(27 days)
This device is capable of monitoring:
- Heart Rate .
- Respiration Rate .
- Invasive Pressure .
- Non-Invasive Pressure .
- . Arrhythmia
- Temperature ◆
- Arterial oxygen saturation .
- Pulse rate .
- (central) apnea .
- end-tidal CO2 .
- ST Segment Analysis .
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.
The VF4 release of the INFINITY GammaXL (SC 6802XL) supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. An alarm indicator has been added to the top center of the device that illuminates in red or yellow for the purpose of displaying both life threatening and serious alarms respectively.
The provided documents describe a 510(k) submission for modifications to the INFINITY GammaXL physiological patient monitor. The submission asserts that the modified device is as safe and effective as its predicate device (SC 6802XL, K030313 / K993974). However, the documents available do not contain detailed acceptance criteria, reported device performance data in a tabular format, or information about specific studies that prove the device meets such criteria.
The submission states: "Testing in accordance with internal design control procedures has verified that the INFINITY GammaXL with VF4 modifications is as safe and effective as the SC 6802XL as submitted in 510(k) K030313." It also mentions "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable." This suggests that the modifications were primarily related to user interface ("look and feel"), mechanical design, and the addition of an alarm indicator, and that extensive new clinical performance data (beyond what was established for the predicate device) was not deemed necessary for this particular 510(k) submission.
Since the provided text does not contain the information requested, I cannot complete the table or answer most of the questions.
Here's a breakdown of what is not available in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission states that testing was done to verify equivalence but doesn't detail performance metrics or acceptance criteria for those tests.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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 applicable. This device is a physiological monitor, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI-driven algorithm, as this is a physiological monitor. The device's performance would be assessed on its ability to accurately measure and alarm on physiological parameters.
- The type of ground truth used: Not specified, beyond the general statement of "testing in accordance with internal design control procedures." For physiological monitors, ground truth typically involves calibrated reference devices.
- The sample size for the training set: Not applicable and not provided, as this is not an AI/ML device requiring a training set in that sense.
- How the ground truth for the training set was established: Not applicable and not provided.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.