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The Devon24D deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

• Aid in the prevention of DVT

• Enhance blood circulation

• Diminish post-operative pain and swelling

• Reduce wound healing time

• Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

• As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

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I apologize, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Devon 24D Deep Vein Thrombosis Prevention Therapy System, confirming its substantial equivalence to previously marketed devices and outlining its indications for use. It does not include details about specific performance metrics, test sets, or ground truth establishment.

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The Devon 24R deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

· Aid in the prevention of DVT

• · Enhance blood circulation
• · Diminish post-operative pain and swelling
• · Reduce wound healing time

· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System."

This document focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.

It does not contain any information about the acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies (like MRMC studies) related to the device's efficacy or accuracy.

Therefore, I cannot fulfill your request for the information about acceptance criteria and the study proving the device meets those criteria based solely on the provided text. The document is administrative and does not detail performance testing results.

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The Devon 24 deep vein thrombosis prevention system is intended to be an easy to use portable by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

• · Aid in the prevention of DVT
• · Enhance blood circulation
• · Diminish post-operative pain and swelling
• · Reduce wound healing time

· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

The Devon 24 deep vein thrombosis prevention therapy system (referred as Devon 24 below) is an easy to use portable pneumatic compression system that noninvasively helps prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). The Devon 24 system consists of a pair of pumps and sleeve assemblies.

The device will alternatively inflate and deflate the garment (sleeve) to stimulate blood flow in the extremities (muscle contraction). The device provides a 40mmHg pressure and followed by a deflation period once it reaches the desired pressure, each cycle time is 50 seconds.

This document, a 510(k) Premarket Notification for the Devon 24 Deep Vein Thrombosis Prevention Therapy System, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics. Therefore, many of the requested sections regarding the study design and results cannot be fully addressed from the provided text.

Based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests conducted, but it does not explicitly state quantitative acceptance criteria or the specific numerical results for each test. Instead, it offers a general conclusion that "The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "samples of the device" for performance and mechanical testing, but the number of units tested is not provided.
• Data Provenance: The tests were conducted internally by Devon Medical Products (Jiangsu) Ltd. in China. The document does not specify if the data involved human subjects or was entirely bench-top testing. Given the type of tests listed, they appear to be primarily bench-top (in-vitro) engineering and functional tests.

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

• Not Applicable. For the engineering and functional tests performed (pressure, cycle time, alarms, battery, burst, electrical safety, software V&V), ground truth is established through measurement instruments and compliance with technical standards and specifications, not through expert human interpretation as would be the case for diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, typically in clinical studies or when human interpretation of data is required to establish a consensus ground truth. The tests described are objective engineering and functional measurements.

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

• No. The document explicitly states: "No animal study or clinical study was conducted." MRMC studies are clinical studies involving human readers/observers.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a physical medical device (intermittent pneumatic compression system), not an algorithm or AI software for diagnosis or image analysis. Its "standalone" performance refers to its functional operation as demonstrated by the engineering tests for pressure, cycle time, etc., which were reported as "performing as intended."

7. The Type of Ground Truth Used:

• Engineering Specifications and Standard Compliance. For the performance tests, the "ground truth" is defined by the device's design specifications (e.g., target pressure, cycle time) and adherence to recognized international standards for electrical safety and electromagnetic compatibility (IEC 60601 series). For biocompatibility, the ground truth was the results of previously conducted biocompatibility tests on the predicate device's materials, per FDA Good Laboratory Practice.

8. The Sample Size for the Training Set:

• Not Applicable. This information pertains to machine learning algorithms. The Devon 24 is a mechanical/electronic device, not an AI or imaging device that uses a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. See point 8.

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