(80 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 the 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 critical care workstation that acts as a display for physiological parameters received from an INFINITY patient monitor (SC 7000/SC 8000/SC 9000XL). Parameters are displayed (audio alarming and flashing visual indications are provided on the INFINITY patient monitor screen).
INFINITY EXPLORER utilizes the syngo (510k K010938) software platform and user interface common to other Siemens Medical modalities. INFINITY EXPLORER with syngo software is capable of displaying DICOM images retrieved from a syngo compatible image archive. A Task Card provides access to DICOM images.
The Siemens INFINITY EXPLORER is a critical care workstation intended to display physiological parameters from INFINITY patient monitors and visually display alarm data. It is also capable of displaying DICOM images.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table. Instead, it relies on a comparison to predicate devices and general statements about safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Display physiological parameters and alarm data accurately from INFINITY patient monitors. | "The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors (SC 7000/SC 9000XL / SC 8000) and to visually display alarm data for those parameters." (Page 2) |
| Capable of displaying DICOM images received over a hospital information system. | "The device is capable of displaying DICOM images received over a hospital information system." (Page 2) |
| Be as safe and effective as identified predicate devices. | "Verification and validations tests have been performed which indicate that the INFINITY EXPLORER is as safe and effective as the predicate devices." (Page 3) |
| Intended Population: Adult, Pediatric, and Neonatal. | "The INFINITY EXPLORER is intended to be used with the same patient populations as the INFINITY Modular Monitors, Adult, Pediatric, and Neonatal." (Page 3) |
| Intended Environment: Healthcare environment where patient care is provided by healthcare professionals. | "In a healthcare environment where patient care is provided by healthcare professionals." (Page 3) |
| Visual Alarm functionality. | "Yes" (Page 3, comparison table) |
| No Audible Alarm functionality. | "No" (Page 3, comparison table) |
| Not connected to patients directly. | "Not connected to patients" (Page 3, comparison table) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for a "test set" in the context of clinical performance data for the INFINITY EXPLORER. It mentions "Verification and validations tests have been performed," but details about these tests, including sample sizes and data provenance (e.g., country of origin, retrospective/prospective), are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. The document focuses on technical equivalence and intended use rather than studies requiring expert-established ground truth for a diagnostic AI.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. As no specific clinical test set is detailed, an adjudication method is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned for the INFINITY EXPLORER. This device is a display and workstation, not an AI diagnostic tool, so such a study would not be applicable in this context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the INFINITY EXPLORER is a display and workstation, not an algorithm or AI product requiring standalone performance evaluation in the usual sense. Its performance is tied to its ability to accurately display data from other devices.
7. The Type of Ground Truth Used
Given the nature of the device (a display and workstation for physiological parameters and DICOM images), the concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) does not directly apply. The performance evaluation would likely focus on the accuracy and fidelity of data display and system functionality when compared against the source data (e.g., patient monitor outputs, DICOM image files).
8. The Sample Size for the Training Set
This information is not applicable. The INFINITY EXPLORER is a workstation/display device and does not inherently involve machine learning models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no mention of a "training set" for this device.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).