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MedHealth DVT Compression Devices MHH900S/MHH900E are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

The Deep Vein Thrombosis (DVT) Pumps MHH900S and MHH900E are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life-threatening condition which can lead to pulmonary embolism. MHH900S and MHH900E are non-invasive mechanical prophylactic devices function as secondary pumps to propel venous blood for patients whose deep vein thrombosis must be prevented after surgeries in Orthopedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.

The two devices separately consist of an air pump and a soft pliable compression garment(s) (Purchased separately) for the foot, calf, or thigh. For MHH900S and MHH900E, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.

The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT.

The provided text describes the MedHealth DVT compression Devices MHH900S/MHH900E and their substantial equivalence to a predicate device (B&J Manufacturing Ltd. Deep Vein Thrombosis (DVT) compression device MHH800 (K200154)). Since this is a submission for substantial equivalence based on non-clinical testing, it does not involve AI or studies with human readers. Therefore, several points in your request are not applicable.

Here's the breakdown of the information based on the provided text:

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

The document provides a comparison of specifications between the proposed devices (MHH900S/MHH900E) and the predicate device (MHH800), and states that non-clinical testing was performed to ensure the system meets its specifications. The specific acceptance criteria for each test are not explicitly stated in a quantified manner, but the document confirms that the device "passed" these tests.

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 relates to non-clinical testing (software validation, cleaning, electrical safety, shelf life, and functional performance testing). These tests typically involve physical units of the device or software code, not patient data. Therefore, "sample size for the test set" and "data provenance" in the context of clinical data are not applicable here.

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 the submission is for a medical device that does not involve expert-mediated ground truth (like image interpretation by radiologists). The tests are based on engineering and performance standards.

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

This is not applicable, as there is no expert adjudication in a non-clinical device testing context.

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

This is not applicable. The device is a "Deep Vein Thrombosis (DVT) compression device," which is a physical medical device (pneumatic compression) and not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable, as the device is not an algorithm or AI.

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

For the non-clinical tests, the "ground truth" is defined by the relevant international and national standards (e.g., AAMI, ASTM, IEC) against which the device's performance is measured. For example, for pressure accuracy, the ground truth is the specified pressure range (e.g., 40 mmHg +10/-5mmHg).

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

This is not applicable, as there is no training set for this device.

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