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The Plicator GSX™ Suturing System is indicated for the endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue.

The Plicator GSX Suturing System (GSX) deploys a pledgeted, suture to approximate and secure tissue within the gastrointestinal tract. The GSX consists of four procedural components: the Plicator® instrument, the Plicator® tissue retractor, the Plicator® tissue grasper and the Plicator GSX™ suture cartridge. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The grasper is made of surgical grade stainless steel, with a nitinol connecting rod and arms. The pledgeted suture is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The suture is housed in a disposable cartridge. Procedurally, the suture cartridge and either the retractor or the grasper are loaded onto the instrument and the instrument is then passed transorally into the gastrointestinal tract to deploy the suture and secure tissue. Once the Plicator instrument has been introduced transorally, the retractor or grasper is engaged into soft tissue in the gastrointestinal tract and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the suture is deployed, creating a transmural fixation of soft tissue.

This document is a 510(k) summary for the Plicator GSX™ Suturing System, a medical device. It focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing a detailed acceptance criteria and study report for the device's performance against specific metrics. Therefore, a direct answer to your request in the requested format is not fully achievable from this document alone.

However, I can extract the relevant information that is present and point out what is missing:

Information Extracted from the Document:

This document describes the Plicator GSX™ Suturing System. It is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process generally does not require the submission of detailed clinical trial data with specific acceptance criteria and robust performance metrics in the same way a PMA (Premarket Approval) would.

Addressing your specific points based on the provided text:

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

   • The document does not provide a table of pre-defined acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy, or a specific mechanical strength threshold) for the device.
   • Instead, it states that performance was demonstrated through:
     • "Bench and animal testing... demonstrated that the system is able to safely and reliably deploy multiple pledgeted sutures."
     • "Bench testing confirmed that the GSX pledgeted suture meets USP requirements."
     • "Testing in the porcine animal model demonstrated successful closure of gastric perforations, with normal results for the healing process."
     • "Biocompatibility testing per ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing confirmed acceptable biocompatibility profiles of patient contact materials."
     • "Published clinical treatment outcomes demonstrate that placement of multiple, GSX pledgeted sutures safely and effectively closes gastric wall defects."

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

   • Animal study: "Porcine animal model" is mentioned, but the number of animals or samples is not specified.
   • Bench testing: Mentioned, but sample sizes are not specified.
   • Clinical data: "Published clinical treatment outcomes" are mentioned, implying retrospective data, but no details on study design, sample size, or country of origin are provided.

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 document is for a mechanical suturing system, not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" as established by experts for a test set (like in diagnostic imaging) doesn't directly apply here. "Ground truth" for mechanical function would be based on objective measurements and observations in bench and animal studies (e.g., successful suture deployment, closure of perforations, material properties).
   • No information on "experts" for establishing ground truth is present.

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

   • Not applicable/Not mentioned, as this is not a diagnostic study requiring inter-rater agreement for "ground truth."

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 is a medical device (suturing system), not an AI or imaging diagnostic tool. No MRMC study would be performed for this type of product.

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

   • Not applicable. This is a manual suturing system; there is no "algorithm" or "standalone" performance in the AI context.

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

   • For bench testing: Compliance with "USP requirements" (United States Pharmacopeia) for the suture material, which are objective, established standards.
   • For animal testing: "Successful closure of gastric perforations" and "normal results for the healing process." This would be observed through direct inspection, potentially histology (pathology), and clinical assessment of the animals.
   • For biocompatibility: Compliance with "ISO 10993-1" standards, which involve specific tests for biological safety.
   • For clinical data: "Published clinical treatment outcomes," which would be patient outcomes data (e.g., successful closure, absence of complications).

8. The sample size for the training set:

   • Not applicable. This document refers to a mechanical device, not an AI model, so there is no "training set."

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

   • Not applicable (no training set).

In Summary:

The provided document is a 510(k) summary focused on demonstrating "substantial equivalence" of the Plicator GSX™ Suturing System to predicate devices. This regulatory pathway typically relies on bench testing, animal studies, biocompatibility, and sometimes reference to existing clinical literature for safety and performance, rather than presenting detailed, prospectively collected clinical trial data with specific, quantitative acceptance criteria and statistical performance measures (like sensitivity/specificity) against a rigorously established ground truth by multiple experts. The document confirms that testing was performed but lacks specific numerical details regarding sample sizes, exact performance metrics, and the precise methodology for establishing "ground truth" observations beyond adherence to standards and observed outcomes.

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The NDO Endoscopic Plication System (EPS) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The NDO Surgical Endoscopic Plication System (EPS) deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication.

Both the retractor and implant cartridge are provided as sterile, single use, disposable components of the EPS. The Plicator instrument is a non-sterile multiple use device that is subject to cleaning and high level chemical disinfection between uses. To facilitate cleaning and high level disinfection of the Plicator instrument with an Automated Endoscope Reprocessor (AER), the EPS will include a non-procedural "cleaning adapter" accessory.

The provided document describes a 510(k) submission for the NDO Surgical Endoscopic Plication System (EPS). This submission focuses on modifications to the cleaning and high-level disinfection instructions and an added accessory rather than a new device or significant design change requiring extensive clinical performance studies. Therefore, the information typically available for software-as-a-medical-device (SaMD) studies (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies) is not applicable here.

Here's an analysis based on the provided text, focusing on the device modifications and the performance data provided for those modifications:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical or algorithmic performance data. The testing performed was simulated use testing for cleaning and disinfection. Therefore, typical sample sizes (e.g., number of patients, images) and data provenance (country, retrospective/prospective) are not applicable.

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

Not applicable. The ground truth for the cleaning and disinfection study was the successful elimination of Mycobacterium terrae to accepted standards, as determined by laboratory testing protocols outlined in ASTM E 1837-96. This does not involve human experts in the way clinical diagnostic studies would.

4. Adjudication Method for the Test Set

Not applicable. This was a laboratory-based performance test following a standardized protocol (ASTM E 1837-96), not a study requiring adjudication of human expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical medical device and its cleaning/disinfection procedures, not an AI or diagnostic application.

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

Not applicable. This submission is not for an algorithm or software. The performance data relates to the physical Plicator instrument's ability to be properly disinfected.

7. The Type of Ground Truth Used

For the cleaning and disinfection study, the ground truth was derived from laboratory testing standards and microbial inactivation as stipulated by ASTM E 1837-96. This standard outlines procedures to determine the efficacy of disinfection processes. The "ground truth" was whether the specified disinfection process effectively eliminated the test microorganism (Mycobacterium terrae) from the device, which is an objective, measurable outcome in a laboratory setting.

8. The Sample Size for the Training Set

Not applicable. This submission is not for an AI/ML device, so there is no "training set."

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

Not applicable, as there is no training set for this device modification submission.

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The NDO Endoscopic Plication System (EPS) is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The NDO Surgical Endoscopic Plication System (EPS) is a device that deploys a suture-based implant in the stomach near the Gastroesophageal Junction thereby creating a full thickness plication of the gastric cardia for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three procedural components: the Plicator instrument, the Plicator retractor and the Plicator implant cartridge. The implant cartridge and retractor are loaded onto the instrument and the instrument is then passed transorally into the stomach to create the plication. The Plicator instrument's shaft, which comes into contact with the patient, is made of polyurethane. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium retention bridges, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the Plicator instrument has been introduced into the stomach, the retractor is engaged into the gastric cardia and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating a full thickness, serosa-to-serosa plication.

Here's an analysis of the provided text regarding the NDO Surgical Endoscopic Plication System (EPS) and its acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance

The submission focuses on modifications to a previously cleared device (predicate EPS) and demonstrates substantial equivalence. Therefore, the "acceptance criteria" are primarily established by the performance of the predicate device and the new device's ability to meet those same levels of safety and effectiveness, especially for the modified components and new features (like multiple implant deployment).

Study Information

1. Sample Size used for the test set and the data provenance:

   • Bench Testing: Not explicitly stated, but typically involves a specified number of samples for each test (e.g., a certain number of leak tests, implant deployments). The provenance is likely internal lab testing by NDO Surgical, Inc.
   • Biocompatibility Testing: Not explicitly stated, but subject to ISO standards for medical device materials. The provenance refers to "patient contact materials" and comparisons to "predicate instrument and implant cartridge."
   • Simulated Use Testing: Not explicitly stated regarding sample size. Provenance is likely in-house testing.
   • Clinical Testing: Not explicitly stated regarding the number of patients or implants. The data provenance is "clinical experience with the predicate device" which implies a prospective or retrospective analysis of human use data, but the "clinical testing" for the modified device would be prospective. The statement "Clinical testing demonstrated that serial placement of multiple, Plicator implants... safely and effectively treats..." strongly suggests a clinical study was performed.

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

   • Not applicable for bench, biocompatibility, and simulated use testing which rely on objective measurements and established protocols.
   • For the clinical testing, the "ground truth" would be the patient's GERD symptoms and their response to treatment, assessed by clinicians (likely gastroenterologists) as part of the study. The number of experts or their specific qualifications (e.g., years of experience) are not detailed in this summary.

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

   • Not applicable for the types of tests described (bench, biocompatibility, simulated use).
   • For clinical studies, adjudication methods (like independent review panels for adverse events or efficacy endpoints) are common, but this detail is not provided in this 510(k) summary.

4. 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 surgical instrument, not an imaging or diagnostic AI device.

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

   • Not applicable. This is a manual surgical device with a human operator.

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

   • Bench Testing: Objective physical measurements and functional performance tests (e.g., water ingress, implant deployment mechanics).
   • Biocompatibility Testing: Compliance with established biocompatibility standards (e.g., ISO 10993).
   • Simulated Use Testing: Observational data on successful and safe deployment in a controlled environment.
   • Clinical Testing: Patient-reported symptoms of GERD, physician assessment of treatment response, and safety outcomes (adverse events). This falls under outcomes data and clinical assessment.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

   • Not applicable. No training set is involved.

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The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride coated with parylene. The retractor is made of surgical grade stainless steel, with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.

The provided document is a 510(k) premarket notification letter and a 510(k) summary for the NDO Surgical Endoscopic Plication System. It discusses the device's substantial equivalence to a predicate device and mentions performance data were submitted, but it does not provide specific acceptance criteria or an explicit study description with detailed results that prove the device meets these criteria.

Therefore, I cannot populate the table and answer the questions as requested, because this information is not present in the provided text. The document states that "Bench top, In-Vivo simulated use and ex-vivo performance testing were completed in support of the substantial equivalence determination," but it does not detail these tests, their acceptance criteria, or their results.

Key Missing Information:

• Specific acceptance criteria for the device's performance.
• Detailed results from any studies (bench top, in-vivo, or ex-vivo).
• Sample sizes for test sets or training sets.
• Data provenance.
• Information about expert involvement for ground truth, adjudication, or MRMC studies.
• Details on standalone performance or ground truth type.

Without this information, I cannot fulfill your request for a table of acceptance criteria, reported performance, and the details of a study proving compliance.

Ask a specific question about this device

The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride. The retractor is made of surgical grade stainless steel. with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.

This document describes the NDO Surgical Endoscopic Plication System (EPS) for treating GERD. However, it is a 510(k) summary for a substantial equivalence determination and does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.

The document states that the device is "substantially equivalent" to a predicate device (K023234) and that "Bench top, In-Vivo simulated use and ex-vivo performance testing was provided in support of the substantial equivalence determination. The testing demonstrates substantially equivalent performance between the two devices." This implies that the acceptance criteria and performance data were assessed against the predicate device's performance, but the specific details are not provided in this public document.

Therefore, I cannot provide the detailed information requested in the prompt, such as specific acceptance criteria, sample sizes, expert qualifications, or details about MRMC or standalone studies.

Here's what can be extracted from the document, though it's limited in scope for your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in this document. The document refers to "substantially equivalent performance" to the predicate device (NDO Surgical Endoscopic Plication System K023234). This would imply passing various bench-top, in-vivo simulated use, and ex-vivo performance tests to demonstrate comparable safety and effectiveness, but the specific metrics and thresholds are not included.
• Reported Device Performance: "The testing demonstrates substantially equivalent performance between the two devices." No specific quantitative metrics (e.g., accuracy, sensitivity, specificity, clinical outcomes) are provided in this summary.

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

• Not specified in this document. The testing mentioned (Bench top, In-Vivo simulated use and ex-vivo) implies test sets were used, but their size and provenance (country, retrospective/prospective) are not detailed.

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

• Not applicable as this is a medical device for treatment, not an AI/diagnostic device where ground truth is typically established by experts for image interpretation. The "ground truth" here would relate to the successful and safe deployment and function of the device, likely assessed by engineers, clinicians, and researchers through various performance tests.

4. Adjudication method for the test set:

• Not applicable/ Not specified.

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 is a medical device for a physical procedure, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable. This is a physical endoscopic device, not a software algorithm.

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

• For this type of device, "ground truth" would generally be related to engineering specifications, successful deployment, structural integrity, and functional outcomes in simulated and ex-vivo environments, and ultimately, clinical outcomes in human studies (though not detailed here). The document refers to "Bench top, In-Vivo simulated use and ex-vivo performance testing," which would evaluate these aspects against predefined criteria, likely derived from the predicate device's performance and established engineering standards.

8. The sample size for the training set:

• Not applicable/ Not specified. This device is not an AI algorithm that requires a "training set."

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

• Not applicable.

In summary, as this is a 510(k) summary for a medical device (Endoscopic Plication System) seeking substantial equivalence, it focuses on demonstrating that the updated device is as safe and effective as a previously cleared predicate and does not provide the detailed performance metrics, acceptance criteria, or study specifics typically found in a clinical trial report or a submission for a novel AI/diagnostic device.

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The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to phamacological therapy.

The Endoscopic Plication System consists of an instrument, retractor, overtube and implant.

The instrument is passed transorally to create a plication in close proximity to the gastroesophageal junction.

The implant is designed to help pass and secure the suture.

The retractor is designed to secure and retract the tissue during the placement of the implant. It is placed down a working channel of the instrument prior to the procedure.

The overtube is designed to protect the esophagus during the procedure.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the specific study proving the device meets those criteria.

The document is a 510(k) premarket notification letter and a 510(k) summary for the NDO Surgical Endoscopic Plication System. While it mentions "Clinical evaluation" under performance data and states "The clinical comparison shows that the NDO Endoscopic Plication System to be at least as safe and effective as the Bard EndoCinch," it does not provide any specific details about:

1. Acceptance criteria: What specific metrics (e.g., success rates, complication rates, improvement in GERD symptoms) were considered, and what thresholds defined acceptance.
2. Reported device performance: The actual numerical results from the clinical study.
3. Sample size: For either the test set or training set.
4. Data provenance: Country of origin, retrospective/prospective.
5. Number and qualifications of experts: For ground truth establishment.
6. Adjudication method.
7. MRMC comparative effectiveness study: No mention of human reader performance or AI assistance.
8. Standalone algorithm performance: No mention of an algorithm, only a device.
9. Type of ground truth: Not specified beyond "clinical comparison."
10. How ground truth was established for training or testing.

The document primarily focuses on establishing substantial equivalence to a predicate device (Bard EndoCinch Suturing System) based on similar intended use, technical characteristics, and the lack of new safety/effectiveness questions from bench and animal testing.

Therefore, I cannot generate the table or answer the specific questions you posed based on the provided text.

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