(184 days)
The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and facility information.
The Sentinel Cardiology Information Management System provides download and storage of data from supported Holter recorders and feeds this data to separate and optional Holter analyzers. The completed reports are stored back in Sentinel.
The Sentinel Cardiology Information Management System facilitates presenting, analyzing, reviewing cardiovascular information, including automatic interpretation of 12 lead ECG and stores the finished reports. The automatic interpretation of 12-lead ECG is not suitable for neonates.
Sentinel supports importing reports from external systems and provides an HL7 interface to external systems. The Sentinel Cardiology Information Management System is intended to be used by a trained user and as an aid to a medical professional in hospital or primary care environment.
The Sentinel Cardiology Information Management System is not intended for patient monitoring.
The Spacelabs Healthcare Ltd. (Spacelabs) Sentinel Cardiology Information Management System (Spacelabs) is a stand-alone software product which can capture, store, access and manage electrocardiograph (ECG), ambulatory blood pressure (ABP), stress test, ergospirometry, spirometry, event and plethysmography data with Holter analyses and reports, together with the corresponding patient information. Sentinel can be used as a single stand-alone installation, or as part of a multi-user network. Sentinel may be used for recording and reviewing of ECG of adults and pediatrics in a clinical environment inside and outside of hospitals.
The provided document does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested. The document focuses on regulatory submission (510(k)) for the Spacelabs Sentinel Cardiology Information Management System, asserting substantial equivalence to predicate devices, and referencing general quality and safety standards for software and medical electrical equipment.
It states:
- "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standard." (Page 6)
- "Verification results indicated that Spacelabs Sentinel complies with the applicable requirements of the standard." (Page 6)
- "Test results indicated that Spacelabs Sentinel complies with predetermined specifications and the applicable standards." (Page 7)
- "The results of these activities demonstrate that Spacelabs Sentinel is as safe, as effective, and performs as well as or better than the predicate device." (Page 7)
However, it does not explicitly list what those "predetermined specifications" or "applicable standards" are in terms of performance metrics (e.g., sensitivity, specificity, accuracy for interpretations), nor does it describe specific studies with sample sizes, ground truth establishment, or expert involvement for these performance metrics.
The "Summary of Performance Testing" section primarily lists compliance with general software development standards (FDA guidance documents, IEC 62304) and electrical safety/usability standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-2-25, IEC 80601-2-30, IEC 62366). While these are important for device safety and functionality, they are not performance criteria related to the diagnostic accuracy of features like "automatic interpretation of 12-lead ECG."
Therefore, based only on the provided text, I cannot complete the table or answer all the requested questions. The document mentions "automatic interpretation of 12-lead ECG" as a feature but does not provide the performance data or details of a study to validate this interpretation.
If more detailed performance study information were available in an accompanying document, it would be needed to answer your request fully.
§ 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).