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ARTIA Tissue Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement in plastic and reconstructive surgery.

ARTIA Tissue Matrix is intended for single patient, one time use only.

ARTIA Reconstructive Tissue Matrix Perforated (ARTIA Tissue Matrix Perforated) is a surgical mesh that is derived from porcine dermis and is processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. ARTIA Tissue Matrix Perforated is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold for cellular and microvascular ingrowth. ARTIA Tissue Matrix Perforated consists of a terminally sterilized sheet of processed porcine dermal matrix provided in various geometric configurations and packaged in a plastic holder enclosed within a pouch. The device is sterilized via electron beam irradiation. The subject device has the same underlying scientific technology, principles of operation, Intended Use and Indications for Use as the cleared predicate device, ARTIA Tissue Matrix (K142326). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a 3mm diameter circular pattern of perforations (holes) throughout the tissue matrix.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and answer all the questions regarding acceptance criteria and a study proving device performance as it relates to an AI/ML device.

The document is a 510(k) premarket notification for a medical device called ARTIA Reconstructive Tissue Matrix Perforated, which is a surgical mesh. This process establishes substantial equivalence to a predicate device, not necessarily a study demonstrating the device meets specific acceptance criteria in the manner one would for an AI/ML product's performance metrics.

Specifically, the document discusses bench testing for the surgical mesh to demonstrate substantial equivalence to a predicate device, not clinical performance or AI/ML algorithm performance.

Here's a breakdown of why the information is not available in the provided text:

• No AI/ML Device: The device described (ARTIA Reconstructive Tissue Matrix Perforated) is a surgical mesh, not an AI/ML-driven medical device. Therefore, questions related to AI/ML performance, training sets, and expert adjudication are not applicable.
• No Acceptance Criteria for AI/ML Performance: The acceptance criteria mentioned are for mechanical properties of a surgical mesh (e.g., mesh thickness, tensile strength, burst strength), not for AI/ML algorithm outputs like sensitivity, specificity, or accuracy.
• No Performance Data in the Requested Format: While the document states that "Performance data demonstrates that ARTIA Tissue Matrix Perforated has similar mechanical properties and meets the established specifications as the predicate device," it does not provide the specific numerical results or a direct comparison table as requested for an AI/ML device.
• No Clinical Study for Effectiveness: The document explicitly states: "Clinical Testing: No clinical testing was included in this submission." This means there is no study establishing clinical effectiveness or comparative performance with human readers.
• No Ground Truth: The concept of "ground truth" as it applies to AI/ML model training and evaluation (e.g., pathology, expert consensus on imaging) is not relevant for a surgical mesh. The "ground truth" for the mesh would be its physical and chemical properties, which are evaluated by bench tests.
• No Training/Test Sets: As this is not an AI/ML device, the concepts of training sets and test sets for algorithm development and evaluation are not applicable.

Therefore, I cannot fulfill your request based on the provided text. The information requested pertains to the evaluation of AI/ML-driven medical devices, while the provided document describes a traditional surgical mesh device.

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