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The Medilog FD4 Hoher monitor is intended to be used in the diagnosis of various cardiac disorders by the recording of ECG in an ambulatory mode. These disorders principally include cardiac arrhythmia's and myocardial ischeamia.

The ECG data is used by the physician as an aid in the diagnosis of the patients condition. In some circumstances the patient may be hospitalised as part of the medical evaluation and Holter monitoring may be performed in conjunction with other non-invasive or invasive procedures. In such cases there is no interaction between the FD4 and other equipment.

Decer poton it looks like an MR63. The difference being the analogue cassette mechanism has been replaced with a digital acquisition module containing a slot for a PCMCIA Flash ATA card.

The patient is connected to the FD4 via disposable electrodes attached to the chest. These detect the electrical signals generated by the heart, which are then transferred to the recorder via the electrode leads and patient cable. In the recorder, these signals are amplified, filtered, digitised and compressed without loss before being stored on a removable PCMCIA Flash ATA card. At the completion of recording the flash memory card is removed and the recorded ECG data is replayed and analysed on the Oxford Instruments ECG Analysis System.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: A total of 29 recordings. 17 of these were performed in tandem with the predicate device (MR63).
• Data Provenance: The data came from a variety of sources:
  • A programmable simulator (giving "researchiseble" EKGs - likely representative samples)
  • An EKG generator (providing real patient data from a database of recordings - likely retrospective, but no specific country of origin is mentioned)
  • Human volunteers (prospective data, but no specific country of origin is mentioned)

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

• Number of Experts: The document states "Successful review by Oxford Instruments clinical specialist." This implies at least one clinical specialist was involved.
• Qualifications of Experts: The qualification provided is "clinical specialist" at Oxford Instruments. Further specifics (e.g., years of experience, specific medical specialty like cardiology or electrophysiology) are not provided.

4. Adjudication Method for the Test Set

• The document mentions "Successful review by Oxford Instruments clinical specialist." This suggests a single expert review. There is no indication of an adjudication method involving multiple experts (e.g., 2+1, 3+1). It appears to be a single-reader review based on the stated acceptance criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
• The study compared the FD4 device's performance to its predicate device (MR63), but this was a technical/signal comparison, not a human reader performance study. The FD4 is a data acquisition device, not an AI interpretation system.

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

• This device (Medilog FD4) is a Holter monitor designed for recording ECGs, not for automated interpretation or diagnosis. It records and stores data for later analysis by a physician using a separate "Oxford Instruments ECG Analysis System" (Medilog Optima & Excel 2).
• Therefore, the concept of "standalone algorithm performance" as typically applied to AI-based diagnostic devices does not directly apply to the FD4. The performance testing focuses on the quality of the recorded signal and its comparability to the predicate device.

7. The Type of Ground Truth Used

• The ground truth for the trial results was based on several metrics:
  • Technical/Operational Criteria: Intended recording duration, successful download, signal quality/gain comparability with predicate, absence of recording/replay problems.
  • Clinical Relevance: Detection of patient events, heart rate variability monitored and logged for comparison.
  • Expert Review: Successful review by an Oxford Instruments clinical specialist.
• Given the nature of the device (a recorder), the "ground truth" is less about a definitive medical diagnosis and more about the fidelity and completeness of the ECG data captured and reviewed by an expert. It's a combination of objective technical performance and subjective expert assessment of data utility.

8. The Sample Size for the Training Set

• The document does not mention a training set for the FD4 device. This is because the FD4 is a hardware device for acquiring data, not a machine learning algorithm that requires training. The "Medilog Optima & Excel 2" analysis system might potentially incorporate algorithms, but the FD4 itself is a data acquisition unit.

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

• As no training set is mentioned for the FD4 device, this question is not applicable.

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