(115 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 nond/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
The modification is a change that provides support for the MRx Monitor/Defibrillator and the M3177 Trend Display.
The provided document, K062271, is a 510(k) summary for the Philips Medical Systems M3290A IntelliVue Information Center Software Release J.00. This document primarily describes the substantial equivalence of the new device to previously cleared predicate devices and the scope of its intended use. It largely refers to previous clearances and does not detail new, specific performance studies with acceptance criteria for this particular software release.
The relevant section for performance claims is Section 7 of the 510(k) Summary, which states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved system level tests, integration tests, environmental tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that web software interface functionality meets all reliability requirements and performance claims."
Based on this, the document asserts that the new software release meets the same performance standards as its predicate devices, but it does not provide specific numerical acceptance criteria or detailed study results within this particular submission.
Therefore, for this specific 510(k) submission, the requested information detailing acceptance criteria and studies proving the device meets them cannot be fully provided as it is not explicitly present in the given text. The submission instead relies on the equivalence to previously cleared devices which presumably had such studies.
Here's a breakdown of what can be inferred or explicitly stated from the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Performance | Based on specifications cleared for predicate device(s) | "Test results showed substantial equivalence." |
| Functionality | Based on specifications cleared for predicate device(s) | "Test results showed substantial equivalence." |
| Reliability | Based on specifications cleared for predicate device(s) | "Results demonstrate that web software interface functionality meets all reliability requirements and performance claims." |
| Safety | Based on specifications cleared for predicate device(s) | "Test results showed substantial equivalence." |
| Integration | N/A (tested as part of "integration tests") | "Test results showed substantial equivalence." |
| Environmental | N/A (tested as part of "environmental tests") | "Test results showed substantial equivalence." |
Limitations: The document does not provide specific numerical or qualitative acceptance criteria for these metrics, nor does it present detailed performance results beyond a statement of substantial equivalence to the predicate and meeting reliability requirements.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any test sets used in verification and validation. It also does not provide information on the data provenance (e.g., country of origin, retrospective/prospective). The testing focused on system-level, integration, environmental, and safety tests, which typically do not involve patient data in the same way clinical studies might.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. Given the nature of the device (information center software that supports monitoring, including arrhythmia and ST segment), ground truth would likely be established based on accepted clinical standards or reference devices, but the process is not detailed here.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study is mentioned. The document describes system-level, integration, environmental, and safety testing, not comparative effectiveness studies with human readers.
6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Study Was Done
The document refers to verification, validation, and testing activities, including system-level functional tests. This implies that the software's performance was evaluated independently against its specifications. However, specific details of an "algorithm-only" performance study (e.g., for arrhythmia detection accuracy independent of clinician interpretation) are not provided. The device itself is an "Information Center Software," implying it presents data to a clinician, so its performance is inherently linked to human interpretation to some degree.
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used. For monitoring devices like this, ground truth would typically come from:
- Reference measurements: Gold-standard devices or manual assessment using established clinical protocols for physiological parameters.
- Consensus: For subjective interpretations or complex events like arrhythmias, expert consensus could be used if human review was part of the ground truth process.
The provided text does not elaborate on how ground truth was established for the tests mentioned.
8. The Sample Size for the Training Set
This information is not applicable. The device is described as "software release J.00" for an information center, supporting existing monitors. There is no indication that this software uses machine learning algorithms that would require a "training set" in the conventional sense. The testing focuses on system functionality, integration, and reliability, rather than the performance of a newly developed predictive algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as no training set for machine learning is indicated.
§ 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.