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The GERDX®-System is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The GERDX-System is a sterile application and suture system indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The GERDX-System consist of following procedural components: GERDX-Applicator, GERDX-Tissue Retractor, GERDX-Suture System and the GERDX-Guide Wire.

The Suture System and the Tissue Retractor are loaded onto the Applicator. The Guide Wire is placed within the antrum of the stomach by standard procedure. By use of the Guide Wire, the Applicator is introduced orally and advanced through the esophagus into the stomach. After removing the Guide Wire a thin profile gastroscope is inserted into a channel within the Applicator and the Applicator is positioned under direct endoscopic visualization at the target location within the gastrointestinal (GI) tract. The Tissue Retractor is advanced out of the distal tip of the Applicator. Gastric tissue is engaged by the Tissue Retractor and withdrawn into the Applicator, thereby pulling the tissue into the open arms of the Applicator. The arms of the Applicator are then closed to grasp and approximate the target tissue. The Suture System is then deployed to transmurally affix the GI tissue. The procedure is repeated to deploy additional Suture Systems if necessary. The number of Suture Systems that are placed will vary based on patient anatomy and physician's judgement. Parts of the Suture System remain within the patient.

The provided text is a 510(k) summary for the GERDX-System, an endoscopic suture/plication system for treating GERD. Medical devices in this category (Class II) are reviewed for substantial equivalence to existing predicate devices, rather than requiring extensive clinical trials for approval. Thus, the information available is focused on demonstrating equivalence rather than a detailed efficacy study with defined acceptance criteria for device performance in the same way a novel drug or high-risk medical device might require.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the typical sense of a clinical trial for efficacy (e.g., target reduction in symtom score or a specific diagnostic sensitivity/specificity). Instead, the studies aim to demonstrate equivalence in performance and safety to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Bench Tests: The specific sample size for the side-by-side bench tests is not mentioned. Data provenance is not specified but would typically be from the manufacturer's internal testing.
• Clinical Testing: The document refers to "Two peer-reviewed articles have been published." The details of these studies, including sample size, country of origin, and whether they were retrospective or prospective, are not available in this summary.
• Animal Testing: The sample size for the porcine model studies is not mentioned. Data provenance would be from a GLP-conform laboratory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not explicitly provided in the 510(k) summary. For a device like this, ground truth would likely refer to clinical outcomes (symptom reduction, physiological measures of reflux) as assessed by clinicians or researchers, rather than an "expert read" of images.

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

This information is not provided. It's improbable that an adjudication method like 2+1 or 3+1 (typically used for image interpretation in AI studies) would be relevant for the type of clinical or bench tests described for this device.

5. 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

An MRMC study was not done. This device is not an AI-powered diagnostic or assistive tool, but rather a surgical device (endoscopic suture/plication system). Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This is not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Bench Tests: The ground truth for bench tests would be defined by engineering standards and measurements of physical forces and properties.
• Biocompatibility: Ground truth is established by adherence to ISO 10993-1:2018 standards and associated laboratory testing.
• Clinical Testing: The "effectiveness" mentioned in the peer-reviewed articles would likely be based on patient-reported outcomes (e.g., symptom scores, quality of life), physiological measurements (e.g., pH monitoring), or endoscopic findings, representing "outcomes data."
• Animal Testing: Ground truth for safety and feasibility in animal studies would be based on direct observation, histological analysis, and other relevant physiological measurements in the porcine model.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI models. It is a physical medical device.

9. How the ground truth for the training set was established

As there is no "training set" for this device, this question is not applicable.

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