Search Results

Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter.

Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.

Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.

Heartrak Smart ECAT is a cardiac event recorder that is used to continuously scan and capture ECG signals. Patients can use Heartrak Smart ECAT to capture ECG data both before and after they experience a cardiac symptom. Heartrak Smart ECAT can capture and automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation.

Heartrak Smart ECAT can store up to 30 days of ECG data in its memory. The physician can use a compatible wireless device to set event recording times and autotriggering parameters and then upload them to a patient's monitor.

Using wireless technology, Heartrak Smart ECAT, when placed within range (less than 10 meters) of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.

The physician is to instruct the patient on the proper use and care of the Heartrak Smart ECAT monitor. Patients should be told to contact their physician if they have any further questions.

This document describes a 510(k) premarket notification for the "Heartrak Smart ECAT" cardiac event recorder. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a de novo clinical study with specific acceptance criteria and performance results in the format requested.

Therefore, the information required to fully answer the request (acceptance criteria, specific study results for the device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not explicitly provided in this 510(k) summary.

510(k) submissions typically focus on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device (predicate device) in terms of intended use, indications for use, technological characteristics, and safety and effectiveness. They often rely on bench testing, comparison to predicate devices, and sometimes non-clinical performance data rather than extensive human clinical trials with predefined acceptance criteria for AI algorithms.

However, based on the provided text, I can extract information related to the device and its intended function, and highlight what is not present:

Device Description and Intended Use:

The Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. It registers symptomatic and asymptomatic cardiac events (manual or auto-triggered) and uploads recorded ECG data to a receiver for review and analysis by a physician.

The document indicates that the device has "embedded arrhythmia detection algorithms" capable of auto-triggering for events like Bradycardia, Tachycardia, and Atrial Fibrillation. This suggests an AI-like component or automated analysis, but details on its performance are not given as "acceptance criteria" and "reported performance" in the requested tabular format.

Here's an attempt to answer the request based only on the provided text, with clear indications of what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • The document mentions data can be "reviewed and analyzed at a physician's office, clinic, or monitoring center," implying expert review as part of the intended use, but not for establishing ground truth in a clinical study context for the device's algorithms.

4. Adjudication method for the test set (e.g., 2+1, 3+1, none)

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned or indicated.
  • This type of study is not typically a requirement for 510(k) clearance based on substantial equivalence.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: Not explicitly described.
  • While the device has "embedded arrhythmia detection algorithms," the document does not detail a standalone performance study of these algorithms with metrics like sensitivity and specificity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not specified for any internal validation of the "embedded arrhythmia detection algorithms."
  • The device's output (recorded ECG waveform and ECG parameter data) is intended for "review and analysis at a physician's office, clinic, or monitoring center," which implies human expert interpretation as part of the clinical workflow, but not as the ground truth for evaluating the device's internal algorithms in a study.

8. The sample size for the training set

• Sample Size (Training Set): Not specified.
  • Information on a "training set" would typically be relevant if the device involved a machine learning algorithm explicitly described as such, and if a detailed performance study was conducted. This 510(k) summary is for a device with "embedded arrhythmia detection algorithms" but does not delve into the specifics of their development or internal validation datasets.

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): Not specified.

Summary of Missing Information:

This 510(k) submission primarily focuses on demonstrating substantial equivalence of the Heartrak Smart ECAT to predicate devices (Heartrak Smart AF and CG-6108 Arrhythmia ECG Event Recorder) based on functional and technological characteristics (e.g., 3-lead patient cable, continuous monitoring, RF data transmission, auto-triggering for Bradycardia, Tachycardia, Atrial Fibrillation). It does not provide the detailed performance metrics, study designs, sample sizes, or specifics regarding ground truth and expert adjudication that would be expected for a comprehensive evaluation of an AI/algorithm's acceptance criteria and performance as requested.

Ask a specific question about this device

Heartrak Smart AF is a hand-held, portable, externally applied, cardiac event recorder that is intended for transtelephonic use. Patient calls a receiving center at the hospital or physician's office from the patient's home to play back the recording. Heartrak Smart AF converts electrocardiogram (ECG) signals into audio tones which are transmitted over the telephone lines.

Heartrak Smart AF does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.

Heartrak Smart AF is a hand-held, portable, externally applied transtelephonic cardiac event recorder device, which is intended for transtelephonic use.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The document (K071130) describes the Heartrak Smart AF device, a transtelephonic cardiac event recorder with an added module for Atrial Fibrillation (AFib) detection.

Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, it indicates that the device's performance was evaluated against established standards and protocols. The core implicit acceptance criterion is that the AFib detection module, when added to the existing device, performs according to these standards, and that there are no new issues of safety or effectiveness compared to the predicate device.

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document mentions "available annotated MIT-BIH AFIB database and MIT-BIH Arrhythmia database (Series 100 and Series 200)". The exact number of recordings or patients from these databases used in the test set is not specified in the provided text.
   • Data Provenance: The MIT-BIH databases are widely recognized, publicly available databases of physiological recordings. They are derived from various sources, typically from multiple medical centers, and thus generally represent data from different countries (primarily the US for the MIT-BIH databases). The document does not specify the country of origin. The data is retrospective, as it refers to existing and curated databases.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document states that the databases used are "annotated". This implies that expert review was performed during the creation of these databases to establish ground truth. However, the number of experts or their specific qualifications for the annotation of the MIT-BIH databases are not detailed in this submission.

3. Adjudication method for the test set:

   • The document does not describe the adjudication method specifically for the Heartrak Smart AF's use of the databases. The "annotation" of the MIT-BIH databases typically involves expert review, but the specific adjudication protocol (e.g., 2+1, 3+1) used during their original creation is not mentioned here.

4. 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, an MRMC comparative effectiveness study was not done. The Heartrak Smart AF is described as a device that converts ECG signals to audio tones for transmission. It "is not a diagnostic tool and performs no diagnostic functions," and the new AFib module is part of the internal firmware. The evaluation was a standalone algorithmic performance against a database, not an assessment of human reader improvement with AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone algorithmic performance study was done. The text explicitly states, "The atrial fibrillation detection module was tested, using available annotated MIT-BIH AFIB database and MIT-BIH Arrhythmia database (Series 100 and Series 200)... to derive performance statistics for Heart Smart AF." This indicates direct evaluation of the algorithm against existing ground truth data.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The ground truth was established by expert consensus/annotation during the creation of the MIT-BIH AFIB and Arrhythmia databases. The term "annotated ECG databases" directly refers to expert-labeled data.

7. The sample size for the training set:

   • The document does not specify the sample size for the training set. It only mentions testing the AFib detection module. It is possible that the module was developed and possibly trained using parts of these same (or similar) public databases, but this is not explicitly stated, nor is the size of any training set.

8. How the ground truth for the training set was established:

   • Since the training set size and its specific source are not mentioned, how its ground truth was established is not provided in the document. If components of the MIT-BIH databases were used for training, their ground truth would also be expert annotation.

Ask a specific question about this device

Used as a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope and syncope events.

Heartrak Smart AT/ Heartrak Smart ² is a patient-activated transtelephonic ECG loop memory monitor which records cardiac patients' symptoms. The patient calls the receiving center, hospital or physician's office from the patient's home. Heartrak Smart AT/Heartrak Smart² converts signals into audio tones which are transmitted over telephone lines. Heartrak Smart AT/Heartrak Smart" is a hand held, portable, externally applied device which is intended for transtelephonic use. Heartrak Smart AT/Heartrak Smart² does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AT/Heartrak Smart² is not a diagnostic tool and performs no diagnostic functions.

The provided text is a 510(k) summary for the Heartrak Smart AT/Heartrak Smart2 device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding an acceptance criteria table, detailed study design, sample sizes, expert qualifications, and specific performance results like sensitivity, specificity, or MRMC outcomes is not present in the provided document.

Instead, the document highlights:

• Predicate Device: Heartrak XL (K960499)
• Basis for Substantial Equivalence: Identical intended use, materials, packaging, labeling, method of operation, and manufacturing methods as the predicate device. It also states that the safety and effectiveness are substantially equivalent, and the technological characteristics are equivalent to the predicate and other event recorders.
• Intended Use: As a supplement to Holter Monitoring to document infrequent/transient symptoms such as lightheadedness, chest discomfort, palpitations, pre-syncope, and syncope events.
• Device Function: Patient-activated transtelephonic ECG loop memory monitor which converts signals into audio tones for transmission over telephone lines. It explicitly states it is not a diagnostic tool and performs no diagnostic functions.

In summary, this 510(k) relies on demonstrating similarity to an already approved device rather than providing a new clinical study with the detailed performance metrics requested. Consequently, sections like "Acceptance Criteria," "Reported Device Performance," "Sample Size for Test Set," "Number of Experts," "Adjudication Method," "MRMC Study," "Standalone Performance," "Type of Ground Truth," and "Training Set Information" cannot be filled from the given text.

Ask a specific question about this device

Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices. It is intended that the Cardiostation will be used by physicians and cardiac laboratories supervised by physicians.

Cardiostation is a transtelephonic cardiac monitoring station intended to provide the reception and evaluation of the ECG signal, transmitted via standard telephone lines, using commercially available transtelephonic cardiac monitoring devices.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, or study details. This document appears to be an FDA 510(k) clearance letter for a device called "Cardiostation," primarily focusing on its substantial equivalence to a predicate device and its indications for use. It does not include a study report or performance data.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device