(22 days)
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 intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias, and produce events/s] prms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients.
The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients.
The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagrosis of those measurements.
The modification is a software-based change that adds the following features: - Atrial Fibrillation alarm - Heart Rate configuration to short or yellow long alarm - Addition of messages indicating causes of invalid OT measurement
The provided document is a 510(k) premarket notification for the Philips ST/AR ST and Arrhythmia Software, Release J.0. It states that the device is substantially equivalent to previously cleared devices and outlines the new features, such as Atrial Fibrillation alarm. However, the document does not contain specific acceptance criteria or detailed study results with the requested information (sample sizes, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details). It broadly states that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate," and that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."
Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The document is a regulatory submission summary, not the full study report.
To address your request, I will explain what would be expected in such a study for a device like this and how the information would typically be presented, acknowledging that the specifics are missing from the provided text.
Based on the provided text (K080461 - Philips ST/AR ST and Arrhythmia Software, Release J.0), the following information is available or can be inferred:
- Device Name: Philips ST/AR ST and Arrhythmia Software, Release J.0
- New Features: Atrial Fibrillation alarm, Heart Rate configuration, messages for invalid QT measurement causes.
- Predicate Devices: K964122, K991773, K001348, K003621, K014261, K021251, K033513, K040357, K070260 (Philips ST/AR ST and Arrhythmia Software), K073462 (GE Dash monitor), K031320 (GE EK-Pro Arrhythmia Detection Algorithm).
- General Statement on Testing: "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, performance 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."
Missing Information (Not present in the provided document):
- Specific numerical acceptance criteria for each performance metric.
- Reported device performance values against these criteria.
- Sample sizes for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study (effect size, improvement with AI assistance).
- Details of standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- Method for establishing ground truth for the training set.
Hypothetical Example of Acceptance Criteria and Study Design (What would typically be found in a more detailed submission for an arrhythmia detection algorithm, not based on the provided text directly):
Given the device includes an "Atrial Fibrillation alarm" as a new feature, a study validating this specific feature would typically involve comparing the algorithm's detection of Atrial Fibrillation (AFib) against a ground truth established by expert cardiologists.
Hypothetical Table of Acceptance Criteria and Reported Device Performance (Illustrative, not from the provided text):
| Performance Metric (for AFib Detection) | Acceptance Criteria | Reported Device Performance (Hypothetical) |
|---|---|---|
| Sensitivity (AFib events) | ≥ 90% (with 95% CI lower bound > 85%) | 92.5% (95% CI: 90.1% - 94.7%) |
| Specificity (Non-AFib events) | ≥ 80% (with 95% CI lower bound > 75%) | 83.2% (95% CI: 80.9% - 85.3%) |
| Positive Predictive Value | ≥ 75% (with 95% CI lower bound > 70%) | 78.1% (95% CI: 75.5% - 80.6%) |
| False Alarm Rate (per 24 hours) | ≤ 5 false alarms/24 hours | 4.1 false alarms/24 hours |
| Detection Latency | Median detection within 15 seconds of AFib onset (for sustained episodes) | Median: 12 seconds |
Detailed Study Information (Illustrative, not from the provided text):
-
Sample Size for Test Set and Data Provenance:
- Sample Size: 2,500 hours of continuous ECG recordings.
- Data Provenance: Retrospective, collected from five major hospitals across the United States, Europe (Germany, UK), and Japan. The dataset included a diverse patient population (age, gender, comorbidities) representing the intended use population (adults).
-
Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: 3 independent electrophysiologists.
- Qualifications: All experts were board-certified cardiologists with sub-specialty certification in electrophysiology, each with a minimum of 10 years of experience in ECG interpretation and arrhythmia diagnosis.
-
Adjudication Method for the Test Set:
- Method: 2+1 Adjudication.
- Each ECG recording segment was independently reviewed by two electrophysiologists.
- If the two initial reviewers agreed on the presence or absence of AFib, that consensus became the ground truth.
- If the two initial reviewers disagreed, a third, senior electrophysiologist (the "tie-breaker") reviewed the segment, and their decision established the ground truth.
- Method: 2+1 Adjudication.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No, an MRMC study was not performed for this 510(k) submission, as the focus was on the performance of the algorithm itself in detecting new features like AFib in a standalone manner, with comparison to predicate algorithms, rather than comparing human reader performance with and without AI assistance for this specific feature. (However, for image-based AI or diagnostic AI, MRMC studies are common).
-
Standalone (Algorithm Only) Performance:
- Was it done?: Yes. The performance metrics presented in the hypothetical table above represent the standalone performance of the Philips ST/AR ST and Arrhythmia Software, Release J.0 algorithm in detecting AFib based on the ECG input, without human intervention in the detection process.
-
Type of Ground Truth Used:
- Type: Expert Consensus. The ground truth for the presence or absence of Atrial Fibrillation was established by the independent review and adjudication of the electrophysiologists as described in section 3.
-
Sample Size for the Training Set:
- Sample Size: 15,000 hours of continuous ECG recordings. This dataset was distinct from the test set to ensure independent evaluation.
-
How the Ground Truth for the Training Set Was Established:
- Method: The ground truth for the training set was established through a combination of automated pre-annotation followed by expert review and correction. An initial algorithmic pass provided preliminary annotations for various arrhythmias, including AFib. These annotations were then meticulously reviewed and corrected by a team of experienced ECG technicians under the supervision of a lead electrophysiologist. For ambiguous cases, adjudication by two independent electrophysiologists ensured accuracy, similar to the test set ground truth establishment process, but with a higher throughput focus.
Conclusion from the provided K080461 document:
The provided 510(k) summary (K080461) indicates that the device underwent "Verification, validation, and testing activities" and that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." This is a general statement required for a 510(k) summary and does not include the detailed performance data, acceptance criteria, sample sizes, ground truth methodology, or expert qualifications that you requested. Such detailed information would typically be found in the full submission, which is not publicly available under the 510(k) summary.
§ 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.