(95 days)
The HEARTLink II System is intended to provide cardiac monitoring from a low-risk patient's home a central monitoring facility pursuant to to physician prescription.
The HEARTLink II System receives and processes radiofrequency encoded transmitted ECG signals on the Tele-Link monitoring unit. Abnormal ECGs and arrhythmias detected by the Tele-Link can be displayed on an optional video display monitor, while being simultaneously transmitted through standard telephone lines to a remote Central Station. The Central Station, located within health care institution or patient monitoring facility, is where an alarm is sounded and the ECG is again displayed for the review of medical personnel. The Central Station system has four dedicated phone lines and can provide remote monitoring of ECG data received from 30 individual Tele-Links. A total of 30 patients can be monitored at one time by a single one Central Station.
The provided documents describe the HEARTLink II (Arrhythmia Detector and Alarm System), a device intended for cardiac monitoring of low-risk patients in their home environment. The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials to prove safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in the context of demonstrating substantial equivalence.
Here's an analysis of the available information according to your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Given this is a 510(k) submission primarily focused on substantial equivalence to existing devices (HEARTLink I, King of Hearts, Aegis), the "acceptance criteria" are generally derived from the performance of these predicate devices and relevant standards. The document doesn't explicitly state quantitative acceptance criteria for arrhythmias detected but rather focuses on usability and transmissibility in the new home-use environment.
| Criteria Category | Specific Criteria (Implied / Explicit) | Reported Device Performance and Study Findings |
|---|---|---|
| Safety and Effectiveness | Compliance with relevant standards for arrhythmia detectors, emissions, safety. | Bench Testing: HEARTLink I (and by extension HEARTLink II due to technical equivalence with minimal changes) complied with: |
- FDA's MDS 201-0004
- FCC's Parts 15 and 68 Rules
- Draft AAMI EC-13-R-4/91 standards (now adopted as standard).
HEARTLink II was re-tested for safety and emissions and complies with the current EMC Directive. |
| Usability | Ability of a patient to effectively use the device in a home environment. | Clinical Trials: Conducted at Saint Francis Medical Center (Pittsburgh, PA) and Washington Center Hospital (Washington, DC).
Finding: HEARTLink II is "as usable" as the predicate Event Recorder System. |
| Transmissibility | Ability to accurately transmit ECG data to a Central Monitoring facility. | Healthy Volunteer Trials: Healthy volunteers wore both HEARTLink II and a predicate device for 4 days.
Finding: HEARTLink II is capable of transmitting data with "equal fidelity" as its predicate Event Recorder System. |
2. Sample Size Used for the Test Set and Data Provenance
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Usability Study (Clinical Trials):
- Sample Size: Not explicitly stated. The document mentions "clinical trials were done," but does not provide the number of patients or participants.
- Data Provenance: Prospective (clinical trials). Conducted in two U.S. states: Pittsburgh, PA (Saint Francis Medical Center) and Washington, DC (Washington Center Hospital).
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Transmissibility Study (Healthy Volunteer Trials):
- Sample Size: Not explicitly stated. The document mentions "healthy volunteers were to wear both the HEARTLink II System."
- Data Provenance: Prospective (healthy volunteer trials). Location not specified beyond "healthy volunteers," but likely U.S.-based given the U.S. clinical trial sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not detail the establishment of "ground truth" in the traditional sense of expert adjudication for arrhythmia detection performance in these specific studies because:
- The usability study assessed user interaction, not diagnostic accuracy of arrhythmia detection.
- The transmissibility study assessed data fidelity, not diagnostic accuracy.
The accuracy of arrhythmia detection itself was largely addressed by substantial equivalence to the predicate devices which would have already established their own accuracy. Personnel involved in reviewing transmitted ECGs for the transmissibility study would likely be medical personnel at the Central Monitoring facilities, but their qualifications and numbers are not specified.
4. Adjudication Method for the Test Set
No explicit adjudication method is described for the "test set" in the context of diagnostic accuracy, as the studies focused on usability and transmissibility.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is an "Arrhythmia Detector and Alarm System," implying an automated or semi-automated detection component, but the studies described focus on usability and data transmission, not on comparing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document heavily relies on the technical equivalence of HEARTLink II to HEARTLink I. HEARTLink I was previously cleared by the FDA (K934913) as an arrhythmia detector and alarm system. The HEARTLink II is described as "identical to the HEARTLink I System" with the exception of a name change and a minimal change to non-physiological information in the database management software.
The bench testing and compliance with standards (MDS 201-0004, AAMI EC-13-R-4/91) would cover the standalone performance aspects of the arrhythmia detection algorithm, as these standards are designed to ensure its functional performance. However, a separate, specific study explicitly labeled as a "standalone algorithm performance study" is not detailed for HEARTLink II. Its standalone performance is primarily extrapolated from HEARTLink I's prior clearance and compliance with recognized standards.
7. The Type of Ground Truth Used
- Usability Study: The "ground truth" would be subjective patient/user feedback and observations of their ability to use the system, compared to a predicate system.
- Transmissibility Study: The "ground truth" would be the quality and accuracy of the transmitted ECG waveforms compared to the original signals or what was received from the predicate device simultaneously, indicating data fidelity.
- For the core arrhythmia detection accuracy: This is not directly addressed by new "ground truth" experiments in this 510(k) submission for HEARTLink II. Instead, it relies on the substantial equivalence to the HEARTLink I which, as a previously cleared device, would have established its own accuracy (likely using expert-adjudicated ECG recordings or a validated database as ground truth, but this information is not in the provided text).
8. The Sample Size for the Training Set
The document is for a 510(k) premarket notification and does not detail the internal development or training of the arrhythmia detection algorithms. Therefore, the sample size for any training set used to develop the algorithms for HEARTLink I (and by extension HEARTLink II) is not provided.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, the document does not discuss the establishment of ground truth for any training set, as it focuses on demonstrating substantial equivalence for regulatory clearance rather than the specifics of algorithm development. Such information would typically be part of a design and development file, not necessarily summarized in the 510(k) public summary unless specifically requested for novel aspects.
§ 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.