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The ActiTrainer is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The ActiTrainer is housed in a polycarbonate plastic housing. It is 8.5 cm long by 3.4 cm wide by 1.6 cm thick and it weights 51 grams. It also has an optional Polar heart strap. Data is downloaded into a PC via a USB plug and the data is displayed with ActiGraph LLC's ActiLife software.

This document describes the ActiTrainer, an activity monitor, and its substantial equivalence to a predicate device, the Actigraph. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria with numerical performance values for parameters like sensitivity, specificity, accuracy, or other commonly used metrics in medical device studies.

Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, which is a common pathway for 510(k) clearance.

Therefore, many of the requested sections regarding acceptance criteria and performance study details cannot be fully answered from the provided text.

Here is an attempt to answer based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, the "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics. The performance is assessed by comparing the ActiTrainer's specifications to those of the Actigraph (K040554).

Study Details (as much as can be inferred from the document):

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 does not describe a "test set" in the context of a performance study with human subjects or a dataset for algorithm validation. The comparison is based on the specifications of the new device (ActiTrainer) against the specifications of the predicate device (Actigraph). This is a technical comparison, not a clinical trial or algorithm validation study. Therefore, there is no sample size for a test set or data provenance in the traditional sense.

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 is not applicable as there was no "test set" requiring ground truth establishment by experts for performance evaluation. The ground truth for proving substantial equivalence lies in the technical specifications and intended uses being comparable.

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

Not applicable, as no test set was described that would require adjudication.

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. The ActiTrainer is an activity monitor, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

This refers to the device's inherent function. The ActiTrainer operates as an algorithm-only device (it records and processes physical movement data without continuous human intervention during data collection). The "study" presented is a comparison of its technical specifications to a predicate, not an evaluation of its standalone performance in a clinical setting with numerical outcomes.

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

For the purpose of 510(k) clearance in this context, the "ground truth" is primarily the established technical specifications and intended use of the legally marketed predicate device (Actigraph K040554). The ActiTrainer's specifications and intended use are compared against these predicate "truths" to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This document describes a 510(k) submission for a physical activity monitor, not an AI/machine learning algorithm that requires a "training set."

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

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

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