(57 days)
The Datex-Ohmeda S/5 PSM module (consisting of E-PSM and E-PSMP modules) and accessories are 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 patients 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 S/5 PSM Module, (consisting of E-PSM and E-PSMP modules) 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 module is compatible with the Datex-Ohmeda S/5 FM monitor with L-FICU04...00 and L-FICU04A..00 which has a separate 510(k).
There are 2 different model variants of the module:
E-PSMP: (includes all possible parameters) NIBP, ECG, SpO2, 2T, 2inv. press.,Resp
E-PSM: (does not include invasive pressures) NIBP, FCG, SpO2, 2*T, Resp.
E-PSMP is a hemodynamic plug-in parameter module including the NIBP measurement, 12-lead ECG with the Impedance Respiration measurement, SpO2 with the plethysmographic waveform, two invasive pressure measurements (PL and P2) and two temperature measurements (T1 and T2). This module can be used in the FM modular monitor.
The monitor displays waveforms and measurement readings, and handles the trending and alarm management. The monitor software handles the ECG (including arrhythmia detection) and the Impedance Respiration measurement. The modules measure signals and send them to the monitor. The NIBP, SpO2, Temperature and Invasive Pressure algorithms are in the module. There are two available options of the module: E-PSMP with invasive pressures P1 and P2 and E-PSM without invasive pressures. There are two parameter circuit boards inside the E-PSMP module for Panel A and Panel B. Each processing board has a microcontroller with software.
The provided text describes a medical device, the Datex-Ohmeda S/5 PSM Module, and its compliance with various safety standards. However, it does not contain information about specific acceptance criteria for a device's performance (e.g., sensitivity, specificity, accuracy targets), nor does it describe a study conducted to demonstrate that the device meets such criteria.
The document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is not present in the provided text.
The document primarily provides organizational information, device description, intended use, indications for use, and a list of safety standards with which the device complies. It states that "The device has been validated and verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made," followed by a list of standards. This indicates that non-clinical testing was performed to demonstrate compliance with these standards, but the specifics of how the device performed against criteria within these standards are not detailed in this summary.
To answer your specific questions:
- A table of acceptance criteria and the reported device performance: Not provided in the text.
- Sample size used for the test set and the data provenance: Not provided in the text. The document refers to "nonclinical testing" and compliance with standards, but no details of test sets, sample sizes, or data provenance are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided, as detailed performance studies with ground truth establishment are not described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: Not provided. The summary is focused on substantial equivalence based on technical characteristics and compliance with standards, not comparative effectiveness with human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. The device is a physiological monitor, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided, as it's a physiological monitor, not an AI algorithm that typically has a training set.
- How the ground truth for the training set was established: Not applicable/Not provided.
§ 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.