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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 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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