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The IMMIX™ PlastiFilm is to be used wherever temporary wound support is required, to reinforce soft tissue where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing, or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

The IMMIX™ PlastiFilm is manufactured using poly(D,L-lactide-coglycolide) polymer and triethyl 2-acetylcitrate or tributyl 2-acetylcitrate. The device will be provided in sheets of 10 mm x 10 mm to 120 mm x 120mm. Other shapes and sizes will be provided as needed for particular surgical procedures. Additionally, the device can be cut with scissors to obtain desired shapes and sizes.

The thickness of the IMMIX™ PlastiFilm will range from 50 to 300 microns, according to the region to be treated, and will be provided with and without macroporous holes. The holes will range from 100 microns to 1000 microns in diameter. The holes may be aligned, offset, or random patterns. The borders of the sheets may be aligned with the holes to attach suture material.

The provided text describes a 510(k) premarket notification for a medical device called IMMIX™ PlastiFilm. This document details the device's composition, intended use, and the testing conducted to support its clearance. However, it does not contain any information regarding acceptance criteria or a study that uses acceptance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, accuracy, F1-score).

The regulatory context of this document (510(k) clearance in 2003) predates the common requirements for AI/ML device performance studies and acceptance criteria as they are understood today. The "Testing" section focuses on material properties and biocompatibility, not on a machine learning algorithm's performance.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets them because the provided text does not contain such details. The device described, IMMIX™ PlastiFilm, is a polymeric surgical mesh, not an AI/ML diagnostic or prognostic device that would typically have performance metrics and associated acceptance criteria as requested in your prompt.

Here's why the requested information cannot be extracted:

• No AI/ML Component: The device is a physical surgical mesh, not an AI/ML algorithm.
• No Performance Metrics: There are no metrics like sensitivity, specificity, or accuracy reported.
• No Test/Training Sets: There's no mention of data sets used to train or test an algorithm.
• No Ground Truth Establishment: The concept of establishing ground truth for an AI model is not applicable here.
• No Expert Adjudication/MRMC Study: These are specific to AI/ML software evaluations.

The "Testing" section mentions:

• Biocompatibility assessment: Performed by an independent certified laboratory.
• Degradation testing: Performed in a physiological buffered saline solution at 37 ℃, showing full resorbability over months.
• Suture pullout testing: Performed by OsteoBiologics on a family of PlastiFilm products, demonstrating the films could withstand "substantial loads and deformations."

These are physical and chemical property tests, not performance studies for an AI/ML algorithm.

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