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The Applied Tissue Technologies PWD™ Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts.

The Applied Tissue Technologies PWDTM Platform Wound Dressing is a single use device. Its transparency permits the healthcare practitioner to observe the progress of the wound healing without removing the wound dressing. There is an access port to administer negative pressure wound therapy. The PWD is intended to be used for a maximum of 3 days. Therapy duration may be less than indicated if clinical practice or other factors require more frequent dressing changes.

The PWD will be marketed in five different shapes and sizes, all having the same intended use. The five sizes are identified as follows.

PWDTM Platform Wound Dressing
Description | Catalog/REF #
1" Round | AT1070-01
2" Round | AT1071-01
3" Round | AT1072-01
1" x 3" Oblong | AT1073-01
3" x 5" Oblong | AT1074-01

This FDA 510(k) premarket notification for the PWD™ Platform Wound Dressing indicates that it is a device, not an AI/ML algorithm, and therefore the requested information regarding acceptance criteria and studies for an AI/ML device is not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (PWD™ Platform Wound Dressing, K182409) for a new, larger size of the existing wound dressing. Substantial equivalence for medical devices typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a legally marketed predicate device.

Here's why the AI/ML specific questions cannot be answered from this document:

• No AI/ML Component: The device description is for a physical wound dressing used in conjunction with a negative pressure wound therapy system. There is no mention of any AI, machine learning, or software component that performs diagnostic, prognostic, or treatment guidance functions.
• Performance Data: The "Nonclinical Performance Data" section states that "testing was conducted to demonstrate that the additional dressing size has the same performance characteristics as the predicate device." This typically refers to physical and functional testing relevant to the wound dressing itself (e.g., integrity, adhesion, ability to interface with the NPWT system, material compatibility), not to the accuracy or performance metrics of an AI/ML model against a ground truth.

Therefore, the requested tables and details about acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information are not present in this document because they are characteristic of AI/ML device submissions, not physical medical device modifications like this wound dressing.

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