(29 days)
The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories is intended for monitoring hemodynamic parameters of hospitalized patients.
The Datex-Ohmeda S/5 PSM module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories are indicated for monitoring of hemodynamic parameters of all hospital patients. The hemodynamic parameters of the module comprise ECG (including STsegment 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 lbs.) and up.
The device is indicated for use by qualified medical personnel only.
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 (P1 and P2) and two temperature measurements (T1 and T2). E-PSM is a hemodynamic plug-in parameter module for a modular monitoring system. This module can be used in the S/5 FM modular monitor and in other monitors using the new F-CU5P frame. With the new mounting accessories for the PSM module, E-PSM(P) plug-in parameter module can be removed from the FM monitor frame or S/5 F-CU5P frame and used near the patient on an IV-pole or anesthesia machine. Via the new E-INTPSM module and the new mounting accessories for the S/5 F-CU8 frame or with Compact Monitor frames or used near the patient on IV pole or anesthesia machine. S/5 F-CU8 frames or Compact Monitor frames have the software license. The monitors display waveforms and measurement readings, and handle the trending and alarm management. The ECG (e.g. heart beat detection and arrhythmia detection) and respiration algorithms are in the monitor software. The modules measure and process the measurement 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 module with Invasive pressures P1 and P2 and E-PSM without P1 and P2. There are three main boards inside the E-PSM(P) module for processing the measurement signals. Each parameter board has its own software. The new E-INTPSM module and the new mounting accessories are needed for a mechanical and electrical interfacing between the E-PSM(P) module and the monitor. The E-INTPSM module and the new mounting accessories include only connections for the power supply and module bus data communication. There are no microcontrollers or software in the module or mounting accessories.
This document describes an FDA 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study with detailed acceptance criteria and performance metrics in the way a new, high-risk device might.
Based on the provided text, the device in question is the Datex-Ohmeda S/5 E-PSM(P) Module (consisting of E-PSM, E-PSMP and E-INTPSM Modules) and accessories, a multi-parameter hemodynamic module.
Here's an analysis of the requested information based on the document:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state specific numerical acceptance criteria or detailed performance metrics in a table format for the new device. Instead, it relies heavily on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda E-PSM module, K043551). The core "acceptance criteria" presented are that the device is substantially equivalent in safety and effectiveness to the predicate.
The document claims:
- "The Customer and parameter specifications are the same except the Venous stasis values of the NIBP measurement"
- "have the same safety and effectiveness"
Therefore, the reported performance is implied to be equal to that of the predicate device (K043551), with a specific mention of a modification related to NIBP venous stasis. Without the details of the predicate device's performance, precise numerical values cannot be extracted from this document for the new device.
2. Sample size used for the test set and the data provenance:
The document states: "The device has been thoroughly tested through validation and verification of specifications." It lists various IEC, ANSI/AAMI, CAN/CSA, EN, and ISO standards that the device complies with.
However, the document does not provide details on:
- Sample size used for any specific testing (e.g., number of patients, test cases).
- Data provenance (e.g., country of origin, retrospective or prospective nature of the "validation and verification").
This type of information is typically not included in a 510(k) summary focused on substantial equivalence to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention using experts to establish ground truth for a test set. This is consistent with a 510(k) submission where the primary method of validation is compliance with established standards and comparison to a predicate device, rather than a clinical trial requiring human expert consensus for ground truth.
4. Adjudication method for the test set:
Not applicable, as no information on expert-adjudicated test sets is provided.
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 multi-parameter hemodynamic monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study or AI-related effectiveness is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone physiological monitor, designed to measure and display parameters. Its performance is based on its measurement algorithms and hardware. The document's statement about "validation and verification of specifications" implies standalone testing against engineering and regulatory standards. However, specific details of "algorithm-only" performance are not provided beyond compliance with listed standards.
7. The type of ground truth used:
The "ground truth" for this device's performance is implicitly established by the compliance with various international and national standards (e.g., IEC 60601-1, ISO 9919, EN 12470-4). These standards define acceptable accuracy, safety, and electromagnetic compatibility for medical devices of this type. The testing performed to meet these standards would have used reference measurement systems as their "ground truth."
8. The sample size for the training set:
Not applicable. This is a traditional medical device, not an AI/Machine Learning device that requires a "training set" in the context of supervised learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML model for this device.
§ 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.