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The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

Uni-port is a single use manual operated surgical retractor comprised of three components; main body, wound retractor and filter. The main body consist of combinations of several ports of various size (5mm, 12mm, 15mm and 28mm). The wound retractor is a flexible polyurethane film that has two rings attached at each end and a Thandle connected with thread for easily removal after procedure. The single (lower) ring is inserted into the abdomen for fixation and double (upper) ring is connected with main body. The filter is provided separately to filter out harmful gas generated in the abdominal cavity, it is easy to ensure a clear view.

The provided text is a 510(k) summary for the Uni-port device, which is described as a medical device for laparoscopic surgery. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithm performance, nor does it discuss acceptance criteria in the context of an AI/ML device. The text exclusively describes a physical medical device (a surgical retractor) and its technical equivalence to existing devices through bench testing and material comparisons.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (for an AI/ML context)
• Sample sizes for test sets or data provenance (related to AI/ML)
• Number of experts or their qualifications for ground truth establishment (related to AI/ML)
• Adjudication method (related to AI/ML)
• MRMC comparative effectiveness study or human reader improvement with AI
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data - related to AI/ML)
• Sample size for the training set (related to AI/ML)
• How ground truth for the training set was established (related to AI/ML)

The acceptance criteria and studies mentioned in the document are for a traditional physical medical device, focusing on:

• Shelf-Life Test
• ISO 10993-5 - Cytotoxicity
• ISO 10993-10 - Sensitization & Intracutaneous Reactivity
• ISO 10993-11 - Acute systemic toxicity & Pyrogens
• Other bench testing: Surface, Measurement, Tensile strength, Airtightness, Fatigue resistance, Extractable substances, Comparative performance.

The conclusion is that "All the test results support substantial equivalence to the predicate devices" and "Bench test results allowed to conclude that Uni-port is substantially equivalent to the predicate devices for its intended use."

To summarize, while the document confirms the device meets acceptance criteria for a physical medical device, it does not provide the specific AI/ML-related details requested in your prompt.

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