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The Plexus RP00 Disposable Portable Deep Vein Thrombosis (DVT) Prevention Device is intended to be used in either home or clinical settings for:

• · Aiding the prevention of DVT onset
• · Enhancing blood circulation in the lower extremities
• · Diminishing post-operative pain and swelling
• · Reducing wound healing time, and
• · Serving as a prophylaxis for DVT for stationary or bedridden individuals

· 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

The Plexus RP100 Portable Deep Vein Thrombosis ("DVT") Prevention Device is an electronic device that helps to prevent the onset of deep vein thrombosis by stimulating blood flow and increasing venous flow velocity. Each RP100 DVT Prevention Device consists of a pump body and a pressure sleeve with internal air bladder. When turned on, the air bladder inside the sleeve will be automatically inflated to a pre-set level, thereby providing intermittent pressure to the calf.

The commercial saleable package will consist of two pump units with their sleeves, one for each leg.

The unit operates by inflating the air bladder until the pressure reaches 50mmHg. After reaching this pressure level, the unit will automatically deflate for 50 seconds to complete one cycle. Therapy could persist as long as the patient needs or is instructed by their physician. When the therapy ends, the patient simply would turn off the device by the press of a power button.

The provided text describes the 510(k) premarket notification for the Plexus RP100 Disposable Portable Deep Vein Thrombosis Prevention Device. This document primarily focuses on demonstrating substantial equivalence to a predicate device (Cirona 6300 DVT Prevention Device, K151189) through non-clinical testing rather than proving performance against specific acceptance criteria for an AI or imaging device with a detailed study.

Therefore, many of the requested details, such as those pertaining to AI/ML model performance, human expert adjudication, MRMC studies, and detailed ground truth establishment for a training set, are not applicable to this type of medical device submission. The device described is a physical compression device, not an AI or imaging system.

Here's an analysis based on the information provided, highlighting which elements are present and which are not applicable:

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

The document lists "Functional Performance Testing" which includes test items and their results, indicating that "Design requirements met" was the acceptance criterion for each.

Additionally, there are biocompatibility and electromagnetic compatibility/electrical safety tests, all of which "Passed."

2. Sample sized used for the test set and the data provenance

• Sample Size: The document does not specify the exact number of units or cycles tested for each functional performance test. It only states that the "Design requirements met" for each.
• Data Provenance: Not specified in terms of country of origin for testing, nor whether it's retrospective or prospective. Given it's functional performance testing of a physical device, it's typically done in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a physical device, not an AI or imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests would be objective measurements against engineering specifications.

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

• Not Applicable. See point 3.

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. The document explicitly states: "No clinical testing was performed to support the claim of substantial equivalence to the Cirona 6300 device." This is a mechanical device, not an AI-assisted diagnostic tool for human readers.

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.

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

• For the functional performance tests, the "ground truth" would be established engineering specifications and objective measurements (e.g., precise pressure readings, time measurements, battery life measurements). This is not linked to expert clinical consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The sample size for the training set

• Not Applicable. This device does not have a "training set" in the context of AI/ML.

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

• Not Applicable. See point 8.

Summary regarding AI/ML-specific questions:

The provided documentation is for a mechanical medical device (a DVT prevention device), not a software-driven AI or imaging diagnostic tool. Therefore, questions related to AI models, training sets, test sets for AI performance, expert adjudication, MRMC studies, and specific types of clinical ground truth (like pathology or outcomes for diagnostic accuracy) are not relevant to this submission. The demonstration of safety and effectiveness for this device relies on non-clinical engineering and bench testing, as explicitly stated in the document ("No clinical testing was performed").

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