(15 days)
The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient detects symptoms indicated to him by his physician. It is indicated when such recordings are required for diagnosis, prognosis, and management of transient symptoms such as dizziness, syncope, palpitations, and arrhythmias.
The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone. The unit has two modes: Post-event and Arrhythmia, or "Looping.". In post-event mode, the unit records a period of ECG following the pressing of a button by the patient. The unit can also determine the pulse duration of implanted pacemakers in Post-Event mode. In arthythmia mode, the unit is a so-called "looping recorder." it is always active, and thus records a sample of ECG both before and after the "patient event."
The unit records a 3-lead ECG, using four electrodes. Normally, the unit records the limb leads.
The Central Station unit is the Paceart WINCPTS 86-12 system (K915632).
The physician can program the unit and set the number of recordings and the duration of the recording that can be made before they must be transmitted to the central station.
The provided text does not contain specific acceptance criteria or a study demonstrating that the TX3 Cardiac Event Recorder meets such criteria.
Instead, it's a 510(k) Summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against predefined acceptance criteria.
Therefore, I cannot provide the requested table or detailed information about a study proving the device meets acceptance criteria. However, I can infer some points based on the provided text:
Based on the provided document, the following information can be extracted:
- A table of acceptance criteria and the reported device performance
The document does not specify quantifiable acceptance criteria for device performance. It states that the device and/or its predicate "met the requirements of AAMI standard EC38" and that "software has had extensive validation testing." However, no specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection, or accuracy of pacemaker pulse duration measurement) or corresponding target values are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified (See Note 1) | Met requirements of AAMI standard EC38 |
| Not specified | Software had extensive validation testing |
*Note 1: While AAMI EC38 is a standard for ambulatory electrocardiographs, the document does not break down which specific requirements were met or provide quantitative results from meeting those requirements.*
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* Sample Size: Not specified.
* Data Provenance: Not specified. The document explicitly states "Clinical tests: Not required." This implies that the validation relied on non-clinical testing and equivalence arguments, not on clinical data collected from patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical tests or human expert ground truth establishment for a test set are mentioned. The testing focused on engineering standards and software validation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests were performed requiring adjudication of results against a ground truth. -
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 mentioned or implied. The device is an event recorder, not an AI-assisted diagnostic tool that aids human readers. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the TX3 as a "Cardiac Event recorder" that records ECGs and transmits them to a central station (Paceart WINCPTS 86-12 system). The "unit can also determine the pulse duration of implanted pacemakers in Post-Event mode." This suggests standalone algorithmic functions for pacemaker pulse duration, but no specific performance study for this standalone algorithm is detailed beyond the general statement about meeting AAMI EC38 and extensive software validation. The overall device is a recorder; its performance is related to its ability to accurately capture and store ECGs, not to interpret them in an AI context. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests mentioned (AAMI standard EC38 and software validation), the ground truth would likely be established by:- AAMI EC38: Reference standards for electrical performance, accuracy of recording, signal integrity, and safety parameters as defined by the standard.
- Software Validation: Requirements specifications, expected outputs for given inputs, and absence of bugs, verified through testing. No biological or clinical ground truth is implied for these tests.
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The sample size for the training set
Not applicable. The device is a hardware cardiac event recorder with associated software, not a machine learning or AI model that requires a distinct "training set." -
How the ground truth for the training set was established
Not applicable (no training set for an AI model).
§ 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).