(18 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/alarms 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 modification is a software-based change that provides Cardiotach functionality without arrhythmia analysis and ST Segment Analysis without arrhythmia analysis.
The provided text describes a 510(k) summary for the Philips ST/AR ST and Arrhythmia Software, Release E.1. However, it does not contain detailed information regarding acceptance criteria, specific device performance metrics, sample sizes for test or training sets, ground truth establishment methods, or whether MRMC or standalone studies were conducted.
The document mainly focuses on establishing substantial equivalence to previously cleared predicate devices through software-based changes. It states that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." and "The results demonstrate that ST/AR Release E.1 meets all reliability requirements and performance claims." but does not elaborate on what these specifications or claims are.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer the questions based only on the provided information, noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Based on specifications cleared for predicate device | Test results showed substantial equivalence to the predicate device. |
| Meet all reliability requirements | Addressed; results demonstrate meeting requirements. |
| Meet all performance claims | Addressed; results demonstrate meeting claims. |
(Note: Specific numerical criteria for performance (e.g., sensitivity, specificity, accuracy for arrhythmia or ST detection) are not provided in the text.)
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "test results" and "system level tests, performance tests, and safety testing from hazard analysis" but does not provide details on the number of cases or patients used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not specified. The document describes the device as "ST/AR ST and Arrhythmia Software" which is a standalone software, not explicitly an AI-assisted interpretation tool for human readers in the context of comparative effectiveness.
- Effect Size: Not applicable/not provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Evaluation: Yes, implied. The testing activities mentioned ("system level tests, performance tests") evaluated the device's inherent capabilities against predicate device specifications, suggesting a standalone evaluation of the algorithm. The device itself is described as "Software" that provides "Cardiotach functionality" and "ST Segment Analysis," indicating it operates independently to perform these functions. However, specific standalone metrics (e.g., sensitivity, specificity) are not provided.
7. The type of ground truth used
- Type of Ground Truth: Not specified. Given the context of arrhythmia and ST segment analysis, it would typically involve expert consensus on ECGs, potentially correlated with clinical outcomes or other diagnostic tests, but this is not explicitly stated in the document.
8. The sample size for the training set
- Sample Size for Training Set: Not specified.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not specified.
In summary, the provided submission primarily focuses on the regulatory aspect of substantial equivalence based on a software modification, rather than a detailed technical performance study with quantitative results and specific methodologies for clinical validation. This type of information is often found in more detailed technical reports or other sections of a 510(k) submission not included in this 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.