(30 days)
Indicated 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.
The IntelliVue Information Center Software is central station software that runs on off-the-shelf Wir interest and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips M3290B IntelliVue Information Center Software:
Based on the provided text (K102495), the device in question is the M3290B IntelliVue Information Center Software release A.0.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics in a table format. Instead, it refers to a qualitative assessment against predicate device specifications.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Adherence to predicate device specifications | "Test results showed substantial equivalence." |
| Meeting defined reliability requirements | "The M3290B IntelliVue Information Center Software meets all defined reliability requirements." |
| Meeting performance claims | "The M3290B IntelliVue Information Center Software meets all... performance claims." |
| Functionality consistent with predicate device | Verified through "system level tests, performance tests, and safety testing." |
| Safety consistent with predicate device | Verified through "hazard analysis." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any test set (e.g., number of patients, number of cases).
The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for a test set. This type of study does not appear to have been conducted based on the provided information.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as a specific test set requiring expert adjudication 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. The submission focuses on substantial equivalence to predicate devices, not on comparing performance with and without AI assistance for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The entire device is an "algorithm only" (software) system that provides information to human users. The testing described is for the standalone software performance, not in comparison to human-in-the-loop performance. The verification and validation activities were for the software itself.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The concept of "ground truth" as typically understood in AI/ML validation (e.g., pathology, expert labels) is not explicitly detailed. Instead, the document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies that the 'ground truth' for the software's functions (e.g., displaying physiological waves, parameters, generating alarms) was adherence to the established performance and functional specifications of the previous, cleared versions of the software.
8. The Sample Size for the Training Set:
The document does not mention a training set sample size. This is likely because the device is a software update (release A.0) to an existing, cleared product (IntelliVue Information Center Software) and not presented as a machine learning model that requires a distinct "training set" for its development. The testing focused on verification and validation of the new release against established specifications, not on training a new algorithm.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, the method for establishing its ground truth is not applicable/not provided.
Summary of Findings:
The K102495 submission for the M3290B IntelliVue Information Center Software is a 510(k) premarket notification asserting substantial equivalence to previously cleared predicate devices. The study detailed is not a clinical performance study involving patient data, expert adjudication, or AI model training. Instead, it describes a series of verification and validation (V&V) activities (system level tests, performance tests, safety testing, hazard analysis) to demonstrate that the new software release meets the specifications and reliability requirements of its predicate. The "acceptance criteria" were essentially the specifications already cleared for the predicate device, and the "study" was the V&V process that confirmed the new release met these existing criteria.
§ 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.