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DVT Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.

The DVT Motion Pneumatic Compression Device is a portable, rechargeable battery-powered device intended for prescribed home use or hospital use to help prevent Deep Vein Thrombosis (DVT) in patients by stimulating blood flow. This is accomplished using an electronically controlled pump delivering a set amount of air to the leg garment that compresses the calf and aids blood flow through the lower extremities. The pump will inflate to a preset pressure of 50mmHg and deflate once this pressure is reached. The cycle continues until the unit is turned off. The tube free solution comes complete with a fully integrated lithium ion battery that supplies over 18 hours of treatment on a single charge, assuring that patients can be transported easily from the hospital to their homes without interruptions in treatment.

The provided text describes the 510(k) premarket notification for the "DVT Motion Pneumatic Compression Device." This device is a medical device and not an AI/ML-driven diagnostic or treatment system. Therefore, the questions related to AI/ML specific concepts like "acceptance criteria for AI models," "training set," "ground truth establishment," "experts for ground truth," "adjudication methods," and "MRMC comparative effectiveness studies" are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (VascuEase IC-1200-WH) through non-clinical performance and safety testing, not on the performance of a predictive algorithm.

However, I can extract information related to the device's performance based on the non-clinical testing mentioned.

Here's what can be extracted:

Device Performance and Proof of Meeting Acceptance Criteria

The document states that the "DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use" based on a series of non-clinical safety and performance studies. The specific acceptance criteria themselves are not detailed in the provided text, only the tests performed to demonstrate compliance.

1. Table of Acceptance Criteria and Reported Device Performance

As the specific numerical acceptance criteria are not explicitly detailed for each test within the document, I can only provide the types of tests performed and the general statement of compliance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for individual non-clinical tests. The tests were performed on the device itself.
• Data Provenance: The tests were conducted on the "subject device" (DVT Motion Pneumatic Compression Device) by Koge Micro Tech Co., Ltd. The document does not specify the country of origin of the labs, but Koge Micro Tech Co., Ltd. is located in Taiwan. These were prospective tests performed on the device to demonstrate its performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not Applicable: This is a physical medical device clearance, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for these tests comes from engineering standards and measurements, not human interpretation of data.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this does not involve human adjudication for a test set in the context of an AI/ML model.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, Not Applicable: No MRMC study was performed as this is not an AI/ML diagnostic or image analysis device. The study type was non-clinical testing against engineering standards and comparison to a predicate device.

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

• Not Applicable: This is not an algorithm. The "software validation" mentioned refers to the software controlling the pneumatic compression device, ensuring its proper functioning, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

• "Ground truth" was established by predefined engineering standards and test methodology. For example, pressure measurements are compared against a specified mmHg range, and cycle times against a target duration. The document states that "All the test results demonstrate DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use."

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" in the AI/ML sense for this device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: There is no "training set" for this device.

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