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The EISCHO Intermittent compression Boot is intended for first aid treatment of minor sportrs injuries. It is intended to relieve minor aches and pains and to increase circulation in the patient's lower limbs. It simulates kneading and stroking of tissues by using an inflatable pressure cuff.

This device is an inflatable garment or boot that is intended for use on patients' lower limbs. It consists of two chambers. The upper chamber envelops the lower extremity and the lower chamber is located under the foot. The interior panel has been sealed onto the exterior panel. When pressure is applied to the lower chamber by the patient's foot, air moves from the lower chamber to the upper chamber through the air passageways shaded in blue. The boot is placed on the patient and then inflated by attaching a hand pump to the port at the top of the boot. The boot is then inflated by means of the patient placing pressure on the foot. At this point, the pressure in the upper chamber increases which causes a compression of the limb. When the patient lifts his/her foot, the air passes from the upper chamber to inflate the lower chamber, which causes the overall boot pressure to return to nominal pressure. The pressure may be applied while walking, standing, sitting or lying. The patient repeats this process until the therapy session is completed. To deflate the boot, the patient presses inward on the valve stem with his/her finger or uses the cap that is attached to the valve. The deflated boot is then easily removed.

The provided document is a 510(k) premarket notification for an Intermittent Compression Boot. It is a submission to the FDA seeking to demonstrate substantial equivalence to a predicate device, not a study reporting on the performance of the device against specific acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth establishment) are not applicable as this document does not describe such a study.

However, I can extract information related to the device's intended use which serves as the basis for its acceptance into the market by the FDA as "substantially equivalent."

Here's a breakdown based on the provided text, indicating where information is not applicable:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are implicitly the requirements for demonstrating substantial equivalence to a predicate device. The "performance" is demonstrated by showing that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The remaining information directly related to a "study" as implied by the questions is not present in this 510(k) document, which generally relies on pre-clinical data, literature review, and comparison to a legally marketed predicate, rather than a de novo clinical trial demonstrating performance against specific numerical acceptance criteria.

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

• N/A. This document does not describe a clinical study with a test set of patients/data. It is a regulatory submission for substantial equivalence.

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)

• N/A. Ground truth for a test set is not applicable as no such test set is described. The "ground truth" here is the prior FDA clearance of the predicate device.

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

• N/A. No test set or adjudication method is described.

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

• N/A. This device is a mechanical boot, not an AI or imaging device, and no MRMC study or human reader assistance is relevant or described.

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

• N/A. This is a mechanical device, not an algorithm.

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

• N/A in the context of a "study." For the purpose of the 510(k), the "ground truth" or standard for comparison is the legally marketed predicate device (EISCHO, Inc.'s Intermittent Compression Boot for professional use, K964957) and its established safety and effectiveness profile.

8. The sample size for the training set

• N/A. There is no "training set" as this is not a machine learning device or a clinical study involving data collection for training.

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

• N/A. Not applicable for the reasons stated above.

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