(66 days)
- The system may be used to store, retrieve, edit and report records of biologic origin such as ECG, exercise stress and Holter tests.
- The system can receive tests from a variety of devices. Data is then available through . onscreen display, printer, email, fax, HIS (Hospital Information System) results reporting interface or via customized database queries.
- . Users may view and edit interpretative statements and measurements through the onscreen display.
- The system can calculate multiple QTc metrics based upon acquired ECG data. ●
- The system does not modify the original ECG waveform information, nor does it provide an automated ECG interpretive analysis of the data.
- . The system is designed to provide information for qualified clinicians responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease.
- The system is designed for use in a clinical setting by physicians, nurses, clinical . technicians, medical records personnel and medical record transcriptionists.
The Pyramis system is a personal computer based, comprehensive data management tool, with multi-tasking capabilities for receiving, editing, retrieving, and printing of ECG, Stress and Holter reports. The Pyramis system uses a transactional client/server database model with database transactional backup logging. User interface tools include bar coding, batch processing, on-screen diagnostic quality waveform viewing, customized header format, dynamic record retrieval and automated Quality Assurance reports on demand. Records can be accessed upon demand and transmitted remotely. The Pyramis system also uses industry standard protocols for communication so it can interface with the hospital's information system.
The Pyramis system can be comprised of two functional components; the client application (user interface), and a suite of server applications that serve to acquire the ECG, Stress and Holter records, store them in a database and print/fax/email and export (distribute) those selected records.
The provided text is a 510(k) Summary for the Pyramis ECG Management System. It outlines the device's description, intended use, and technological comparison to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
This document is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to an already legally marketed device (the predicate device). It focuses on comparing the new device's features and safety/efficacy to the predicate, rather than detailing specific performance acceptance criteria and a study to meet them.
Therefore, I cannot provide the requested information from this input. The sections of your request that cannot be answered are:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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 available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a data management system, not an AI algorithm performing interpretations.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document states: "Neither device modifies the original waveform as provided by the ECG recording device." and "The system does not modify the original ECG waveform information, nor does it provide an automated ECG interpretive analysis of the data." This indicates that the device's primary function is data management, storage, viewing, and transmission, not diagnostic interpretation or modification of raw data. Therefore, the types of performance studies typically associated with AI-driven diagnostic devices (like those requiring ground truth, expert consensus, MRMC studies, etc.) would not be applicable to this specific device description.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).