (Invasive blood pressure monitoring equipment)
- IEC 60601-2-49:2001 (Multi-function patient monitoring equipment)
- EN 12470-4:2000 (Clinical thermometers - Part 4: Electrical thermometers for continuous measurement)
- ISO 9919 (1994) / EN 865:1997 (Pulse oximeters - Particular requirements for safety and essential performance)
- UL 2601-1 : 1997
- Reported Device Performance: The document states that the device "has been thoroughly tested through validation and verification of specifications" and concludes that "there are no new questions of safety and effectiveness... as compared to the predicate device." This implies that the device met the requirements of all listed standards. Specific numerical performance data (e.g., accuracy ranges for NIBP, SpO2, temperature, ECG bandwidth) are not provided in this summary but would be detailed in the full validation and verification reports submitted to the FDA.
§ 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.