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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 Gastric tissue is engaged by the Tissue Retractor and withdrawn into the Applicator, thereby pulling the tissue into the open arms of the Applicator.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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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 Medigus Ultrasonic Surgical Endostapler (MUSE™) System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.

The Medigus Ultrasonic Surgical Endostapler (MUSE™) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.

The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile (EtO) and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application.

The control console includes the insufflation, light and camera electronics.

The associated accessories include:

• Irrigation bottle with liquids for irrigation of the camera lens
• Silicon tubes for connecting the console and other accessories to the stapler
• Standard overtube for protecting patient's pharynx
• Tweezers to remove and replace staple cartridge
• Staple cartridges

The provided text describes a 510(k) premarket notification for the Medigus Ultrasonic Surgical Endostapler (MUSE™) System. The document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new diagnostic or AI-driven device.

Based on the information provided, here's an analysis:

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

The document does not explicitly list acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes for the MUSE system itself. Instead, it relies on comparison to a predicate device.

The "acceptance criteria" here are fundamentally about demonstrating that the modified device (which has a different overtube) is as safe and effective as the predicate device (which is K143634 Medigus SRS Endoscopic Stapling System (Trade Name MUSE)).

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

The document does not detail specific "test set" sample sizes, data provenance, or study types (retrospective/prospective) in the context of comprehensive clinical or performance studies for the MUSE system's effectiveness. The "performance data" mentioned (dimensional, mechanical, biocompatibility) are likely engineering tests and not clinical studies with patient sample sizes.

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 to the type of submission described. The submission focuses on substantial equivalence based on engineering and bench testing, not on interpreting data where expert consensus would establish ground truth (e.g., for diagnostic imaging).

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

This information is not applicable to the type of submission 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

An MRMC study is not mentioned because this device (an endoscopic stapler) is a surgical tool, not an AI-assisted diagnostic or interpretation system that would involve "human readers" or AI assistance.

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

This information is not applicable. The MUSE system is an operative device, not a standalone algorithm.

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

The concept of "ground truth" as typically used in diagnostic or AI studies is not directly applicable here. For the engineering tests mentioned (dimensional, mechanical, biocompatibility), the ground truth would be established by validated test methods, reference standards, and laboratory measurements. For substantial equivalence, the "ground truth" is that the predicate device is already legally marketed and presumed safe and effective.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable. There is no mention of a "training set."

Summary of what the document focuses on:

The provided document is an FDA 510(k) clearance letter for a modified medical device. The "study" described is a demonstration of substantial equivalence to a previously cleared predicate device (K143634 Medigus SRS Endoscopic Stapling System).

The primary evidence given to support substantial equivalence are:

• Dimensional comparisons: Showing that the modified device's measurements are consistent with the predicate.
• Mechanical Testing: Demonstrating that the modified device's functional and structural integrity match the predicate.
• Biocompatibility Testing: Ensuring that the materials of the modified device are safe for human contact, likely conforming to ISO standards.

The key point is that the only difference between the predicate and the subject device is the manufacturer of the overtube. The FDA concluded that these minor differences do not raise any new or different questions of safety or effectiveness, and that the performance data demonstrates comparable performance to the predicate. Therefore, the acceptance criteria are met by proving the new device is essentially the same, with no negative impact on safety or efficacy, as the already-approved predicate 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 MUSE System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy

The MUSE system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile (EtO) and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application. The control console includes the insufflation, light and camera electronics. The associated accessories include: Irrigation bottle with liquids for irrigation of the camera lens, Silicon tubes for connecting the console and other accessories to the stapler, Standard overtube for protecting patient's pharynx, Tweezers to remove and replace staple cartridge, Staple cartridges.

The provided text is a 510(k) summary for the Medigus Ultrasonic Surgical Endostapler (MUSE) System. It describes the device, its intended use, and its comparison to a predicate device, as well as performance data provided to support substantial equivalence.

However, the document does not contain acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the format requested. The "Performance Data" section lists types of tests conducted (e.g., electrical safety, software verification, mechanical testing, animal model validation) but does not provide details on specific acceptance criteria for these tests, nor does it present the results in a comparative table with reported device performance against those criteria.

The document details that the modified MUSE System's substantial equivalence is determined by its similarity to a predicate device (K132151 Medigus SRS Endoscopic Stapling System) in intended use, indications, principles of operation, and fundamental technology, with minor differences not raising new safety or effectiveness concerns.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study that proves the device meets them, as this specific information (especially in the structured format requested) is not present in the provided text.

Based on the information available, I can extract the following, but it does not directly answer the core request about acceptance criteria and their proof:

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

• Not provided in the document. The document lists types of tests (Electrical safety and electromagnetic compatibility (EMC), Software verification and validation testing, Mechanical Testing, Animal Model Validation) but does not specify individual acceptance criteria or reported performance values against those criteria.

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

• Not provided in the document. The document mentions "Animal Model Validation" but does not detail the number of animals used or other test sets, nor their provenance (country of origin, retrospective/prospective).

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

• Not provided in the document. The types of studies listed (electrical safety, software, mechanical, animal) do not inherently involve "experts to establish ground truth" in the way clinical studies for AI/diagnostic devices would.

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

• Not provided in the document. This applies more to clinical trials or diagnostic accuracy studies, which are not detailed here.

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/Not provided. This device is an endoscopic stapler, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

• Not applicable/Not provided. This device does not feature an algorithm for standalone diagnostic performance.

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

• Not provided in the document for the performance data mentioned. For mechanical testing, the "ground truth" would be engineering specifications; for software, it would be functional requirements; for animal models, it would be physiological responses/outcomes observed by a veterinarian. Specifics are not given.

8. The sample size for the training set:

• Not applicable/Not provided. As this is a medical device (endoscopic stapler) and not an AI/ML algorithm that requires a "training set," this information is not relevant to the document.

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

• Not applicable/Not provided. (See point 8).

In summary, the provided document is a regulatory submission for a medical device that establishes substantial equivalence, but it does not contain the detailed clinical study data, particularly acceptance criteria and performance against those criteria, that your request outlines for AI/diagnostic devices.

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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 SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.

The Medigus SRS is an Endoscopic Surgical Stapling System. The system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.

The endoscopic stapler is a single use, sterile device which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil.

The distal tip is retroflexed to align with the staple cartridge located in the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application.

The control console includes the insufflation, light and camera electronics.

The associated accessories include:

• . Irrigation bottle with liquids for irrigation of the camera lens
• Silicon tubes for connecting the console and other accessories to the stapler .
• . Standard overtube for protecting patient's pharynx
• Tweezers to remove and replace staple cartridge .
• . Staple cartridges

Differences between the predicate device and subject device are summarized as follows:

• The subject device has a single console whereas the predicate had two consoles.
• The subject device has an improved user interface and software controls . compared to the predicate.
• . The subject device uses an electric motor to power staple ejection, whereas the predicate device manually ejected staples.
• . The subject device contains an alignment pin mechanism to allow accurate alignment of the stapling anvil and cartridge.
• The subject devices uses an LED for illumination, whereas the predicate . contained a Xenon lamp.
• . The subject device contains a CMOS camera, whereas the predicate contained a CCD camera.

The provided text describes a medical device, the Medigus SRS Endoscopic Stapling System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in a clinical or AI-related context.

The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a previously cleared device. This type of submission typically relies on non-clinical performance data (e.g., biocompatibility, electrical safety, mechanical testing) and comparison of technical characteristics to the predicate, rather than a clinical trial with acceptance criteria for device performance against ground truth.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis of the provided information in relation to your request:

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

• Not found. The document does not specify quantitative clinical acceptance criteria or report device performance against such metrics. It lists non-clinical performance data categories that were submitted (Biocompatibility, Electrical safety, Software validation, Sterilization validation, Mechanical and acoustic testing, LED photobiological and thermal safety testing, Camera/optics characterization testing) but does not provide specific criteria or results for these.

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

• Not found. This information would typically come from a clinical trial or a specific performance study, which is not detailed in this 510(k) summary. The listed performance data are non-clinical.

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 found. Ground truth establishment by experts is relevant for clinical or diagnostic AI studies. This document concerns a surgical stapling system for which this type of ground truth is not applicable in the context of this 510(k) submission.

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

• Not found. N/A, as no expert-adjudicated test set 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 found. N/A, as this device is a surgical tool, not an AI-assisted diagnostic or interpretation system that would involve human readers.

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

• Not found. N/A, as this is a surgical device, not an AI algorithm. Its "standalone" performance would refer to its mechanical and functional operation, which is covered by the non-clinical tests mentioned.

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

• Not found. N/A. For a surgical device, "ground truth" often relates to successful surgical outcomes or objective measurements from mechanical tests. The document implies that the device's function was verified through mechanical and other non-clinical tests rather than by comparison to clinical ground truth derived from patient outcomes or pathology in a study specific to this submission.

8. The sample size for the training set

• Not found. N/A, as this is not an AI/ML device that requires a training set in the conventional sense.

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

• Not found. N/A, as this is not an AI/ML device.

Summary regarding the provided text:

The document describes the Medigus SRS Endoscopic Stapling System and focuses on demonstrating its substantial equivalence to an existing predicate device (K120299 Medigus SRS Endoscopic Stapling System) for a 510(k) clearance.

• Intended Use/Indications for Use: The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach to create an anterior partial fundoplication for treating symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
• Differences from Predicate Device: The document highlights several technical differences in the subject device, such as a single console, improved user interface, electric motor for staple ejection (vs. manual), an alignment pin mechanism, LED illumination (vs. Xenon lamp), and a CMOS camera (vs. CCD camera).
• Performance Data (Non-clinical): The substantial equivalence determination was supported by non-clinical performance data, including:
  • Biocompatibility testing
  • Electrical safety and electromagnetic compatibility
  • Software validation
  • Sterilization validation
  • Mechanical and acoustic testing
  • LED photobiological and thermal safety testing
  • Camera/optics characterization testing
• Conclusion: The device has the same intended use and indications, and similar principles of operation and technological characteristics as the predicate. The minor differences do not raise new questions of safety or effectiveness, and the performance data supports its equivalence.

In conclusion, this 510(k) summary demonstrates that the Medigus SRS Endoscopic Stapling System is substantially equivalent to its predicate based on non-clinical performance and technological comparison, rather than a clinical study with specific acceptance criteria as you've outlined for AI or diagnostic devices.

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