(30 days)
This device is capable of displaying physiological parameters received from INFINITY Modular monitors 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 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. The VF4 modifications include:
- New MDSII Hardware
- New user interface with enhanced monitor applications
The provided text is a 510(k) summary for the INFINITY Explorer with VF4 and MDS II. It describes a software-driven application that extends the viewing capability of physiological monitors. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, a common component of performance testing for AI/ML-enabled devices. The submission is for a device modification of an existing product, and focuses on general device functionality, safety, and regulatory compliance rather than performance metrics of the device as related to a specific diagnostic or prognostic task.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
What is present in the document is a statement regarding non-clinical performance data:
"Assessment of non-clinical performance data for equivalence: Testing in accordance with internal design control procedures indicates no new issues relative to safety and efficacy for INFINITY EXPLORER with software version VF4 and the new MDS II."
This statement indicates that internal testing was conducted, but it does not provide specific acceptance criteria, study details, or performance metrics. It also explicitly states "Assessment of clinical performance data for equivalence: Not applicable," implying that no standalone clinical performance study was deemed necessary for this specific device modification under the 510(k) pathway.
This type of submission is common for minor modifications to existing medical devices where the primary focus is to ensure that the changes do not introduce new safety or efficacy concerns, rather than to establish or re-establish performance against specific clinical endpoints.
§ 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).