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The Reynolds Lifecard CF 7-Day Holter recorder is a modification of the Reynolds Lifecard CF Holter Recorder, K001025. It is indicated when it is desired to record the patient's ambulatory electrocardiogram. It is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days.

The device is a portable Holter recorder designed to record the patient's ambulatory electrocardiogram for up to seven days (with the appropriate flashcard and battery). The unit uses a data compression system to store seven days of ECG data in extended mode. In "standard" mode (up to two days of recording) the unit is identical to the predicate device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reynolds Medical Ltd. Lifecard CF 7-Day Holter Recorder:

Based on the provided text, the device is explicitly stated to not have clinical testing requirements, as it is considered substantially equivalent to a predicate device. Therefore, many of the requested categories related to clinical study design and performance metrics against ground truth are not applicable or cannot be extracted from this document.

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

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

• Not Applicable. The document explicitly states "Clinical tests: None required." The performance data section focuses on non-clinical tests and equivalence to a predicate device, not clinical performance against a test set.

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)

• Not Applicable. As no clinical tests were required or performed, there was no test set requiring ground truth established by experts.

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

• Not Applicable. No clinical test set.

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

• Not Applicable. This device is a Holter recorder and explicitly states it "does no analysis." It is not an AI-assisted diagnostic tool, and no MRMC study was performed.

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

• Not Applicable. The device performs no analysis. Its function is data recording. The "compression algorithm has been separately tested," which is a standalone evaluation of that specific component, but not in the context of an overall diagnostic algorithm's performance against clinical ground truth.

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

• Not Applicable for clinical performance. For the non-clinical tests (AAMI EC38, IEC 601-1, IEC 601-1-2), the "ground truth" would be the specifications and requirements defined within those standards, which are typically measured against calibrated instruments and known electrical signals, not clinical outcomes or expert consensus. The software validation and compression algorithm tests would rely on their own internal verification and validation criteria, which would involve comparing outputs to expected results for known inputs.

8. The sample size for the training set

• Not Applicable. This document does not describe a machine learning or deep learning model that would require a "training set" in the conventional sense for clinical performance. The software and compression algorithm validation would involve internal test data, but not a "training set" like in AI/ML applications.

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

• Not Applicable. No training set for a clinical algorithm.

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