(181 days)
The Infinity CentralStation (ICS) is intended for use by trained health care professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.
Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.
The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.
The provided text is a 510(k) premarket notification for the Infinity CentralStation Wide, a medical device for centralized patient monitoring. It describes the device's indications for use, comparison to a predicate device, and performance data from verification and validation testing.
However, the document does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance for such a set.
- Details on experts establishing ground truth, their qualifications, or adjudication methods.
- Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
- Results from a standalone (algorithm-only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set or how ground truth for a training set was established.
The document focuses on:
- Cybersecurity modifications and defect fixes as the "significant change modifications" introduced in this submission (page 4).
- Verification and Validation Testing primarily in the context of these cybersecurity enhancements and compliance with design controls (21 CFR 820.30) (page 4). The text states that "results of Verification testing confirm that the modified device continues to meet equivalent criteria demonstrating substantial equivalence to the predicate device" and "Validation test results support the claim of substantial equivalence to the predicate device and do not raise new issues of safety and effectiveness." (page 4).
- Compliance with various medical device standards (e.g., IEC 60601 series), as detailed in the table on page 6.
In summary, this 510(k) pertains to modifications (primarily cybersecurity) to an existing device (Infinity CentralStation Wide VG5 compared to VG4). It leverages the substantial equivalence pathway, meaning it demonstrates that the modified device is as safe and effective as a legally marketed predicate device. This type of submission usually does not require extensive clinical performance studies with acceptance criteria as would be needed for a novel AI/ML-based diagnostic device in a de novo or PMA submission.
Therefore, I cannot extract the requested information from the provided text. The document does not describe the kind of performance study you're asking about (e.g., diagnostic accuracy, reader study) with specific acceptance criteria as if it were a new AI algorithm being tested for diagnostic performance.
§ 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.