(12 days)
For central monitoring of 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.
PIC Software Release D.02.
PIC Software, Release D.02.
Application Server Software, Release A.0.
UDP Server Software, Release A.0.
TCP/IP PC Client Software, Release A.0
UDP PC Client Software, Release A.0.
The provided text describes a 510(k) summary for the PIC Software Release D.02. This submission focuses on software modifications rather than clinical performance studies typically associated with detailed acceptance criteria for diagnostic devices. Therefore, the information requested about acceptance criteria, study design, and ground truth establishment, which are common for AI/ML-based diagnostic devices, is not explicitly available in this document.
However, based on the text, here's what can be inferred and stated:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide specific quantitative acceptance criteria or detailed reported device performance metrics in a tabular format. Instead, it makes a general statement:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Specifications cleared for predicate devices | "Test results showed substantial equivalence. The results demonstrate that the software functionality meets all reliability requirements and performance claims." |
Explanation: The acceptance criteria were based on the existing specifications of the predicate devices (HP CentralVue Software device, K964832, K993171, K993907, K001057, and K011093). The device was deemed to meet these criteria by demonstrating "substantial equivalence" and satisfying "all reliability requirements and performance claims" through verification, validation, and testing activities.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. The text mentions "system level tests, integration tests, and safety testing from hazard analysis," but does not specify the sample size of data (e.g., patient records, physiological waveforms) used for these tests, nor their provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. As this is a software modification submission and not a clinical performance study involving diagnostic interpretation, the concept of "ground truth" derived from expert consensus for a test set is not applicable or detailed.
4. Adjudication Method for the Test Set:
This information is not provided in the document. The nature of the testing described (system, integration, safety) does not suggest a need for expert adjudication of results in the way a diagnostic algorithm's output would typically be evaluated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done as described in the provided text. The submission focuses on software changes and their substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device is a "Philips M3290A Information Center Software" which serves to "display physiologic waves, parameters and, trends, to format data... and the secondary annunciation of alarms." It also provides "primary annunciation of alarms, and configuration and control access for networked telemetry monitors." While the software performs functions independently (e.g., alarm annunciation, data display), the document does not explicitly describe a "standalone" performance study in the context of a diagnostic algorithm without human input for interpretation. The software acts as a central monitoring system. The functionality implies it provides information that humans (clinicians) will then use.
7. The Type of Ground Truth Used:
The document does not explicitly mention the "type of ground truth" in the context of a diagnostic dataset (e.g., pathology, outcomes data, expert consensus). Instead, the "ground truth" for the software's performance validation was based on:
- Predicate device specifications: The new device's performance was compared against the established specifications and expected behavior of the legally marketed predicate devices.
- Reliability requirements and performance claims: The software functionality was tested to ensure it met pre-defined reliability requirements and performance claims inherent to its intended use (displaying physiological data, alarming).
8. The Sample Size for the Training Set:
This information is not provided in the document. As this is a software modification submission for a central monitoring system, it's unlikely to involve a "training set" in the sense of machine learning for diagnostic image analysis or similar AI applications. The software's logic and algorithms are likely based on established physiological monitoring principles rather than being "trained" on a large dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided. Since a training set for machine learning or AI is not described, the method for establishing its ground truth is also not discussed. The software's functionality is rooted in engineering specifications and physiological monitoring standards rather than learned patterns from a dataset.
§ 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.