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.

Device Description

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.

AI/ML Overview

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.

Summary

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Mediqus leading
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MAR 19 2014

510(k) Summary

Medigus SRS Endoscopic Stapling System

Criteria	Information
510(k) Owner	Medigus Ltd.Building 7AOmer Industrial ParkOmer, 84965 IsraelPhone: +972-8-6466880Fax: +972-8-6466770
Date Prepared	March 18, 2014
Contact Person	Sheila Stevens, PhDUS Clinical and Regulatory Affairs
Device Name	Medigus SRS Endoscopic Stapling System
Trade Name/Proprietary Name	Medigus Ultrasonic Surgical Endostapler(MUSE)
Common Name	Endostapler, endoscopic stapler
Classification Name	Endoscopic Suture/Plication System, GastroesophagealReflux Disease (GERD)21 CFR 876.1500- Endoscope and Accessories; Class II;Product code: ODE
Predicate Device	K120299 Medigus SRS Endoscopic Stapling System
Intended Use/Indications for Use	The SRS Endoscopic Stapling System is intended forendoscopic placement of surgical staples in the soft tissue ofthe esophagus and stomach in order to create anterior partialfundoplication for treatment of symptomatic chronic GastroEsophageal Reflux Disease in patients who require andrespond to pharmacological therapy.

Device Description

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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.

Performance Data

The following non-clinical performance data was provided in support of the substantial equivalence determination:

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

Substantial Equivalence

The Mediqus SRS Endoscopic Stapling System has the same intended use and indications and similar principles of operation, and technological characteristics as the cleared, predicate version of the device. The minor differences in the subject device's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the subject device is as safe and effective as the predicate SRS Endoscopic Stapling System. Thus, the subject device is substantially equivalent to the predicate device.

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Public Health Service

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

March 19, 2014

Medigus, Ltd. Sheila S. Stevens, Ph.D. US Regulatory and Clinical Affairs 2121 North California Blvd., Suite 290 Walnut Creek, CA 94596

Re: K132151

Trade/Device Name: SRS Endoscopic Stapling System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: March 13, 2014 Received: March 18, 2014

Dear Sheila S. Stevens,

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 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.

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Page 2 - Sheila S. Stevens, Ph.D.

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 tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/8 description: The image shows the text "Benjamin Fisher-S". The text is in a bold, sans-serif font. The letters "DA" are stylized with a geometric pattern.

Benjamin 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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Attachment 13

Indications for Use Statement

510(k) Number (if known):_K132151

Device Name:

SRS Endoscopic Stapling System

Indications for Use:

Prescription Use × (Per 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin-S
2014.03 -04'00'

Page 1 of 1

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.