(113 days)
The King of Hearts Express® II cardiac event recorder is a patient-activated device designed for diagnostic evaluation of transient symptoms such as dizziness, palpitations, syncope and chest pain. The recorder provides single lead or multiple lead ECG morphology, which may be used to visualize arrhythmias, ST segment changes, SVT, heart block, re-entrant phenomena, and p-waves. The recorder may also provide automatic recording for detected bradycardia or tachycardia rhythms. The recorder may be used with pacemaker patients to assess pacemaker activity.
These devices are non-invasive, external ambulatory electrocardiographic (ECG) memory monitors. They are designed for evaluation of transient symptoms like dizziness, palpitations, and chest discomfort, and may be incorporated as part of rehabilitation, or medical treatment follow-up, where such symptoms may be present.
The new devices are capable of recording one or more leads of surface ECG. The additional features options permit automatic recording of ECG based upon measured heart rate or changes in heart rate, and/or pacemaker pulse detection and enhancement. A serial port connection is available for data communication, in addition to the standard acoustically coupled FM signal provided for trans-telephonic communications of the ECG.
This 510(k) summary for the King of Hearts Express® II and King of Hearts Express® EZ II ambulatory event recorders does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
Here's why and what information is provided:
Key Takeaways from the Provided Document:
- Substantial Equivalence: The primary claim for this device is "substantial equivalence" to previously marketed predicate devices (Instromedix King of Hearts Express 3X, Prince, 1200, CarryAll; Braemar ER720; TZ Medical HeartAide Plus II; Card Guard CG-6500). This indicates that the regulatory approval was based on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than requiring extensive de novo clinical trials with specific acceptance criteria.
- "Non-Significant Risk": The devices are categorized as Class II, "non-significant risk devices." This classification often influences the type and extent of data required for regulatory submission, usually leaning away from large-scale clinical trials with pre-defined acceptance criteria for novel performance.
- Identical Features and Functions (to predicates): The document explicitly states: "Features and functions are identical to identified predicate devices." This is a crucial point for substantial equivalence.
- No Mention of Performance Metrics or Studies: There is no discussion of sensitivity, specificity, accuracy, or any other quantitative performance metrics, nor is there any mention of a specific study designed to "prove" the device meets such metrics.
What is Missing (and why it's likely not in this type of 510(k) submission):
The sections of your request (acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are typically found in submissions for novel devices or devices where substantial equivalence cannot be merely demonstrated by comparison to existing predicate devices. For a 510(k) focused on substantial equivalence to multiple already approved predicate devices with "identical features and functions," the FDA often relies on the established safety and effectiveness of those predicates.
Attempting to Fill the Table Based on the Provided Information (with significant caveats):
Given the lack of specific performance studies, I can only state what the submission implies about performance based on substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|---|
| Functional Equivalence | Device functions (ECG recording, lead types, automatic recording, pacemaker detection, data communication) must be identical or substantially equivalent to predicate devices. | The King of Hearts Express® II and EZ II are described as having "identical" features and functions to the predicate devices (Instromedix King of Hearts Express 3X, Prince, 1200, CarryAll; Braemar ER720; TZ Medical HeartAide Plus II; Card Guard CG-6500). This implies these functions meet the established performance of the predicates. |
| Safety | Device must pose "non-significant risk" and be as safe as predicate devices. | The devices are categorized as Class II, non-significant risk devices, and the submission states: "The safety and effectiveness of these devices is substantially equivalent to the predicate devices. There are no known contraindications for use of this type of device." |
| Effectiveness (Clinical Purpose) | Device must be effective for its intended use (diagnostic evaluation of transient symptoms, ECG morphology visualization, arrhythmia detection) as predicate devices. | The submission claims "The safety and effectiveness of these devices is substantially equivalent to the predicate devices." It also lists the Indications For Use, which align with the function of similar ambulatory event recorders. |
| Technical Performance (e.g., Signal Quality) | (Not explicitly stated, but implied by functional equivalence) ECG signal quality and recording reliability expected to be equivalent to predicate devices. | "Multilead ECG, pacemaker pulse enhancement, rate-triggered recording, and other features...present a non-significant risk." This implies these technical aspects are performing as expected and are comparable to predicate devices. No specific quantitative metrics are provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. It is highly likely that no specific, independent "test set" with a defined sample size for performance evaluation was used in the manner of a clinical trial. The submission relies on the established performance of predicate devices.
- Data Provenance: Not applicable, as performance data (in the sense of a test set) is not presented. The basis for comparison is the design and function of existing, legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" establishment by experts on a test set is mentioned or implied, as the submission does not present performance data from a novel study.
4. Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication for ground truth is mentioned.
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:
- No MRMC study was done (or at least none is reported in this summary). This device is an ambulatory ECG recorder, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm's diagnostic performance. The device records ECG data for human interpretation. Its "standalone" performance would relate to its ability to accurately record and transmit ECG signals, which is implied to be equivalent to predicates.
7. The type of ground truth used:
- Not applicable. No ground truth for an analytical or clinical performance study is reported. The "truth" for this submission is based on the regulatory precedent set by the predicate devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that would require a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary: This 510(k) submission is for a device seeking approval based on substantial equivalence to existing devices, meaning it is considered as safe and effective as those already on the market because its features and functions are "identical." Therefore, it does not contain the detailed performance metrics, study designs, or expert adjudications that would be present in a submission for a novel device requiring a de novo performance study.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).