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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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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 envelopes the lower extremity and the lower chamber is located under the foot.

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 inflated to the desired pressure

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.

This document describes a premarket notification summary for a medical device, the EISCHCO Inflatable Massager Boot. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific performance acceptance criteria.

Therefore, for aspects related to acceptance criteria, device performance, and study methodology (like sample size, ground truth, expert review, MRMC studies, standalone performance, and training set details), the information is not available in the provided text.

Here's a breakdown based on the input text:

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

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

• Not applicable/Not provided. This document is a premarket notification for demonstrating substantial equivalence. It does not describe a clinical study with a test set of data.

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/Not provided. No test set or ground truth establishment process is described.

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

• Not applicable/Not provided. No test set or adjudication process 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

• No. An MRMC study was not conducted or mentioned. The EISCHCO Inflatable Massager Boot is a physical therapeutic device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical device, not an algorithm. Standalone performance as described in the prompt is not relevant here.

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

• Not applicable/Not provided. No ground truth for device performance is established or discussed within this document. The "ground truth" in the context of this submission is the established function and safety profile of the predicate device (Chattanooga Group's, Inc. Intermittent Compression System K832920) against which the new device is compared for substantial equivalence.

8. The sample size for the training set

• Not applicable/Not provided. No training set is involved as this is not an AI/machine learning device.

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

• Not applicable/Not provided. No training set or ground truth establishment process is described.

Summary based on the document:

The provided document is a Premarket Notification Summary (510(k)) for the EISCHCO Inflatable Massager Boot. Its primary objective is to demonstrate substantial equivalence to an existing legally marketed device (the predicate device: Chattanooga Group's, Inc. Intermittent Compression System K832920).

The "study" that proves the device meets "acceptance criteria" in this context is the argument of substantial equivalence.

• Acceptance Criteria (implicit): The primary "acceptance criterion" for a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that it has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness AND the device is as safe and effective as the legally marketed device.
• Proof: The document explicitly states: "EISCHCO's Inflatable Massager Boot is substantially equivalent to Chattanooga Group's. Inc. Intermittent Compression System K832920." The comparison in Table I (which is referred to but not provided in the snippet) would detail the similarities and differences. The key distinction highlighted is the method of inflation: manual exercise by the wearer for the EISCHCO boot versus a pressure pump for the predicate. The conclusion is that this difference does not negate substantial equivalence.

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