The provided text is a 510(k) summary for the SILS™ Port, a surgical trocar. It includes information about the device's intended use and performance data, but it does not contain the specific details required to answer your questions about acceptance criteria, study design, and ground truth establishment.

The document states: "In-vitro and in-vivo testing has been performed in support of the intended use of this device." However, it does not elaborate on the specific acceptance criteria, the results of these tests, sample sizes, expert qualifications, or how ground truth was established.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
If a standalone study was done: While "in-vitro and in-vivo testing" is mentioned, the specific nature of these studies (e.g., standalone vs. human-in-the-loop) and their results are not detailed.
The type of ground truth used: This information is not present.
The sample size for the training set: This information is not present.
How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and the general statement of performance testing, rather than a detailed breakdown of a specific clinical or performance study with acceptance criteria and ground truth methodology.

Summary

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Kob2619

510(K) SUMMARY:

510(k) Summary of Safety and Effectiveness:

SUBMITTER:

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473

CONTACT PERSON:

Robert Zott Program Director, Regulatory Affairs Phone: (203) 492-6013 Fax: (203) 492-5029

DATE PREPARED:

TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

PREDICATE DEVICE(S):

September 8, 2008

SILSTM Port

Surgical Trocar

Endoscope and/or accessories

K981941: Dexide™ Multaport Cannula Reducer and Accessories

K012539: Versa Step™ Reposable System

K954108: Modified Versaport™ Trocar

K072814: Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."

K945457: Auto Suture™ Modified Grip

K073170: R-Port II Laparoscopic Access Device

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

DEVICE DESCRIPTION:

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9 2619

INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

MATERIALS:

For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

The SILSTM Port provides the ability to use three conventional laparoscopic trocars and an insufflation port through a single incision while providing the ability to maintain pneumoperitoneum.

All components of the SILSTM Port are comprised of materials that have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices --Part 1: Evaluation and Testing.

PERFORMANCE DATA:

In-vitro and in-vivo testing has been performed in support of the intended use of this device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing the federal government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the left side of the eagle, while "USA" is positioned on the right side.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Covidien % Mr. Robert Zott Regulatory Affairs Program Director 60 Middletown Avenue North Haven, Connecticut 06473

NOV - 7 2008

Re: K082619

Trade/Device Name: SILS™ Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 27, 2008 Received: October 28, 2008

Dear Mr. Zott:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.

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Page 2 - Mr. Robert Zott

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko82619

Indications for Use

510(k) Number (if known):

K082619

Device Name:

SILS ™ Port

Indications For Use:

For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-On)

Division of General. Restorative, and Neurological Devices

K082619 510(k) Number_

Page 1 of

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.