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The AIR COMPRESSION BOOTS is intended for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas in people who are in good health. The AIR COMPRESSION BOOTS simulates kneading and stroking of tissues by using an inflatable garment.

This product operates through an air pump stored internally, sending air into the air bag, inflating and deflating through the alternate work of the solenoid valve, and squeezing the leg to achieve a massage effect. This product consists of hand controller, air pump, air valve and leg bag. The following model numbers are identical in circuitry and electrical, mechanical and physical construction; the only differences are the size and model number for trading purpose. The model 1018196 is for the 26-inch size and model 1018195 is for the 32-inch size.

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Intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated area in people who are in good health.

Bio Compression Systems' Sequential Circulators are powered inflatable tube massagers which consist of a segmented pneumatic sleeve ("garment") connected to a pneumatic compression pump ("pump"). The pump cyclically inflates the garment's segments ("chambers") in sequence from the distal end toward the trunk of the body. The sequential inflation of the garment simulates kneading and stroking of tissues with the hands, increasing circulation on the limb worn.

The core components of the pump are the motor, air compressor, disc valves, and micro switch. The air compressor generates air flow into a stationary disc valve. The motor moves a rotating disc valve. The geometry of the disc valve directs air flow and cyclically triggers the micro switch.

The pump is controlled by softkeys and an LED display (models SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL) or by a touch screen LCD (models SC-4004-DL, SC-4008-DL).

The device uses the Predicate Device's garments.

The provided text is a 510(k) Pre-market Notification for a medical device (Sequential Circulators) and does not contain information about a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, which would include details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data for safety and electrical compatibility, and functional verification, rather than a clinical efficacy or diagnostic accuracy study.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in the format of diagnostic metrics (e.g., sensitivity, specificity, AUC) or a study proving those criteria are met. Instead, it lists technical standards and verification testing.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the device itself being tested against technical standards, not a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant here.

4. Adjudication method for the test set: Not applicable.

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. This is not an AI/diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device's performance relates to compliance with engineering and safety standards, and functional specifications.

8. The sample size for the training set: Not applicable. This is not a machine learning/AI device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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