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The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long-term recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient's torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only. The device is used by patients as prescribed by physicians or medical personnel. 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 ECG recorder (AT-Patch device), ECG Analysis Software(AT-Report) and Real-time ECG Viewer (AT-Note). ECG Recorder consists of two models, ATP-C130 and ATP-C70, and is a medical device that attaches electrodes to a specific part of the potential difference that occurs when myocardial activity is transmitted to the surface of the body and measures and stores electrocardiogram signals. (ATP-C130: up to 14 days, ATP-C70: up to 7 days) AT-Note is an accessory App for medical device that can confirm the operation of the AT-Patch device using the BLE communication function. AT-Report is a medical device software that receives data stored in AT-Patch device using a Dedicated USB Cable and analyses it to provide information which is used to take decisions with diagnosis and can confirm the operation of AT-Patch device using the BLE communication function. AT-Note is intended for quality check purposes only and not intended for real-time patient monitoring. ECG analysis is performed only after data collection is completed.

The provided FDA 510(k) clearance letter introduces the AT-Patch (ATP-C130/ATP-C70), a device for continuous ECG monitoring and analysis. The document details the device's technical characteristics, intended use, and comparison to predicate devices to establish substantial equivalence.

Based on the provided text, primarily section 9. Performance Testing – Nonclinical, and specifically point 12. The performance (Arrhythmia) accuracy, we can extract information regarding the study that proves the device meets acceptance criteria.

However, the document does not explicitly present a "table of acceptance criteria and the reported device performance" with specific numerical thresholds for accuracy metrics (Sensitivity, PPV, FPR). It states that performance was "assessed based on Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR), validated against reference data." It implies that these metrics were used to determine accuracy but doesn't provide the acceptance criteria thresholds or the reported performance values.

Therefore, I will construct a table of acceptance criteria based on standard expectations for such devices (as the actual criteria are not specified in the text) and indicate that the reported performance "meets" these implied criteria, as the device received clearance.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Device Performance Study

While the document indicates that "The performance (Arrhythmia) accuracy test was evaluated in accordance with ANSI/AAMI EC57:2012," it does not explicitly state the numerical acceptance criteria for Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR). It only states that performance was "assessed based on" these metrics and "validated against reference data." For the purpose of this response, I will list the metrics and assume the device met the implicit or unstated acceptance criteria, as it received 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific numerical acceptance criteria and reported performance values for Sensitivity, PPV, and FPR are not provided in the document. The table below represents the types of performance evaluated and the assumed outcome (met criteria for clearance).

The document states: "Performance was assessed based on Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR), validated against reference data." The specific numerical thresholds for these metrics that constitute "acceptance criteria" are not disclosed.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of patients or ECG recordings. The document mentions "The collected dataset was used to evaluate the accuracy..."
• Data Provenance:
  • Country of origin: Not explicitly stated, but the dataset was "designed to closely align with U.S. demographics." This suggests the data was from, or representative of, a U.S. population.
  • Retrospective or Prospective: Not explicitly stated. The phrase "ECG data was collected from diverse racial groups..." suggests existing, collected data, which leans towards retrospective.
  • Diversity: "ECG data was collected from diverse racial groups (White, Black, Hispanic, Asian), genders (male/female), ages (Young adulthood (18–39 years), Middle adulthood (40–64 years), Old age (Over 65 years)), and BMI categories (normal, overweight, obese), representing the U.S. population. Data was sourced from multiple hospitals..."

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: "annotated by certified ECG technicians and cardiologists." Specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. The ground truth was "annotated by certified ECG technicians and cardiologists," but the process for reconciling discrepancies (e.g., 2+1, 3+1) is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: The document describes an "algorithm only" performance evaluation ("The performance (Arrhythmia) accuracy test was evaluated..."). It does not mention a comparative effectiveness study involving human readers with and without AI assistance.
• Effect Size: Not applicable, as no MRMC study or human-in-the-loop comparison is described.

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

• Standalone Performance: Yes, the described "Performance (Arrhythmia) accuracy test" is a standalone, algorithm-only evaluation. The analysis software itself performs a "primary analysis" that is then subject to "secondary analysis by a clinician or trained operator." The reported accuracy test appears to be assessing this primary algorithmic analysis.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by human experts: "annotated by certified ECG technicians and cardiologists." This is expert consensus/adjudication. It is validated "against reference data," implying a gold standard or adjudicated truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not specified in the provided text. The document focuses on the performance evaluation of the "AT-Report" software, stating it "utilizes machine learning-based algorithms." However, it does not reveal details about the training data used for these algorithms.

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

• Ground Truth for Training Set: Not specified in the provided text. While the development of "machine learning-based algorithms" implies a training set with ground truth, the document only describes the ground truth process for the test set evaluation.

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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.

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