(19 days)
M3290A: For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
M4840A: For ambulatory and bedside monitoring of ECG and SpO2 parameters of adult and pediatric patients in healthcare facilities to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The M3290A IntelliVue Information Center Software Release F.0 and M4840A Telemetry System II with M4841A TelePac+. The modification is a change that modifies the ECG processing, adds 4 high priority SpO2 limit alarm conditions and waveform export, and changes the radio technology.
The provided text is a 510(k) summary for the Philips IntelliVue Information Center Software Release F.0 and M4840A Telemetry System II with M4841A TelePac+. While it outlines the device's substantial equivalence to predicate devices and its indications for use, it does not include detailed information regarding specific acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology for establishing ground truth as requested in your prompt.
The document states: "Verification, validation, and testing activities have successfully established the performance, functionality, and reliability established the performance, and many and the predicates. Charactercriberob testing involved by bean environmental ceseb, and based on the specifications cleared for the Pass/rail Criteria Were Dabstantial equivalential equivalence." This is a general statement and does not provide the specifics you're looking for.
Therefore,Based on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and the study proving the device meets those criteria. The 510(k) summary focuses on substantial equivalence to predicate devices and general statements about verification and validation, rather than a specific performance study with detailed methodology and results.
Here's a breakdown of what cannot be found in the provided text:
- Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document mentions "Pass/fail Criteria Were Dabstantial equivalential equivalence" but does not define these criteria or report the device's performance against them.
- Sample Size Used for the Test Set and Data Provenance: Not mentioned.
- Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. The document primarily discusses the device itself, not its impact on human reader performance.
- Standalone (Algorithm Only) Performance Study: Not mentioned. The focus is on the device as a whole system.
- Type of Ground Truth Used: Not mentioned.
- Sample Size for the Training Set: Not mentioned. (It's worth noting that for a 510(k) in 2004, a "training set" in the modern AI sense might not have been a primary focus or explicitly documented in this manner for a re-submission involving software updates.)
- How Ground Truth for the Training Set Was Established: Not mentioned.
Conclusion based on the provided text:
The provided document is a 510(k) summary from 2004, which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing a detailed performance study with explicit acceptance criteria and corresponding results in the format you've requested. It indicates that the device has undergone verification, validation, and testing to establish its performance, functionality, and reliability, but it does not present the specifics of these tests or their outcomes as a dedicated performance study.
§ 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.