(150 days)
The Kardia Band System is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Kardia Band System also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician). The Kardia Band System is intended for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals.
The Kardia Band System is a trans-telephonic (transmission by telephone) ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes the computing power of the Apple, Inc. Apple Watch to obtain and analyze single-channel ECG. The Kardia Band System consists of the Kardia Band Hardware (watchband), the Kardia watch app software (installed on the Apple Watch), and the Kardia phone app software (installed on the Apple iPhone). The Kardia Band System transmits the ECG signal from its electrode to the Kardia watch app on the Apple Watch to be analyzed and presented to the user. All ECGs are synced with the user's account.
The provided text describes the Kardia Band System, an ECG device, and its substantial equivalence determination based on non-clinical and clinical testing. However, it does not explicitly state specific acceptance criteria or provide a detailed study that proves the device meets specific performance criteria.
It primarily asserts "very strong mathematical correlation and qualitative clinical equivalence" to a predicate device (Kardia Mobile K142743) and that the clinical study was "sufficient to draw a conclusion of substantial equivalence based on meeting qualitative and quantitative acceptance criteria."
Therefore, based only on the provided text, I cannot provide a detailed answer to all your questions because much of the requested information (like specific numerical acceptance criteria, detailed performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment specifics for the clinical study) is not present.
However, I can extract the information that is implicitly or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The text states, "The study is sufficient to draw a conclusion of substantial equivalence based on meeting qualitative and quantitative acceptance criteria." It also mentions "generates rhythm strip data that meets the clinical quality requirements for accurate cardiac rhythm diagnosis" and "very strong mathematical correlation and qualitative clinical equivalence" to the predicate device. However, the specific numerical values or defined qualitative benchmarks for these criteria are not provided.
- Reported Device Performance: The text generally asserts that the device meets the unspecified "clinical quality requirements" and shows "very strong mathematical correlation and qualitative clinical equivalence" to the predicate. No specific performance metrics (e.g., sensitivity, specificity, accuracy for AF detection) are given in the provided document for the Kardia Band System itself.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: Not explicitly stated. (e.g., country of origin, retrospective/prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication method for the test set:
- Adjudication Method: Not explicitly stated.
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 explicitly stated. The clinical testing section focuses on the device's ability to generate rhythm strip data meeting quality requirements and showing equivalence, rather than a comparative effectiveness study involving human readers with and without AI assistance. This device is described as detecting atrial fibrillation and normal sinus rhythm, suggesting an automated algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device's description of "detects the presence of atrial fibrillation and normal sinus rhythm" implies a standalone algorithmic performance component. The clinical testing likely evaluated this standalone performance, but the details are not explicitly stated.
7. The type of ground truth used:
- The text mentions the device "generates rhythm strip data that meets the clinical quality requirements for accurate cardiac rhythm diagnosis" and detects "atrial fibrillation and normal sinus rhythm." This strongly suggests the ground truth would be based on expert consensus interpretation of ECGs, likely by cardiologists, to establish the presence or absence of AF or normal sinus rhythm. However, this is an inference based on the device's function, not an explicit statement.
8. The sample size for the training set:
- Not explicitly stated.
9. How the ground truth for the training set was established:
- Not explicitly stated.
Summary of what is explicitly stated or strongly implied regarding the study:
- Study Type: Clinical performance testing was conducted.
- Purpose: To demonstrate that the Kardia Band System generates rhythm data meeting clinical quality requirements for accurate cardiac rhythm diagnosis and to show substantial equivalence to the predicate device (Kardia Mobile).
- Outcome: The study showed "very strong mathematical correlation and qualitative clinical equivalence" to the predicate device and was deemed sufficient to conclude substantial equivalence based on meeting unspecified "qualitative and quantitative acceptance criteria."
§ 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).