(49 days)
The Epicardia 50000 system is indicated as a screening tool for patients who require ambulatory EDG montaring for extended time periods. The system rocarde and analyzes the cation's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised If nocessary by a trained operator and then confirmed by a qualified oliniolan.
The EPICARDIA System is a screening tool for patients who require ambulatory ECG monitoring for extended time periods. The system records and analyzes the patient's ECG, and provides various summary reports that detail any clinically-significant events the patient may have had, based on the EPICARDIA classifications. These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician.
Here's an analysis of the provided text regarding the Epicardia 5000 device, focusing on the acceptance criteria and study details:
This submission (K090834) is a 510(k) Pre-Market Notification, which primarily demonstrates substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, no specific quantitative acceptance criteria or detailed performance metrics are explicitly stated for the Epicardia 5000. This is typical for a 510(k) submission where the goal is to show equivalence to an already marketed device, not necessarily to prove specific performance against novel criteria.
The submission focuses on the discussion of non-clinical tests performed, stating: "All testing performed on the Epicardia 5000 was derived from the risk assessment which evaluated the effects of the feature changes. Testing included software validation testing." This implies that the 'acceptance criteria' were likely tied to the successful completion of software validation and risk assessment mitigation, ensuring the new features did not negatively impact the device's fundamental function or safety/effectiveness compared to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Discussion of Clinical Tests Performed: Not Applicable". This indicates that no new clinical test set, in the traditional sense, was used to evaluate the Epicardia 5000's performance in humans. The evaluation was primarily based on software validation and comparison to the predicate device's existing performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical tests were performed, there was no test set for which ground truth was established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document states "Discussion of Clinical Tests Performed: Not Applicable."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device's "ECG Analysis" component is mentioned as "Diogenes SV" (an updated version of the predicate's "Diogenes"), no specific standalone performance study of this algorithm is detailed. The description states: "The system records and analyzes the patient's ECG, and provides various summary reports... These reports are then reviewed, revised if necessary by a trained operator and then confirmed by a qualified clinician." This indicates a human-in-the-loop system, and no data is presented for the algorithm operating in a purely standalone mode without human review and confirmation. The testing focused on software validation, which would assess the algorithm's functional correctness but not necessarily its clinical performance in isolation.
7. The Type of Ground Truth Used
Given that clinical tests were "Not Applicable," there's no mention of specific clinical ground truth (e.g., pathology, outcomes data). The 'ground truth' for the software testing would have been the expected output or behavior according to the software design specifications and risk assessment.
8. The Sample Size for the Training Set
The document does not mention any training set for the Epicardia 5000. As it's a 510(k) submission for a device that uses an analysis system (Diogenes SV), it's possible the "Diogenes SV" algorithm itself was developed with training data, but no details regarding this are provided in this specific submission. The focus is on the substantial equivalence of the system rather than the development of the underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set details are provided in this document.
Summary Takeaway:
The K090834 submission for the Epicardia 5000 is a 510(k) pre-market notification that explicitly states "Discussion of Clinical Tests Performed: Not Applicable." Therefore, it does not provide detailed information on acceptance criteria, test set sample sizes, expert ground truth establishment, or multi-reader studies as would be expected for a device proving novel safety or effectiveness claims. The basis for its clearance is a comparison to a predicate device (Epicardia 4000) and evidence of non-clinical software validation demonstrating that the technological changes do not raise new safety or effectiveness concerns.
§ 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.