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The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride coated with parylene. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.

The provided document is a 510(k) premarket notification letter and a 510(k) summary for the NDO Surgical Endoscopic Plication System. It discusses the device's substantial equivalence to a predicate device and mentions performance data were submitted, but it does not provide specific acceptance criteria or an explicit study description with detailed results that prove the device meets these criteria.

Therefore, I cannot populate the table and answer the questions as requested, because this information is not present in the provided text. The document states that "Bench top, In-Vivo simulated use and ex-vivo performance testing were completed in support of the substantial equivalence determination," but it does not detail these tests, their acceptance criteria, or their results.

Key Missing Information:

• Specific acceptance criteria for the device's performance.
• Detailed results from any studies (bench top, in-vivo, or ex-vivo).
• Sample sizes for test sets or training sets.
• Data provenance.
• Information about expert involvement for ground truth, adjudication, or MRMC studies.
• Details on standalone performance or ground truth type.

Without this information, I cannot fulfill your request for a table of acceptance criteria, reported performance, and the details of a study proving compliance.

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