(23 days)
This device is capable of displaying physiological parameters received from INFINITY monitors (SC 7000, SC 8000, SC 9000XL) and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.
The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The device is intended for use with the adult, pediatric and neonatal populations.
The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors (SC 7000, 8000 9000XL) and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. In the initial release of the Infinity EXPLORER, the software was run on Siemens' own dedicated Medside Data Station (MDS), a patient vicinity computer based on Low Power Intel Pentium-III embedded processor.
The subject of this submission is a modification implemented that enables the INFINITY EXPLORER to run on a commercially available patient vicinity computer. With the release of software version VF2.1 the INFINITY EXPLORER has been tested for use with the Medside Data Station II (MDS II).
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for the Siemens INFINITY Explorer, which describes a software modification to run on a commercially available patient vicinity computer.
The summary focuses on:
- Device Identification and Description: Detailing the INFINITY Explorer, its purpose, and the modification being submitted (enabling it to run on the Medside Data Station II).
- Intended Use: What the device is designed to do (display physiological parameters, alarm data, and DICOM images).
- Regulatory Information: Classification, predicate device, and contact details.
- FDA Correspondence: A letter from the FDA stating that the device is substantially equivalent to a legally marketed predicate device.
Specifically, the document states:
- "Assessment of non-clinical performance data for equivalence: Section J" - This indicates that non-clinical performance data was assessed for equivalence, but details of the acceptance criteria, the study performed, or its results are not included in this summary. "Section J" likely refers to a section within the full 510(k) submission, which is not provided here.
- "Assessment of clinical performance data for equivalence: Not applicable" - This directly states that clinical performance data was not applicable for this submission, meaning no clinical study was performed for this specific modification to prove performance.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text. The document focuses on regulatory equivalence for a software modification, not a performance study against predefined criteria.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).