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510(k) Data Aggregation
(209 days)
Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary records, consisting of measurements, text and digitized waveforms, with associated reports and documents. Users do not need to download or install any additional software or plug-ins to use the zero-footprint browser client.
Cordiana Dx16 provides authenticated users the ability to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools. Cordiana Dx16 is intended for use by healthcare professionals, including (but not limited to) physicians, nurses and medical technicians, trained on the use of the software.
Cordiana Dx16 is intended to be used in hospitals or facilities providing patient care, where cardiopulmonary studies are stored in a remote storage system, such as a Picture Archive and Communication System (PACS), with which records, reports and documents can be queried, retrieved and stored using DICOM or similar interface standards.
Cordiana Dx16 does not provide storage of records or associated reports and documents, does not modify the original record and waveform information, and is not intended for real-time monitoring.
Indications for use of Cordiana Dx16 are quantification and reporting of cardiopulmonary function of patients (adults and children of any age from birth upwards) with suspected disease to support the physicians in the diagnosis.
Cordiana Dx16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis.
Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary studies from various cardio-pulmonary device manufacturers.
The studies are stored in open standardized formats in a remote storage system, such as a Picture and Communication System (PACS) or a Vendor Neutral Archive (VNA). Cordiana Dx16 does not provide own storage of records or associated reports and does not modify records or the original waveform information stored on the remote storage system.
Authenticated users can use Cordiana Dx16 to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools.
The system consists of two logical parts which are installed, configured and maintained as one:
- A web server, which is installed centrally in a hospital's IT infrastructure. The Gateway serves as a stateless server to the browser clients. It also serves as a client to the remote storage system, such as the PACS/VNA, with which records, reports and documents are queried, retrieved and stored using the DICOM standard.
- Zero-footprint browser clients, which are loaded and updated on demand as single-page applications into an HTML5 enabled web-browser. Users do not need to download or install any additional software or plugins to use the clients.
Cordiana Dx16, when used as intended with a remote storage system, acts as a traditional cardiopulmonary data management system, such as an ECG Management System.
The clients can optionally be integrated ("embedded") as-is with an external application which provides authentication and workflow support. When authentication is done in the external application, the externally authenticated user's credentials are passed to Cordiana Dx16 using Single Sign-On Authentication. When the external application provides workflow support, the search screens are bypassed, and the user is brought directly to a requested study.
Cordiana Dx16 does not store studies or patient related information in the browser clients, does not directly communicate with cardiographs or other acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to quantify measurements (e.g. intervals and amplitudes) or provide diagnostic statements.
Cordiana Dx16 functions as a non-real-time system and is not intended for real-time monitoring.
The provided text describes the Cordiana Dx16, a web-based software system for viewing, editing, and printing cardiopulmonary records. However, the document does not contain information about specific acceptance criteria, tabulated device performance data, sample sizes for test or training sets, details on expert ground truth establishment, or any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
The document focuses on demonstrating substantial equivalence to a predicate device (MUSE Cardiology Information System K152993) by comparing functional and technical characteristics, and by stating that non-clinical testing was performed.
Here's an analysis based on the available information, with missing sections noted:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document states that "Non-clinical testing performed included software verification... to ensure that Cordiana Dx16 meets design specifications and requirements. Unit and system level testing included assurance of interoperability with representative remote systems and accuracy of displayed waveforms and related information in a simulated user test environment." It also mentions "Bench testing performed verified the Cordiana Dx16 display and measurement capabilities using sample cases based on technical characteristics and relevancy to the intended function of the Cordiana Dx16 application." However, the specific acceptance criteria and the quantitative results (e.g., accuracy percentages, error rates, or specific values for measurement consistency) are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "sample cases" for bench testing but does not specify the number of cases or their origin (e.g., retrospective/prospective, country of origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The device is a "Programmable Diagnostic Computer" for reviewing and editing cardiopulmonary records. While human experts would typically be involved in establishing ground truth for such data, the document does not mention the use of experts for the test set.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the absence of details on expert involvement, no adjudication method 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the document, and it seems unlikely given the nature of the device. The Cordiana Dx16 is described as a system for viewing, editing, and managing cardiopulmonary records, not as a device that provides automated diagnostic interpretations or AI assistance for human readers in the sense of improving their diagnostic performance (e.g., by detecting abnormalities). It explicitly states: "Cordiana Dx16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis." and "Cordiana Dx16 does not use any automatic electronic data processing and pattern recognition methods to quantify measurements (e.g. intervals and amplitudes) or provide diagnostic statements." Therefore, an MRMC study related to AI assistance for human readers would not be applicable to this device's stated functionality.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
A standalone performance study for an algorithm is not applicable in the context of this device. As mentioned above, the device does not employ "automatic electronic data processing and pattern recognition methods to quantify measurements... or provide diagnostic statements." It is a web-based system for manual review and editing by healthcare professionals.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance testing, beyond verifying "accuracy of displayed waveforms and related information" and "display and measurement capabilities using sample cases." Given its function as a viewing and editing system, the ground truth would likely refer to the fidelity of the displayed data compared to the original source, and the accuracy of manual measurement tools. This would typically be based on established standards for waveform display and measurement.
8. The Sample Size for the Training Set
This information is not provided in the document. The device is not described as using machine learning or AI that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. As the device does not appear to be an AI/ML product requiring a training set, the concept of establishing ground truth for a training set is not relevant here.
Summary of what the document does provide regarding "proof" of meeting criteria:
The "proof" provided for the Cordiana Dx16 predominantly relies on:
- Substantial Equivalence to a Predicate Device: The majority of the "Performance Testing" and "Substantial Equivalence Discussion" sections are dedicated to comparing Cordiana Dx16 to the MUSE Cardiology Information System (K152993) and arguing that any differences (like data storage method) do not raise new questions of safety or effectiveness.
- Compliance with Standards: The manufacturer states that the device's development conformed to various recognized consensus standards (e.g., IEC 62304 for software lifecycle processes, IEC 62366-1 for usability engineering, ISO 14971 for risk management, NEMA PS 3.1 – 3.20 for DICOM, and IEC 60601-2-25 for electrocardiographs).
- Non-Clinical Testing: The document briefly mentions "software verification" to meet design specifications, "unit and system level testing" for interoperability and accuracy of displayed information, and "bench testing" to verify display and measurement capabilities. It concludes that "In all instances, the Cordiana Dx16 functioned as intended by the design requirements and the observed results demonstrated substantial equivalence with the predicate device." However, no specific data or metrics from these tests are quantifiable in the document.
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