Search Results

The device is intended to measure, save, and view continuous electrocardiogram (ECG) information for long-term recording (up to 14 days) from ambulatory patients by attaching to the skin surface. ECG records are stored in the the device for review after the recording period (up to 14 days) is completed, and are not intended for for real-time monitoring. The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis. The device allows patient and clinicians to view the ECG signal recorded in real-time solely for the purpose of visual assessment of the recording quality; the ECG signal displayed in real time is not intended for any clinical or diagnostic use. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.

AT-Patch consists of 1) AT-Patch device, 2) Software for ECG viewing (ATR-C130), 3) App (ATN-C130) that communicates with the device and allows the patient to view the ECG waveform for visual assessment of the recording quality, and included parts (Dedicated Cable, BLE Dongle and USB memory). AT-Patch an ambulatory ECG recorder, designed to continuously acquire and store patient's ECG for up to 14 days. The AT-Patch can connect to the device applicaitn (ATN-C130) torecord symptoms with the App during operation and to check the ECG recording. The device is not intended for real-time monitoring.

The provided text does not contain detailed acceptance criteria for the device (AT-Patch) based on specific performance metrics, nor does it describe a study specifically designed to prove that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Zio SkyRunner (SR) ECG Monitoring service, K143513) through various tests and comparisons.

The document discusses performance testing in a general sense, confirming compliance with several standards, but it does not provide a table of acceptance criteria with reported device performance results.

Here's an analysis of what can be extracted from the provided text and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance:

• Not provided in the text. The document lists various standards (e.g., IEC 60601-1, ANSI/AAMI EC12) that the device was tested against and states that "The test results met the electrical safety and EMC requirements" and "The Test results met the performance requirements." However, it does not specify quantitative acceptance criteria or the measured performance values for specific device functions (e.g., accuracy of ECG measurement, signal-to-noise ratio).

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

• Not provided in the text. The document mentions various performance and safety tests but does not specify the sample size for any of these tests or the origin of any data used (e.g., number of patients, retrospective/prospective study design, country of origin).

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

• Not applicable/Not provided in the text. The AT-Patch device "does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis." Its primary function is to measure, save, and view ECG data for manual review. Therefore, there's no mention of establishing ground truth for automated detection algorithms, and consequently, no information about experts for this purpose.

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

• Not applicable/Not provided in the text. As there is no automated analysis requiring expert adjudication to establish ground truth for algorithm performance, this information is not present.

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, this was not done. The device "does not include automated ECG analysis functions" and "is not intended for automated analysis." Therefore, a comparative effectiveness study involving AI assistance for human readers is not relevant to this device's stated capabilities and was not performed.

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

• No, this was not done. The device explicitly states that "The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis." Thus, there is no standalone algorithm performance to evaluate.

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

• Not applicable/Not provided in the text. Since the device does not perform automated analysis, the concept of "ground truth" for algorithm performance evaluation, as it pertains to AI/CADe devices, is not relevant here. The tests performed are related to the physical and electrical performance of the ECG recorder itself (e.g., battery life, adhesion, electrical safety, EMC, biocompatibility).

8. The sample size for the training set:

• Not applicable/Not provided in the text. As there is no automated analysis or AI component, there is no training set mentioned or required.

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

• Not applicable/Not provided in the text. For the same reasons as above, this information is not relevant.

Summary of available information regarding criteria and studies:

The document focuses on:

• Safety and Performance Standards Compliance: The device underwent tests for electrical safety (IEC 60601-1, IEC 60601-2-47, IEC 60601-1-2, IEC 60601-1-11), biocompatibility (ISO 10993 series), software validation (IEC 62304), usability (IEC 62366-1), cybersecurity, battery life, patch adhesion persistence, and ECG electrode performance (ANSI/AAMI EC12:2000 (R2015)).
• Verification of Intended Use Period: "As a result of testing according to the internal criteria, it has been verified that this device can be use for up 14 days and satisfies the warranty period of 1 year." This indicates an internal test for battery life/recording duration.
• QoS (Quality of Service) testing: Performed according to ANSI TIR 69:2017.
• Defibrillation Safety: Tested using an alternative method of IEC 60601-1 Clause 8.5.5.2, demonstrating safety but not being defibrillation-proof.

The key takeaway is that the AT-Patch is an ECG recorder for manual review and does not incorporate automated analysis, which simplifies the regulatory requirements in terms of AI/CADe typical acceptance criteria and study designs for algorithmic performance. The studies and tests performed are primarily related to the physical, electrical, and data recording integrity and safety of the device, rather than the accuracy of an automated diagnostic or detection algorithm.

Ask a specific question about this device