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.

AI/ML Overview

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:

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."
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.
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.
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."
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.
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.
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).
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."
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NDO Surgical, Inc. Mr. John J. Vozella VP RA/Clinical/QA 125 High Street, Suite 7 Mansfield. MA 02048

JUL 2 7 2015

Re: K073671

Trade/Device Name: Plicator GSX™ Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): December 21, 2007 Received (Date on orig SE ltr): December 27, 2007

Dear Mr. Vozella,

This letter corrects our substantially equivalent letter of March 26, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 -

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):_KO Blo U

Device Name: Plicator GSX™ Suturing System

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

Prescription Use X (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 C.F.R. 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy C. Brogdon

Division Ston-Off Division of Reproductive. Abdo and Radiological Devi 510(k) Number.

\\DC - 71403/600 - 0869482.01

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KO72671 pg. 10+3

5. 510(K) SUMMARY

MAR 2 6 2008

1. SUBMITTER:

NDO Surgical, Inc. 125 High St. Mansfield, MA 02048 Telephone: 508-337-8881 Fax: 508-337-8882

Contact: John J. Vozella, V.P. Regulatory/Clinical/QA Date Prepared: December 21, 2007

2. DEVICE:

Trade Name: Plicator GSXTM Suturing System Common Name: Endoscope accessory Classification Name: Endoscope and accessories Class: II

3. PREDICATE DEVICE:

NDO Surgical Plicator™ Endoscopic Plication System (K071533; K072125) Bard® EndoCinch™ Suturing System (K994290; K003956) EndoGastric StomaphyX Device and Accessories (K062875) InScope Tissue Apposition System (K070151)

4. DEVICE DESCRIPTION:

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K073671 pa 2 of 3

5. INTENDED USE:

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

6. COMPARISON OF CHARACTERISTICS:

The proposed Plicator GSX™ Suturing System (GSX), is identical in design, materials and fundamental operating principles to the predicate Plicator Endoscopic Plication System (EPS) device (K023234, K032820, K071533), except that:

. the Plicator GSX pre-tied, pledgeted suture will be offered in two different lengths (the EPS only offers one suture length),
a tissue grasper is being offered as a procedural accessory component to . the GSX system (the predicate EPS does not include this accessory component) and
. a cartridge release accessory (CRA) is being offered as a non-procedural accessory component to the GSX system (the predicate EPS does not include this accessory component).

The GSX System is also similar to the other listed predicate devices in that they are all designed to reach the desired suture location under endoscopic visualization, grasp tissue in some fashion and place sutures, clips or fasteners in a targeted soft tissue location. All devices share common features such as: singleuse sterile components and delivery of the soft tissue fixation component via manual actuation of a mechanism on the deployment system. Finally, the Plicator GSXTM Suturing System and the predicate devices have the same or similar intended use, which is to endoscopically place sutures, clips or fasteners to approximate soft tissue.

7. PERFORMANCE DATA:

Bench and animal testing of the Plicator GSX™ Suturing System 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 and 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 used in the Plicator GSXTM Suturing System.

Published clinical treatment outcomes demonstrate that placement of multiple, GSX pledgeted sutures safely and effectively closes gastric wall defects.

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K07-3671 pg. 3 of 3

8. CONCLUSION:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the Plicator GSX™ Suturing System has been shown to be equivalent in technology, method of operation and intended use to the currently marketed predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.