(66 days)
The INFINITY Modular monitors are capable of monitoring:
- . Heart rate
- Respiration rate .
- . Invasive pressure
- . Non-invasive pressure
- . Arrhythmia
- . Temperature
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- . ST Segment Analysis
- 12-Lead ST Segment Analysis .
- tcp02/tcpC02 .
- EEG signals .
- FiO2 .
Software version VF5 is the latest release of the Infinity Modular Monitors, including the Infinity Vista XL and Gamma X XL (variants of the SC 7000 and Delta monitors) that supports direct connection to the Scio gas module, display of data received from the Infinity BisX and Infinity Trident NMT pods, as well as other minor software modifications.
The provided text is a 510(k) summary for modifications to Draeger Medical Systems' Infinity Modular Monitors. It states that the device modifications do not alter the fundamental technology and that "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions". It explicitly states "Assessment of clinical performance data for equivalence: Not applicable".
Therefore, the submission does not contain a study demonstrating the device meets acceptance criteria as typically understood for a new product, but rather asserts equivalence to a previously cleared device for software modifications.
Given this, I cannot extract the requested information as the document explains that no new study demonstrating acceptance criteria was performed. The acceptance criteria and performance are implicitly those of the predicate device (Infinity Modular Monitors, K033694 and Infinity MIB, K033807), as the modifications are deemed not to have changed the fundamental technology or safety/effectiveness.
To directly answer your points based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The submission states "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This indicates a determination of equivalence rather than performing a new study against specific, newly defined acceptance criteria for the modified device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set adjudication is described.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The modifications are to software for a physiological monitor, not a standalone diagnostic algorithm. The phrase "Verification and validation testing performed" refers to internal design control procedures, not necessarily a performance study in the sense of demonstrating a new algorithm's accuracy from scratch.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth is described.
8. The sample size for the training set
Not applicable. No new training set is described for an algorithm in this submission.
9. How the ground truth for the training set was established
Not applicable. No new training set or ground truth establishment is described.
§ 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.