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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® 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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