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The EndoGastric Solutions EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia

The EndoGastric Solutions EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories is a disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. Two polypropylene fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed simultaneously from the proximal device end, to the distal end down two separate channels via lumens in a flexible shaft where they are then in position for deployment into the tissue. The operator, controlling the distal end of the device through the mechanical controls captures and positions a fold of tissue at the gastroesophageal junction. The delivery trigger mechanism deploys both fasteners simultaneously at the captured tissue position, creating a permanent surgical fundoplication. Additional fasteners are used as needed to complete the valve restoration.

The provided text is a 510(k) summary for the EsophyX Z Fastener Delivery Device. This document is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device, and thus does not include a study design or acceptance criteria in the typical sense of a clinical trial for a novel device.

The "acceptance criteria" and "device performance" in this context refer to the device's ability to meet its design specifications and user needs, and perform as safely and effectively as its predicate device. This is primarily demonstrated through verification and validation testing, rather than a clinical study measuring diagnostic accuracy or treatment outcomes against a predefined numerical threshold.

Therefore, many of the requested elements for describing a study are not directly applicable or are not detailed in this type of regulatory document.

However, I can extract the relevant information regarding the performance data and how substantial equivalence was established:

Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) Summary)

| Acceptance Criteria (Implied) | Reported Device Performance Description of How Performance was Verified |
| :----------------------------------------------------------------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Meets Design Specifications and User Needs | The EsophyX Z modifications met design specifications and user needs. The device meets product specifications and user requirements. Verification and validation testing results were provided. |
| Functional Performance (Fastener Deployment, Endoscope Insertion/Withdrawal) | Functional performance was confirmed. Testing included: fastener deployment, endoscope insertion and withdrawal, shielded stylets, retractor performance, sharp edges, and rotational and translational performance. As part of design validation, animal labs were performed verifying fastener deployment in various tissue types. |
| Substantially Equivalent in Safety and Effectiveness to Predicate Device | The EsophyX Z is as safe and effective and performs as well as the predicate device (EsophyX2 HD System). This conclusion is based on the intended use, indications for use, product technical information, performance testing and biocompatibility information provided in the premarket notification. |
| Biocompatibility | The device components are biocompatible. Biocompatibility information was provided in the premarket notification (specific details of testing are not in this summary). |
| Maintenance of Technological Characteristics | The device shares key technological elements with the predicate device, including: a flexible shaft, fastener delivery device inserted transorally with a separate endoscope for visualization; polypropylene, H-shaped fasteners as permanent implants; use of tissue invagination to correct hiatal hernias up to 2cm; and mechanical user interface controls for fastener loading, tissue capture, positioning, and deployment. | Demonstrated through summary of technological characteristics compared to the predicate device. |

Detailed Study Information (Based on provided text):

1. Sample size used for the Test Set and Data Provenance:

   • The document mentions "animal labs were performed verifying fastener deployment in various tissue types" for design validation. However, the specific sample size (number of animals or fasteners) for these animal labs is not specified in the provided 510(k) summary.
   • The data provenance is animal (pre-clinical), rather than human clinical data. The summary states: "Clinical evaluation as part of design validation was not required for the modifications made to the EsophyX Z to establish safety and effectiveness equivalence."

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

   • This information is not provided as the assessment was primarily engineering verification and animal model testing, not human expert interpretation of clinical data.

3. Adjudication method for the test set:

   • Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers or assessments. This information is not applicable/provided for the engineering and animal testing described.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and its effect size:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical evaluation as part of design validation was not required..."

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

   • This is a mechanical device, not an algorithm. Therefore, the concept of "standalone algorithm performance" is not applicable. The device's performance was evaluated inherently without a "human-in-the-loop" in the sense of an AI-assisted reading workflow; rather, it evaluates the device's mechanical and functional operation.

6. The type of ground truth used:

   • For the animal labs, the "ground truth" was likely direct observation of fastener deployment and tissue approximation in animal tissues, evaluated against the expected mechanical and functional outcomes.
   • For the other tests (dimensional, mechanical, performance specifications), the "ground truth" was the device's design specifications and user requirements.

7. Sample size for the training set:

   • This is a mechanical device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of data for model training is not applicable.

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

   • As this is not an AI/ML device, the concept of a "training set" and its ground truth is not applicable.

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