(70 days)
EASI ECG is intended for monitoring multiple leads of ECG of adults, pediatrics and neonates. ST. Segment monitoring is restricted to adult patients only.
EASI ECG is indicated for use by health care professionals whenever there is a need to monitor ECG of adult, pediatric, or neonatal patients including arrhythmia monitoring or ST segment changes of adult patients, to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms, including:
- Assessment of symptoms that may be related to rhythm disturbances of the heart
- -Patients with palpitations
- The evaluation of arrhythmias in patients from neonatal to pediatric to adult age
- arrhythmia
- -- Assessment of efficacy of anti-arrhythmic therapy
- -- Assessment of pacemaker function
- Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing
Not Found
The provided text describes the 510(k) summary for the EASI ECG device (K033513). However, it is very brief regarding detailed acceptance criteria and study particulars. Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard (Implied) | Device Performance (Reported) |
|---|---|---|
| Substantial Equivalence | To predicate device (K020456 and K990476 & K032858) | "Testing involved performance verification... and comparison of results to the predicate and direct ECG. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that EASI ECG meets all requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 1185 patients.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is referred to as a "database."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified. The text only mentions "comparison of results to the predicate and direct ECG."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study is not mentioned. The comparison was primarily against a predicate device and "direct ECG."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance verification involved the device (EASI ECG) being compared to "direct ECG" and a "predicate" algorithm/device. This implies a standalone evaluation of the EASI ECG algorithm's output.
7. The Type of Ground Truth Used
- The "ground truth" for the test set appears to be derived from a "direct ECG." This suggests a reference standard obtained by conventional, established ECG recording methods.
8. The Sample Size for the Training Set
- Not specified. The document only mentions the test set of 1185 patients.
9. How the Ground Truth for the Training Set Was Established
- Not specified, as the training set details are not provided.
Summary of Limitations in the Provided Information:
The 510(k) summary provided is very high-level and lacks specific details regarding:
- The exact "Pass/Fail criteria" for substantial equivalence.
- The specific metrics used for comparison (e.g., accuracy, sensitivity, specificity for arrhythmia detection or ST segment analysis).
- Details on the "direct ECG" used as a reference.
- The nature of the "database" of 1185 patients (e.g., demographics, disease prevalence, data collection method).
- Any details about the training data or how its ground truth was established.
- The role of human experts in establishing ground truth for either the training or test sets.
§ 870.2350 Electrocardiograph lead switching adaptor.
(a)
Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.(b)
Classification. Class II (performance standards).