Search Results

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:

1. 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.

*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.

3. 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.

4. 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.

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 mentioned or implied. The device is an event recorder, not an AI-assisted diagnostic tool that aids human readers.

6. 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.

7. 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.

8. 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."

9. How the ground truth for the training set was established
   Not applicable (no training set for an AI model).

Ask a specific question about this device

The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center, with the ability to record three electrocardiographic leads or to derive 12 electrocardiographic leads from the three transmitted.

The HomeTrak Plus Cardiac Twelve-Lead Event Recorder is a patient-activated ambulatory cardiac event monitor and associated central-station receiving equipment which are to be used for recording infrequent and elusive heart arrhythmias and transmitting them by telephone at a later time to a central analysis center. It records three electrocardiographic leads and derives 12 electrocardiographic leads from the three transmitted. When the five electrodes are attached to the patient in the special configuration shown in the manual and the PaceArt WINCPTS central-station software with 12-lead option is used, the physician can either record a twelve-lead electrocardiogram or a three-lead electrocardiogram at the analysis center. The system for derivation of the 12-lead electrocardiogram from the five-electrode recording is called the "EASI" system. There are two elements to the Home Trak Plus system: a "looping" cardiac event recorder, and a special central-station program.

Here's an analysis of the provided text regarding the HomeTrak Plus EASI Event Recorder System's acceptance criteria and studies:

Summary of Device Performance Study Information for HomeTrak Plus EASI Event Recorder System

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to record 3 ECG leads.
• Ability to derive 12 ECG leads from 3 transmitted leads (EASI system).
• Safety and efficacy equivalent to legally marketed predicate devices. | Clinical Test 1: "A series of patients had 12-lead electrocardiograms taken with the EASI predicate device and this system. The electrocardiograms were equivalent."
  Clinical Test 2: "An electrocardiogram was taken with the HomeTrak Plus system and a Burdick 12-lead electrocardiograph. The recordings are equivalent."
  Overall Conclusion: "The HomeTrak Plus system is equivalent in safety and efficacy to the legallymarketed predicate devices." This implies that the system successfully records and derives ECG leads in a manner comparable to established, approved devices, meeting the functional and safety expectations. |
  | Correct EASI Coefficient Application: Ensures the 12-lead derivation is accurate. | "The system was tested to show that electrocardiograms are operated on by the correct EASI coefficients." This directly addresses the internal logic and accuracy of the EASI derivation process. |
  | Software Validity: Ensures the underlying software functions reliably. | "The software has had extensive validity testing." This is a general statement indicating a robust testing process for the software component. |
  | Electrical Safety Standards: Compliance with relevant electrical safety regulations. | "The HomeTrak Plus event recorder has had standard electrical safety tests and been tested to EC38." This confirms adherence to recognized electrical safety standards. |
  | Central Station Equipment Compliance: The central station component (CPTS) meets the requirements of a 12-lead ECG system. | "The CPTS central station equipment has been also cleared by the FDA as a 12-lead ECG system (K915632), and meets the requirements for those devices." This confirms the central station's approved status and compliance with relevant standards. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states "A series of patients" in Clinical Test 1. No specific number for the test set is provided.
• Data Provenance: Not explicitly stated, but clinical tests imply prospective data collection from patients. The country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not provide details on the number of experts or their qualifications involved in establishing the ground truth. The comparison is made to a "predicate device" and a "Burdick 12-lead electrocardiograph," implying these established devices served as the de-facto gold standard for comparison, rather than a separate expert panel establishing a new ground truth.

4. Adjudication Method for the Test Set

• No specific adjudication method is mentioned. The comparison is stated as "equivalent," implying a direct comparison of the ECG recordings without a formal multi-reader adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a MRMC comparative effectiveness study is not mentioned. The studies described are focused on demonstrating equivalence of the device's output to existing technologies, not on improving human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the clinical tests essentially demonstrate standalone performance in the sense that the device's output (ECG recordings) is directly compared to other devices. The "equivalent" determination is based on the device's ability to produce similar ECGs, independent of human interpretation during the testing phase.

7. The Type of Ground Truth Used

• The ground truth was established by comparison to legally marketed predicate devices and established medical equipment. Specifically:
  • An "EASI predicate device" (Clinical Test 1)
  • A "Burdick 12-lead electrocardiograph" (Clinical Test 2)
  • The "CPTS central station equipment" previously cleared by FDA (K915632) for 12-lead ECG systems.
  • This indicates a "comparison to a gold standard device" approach.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a "training set" or its sample size. This type of device (an event recorder) primarily records and derives signals based on known physiological principles and algorithms (like the EASI system), rather than using a machine learning model that would require a distinct training set. The "software has had extensive validity testing," but this refers to traditional software engineering validation, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set for an AI/machine learning model is described. The "EASI coefficients" are likely pre-determined constants based on physiological modeling, not learned from a training set.

Ask a specific question about this device