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The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The 3M™ ActiV.A.C.™ Canister - 300ml with Gel is a component of the ActiV.A.C.™ Negative Pressure Wound Therapy System, also referred to as the ActiV.A.C. ™ Therapy System. The ActiV.A.C. ™ Therapy System consists of:

• · an ACTIV.A.C. ™ Therapy Unit,
• · a disposable canister which collects wound exudate (the subject of this submission),
• · a wound interface dressing,
• · a semi-occlusive wound drape, and
• · a sensing pad and lumen.

The 3M™ ActiV.A.C. ™ Canister - 300ml with Gel is a single use disposable component of the ActiV.A.C. ™ Therapy System and is sold separately from the ActiV.A.C. ™ Therapy Unit. It is provided in either a 5 pack or 10 pack configuration.

The Canister is attached to the therapy unit and collects wound exudates. The distal end of the Canister tubing attaches to the dressing tube set using rigid connectors. The Canister has volume graduations and contains a gel pack for fluid solidification and a tubing pinch clamp.

The Canister is composed of MABS (Methylmethacrylate acrylonitrile butadiene styrene).

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically the 3M™ ActiV.A.C.™ Canister - 300ml with Gel. This device is a component of a Negative Pressure Wound Therapy (NPWT) system.

The core purpose of a 510(k) submission is to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This means the device is as safe and effective as a device already on the market and does not introduce new questions of safety or effectiveness.

Crucially, this type of submission does not typically involve the kind of clinical study data with acceptance criteria and ground truth that would be found in a novel device approval or a software as a medical device (SaMD) submission. Instead, it relies on demonstrating equivalence through comparison of technical characteristics, intended use, and performance data if there are significant changes.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document because it's not required for a 510(k) submission for this type of device (a medical device component, specifically a canister for NPWT).

The document explicitly states:

• "There was no performance data or biocompatibility performed to demonstrate equivalence." (Page 7)
• "Clinical and Pre-clinical testing were not necessary to demonstrate equivalence." (Page 7)

The change being reviewed for this specific 510(k) (K241134) for the 3M™ ActiV.A.C.™ Canister - 300ml with Gel is that the "Canister will be provided entirely non-sterile. All other design features remain identical." (Page 6). This is a change in the sterilization method/status, not a new or significantly changed functional device or a software product requiring AI performance metrics.

In summary, none of the specific details you requested (acceptance criteria table, study sample sizes, expert details, adjudication, MRMC, standalone performance, etc.) are available in this document because the nature of the 510(k) submission for this device did not require such studies.

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