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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) is a device that 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. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the Plicator instrument has been introduced into the stomach, the retractor is engaged into the gastric cardia and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating a full thickness, serosa-to-serosa plication.

Here's an analysis of the provided text regarding the NDO Surgical Endoscopic Plication System (EPS) and its acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance

The submission focuses on modifications to a previously cleared device (predicate EPS) and demonstrates substantial equivalence. Therefore, the "acceptance criteria" are primarily established by the performance of the predicate device and the new device's ability to meet those same levels of safety and effectiveness, especially for the modified components and new features (like multiple implant deployment).

Study Information

1. Sample Size used for the test set and the data provenance:

   • Bench Testing: Not explicitly stated, but typically involves a specified number of samples for each test (e.g., a certain number of leak tests, implant deployments). The provenance is likely internal lab testing by NDO Surgical, Inc.
   • Biocompatibility Testing: Not explicitly stated, but subject to ISO standards for medical device materials. The provenance refers to "patient contact materials" and comparisons to "predicate instrument and implant cartridge."
   • Simulated Use Testing: Not explicitly stated regarding sample size. Provenance is likely in-house testing.
   • Clinical Testing: Not explicitly stated regarding the number of patients or implants. The data provenance is "clinical experience with the predicate device" which implies a prospective or retrospective analysis of human use data, but the "clinical testing" for the modified device would be prospective. The statement "Clinical testing demonstrated that serial placement of multiple, Plicator implants... safely and effectively treats..." strongly suggests a clinical study was performed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for bench, biocompatibility, and simulated use testing which rely on objective measurements and established protocols.
   • For the clinical testing, the "ground truth" would be the patient's GERD symptoms and their response to treatment, assessed by clinicians (likely gastroenterologists) as part of the study. The number of experts or their specific qualifications (e.g., years of experience) are not detailed in this summary.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable for the types of tests described (bench, biocompatibility, simulated use).
   • For clinical studies, adjudication methods (like independent review panels for adverse events or efficacy endpoints) are common, but this detail is not provided in this 510(k) summary.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a surgical instrument, not an imaging or diagnostic AI device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a manual surgical device with a human operator.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Bench Testing: Objective physical measurements and functional performance tests (e.g., water ingress, implant deployment mechanics).
   • Biocompatibility Testing: Compliance with established biocompatibility standards (e.g., ISO 10993).
   • Simulated Use Testing: Observational data on successful and safe deployment in a controlled environment.
   • Clinical Testing: Patient-reported symptoms of GERD, physician assessment of treatment response, and safety outcomes (adverse events). This falls under outcomes data and clinical assessment.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. No training set is involved.

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