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The Del Mar Avionics Models 471/472 Sentinel Recorders are ambulatory Electrocardlographic (ECG) recorders intended to acquire multiple brief episodes of ECG Information. Acquisition of ECG information is initiated by the patient, normally in response to encountered symptoms. The Model 471 Sentinel Recorder acquires a single channel of FCG. The Model 472 Sentinel Recorder acquires one or two channels of ECG. The Models 471 and 472 Sentinel Recorders are intended to be used as an ECG Cardiac Monitoring Instrument.

Models 471/472 Sentinel ™ Recorders

The provided document is a 510(k) premarket notification letter from the FDA to Del Mar Avionics regarding their Models 471/472 Sentinel Solid-State Event/Loop Recorders. This type of document declares substantial equivalence to a predicate device, which means a comprehensive study with acceptance criteria, human reader comparisons, and detailed ground truth establishment as you've requested is typically not included in the submission or the FDA's response.

A 510(k) submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical trials with specific acceptance criteria as you've described for AI/ML devices.

Therefore, based solely on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria, study design, expert qualifications, or AI-specific performance metrics. These details are not part of a standard 510(k) clearance letter.

However, I can extract some limited information:

Indications for Use (from the document):

The Del Mar Avionics Models 471/472 Sentinel Recorders are ambulatory Electrocardiographic (ECG) recorders intended to acquire multiple brief episodes of ECG Information. Acquisition of ECG information is initiated by the patient, normally in response to encountered symptoms.

• The Model 471 Sentinel Recorder acquires a single channel of ECG.
• The Model 472 Sentinel Recorder acquires one or two channels of ECG.
• The Models 471 and 472 Sentinel Recorders are intended to be used as an ECG Cardiac Monitoring Instrument.
• The Models 471 and 472 Sentinel Recorders are not suitable for monitoring infants weighing less than 22 pounds (10 kg).

Here's a breakdown of what can and cannot be answered from the provided text:

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

• Cannot be provided. The document states the device is "substantially equivalent" to predicate devices. It does not contain specific performance metrics or acceptance criteria for a new clinical study.

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

• Cannot be provided. The document does not describe test sets, sample sizes, or data provenance. This information would be relevant for a de novo marketing application or a clinical trial, but not typically for a 510(k) clearance where substantial equivalence is demonstrated.

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)

• Cannot be provided. Ground truth establishment, expert review, and qualifications are not mentioned as this relates to a clinical study proving performance, which is not detailed here.

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

• Cannot be provided. No adjudication method is described because no specific test set or study results are presented.

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

• Cannot be provided. This is a clearance letter for a 1997 medical device. AI assistance and MRMC studies in the context of AI are not applicable to the technology or regulatory process described here.

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

• Cannot be provided. The device described (event/loop recorder) is a hardware device for acquiring ECG information, not an algorithm for diagnosis or interpretation in the way AI/ML devices typically function. Therefore, "standalone algorithm" performance as you describe is not relevant.

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

• Cannot be provided. No ground truth is detailed for performance assessment, as the clearance is based on substantial equivalence, not a new clinical validation study in the traditional sense.

8. The sample size for the training set

• Cannot be provided. This document is from 1997. The device described is an ECG recorder, not an AI/ML system that would have a "training set" in the modern sense.

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

• Cannot be provided. As above, the concept of a "training set" and associated ground truth establishment is not applicable to the context of this 1997 device clearance.

In summary: The provided FDA 510(k) clearance letter indicates that the device (Models 471/472 Sentinel Solid-State Event/Loop Recorders) was found substantially equivalent to a predicate device. This regulatory pathway means that the manufacturer did not need to conduct extensive new clinical trials with clearly defined acceptance criteria, performance metrics, and detailed study designs as might be required for a novel device or an AI/ML product today. The fundamental assumption is that if it's equivalent to an already approved device, it meets the necessary safety and effectiveness standards.

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