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Dopplex Centrale (DCII) is a software package that collects and manages real-time data from a maximum of 48 individual fetal monitors which are connected to a central server by means communication links.

Dopplex Centrale is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive and centralised obstetrical surveillance of those maternal patients who are being monitored by otherwise autonomous CTG devices. Fetal heart rate information can be concurrently viewed on up to 50 conveniently sited computers including a central station, patient bedsides, nurses' lounges and physicians' offices.

Dopplex Centrale provides an easy to use means of patient surveillance within a perinatal environment within a hospital. A Dopplex Centrale system is specified, supplied, commissioned and maintained exclusively by the manufacturer, Huntleigh Healthcare, or its appointed agents. It provides storage and archiving of FHR traces together with the associated patient details.

The specific medical indications for the use of this device is :

This device is a prescription device
This device is not intended to contact the patient
This device is used continuously in Obstetrical Departments
Basic fetal trace alerting for antepartum and intrapartum applications
The physiological purpose is indirect. The device is intended to gather and store fetal and maternal information provided by the attached fetal monitors which constitute the primary care sources.

Device Description

The Dopplex Centrale (DCII) monitoring system provides a powerful flexible solution to satisfy current and future central monitoring requirements for perinatal care wards. Various makes of fetal monitor can be linked to Dopplex Centrale which collects data from up to 48 beds in real time. This data is displayed graphically to the user at conveniently sited client workstations. The CTG information is saved using a secure database for subsequent review and patient management. Dopplex Centrale is customisable at manufacturer to cater for disparate needs of particular antenatal clinic or labour ward sites. Dopplex Centrale can be configured to suit the operating protocols of individual customers.

AI/ML Overview

The provided documentation is a 510(k) summary for the Dopplex Centrale (DCII) device, primarily focusing on demonstrating substantial equivalence to a predicate device (Philips OB TraceVue). It describes the device's features and intended use but does not contain explicit acceptance criteria or a detailed study section with performance metrics and statistical analyses typically associated with proving a device meets acceptance criteria.

Therefore, I cannot fulfill all parts of your request with the provided information.

Here's what I can extract and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Summary: The Dopplex Centrale (DCII) system is presented as substantially equivalent to the Philips OB TraceVue system for centralized perinatal monitoring. The evidence for this equivalence relies on a "comprehensive review of the features" of the predicate device as defined in its labeling and marketing information, rather than a quantifiable performance study against predefined acceptance criteria. This means the acceptance criteria are implicitly tied to matching the functionality and safety profile of the predicate device.

Missing Information: The document does not explicitly state specific, quantifiable acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, data transfer speed, reliability in terms of uptime) or provide a dedicated study section with data to prove the device quantitatively meets such criteria. The focus is on functional equivalence and safety compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Derived from Substantial Equivalence Claim)	Specific Criteria (Implicit/Derived)	Reported Device Performance (Summary from Document)
Functional Equivalence	Replicate essential functions of Philips OB TraceVue for centralized perinatal monitoring.	Dopplex Centrale (DCII) "replicates the essential functions of the Phillips OB TraceVue system for applications requiring centralised perinatal monitoring of CTG devices." It collects real-time data from up to 48 fetal monitors, supports various fetal monitor models (including Huntleigh BD4000 and Philips Series 50), and displays CTG information graphically.
Data Management	Collect, save, store, and archive CTG data and patient details.	"The CTG information is saved using a secure database for subsequent review and patient management." "Provides storage and archiving of FHR traces together with the associated patient details." "Provides full patient backup by means of an automated database archive and backup service."
Display and User Interface	Display CTG data effectively, provide alerts, allow user customization.	"The real-time data can be viewed anywhere on the DCII network. Single or multiple traces can be viewed." "Alerts (Bradycardia, Tachycardia, loss of contact, cross-channel twins monitoring verification) are displayed on the CTG trace, in the bed column and as an audible alert." "Customisable at manufacturer to cater for disparate needs." "Configurable trace rates and vertical scales."
Connectivity & Interoperability	Link to various fetal monitors, support HL7, communicate via serial/LAN.	"Various makes of fetal monitor can be linked to Dopplex Centrale." "Capable of data exchange with an external HIS via HL7 interface or similar." "Collection of real-time fetal and vital-signs data from Huntleigh and other supported fetal monitors by third party equipment manufacturers using industry standard data communication protocols." "CTG data transmitted over serial port via direct link or by means of a local area network."
Safety - Electrical	Compliance with relevant electrical safety standards.	"The safety of the computer platform host machines is shown by compliance with the relevant standards for ITE devices such as UL1950, IEC950 or EN60950. The electrical safety requirements for the holistic system have been established by review of EN 60601-1-1."
Safety - Software	Conformance with risk assessment and extensive validation.	"Software safety is demonstrated by conformance with the Risk Assessment requirements BSEN60601-1-4 and extensive validation procedures prior to release to end users."
Intended Use	Same as predicate and other market devices: centralized obstetrical surveillance for healthcare professionals.	"The intended use of this device is the same as the intended use for many other products which are already placed on the market." "This clinical information can be interpreted by medical professionals working within the Obstetric and Gynecology field." "Indicated for use in healthcare facilities by healthcare professionals whenever there is a need for comprehensive and centralised obstetrical surveillance."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The document does not describe a test set in the context of a performance study with patient data. The "review" for substantial equivalence was based on product labeling and marketing information of the predicate device, not primary data from a test set.
Data Provenance: Not applicable, as no test set data is described. The comparison is based on publicly available documentation of the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There was no test set involving human experts establishing ground truth for performance metrics in this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention any MRMC study or any study involving human readers' performance with or without AI assistance. The device is a "monitoring system," not primarily an AI diagnostic or interpretive tool that directly assists human readers in a comparative effectiveness study as typically understood in this context.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The document focuses on the system's functionality and its substantial equivalence to a predicate monitoring system. It does not describe a standalone performance study in terms of quantifiable algorithm output (e.g., accuracy of automatic FHR interpretation). While it mentions "Basic fetal trace alerting," it does not provide performance metrics for these alerts.

7. Type of Ground Truth Used

Not applicable in the context of a performance study. The "ground truth" for the substantial equivalence claim was the features, functions, and intended use as described in the product labeling and marketing information of the predicate device (Philips OB TraceVue).

8. Sample Size for the Training Set

Not applicable. The document does not describe the use of machine learning or AI models that would require a training set in the conventional sense. The device is a data collection, display, and management system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described.

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