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The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:

• · Aid in the prevention of DVT;
• · Enhance blood circulation;
• · Diminish post-operative pain and swelling;
• · Reduce wound healing time;
• Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
  The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a nonserviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection.

The PlasmaFlow is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The housing on the garment is a lightweight, rechargeable battery-powered, electromechanical control unit intended to provide and digitally monitor through two LED screens the inflation cycle for enhanced circulation therapy. The controller on the sleeve allows the unit to inflate distal to proximal. It is intended to be used in the home, travel situations where altitude or lack of mobility occurs, or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).

All pump control unit components are protectively enclosed in a plastic casing which is fixated to a single chamber cuff. The unit is supplied with a non-serviceable, rechargeable battery, to allow user portability, and a power supply transformer for main connection. The pump has two LED screens. The screen allows the prescriber and or patient to verify the pressure, the mode, and total run time.

The Patient Sleeve is a single Polyvinyl Chloride (PVC) air bladder intended to be attached directly to the patient's lower limb. It is intended to provide compression action to the tissue surrounding the venous vasculature in the calf of a patient. A compression unit with two LED screens is connected to sleeve for a completely ambulatory system. The compression unit has the ability to produce different compression modalities.

Default modality will be the same as the predicated devices, which is, a slow inflation up to 55 mmHg of air through the bladder cells. Once pressure is reached, the unit will deflate for approximately 50 seconds. Then the cycle repeats.

Another compression modality will be the step up technology that inflates the air cells at an increase of 10 mmHg pausing at increments of ten to 50 mmHg, with a final increase of 5 mmHg to 55mmHg. Once 55 mmHg is reached, the unit will decrease to 50 mmHg and then decrease in increments of 10 mmHg.

A single touch control switch located on the top of the unit powers on the unit and switches the mode.

Above the power button, a dual color LED light allows the user to verify for power on, low battery, charging and charge completed indication, and an audible alarm (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug/USB chord.

The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric made from a Polyester blended medical fabric or equal, which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs.

In operation, the user simply runs the power ON via the multi-purpose control button. A single user "cuff containing air bladders is connected to the unit. The control unit then fills the cuff to a pressure of 55 mmHg. Cuff pressure is visually monitored by user pressure LED screen, internal pressure switch, and system software. Once the pressure reaches the proper level, the pump is deflated for an approximately 50 second deflate period. The device software ensures the cycle time is a minimum of 60 seconds (the cycle time is the length of time for one complete cycle on one cuff including fill time, exhaust, and relaxation time). The cycle repeats until the unit is turned off.

This document is a 510(k) Premarket Notification for the PlasmaFlow device, which is an intermittent pneumatic compression system intended for preventing Deep Vein Thrombosis (DVT) and improving blood circulation. The submission argues for substantial equivalence to a predicate device, the Innovamed Health Venapro (K133274).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for device performance metrics. Instead, it argues for substantial equivalence by comparing the PlasmaFlow (subject device) with the Venapro (predicate device) across various characteristics and showing that they are either identical or that any differences do not raise new questions of safety or effectiveness.

However, based on the non-clinical testing performed, we can infer some performance aspects:

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

The submission explicitly states: "No clinical testing was performed on the PlasmaFlow to support the decision of substantial equivalence."

Therefore, there is no specific sample size or test set derived from clinical data for the PlasmaFlow device itself mentioned in this document. The data provenance related to "clinical studies" refers to results from predicate devices and not studies conducted on the PlasmaFlow. The non-clinical testing was in-house bench testing and outside laboratory testing.

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

As no clinical testing was performed on the PlasmaFlow and no specific test set data is presented for human interpretation, this information is not applicable to the PlasmaFlow device within this 510(k) submission.

4. Adjudication Method for the Test Set

Again, since no clinical test set for human interpretation was used for the PlasmaFlow device, this information is 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

The PlasmaFlow is an intermittent pneumatic compression device, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study is not applicable as there are no "human readers" interpreting images or data with or without AI assistance in this context.

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

The PlasmaFlow is a mechanical compression device, not an algorithm. Therefore, standalone algorithm performance is not applicable. The non-clinical testing (bench testing, electrical safety, EMC, etc.) can be considered "standalone" in the sense that it evaluates the device's technical performance independently.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the PlasmaFlow device based on non-clinical testing:

• Bench Testing: The ground truth for performance metrics like pressure delivery, cuff fill time, and cycle time was established through objective measurements against defined specifications (e.g., 55 mmHg pressure, 60-second cycle time). These are quantifiable engineering parameters.
• Biocompatibility: Ground truth was established through laboratory testing protocols (e.g., ISO 10993 series) to detect cytotoxicity, sensitization, and irritation.
• Electrical Safety & EMC: Ground truth was established by conformance to international safety standards (e.g., IEC 60601 series), involving specific test procedures and measurements.
• Risk Management: Conformance to quality management system standards (e.g., ISO 14971, ISO 13485).

For the clinical effectiveness for similar devices (predicates): The document refers to published clinical studies evaluating intermittent pneumatic compression devices, which would typically rely on clinical outcomes data (e.g., DVT incidence, blood flow measurements, reduction in pain/swelling). However, these studies were not specific to PlasmaFlow.

8. The Sample Size for the Training Set

As the PlasmaFlow is a mechanical medical device and not an AI/algorithm-based system requiring a "training set" of data, this concept is not applicable.

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

Since a "training set" is not applicable, this information is not relevant.

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