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The NDO Endoscopic Plication System (EPS) 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 (EPS) deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication.

Both the retractor and implant cartridge are provided as sterile, single use, disposable components of the EPS. The Plicator instrument is a non-sterile multiple use device that is subject to cleaning and high level chemical disinfection between uses. To facilitate cleaning and high level disinfection of the Plicator instrument with an Automated Endoscope Reprocessor (AER), the EPS will include a non-procedural "cleaning adapter" accessory.

The provided document describes a 510(k) submission for the NDO Surgical Endoscopic Plication System (EPS). This submission focuses on modifications to the cleaning and high-level disinfection instructions and an added accessory rather than a new device or significant design change requiring extensive clinical performance studies. Therefore, the information typically available for software-as-a-medical-device (SaMD) studies (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies) is not applicable here.

Here's an analysis based on the provided text, focusing on the device modifications and the performance data provided for those modifications:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical or algorithmic performance data. The testing performed was simulated use testing for cleaning and disinfection. Therefore, typical sample sizes (e.g., number of patients, images) and data provenance (country, retrospective/prospective) are not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for the cleaning and disinfection study was the successful elimination of Mycobacterium terrae to accepted standards, as determined by laboratory testing protocols outlined in ASTM E 1837-96. This does not involve human experts in the way clinical diagnostic studies would.

4. Adjudication Method for the Test Set

Not applicable. This was a laboratory-based performance test following a standardized protocol (ASTM E 1837-96), not a study requiring adjudication of human expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical medical device and its cleaning/disinfection procedures, not an AI or diagnostic application.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This submission is not for an algorithm or software. The performance data relates to the physical Plicator instrument's ability to be properly disinfected.

7. The Type of Ground Truth Used

For the cleaning and disinfection study, the ground truth was derived from laboratory testing standards and microbial inactivation as stipulated by ASTM E 1837-96. This standard outlines procedures to determine the efficacy of disinfection processes. The "ground truth" was whether the specified disinfection process effectively eliminated the test microorganism (Mycobacterium terrae) from the device, which is an objective, measurable outcome in a laboratory setting.

8. The Sample Size for the Training Set

Not applicable. This submission is not for an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device modification submission.

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