(98 days)
The IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.
The IntriCon Datrix Centauri MT APETS is a device used for recording patient ECG data for as long as 30 days. Selected data are sent for review from the recorder, through a phone service to a receiving station where they are available for review by a physician or other qualified medical professional. The Centauri MT APETS is capable of 1, 2, and 3-channel recording, depending on the type of cable being used. The recorder can run for up to 30 days. Battery life depends on the mode and battery option chosen by the user. The patient's ECG signal is acquired via commercially available silver-chloride electrodes appropriate for long-term recording.
The provided 510(k) summary for the IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) does not include explicit acceptance criteria nor a detailed study proving the device meets said criteria.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Braemar, Inc. Fusion Wireless Recorder (K081444) and Datrix E-Tac EX-1000 Electrocardiographic Event Recorder (K042022)). The conclusion states: "Comparison to the predicate devices listed shows nearly identical technical data, same indications for use, same safety standards tested to, and raises no new questions of safety or efficacy."
The submission focuses on compliance with general safety and performance standards rather than specific diagnostic accuracy metrics.
Here's an breakdown of the information that can be extracted, and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| None explicitly stated as quantifiable performance metrics. The approval is based on "substantial equivalence" to predicate devices and adherence to general safety standards. | None explicitly stated as quantifiable performance metrics. The device "continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity..." but no performance metrics (e.g., sensitivity, specificity for arrhythmia detection, or accuracy of transmission) are provided. |
Missing Information:
- Specific numerical targets for performance (e.g., sensitivity, specificity, positive predictive value, negative predictive value for arrhythmia detection).
- Data demonstrating the device's ability to accurately detect and transmit various types of arrhythmias.
2. Sample Size Used for the Test Set and Data Provenance:
Missing Information:
- Sample Size for Test Set: The document does not describe any specific clinical or performance test set used to evaluate the device's diagnostic accuracy. It mentions "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system," but details of these tests, including sample size for diagnostic performance, are absent.
- Data Provenance: Without a description of a test set, there is no information on country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Missing Information:
- As no specific test set for diagnostic performance is described, there is no mention of experts or how ground truth was established for such a set.
4. Adjudication Method for the Test Set:
Missing Information:
- No test set for diagnostic performance is described, therefore no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Missing Information:
- No MRMC comparative effectiveness study is mentioned. The submission is focused on the device's standalone functionality and equivalence to predicates, not its impact on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance: The device's intended use explicitly states it "automatically generates an event triggered by an arrhythmia detection algorithm." This implies a standalone algorithm component. However, no performance metrics (e.g., sensitivity, specificity for various arrhythmias) for this algorithm are provided in the document. The submission relies on "substantial equivalence" to predicate devices, which presumably have a similar algorithmic function.
7. Type of Ground Truth Used:
Missing Information:
- Given the lack of a detailed diagnostic performance study, the type of ground truth (e.g., expert consensus, pathology, outcomes data) used for any such evaluation is not stated.
8. Sample Size for the Training Set:
Missing Information:
- No information about a training set or its sample size is provided. This is typical for submissions focused on established technologies demonstrating substantial equivalence, where detailed de novo algorithm development data might not be required.
9. How the Ground Truth for the Training Set Was Established:
Missing Information:
- As no training set is mentioned, there is no information on how its ground truth would have been established.
Summary of Acceptance Criteria and Study Limitations:
The provided 510(k) summary is for a device seeking clearance based on "substantial equivalence" to existing predicate devices. This type of submission generally does not require a detailed clinical performance study with explicit acceptance criteria for diagnostic accuracy, nor does it typically detail the development and validation of AI algorithms with associated training and test sets in the same manner as a de novo submission or a device with novel technology.
The "Performance Testing" section primarily lists compliance with general electrical safety and EMC standards (IEC60601-1:1998, IEC 60601-1-2: 2001, AAMI EC 38-1998) and states that "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system." This indicates engineering and functional testing, not necessarily a clinical study for diagnostic performance.
Therefore, this document does not contain the detailed information requested regarding specific acceptance criteria, diagnostic performance study design, sample sizes, ground truth establishment, or expert involvement for evaluating the arrhythmia detection algorithm's accuracy. The approval is based on the claim that the device is "substantially equivalent" to already-cleared devices, implying its performance characteristics are comparable to those predicates.
§ 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.