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The EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication 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 junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single-use, sterile 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 by ethylene oxide (EO). The delivery device is limited contact and materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.

The permanent contact, implantable SerosaFuse tissue fasteners are constructed of injection molded polypropylene and are of a strength equivalent to 3-0 suture. The SerosaFuse Implantable Fastener Cartridge is dual-lever containing 20 fasteners in each lever, and is designed to be removable. Each fastener consists of a leading leg, interconnecting web and trailing leg. The fastener's unique design allows it to be loaded onto a stylet, passed into and down a small delivery lumen of the device and subsequently delivered through apposed tissue surfaces in the GI tract. When deployed in tissue, the fastener serves as a suture-like implantable.

The system is used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure. The EsophyX Z+ device deploys the SerosaFuse fastener during an endoscopic procedure. 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. The EsophyX Z+ device is capable of transoral tissue approximation, ligation, and full thickness plication in the GI tract. The process essentially mimics the standard surgical technique of grasping tissue and apposing/approximating the tissue, piercing, and suturing the tissue fold. Each of these steps is controlled at the device proximal end, though plication, ligation and gastroesophageal valve formation is accomplished at the distal end of the device.

The provided text describes a 510(k) premarket notification for the EsophyX Z+ Device with SerosaFuse Fasteners and Accessories. The submission claims substantial equivalence to a predicate device, the EsophyX Z Device (K172811).

Crucially, this document does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria, particularly in the context of an AI/ML powered device. The document explicitly states: "This 510(k) submission primarily proposes changes to the instructions for use and other device labeling."

The "Performance Data" section only mentions "Non-clinical testing" including "Labeling verification" and "Benchtop performance testing," which are not clinical studies for efficacy. It concludes that "In all instances, the EsophyX Z+ device functioned as intended and demonstrated passing results." This refers to engineering and functional performance, not clinical outcome or comparative effectiveness against a defined set of clinical acceptance criteria.

Therefore, since the provided text does not contain the information required to answer the prompt (as it is not for an AI/ML device and does not detail a clinical study with acceptance criteria for device performance as a diagnostic or therapeutic tool), I must state that the information is not present in the given document.

The prompt asks for details typically found in submissions for AI/ML devices or devices requiring clinical performance data against specific endpoints (e.g., sensitivity, specificity, clinical outcome measures). This 510(k) submission focuses on a mechanical device demonstrating substantial equivalence through non-clinical testing of its functional similarities and minor labeling changes compared to a cleared predicate.

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The EndoGastric Solutions EsophyX, HD Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the Gl 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 ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less,

The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication 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 iunction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic qastroesophaqeal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

The EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z, K171307) with SerosaFuse Fasteners and Accessories are a prescription use only, disposable, single use systems consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The devices are used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure.

The device is limited contact and materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.

The permanent contact, implantable tissue fasteners are constructed of injection molded polypropylene.

These transoral devices and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the devices' flexible shaft lumen provides visualization of the procedure at all times, from device insertion through extraction. Two fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed 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 ready for deployment into tissue. The operator, controlling the distal end of the devices through the mechanical controls at the proximal end of the devices, captures and positions a fold of tissue at the gastroesophageal junction. The fastener controls deploy both fasteners simultaneously in the EsophyX Z model, or individually in the EsophyX2 HD model, at the captured tissue position. This creates a permanent surgical partial fundoplication. Additional fasteners are used as needed to complete the valve restoration.

This document is a 510(k) summary for the EsophyX®2 HD and EsophyX Z Fastener Delivery Devices, indicating substantial equivalence to previously cleared predicate devices. It focuses on a specification change rather than a new device with independent performance studies. Therefore, much of the requested information regarding new studies and performance data for acceptance criteria is not applicable in the context of this 510(k) submission.

Here's a breakdown based on the provided text:

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

The document does not provide a formal table of acceptance criteria for a new device study because this submission is for a specification change to an already cleared device. The "performance" reported primarily indicates that the device's performance remains the same as the predicate device despite the specification change.

• Acceptance Criteria (Implied for this submission): The device, with the modified specification for clamping pressure, must maintain the same safety and effectiveness profile as the previously cleared predicate devices.
• Reported Device Performance: "As both submission devices are identical to the predicates devices, the performance characteristics remain the same as those cleared previously in submission K171307." The engineering specification change for clamping pressure "does not change either device's operation, safety or effectiveness."

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

• Not applicable. This submission is for a specification change to an existing device. It explicitly states: "the EsophyX Z device/EsophyX2 HD devices (K171307) were used as the predicate without additional in vivo data needed for substantial equivalence as there are no changes made to the devices for this specification change proposal." Therefore, no new test set or data provenance details are provided for this specific submission.

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)

• Not applicable. As no new in vivo or clinical study was conducted for this specific submission, there is no mention of experts establishing ground truth for a new test set.

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

• Not applicable. No new clinical data or test set requiring adjudication was generated for this submission.

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

• Not applicable. This device is a mechanical surgical tool, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human "readers" or AI assistance is irrelevant.

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

• Not applicable. This device is a mechanical surgical tool, not an algorithm. Its operation inherently involves a human-in-the-loop (the surgeon).

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

• Not applicable for this submission. The study proving "substantial equivalence" relies on the previous clearance of the predicate devices. The basis for those original clearances (K171307) would have included performance data, but specific "ground truth" modalities for those past studies are not detailed in this document.

8. The sample size for the training set

• Not applicable. This is a hardware device undergoing a specification change, not an AI algorithm requiring a training set.

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

• Not applicable. As above, this is not an AI algorithm.

Summary of the Study Discussed (Pertaining to this 510(k) submission):

The "study" described in the document is a technical assessment concluding that a proposed engineering specification change to increase the upper design limit for the clamping pressure of the existing EsophyX®2 HD and EsophyX Z devices does not alter the device's fundamental operation, safety, or effectiveness.

• Nature of the "Study": This was not a de novo clinical trial but rather an engineering evaluation and comparison to a previously cleared predicate device (K171307).
• Basis for Conclusion: The conclusion is based on:
  • The devices being "identical" to the predicates, except for the specific clamping pressure tolerance.
  • The principles of operation remaining the same.
  • Reference to consensus standards.
  • Verification and validation testing remaining "unchanged."
  • Biocompatibility testing being consistent.
  • The literature supporting the specification change.
• No New Clinical Data: The document explicitly states "without additional in vivo data needed for substantial equivalence as there are no changes made to the devices for this specification change proposal."

In essence, the "study" demonstrating that the device meets acceptance criteria for this 510(k) relies on the fact that the device (with the modified clamping pressure specification) is demonstrated to be substantially equivalent to a predicate device that has already proven its safety and effectiveness. The acceptance criteria effectively imply that the device with the new specification must perform equivalently to the predicate, and the provided document argues that this is indeed the case.

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EsophyX2 HD Device with SerosaFuse Fasteners and Accessories: The EndoGastric Solutions EsophyX2 HD 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 subject EsophyX devices are unchanged from the currently cleared devices. The principles of operation for the devices are the same and also remain unchanged from the prior clearances. The indications for use for both models are identical.

The EndoGastric Solutions EsophyX Device models (EsophyX2 HD and EsophyX Z, K142113 and K160960, respectively) with SerosaFuse Fasteners and Accessories are a prescription use only, disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The devices are used in an operating room environment, using the Transoral Incisionless Fundoplication (TIF) procedure.

The device is classified as a surface device, mucosal membrane contacting with limited duration. The fastener classification is an implant, with permanent tissue/bone contact. Materials include acrylic/polycarbonate plastics, machined aluminum, stainless steel, nitinol wire, UV cured adhesives, pellethane and nylon.

The implantable tissue fasteners are constructed of injection molded polypropylene.

These transoral devices and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the devices' flexible shaft lumen provides visualization of the procedure at all times, from device insertion through extraction. Two fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed 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 ready for deployment into tissue. The operator, controlling the distal end of the devices through the mechanical controls at the proximal end of the devices, captures and positions a fold of tissue at the gastroesophageal junction. The fastener controls deploy both fasteners simultaneously in the EsophyX Z model, or individually in the EsophyXo HD model, at the captured tissue position. This creates a permanent surgical partial fundoplication. Additional fasteners are used as needed to complete the valve restoration.

The provided text describes a 510(k) premarket notification for the "EsophyX2 HD Device with SerosaFuse Fasteners and Accessories" and "EsophyX Z Device with SerosaFuse Fasteners and Accessories." This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily due to an expanded indication for use rather than presenting novel performance data for the devices themselves.

Therefore, the typical structure of acceptance criteria and a study proving a device meets them (especially for AI/algorithmic medical devices) is not directly applicable in the way you've outlined. This document is a regulatory submission for a mechanical device that has existing clearances. The "study" here refers to a literature review supporting an expanded indication.

However, I can extract information related to the closest aspects of your request based on the provided text, focusing on how the expanded indication was supported:

Understanding the Regulatory Context

This is a 510(k) submission, meaning the manufacturer is demonstrating that their device is "substantially equivalent" to a legally marketed predicate device. This is not a de novo submission or a PMA, which would typically require more extensive clinical trials to prove efficacy from scratch.

In this specific 510(k), the key element is an expanded indication for use. The devices themselves are stated to be "unchanged from the currently cleared devices" and "identical to the predicates devices." Therefore, the submission is not about demonstrating new performance for the device's core function but rather showing that the expanded use case is safe and effective when combined with the device's established performance.

Response to Your Specific Questions:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a mechanical device whose performance is already cleared, and the new aspect is an expanded indication supported by literature, there isn't a direct "acceptance criteria" table in the AI/algorithm sense.

However, we can infer the "criteria" for the expanded indication were based on clinical outcomes reported in existing literature for the combined procedure (laparoscopic hiatal hernia repair then TIF with the EsophyX device).

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

• Sample Size: The clinical outcomes supporting the expanded indication were drawn from a literature review summarizing outcomes from 163 patients across multiple studies.
  • Ihde et al.: 48 patients.
  • Chang et al.: 221 patients (sub-group underwent HHR + TIF, N=46).
  • Janu et al.: ~99 patients.
• Data Provenance: The studies are published clinical literature. The specific countries of origin are not specified, but the journals (e.g., "The American Journal of Surgery," "Journal of the Society of Laparoendoscopic Surgeons") suggest North American or international scope. The studies are retrospective analyses of collected patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided in the text. The "ground truth" here is essentially the reported clinical outcomes in peer-reviewed literature. The authors of these papers conducted the studies and presented their findings, which are then summarized in this submission. There is no mention of external experts specifically establishing "ground truth" for a test set in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. There was no independent "test set" in the sense of a dataset requiring expert adjudication for ground truth. The submission relies on already published clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI device, and the submission does not describe an MRMC study. It describes a literature review supporting an expanded surgical indication for a mechanical device.

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

• Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

• Clinical Outcomes Data from Published Literature: The "ground truth" for the expanded indication is established through the reported efficacy and safety data from published clinical studies on patients undergoing the combined procedure (laparoscopic hiatal hernia repair followed by TIF). This includes objective measures (e.g., GERD-HRQL scores, PPI discontinuation rates) and patient-reported outcomes.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not applicable. As above, no training set for an algorithm is involved. The "ground truth" for the device's primary function was established during its original clearances (K142113 and K160960). For the expanded indication, it was established by the clinical data collected and reported in the cited scientific literature.

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The EndoGastric Solutions EsophyX Z Device with SerosaFuse 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 ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is a prescription use only, 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.

This document is a 510(k) Premarket Notification for the EsophyX® Z Device with SerosaFuse Fasteners and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study design with specific numbers (sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with quantitative performance metrics for the device. Instead, it relies on demonstrating that the modified device "met the design specifications and user needs" and performed "as well as the predicate device."

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

The document mentions "cadaver and animal labs" for "design validation" and "fastener deployment in various tissue types," but it does not provide specific sample sizes for these tests. The data provenance is experimental (cadaver and animal labs), not derived from human patient data in a test set. It does not mention country of origin or whether it was retrospective or prospective in detail, but given the nature of cadaver and animal labs, it would be prospective in an experimental setting.

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

This information is not provided in the document. The document refers to "design specifications and user needs" and "biocompatibility testing," which are typically evaluated against established technical standards and test protocols, not directly against ground truth established by medical experts in a clinical study context for performance metrics.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-read test set requiring adjudication in the context of device performance metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not mentioned or performed as the purpose of this submission is to demonstrate substantial equivalence of a medical device (EsophyX® Z Device with SerosaFuse Fasteners and Accessories) to a predicate device (EsophyX Z System), not to assess human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a medical instrument (Endoscopic Clip Applier, Implantable Fastener and Accessories) and not an algorithm or AI software. Therefore, an "algorithm only" performance study was not conducted.

7. Type of Ground Truth Used

For the mechanical, dimensional, and performance specifications, the ground truth would be based on engineering standards, design specifications, and successful operation within experimental settings (cadaver and animal tissue). For biocompatibility, the ground truth is established by validated laboratory tests (cytotoxicity, sensitization, and irritation or intracutaneous reactivity) against regulatory standards. There is no mention of pathology or outcomes data as a ground truth for the verification and validation reported.

8. Sample Size for the Training Set

This is not applicable as the device is a medical instrument, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set mentioned for this device.

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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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The EndoGastric Solutions EsophyX® 2 HD Device with SerosaFuse is indicated for use in transoral tissue approximation, full thickness plication 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® 2 HD Device with SerosaFuse Fasteners and Accessories consists of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasteners delivered transorally through a flexible shaft into the GI tract via a common delivery mechanism comprised of three elements: a stylet, a pusher rod, and a delivery tube. All three fastener delivery elements run the length of the delivery device. The stylet runs down the inside of the lumen of the delivery tube and the pusher rod rides over the length of the stylet. The stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into position. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded mechanically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the stylet from the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, quided by the stylet which precedes it into the tissue. The leading leq of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing the leading leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated. The device is provided sterile and is a single use device.

The provided document is a 510(k) summary for the EndoGastric Solutions EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for algorithm performance as would be expected for an AI/ML device.

Therefore, much of the requested information cannot be extracted from this document, as it pertains to AI/ML device evaluation, which is not the subject of this 510(k) submission. This submission is for a physical medical device.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

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

This information is not available in the provided document. The document refers to "verification and validation testing" which included "dimensional, mechanical, and performance testing" but does not specify sample sizes for these tests, nor the nature of the data or its provenance.

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 applicable as this is not an AI/ML device requiring expert-established ground truth for a test set.

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

This information is not applicable as this is not an AI/ML device requiring adjudication of a test set.

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:

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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

This information is not explicitly stated in terms of "ground truth" as it would be for an AI/ML device. For a physical device, performance evaluation typically involves engineering specifications, compatibility testing, and simulated use.

8. The sample size for the training set:

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

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The EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener and Accessories is indicated for use in transoral tissue approximation, full thickness plication 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, EsophyX2 device with SerosaFuse Fasteners consist of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasters delivered transorally through a flexible shaft into the Oldy and sterile delivery mechanism comprised of three elements a flexible shaft into the OI tra delivery mechanism comprised of three elements: a style, a pusher rod, and a delivery tube. All three fastener delivery elements run the letinents. I sylet, a pusher rod, and a delivery tube. All three the luments run the delivery tube and the purpos nod ide. The Stylet runs the lumen of the delivery tube and the pusher rod rides over the length of the stylet. The stylet is designed to pierce and hold the pusher fou nace over the length of the stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded automatically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, guided by the stylet which precedes it into the tissue. The leading leg of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue, plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated. The unit is provided sterile and is a single use device.

The provided text describes a Special 510(k) submission for a device modification, the EndoGastric Solutions EsophyX2 System. This type of submission is for modifications to a legally marketed device and typically doesn't involve new clinical studies for effectiveness, but rather verification testing to confirm the modified device performs as intended and is as safe and effective as the predicate device.

Therefore, the input does not contain the kind of detailed information about acceptance criteria, efficacy studies (like MRMC, standalone), ground truth establishment, or sample sizes for clinical trials that would be present in an original 510(k) or PMA. The focus is on demonstrating substantial equivalence through design, performance, and biocompatibility testing against the predicate device.

Given these limitations, here is the information extracted and, where data is not available, a clear indication that it's not provided in the document:

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

The document states: "Verification testing provided proof the modifications met the design specifications". However, it does not detail specific acceptance criteria values or the quantitative results of these performance tests. It broadly asserts that the modifications were validated.

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

This information is not provided in the document. The submission focuses on device modifications and internal verification testing, not a clinical trial with a defined test set of patients.

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 applicable and not provided. As this is a 510(k) for a device modification, there is no mention of a "test set" requiring ground truth established by experts in the context of clinical efficacy. The substantial equivalence is based on engineering and biocompatibility testing.

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

This information is not applicable and not provided.

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

This information is not applicable. The device is a surgical tool (endoscopic clip applier), not an AI-powered diagnostic system, so an MRMC study is irrelevant.

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

This information is not applicable. The device is a surgical tool that requires human operation; it does not operate in a "standalone" algorithmic fashion.

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

For this device modification, the "ground truth" for showing equivalence would have been validated engineering specifications and biocompatibility standards. The document states "biocompatibility testing provided evidence there were no changes to that safety aspect of the device." It does not refer to clinical outcomes, pathology, or expert consensus as ground truth for this modification.

8. The sample size for the training set

This information is not applicable and not provided. The development of this mechanical device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided.

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The EndoGastric Solutions, StomaphyX System with SerosaFuse Fastener is intended for transoral tissue approximation, ligation and full-thickness plication in the G.I. tract.

The EndoGastric Solutions StomaphyX Delivery System and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants delivered through a fastener cartridge. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device, The device uses vacuum to invaginate tissue through a port into a chamber and fastens it using Hshaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. The three elements run the length of the device, inside the outer shaft. The pusher is a hollow tube that rides over the length of the stylet provides a "pilot" hole for the fastener to pass through the tissue and both ride inside the lumen. The stylet is a wire three-faceted, sharpened tip at the distal end to pierce tissue. A fastener is loaded for deployment by depressing the lever on the removable, fastener cartridge located at the proximal end of the device. This action automatically snaps the fastener onto the stylet. When the pusher tube is pushed by the operator, the stylet carnes the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.

This 510(k) summary does not contain information on device acceptance criteria or a study proving the device meets those criteria. The provided text is a summary of a 510(k) submission for a medical device (StomaphyX Delivery Device and Fasteners) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and compares it to existing predicate devices. It also includes the FDA's clearance letter.

Therefore, I cannot populate the table or answer the questions based on the provided text.

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The EndoGastric Solutions StomaphyXTM system with SerosaFuse™ Fastener is intended for tissue approximation, ligation and full-thickness plication in the G.I. tract.

The EndoGastric Solutions StomaphyX™ Delivery Device and Implantable Fasteners consist of an ergonomic, flexible fastener delivery device and sterile polypropylene fastener implants. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device. The device uses vacuum to invaginate tissue through a port into a chamber and fasten it using H shaped polypropylene fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.

The provided text is a 510(k) summary for the EndoGastric Solutions StomaphyX Delivery Device, Fasteners and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study.

Therefore, the document does not contain the acceptance criteria or the details of a study that proves the device meets specific acceptance criteria in the manner requested.

The 510(k) summary states:

• "Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the EndoGastric Solutions StomaphyX™ system with SerosaFusc ™ Fastener has been shown to be substantially equivalent to currently marketed predicate devices."

This indicates that the submission relies on demonstrating similarity to existing devices, rather than presenting a performance study with defined acceptance criteria for a new clinical performance claim.

Specifically, the document does not include information on:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance for such a study.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. A multi-reader multi-case (MRMC) comparative effectiveness study.
5. A standalone (algorithm only) performance study.
6. The type of ground truth used in a performance study (as no such study is detailed).
7. Sample size for a training set (as no AI/algorithm training is implied).
8. How ground truth for a training set was established.

The document's purpose is to establish substantial equivalence for market clearance, not to report on a clinical performance study with specific acceptance criteria that would typically be seen for a new or novel device's functional performance claims.

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The EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener is indicated for use in endoluminal, 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 ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions SerosaFuse™ implantable fasteners, and associated EsophyX delivery device and accessories consist of sterile polypropylene fastener implants and an ergonomic, flexible fastener delivery device. The fasteners and delivery devices are provided sterile and are for single use. The polypropylene fasteners are proprietary and function only with the EGS delivery devices. The delivery devices use either a stainless steel helix or suction to grasp tissue and fasten it using the SerosaFuse polypropylene fasteners. The fastener delivery subsystem comprises 3 elements: stylet, pusher, and a lumen. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.

The provided text describes a 510(k) summary for the EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener and accessories. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, data provenance, expert adjudication, MRMC study, standalone performance, ground truth establishment, and training set details are not explicitly available in the provided document. The document focuses on device description, intended use, and comparison to predicate devices for regulatory approval based on substantial equivalence.

Here's what can be extracted based on the limitations of the provided document:

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

• Not explicitly provided. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable acceptance criteria with reported performance metrics from a study.

2. Sample size used for the test set and the data provenance:

• Not provided. The document does not describe a performance study with a test set. It mentions a 510(k) submission which relies on comparison to predicate devices, not typically a new clinical study for performance metrics in the way implied by these questions.

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

• Not applicable/Provided. No specific test set or ground truth establishment by experts is described in the context of this 510(k) summary.

4. Adjudication method for the test set:

• Not applicable/Provided. No test set requiring adjudication is described.

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:

• Not applicable/Provided. This device is an endoscopic tissue approximation/plication system, not an AI-assisted diagnostic device that would typically involve human readers and an MRMC study.

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

• Not applicable/Provided. This is a medical device for tissue approximation, not an algorithm.

7. The type of ground truth used:

• Not applicable/Provided. As there is no described performance study for the device against specific criteria, the concept of a "ground truth" for performance evaluation is not detailed.

8. The sample size for the training set:

• Not applicable/Provided. This device is not an AI/algorithm-based system that requires a "training set."

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

• Not applicable/Provided. As there is no training set mentioned, this information is not relevant or provided.

In summary, the provided 510(k) summary primarily demonstrates substantial equivalence to existing predicate devices based on intended use and method of operation. It does not detail specific performance studies with acceptance criteria, test sets, or ground truth establishment in the manner typically associated with the evaluation of AI or diagnostic devices.

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