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The intended use of the Chroma Holter Recorder RZ153C is to perform ambulatory ECG on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording.

The basic operation of the Chroma Holter Recorder RZ153C is to collect and store multiple channels of ECG data. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.

The provided text describes a 510(k) premarket notification for the ScottCare Chroma Holter Recorder RZ153C, comparing it to a predicate device, the DXP1000 Holter Recorder. However, the document does not contain specific acceptance criteria, quantitative performance metrics, or detailed study methodology in the way that would typically be presented for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through feature comparison and qualitative outcome of testing.

Here's an analysis based on the information provided, addressing your specific questions to the best of my ability with the given text:

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

The document does not explicitly state quantitative acceptance criteria or performance metrics for the Chroma Holter Recorder RZ153C's functionality. The evaluation is based on demonstrating "substantial equivalence" to the DXP1000 Holter Recorder via comparison of features and functional outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "The Chroma Holter recorder RZ153C was tested alongside the DXP1000 Holter recorder in a number of situations, including simulated normal ECG signals, simulated paced ECG signals, and on-person ECG signals in laboratory tests."

• Sample Size: Not specified. The phrase "a number of situations" implies multiple tests but no specific count of patients, simulated signals, or recording durations.
• Data Provenance: Not specified. It mentions "laboratory tests" and "on-person ECG signals," implying some form of prospective data collection during testing, but details on location or patient demographics are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a Holter recorder, which collects and stores ECG data; it does not perform diagnosis or interpretation itself (as stated: "This recorder is not capable of any diagnosis nor can it provide any interpretation of the data."). The "Holter for Windows software" is mentioned as reading and providing the ability to review, edit, and print the collected data. Therefore, the concept of "ground truth established by experts" for the device's output (raw ECG data) is not applicable here in the same way it would be for an AI/CADe diagnostic device. The ground truth for its performance would be the accurate capture and storage of ECG signals, which was compared against a predicate device. No details on expert involvement for ground truth establishment for the test set are provided.

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

Not applicable, as this is a device that records physiological signals, not an interpretive AI system requiring adjudication of diagnostic outputs. The evaluation focused on the similarity of recorded data between the new device and the predicate.

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 such study was conducted or reported. This device is a data acquisition tool, not an AI/CADe system designed to improve human reading performance.

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

The device is a standalone Holter recorder. Its performance was assessed in "laboratory tests" by comparing its recorded output with that of a predicate device against "simulated normal ECG signals, simulated paced ECG signals, and on-person ECG signals." The assessment was qualitative ("produced results very similar").

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

The "ground truth" implicitly used for the recorder's function would be the known characteristics of the "simulated normal ECG signals" and "simulated paced ECG signals," and the actual cardiac activity of the individuals providing "on-person ECG signals." The assessment compared the device's recorded output against the known inputs or the output of a trusted predicate device, rather than against an expert-adjudicated diagnostic label.

8. The sample size for the training set

This device does not use an "AI algorithm" or machine learning in the sense that would require a dedicated training set. It is a hardware device for recording physiological signals. Therefore, the concept of a "training set" is not applicable.

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

Not applicable, as there is no training set for an AI algorithm.

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The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.

Ambulatory (Holter) ECG intended use:

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
3. Evaluation of patients for ST segment changes.
4. Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or cardiac surgery.)
5. Clinical and epidemiological research studies.
6. Evaluation of patients with pacemakers
7. Reporting of time and frequency domain heart rate variability
8. Reporting of QT Interval

The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).

The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.

The provided text describes a 510(k) submission for the DXP1000 Holter Recorder, focusing on modifications and demonstrating substantial equivalence to a predicate device (Biosensor Model #1005).

Here's an analysis of the acceptance criteria and the study information available in the provided text:

Acceptance Criteria and Reported Device Performance

Note: The primary focus of the modification and validation was the "pacemaker detection logic." The other attributes in the table represent direct comparisons of specifications between the modified device and the predicate.

Study Information

The provided text offers very limited details about the actual study conducted to validate the modified pacemaker detection logic. Here's what can be inferred:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample size: Not specified.
   • Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Number of experts: Not specified.
   • Qualifications of experts: Not specified.

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

   • Not specified.

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 document explicitly states that "ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956)." This indicates the DXP1000 is a recorder only, and any AI/analysis component would be in separate software. Therefore, there's no mention of human readers or AI assistance effect sizes for this specific device.

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

   • Yes, a standalone validation of the "pacemaker detection logic" was performed. The text states, "the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein." This validation pertains to the device's inherent capability to detect pacemakers.

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

   • Not explicitly stated. Given it's pacemaker detection, the ground truth would likely involve expert review of ECG traces or potentially verified pacemaker presence/absence records coupled with ECG data where pacemaker spikes are either known to be present or absent.

7. The sample size for the training set:

   • Not specified. The document focuses on validation of a modified logic, implying existing development, but does not detail a training set for a new AI model.

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

   • Not specified. Assuming any "training" (if applicable, perhaps during the initial development of the pacemaker detection logic in the predicate device or an earlier iteration) involved expert review of annotated ECG waveforms.

In summary: The provided text is a 510(k) summary for a modified Holter recorder. It focuses on physical changes to the device and a slight modification to the pacemaker detection logic. While it states this logic was "validated," it provides minimal details regarding the methodology, sample sizes, ground truth establishment, or expert involvement in that validation study. The document explicitly differentiates this recorder from the ECG analysis software, which would be subject to separate review and where more detailed performance studies for algorithms might be expected.

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