(266 days)
The AfibAlert™ is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
The AfibAlert™ is a cardiac event recorder capable of storing five 45-second events in solid-state non-volatile memory. AfibAlert™ allows patients who have been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to take periodic readings with a computerized rhythm monitor. The system was developed for the patient that has been previously diagnosed with AF, has a history of heart bypass, ablation, or other cardiac abnormality, or is on heart (anti-arrhythmic) medication. In these cases, detecting and determining AF early can potentially reduce the risk of heart attack and stroke.
The device can record a single channel of ECG data in three ways: (1) via the two thumb electrodes, (2) by placement on the chest, or (3) by applying wrist electrodes. In each case, the patient initiates the recording. The recording takes approximately 45 seconds. Immediately following data acquisition, an internal AF algorithm is used to analyze the patient's rhythm. The appropriate LED (light emitting diode) is illuminated to indicate the presence or absence of AF.
If AF is indicated, or concerning symptoms are present, the patient makes a telephone call to a service provider as specified by their physician and transmits the ECG data to the receiving personnel. Data can also be transferred by using a computer.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
The provided document (K052767) is a 510(k) summary for the AfibAlert™ Atrial Fibrillation Detector. It does not contain a detailed study report with specific acceptance criteria, performance metrics, sample sizes, or ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
What is Available in the Document:
- Intended Use: The AfibAlert™ is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
- Device Description: It records single-channel ECG data and uses an internal AF algorithm to analyze the rhythm, indicating its presence or absence via an LED.
- Predicate Devices: The King of Hearts Express AF (K020825), the CG-2211 SelfCheck ECG Transmitter (K012223), and The HeartCard (K010945).
- Functional and Safety Testing: "Electrical, mechanical, and software testing was conducted and data was collected in accordance with applicable standards to ensure that the device performs according to specifications and to verify that the device is suitable for home use."
What is Not Explicitly Stated or Detailed in the Document (and therefore cannot be provided in the table/answers based only on this text):
- Specific, quantified acceptance criteria for AF detection performance (e.g., sensitivity, specificity, accuracy).
- Reported device performance values against such criteria.
- The specifics of any clinical or performance study conducted to evaluate the AF detection algorithm.
- Detailed information about the test set (sample size, data provenance).
- Details about ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
- Information on MRMC studies or standalone algorithm performance.
- Sample size and ground truth methods for a training set.
Based on the provided K052767 document, here is what can be inferred or directly stated regarding acceptance criteria and the study:
The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with explicit acceptance criteria for the device's diagnostic performance. The statement "Electrical, mechanical, and software testing was conducted and data was collected in accordance with applicable standards to ensure that the device performs according to specifications" suggests that the acceptance criteria were likely related to meeting the performance characteristics and safety standards similar to the predicate devices. However, the specific quantitative acceptance criteria for the AF detection performance (e.g., sensitivity, specificity thresholds) are not defined in this summary.
Therefore, the table below reflects what could be derived from the document, acknowledging significant gaps due to the nature of a 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided 510(k) summary (K052767) does not explicitly state specific quantitative acceptance criteria for the AfibAlert™'s AF detection capabilities, nor does it provide detailed reported performance metrics (like sensitivity, specificity, or accuracy) from a clinical study. The document states "Electrical, mechanical, and software testing was conducted and data was collected in accordance with applicable standards to ensure that the device performs according to specifications." This implies that the device met its internal design specifications and relevant standards, which would have implicitly acted as acceptance criteria for its overall functionality and safety.
Given the information, the acceptance criteria would revolve around:
| Acceptance Criterion (Inferred) | Reported Device Performance (Not explicitly quantified in K052767) |
|---|---|
| Functional Equivalence: Ability to record ECG data and provide an analysis for the presence or absence of Atrial Fibrillation. | Demonstrated via "similarities in functional design, method of use for self-monitoring, and indications for use" to predicate devices. The device "uses an internal AF algorithm... to indicate the presence or absence of AF." No specific performance metrics (e.g., sensitivity, specificity) for the AF algorithm itself are provided in this summary. However, the FDA's clearance indicates that the performance was deemed acceptable for its intended use as substantially equivalent to predicate devices, which would have had their own validated performance. |
| Safety and Electrical Performance: Adherence to applicable electrical, mechanical, and software standards. | "Electrical, mechanical, and software testing was conducted and data was collected in accordance with applicable standards to ensure that the device performs according to specifications and to verify that the device is suitable for home use." (No specific test results or standards cited). |
| Predicate Device Performance Equivalence: AF detection performance is at least equivalent to the predicate devices. | The conclusion states "Lechnologies Research Inc. considers the AfibAlert™ Atrial Fibrillation Detector to be equivalent to the predicate devices listed above. This conclusion is based upon the devices` similarities in functional design, method of use for self-monitoring, and indications for use." This implicitly suggests the performance of the AF algorithm would be comparable. The 510(k) process relies on this substantial equivalence demonstration. |
2. Sample size used for the test set and the data provenance
The K052767 document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance study of the AF algorithm. The summary focuses on functional and safety testing rather than a detailed clinical performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The K052767 document does not provide this information. It does not detail how the ground truth for any AF detection performance evaluation was established.
4. Adjudication method for the test set
The K052767 document does not provide this information.
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
The K052767 document does not describe or refer to an MRMC comparative effectiveness study. The device is intended for self-testing and provides an "Afib indicated" or "Afib not indicated" LED output to the patient, who then contacts a service provider if needed. It's not designed to assist expert human readers in interpreting ECGs.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device incorporates an "internal AF algorithm" that "immediately following data acquisition... is used to analyze the patient's rhythm." This implies a standalone algorithm performance is central to its function. However, the K052767 document does not present the results of a standalone performance study (e.g., sensitivity, specificity of the algorithm).
7. The type of ground truth used
The K052767 document does not explicitly state the type of ground truth used for validating the AF detection algorithm's performance. In such devices, common ground truths would typically involve expert cardiologist review of ECGs, potentially coupled with clinical outcomes or other diagnostic tests.
8. The sample size for the training set
The K052767 document does not provide this information. It does not mention any details about the development or training of the AF algorithm.
9. How the ground truth for the training set was established
The K052767 document does not provide this information.
§ 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).