The AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures to include single skin incision applications and specifically where the surgeon anticipates using at least three 5mm cannula ports to establish a path of entry for operating endoscopic instruments.

Device Description

The subject is a surgical trocar and cannula kit is composed of biosafe materials. The device incorporates an expandable elastomer sheath, which serves to hold the cannula vertically in place during endoscopic surgery. The device is used to create and maintain a port of entry during endoscopic surgery. It is fully disposable and is intended for single use only.

AI/ML Overview

The information provided does not contain traditional "acceptance criteria" and "reported device performance" in the context of AI/ML device studies (e.g., sensitivity, specificity, AUC, F1-score). This document is a 510(k) summary for a medical device that is a surgical trocar and cannula kit, not an AI/ML diagnostic or predictive device. Therefore, the questions related to AI/ML specific aspects like sample size for test sets, data provenance, ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through nonclinical (bench top) and in vivo animal studies. The acceptance criteria here are implicitly met by demonstrating that the device performs "at least as safely and effectively as the predicate(s)" across various performance attributes.

Here's a breakdown based on the provided text, adapted to the context of a non-AI/ML device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric / Acceptance Criterion (Implicit)	Reported Device Performance (as demonstrated by testing)
Bench Data (In Vitro):
Leak rate (without trocars, after multiple trocars, after vigorous manipulation)	Confirmed that the device is "substantially equivalent in all manner of operation to the predicate devices" and "at least as safe and effective as the predicate" in maintaining pneumoperitoneum during ordinary use and severe manipulation.
Device insertion and removal evaluation	Confirmed that the device is "substantially equivalent" and "at least as safe and effective as the predicate" regarding insertion and removal forces.
Minimum size of skin incision	Confirmed that the device is "substantially equivalent".
Device fixation	Confirmed that the device is "substantially equivalent" and "at least as safe and effective as the predicate" regarding fixation.
Rigidity / Flexibility	Confirmed that the device is "substantially equivalent".
Size / Dimension	Confirmed that the device is "substantially equivalent".
Sealing Instrument for maintaining insufflation	Confirmed that the device is "substantially equivalent" and "at least as safe and effective as the predicate" in maintaining pneumoperitoneum.
Deployment method	Confirmed that the device is "substantially equivalent" regarding the method of deployment.
Animal Data (In Vivo - Porcine Cholecystectomy):
Ease of port insertion, suturing, and time to insert	"AnchorPort® performed as well as or better than the predicate(s)" in aspects of insertion. "The clinical outcome... was a success with no adverse effects or complications."
Ease of insertion and withdrawal	"AnchorPort® performed as well as or better than the predicate(s)" in aspects of insertion and removal forces.
Ability to maintain pneumoperitoneum	"AnchorPort® performed as well as or better than the predicate(s)" in aspects of maintenance of pneumoperitoneum.
Ability to manipulate instruments for laparoscopic surgery	Demonstrated "conclusively that the device is substantially equivalent." "Performed at least as safely and effectively as the legally marketed devices."
Ability to conduct a typical laparoscopic procedure: cholecystectomy	"The clinical outcome of the porcine cholecysectomy was a success with no adverse effects or complications." Demonstrated "conclusively that the device is substantially equivalent." "Performed at least as safely and effectively as the legally marketed devices."
Ability of anchoring plate to hold the ports in position	"AnchorPort® performed as well as or better than the predicate(s)" in aspects of anchoring and fixation. Demonstrated "conclusively that the device is substantially equivalent." "Performed at least as safely and effectively as the legally marketed devices."

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

Test Set (Bench Data): Not explicitly stated how many devices were tested for each bench test, but it is implied that a sufficient number was used to confirm substantial equivalence. No country of origin is mentioned for the bench data itself, but the submission is from SurgiQuest, Inc. in Orange, CT (USA). This is retrospective for the submission, as the tests were performed to support the 510(k).
Test Set (Animal Data): The document mentions "in vivo animal studies were performed, including a porcine cholecysectomy." The exact number of animals or procedures is not specified, but it refers to "studies" (plural). No country of origin for the animals is specified, but the submission is from a US company. This is retrospective for the submission.

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

For the in vivo animal studies, it states: "by surgeons familiar with the predicate device(s)." The exact number and specific qualifications (e.g., years of experience) are not provided. For bench testing, "robust engineering test methods" were used, implying engineers or technical experts established the ground truth (e.g., measurements, performance against specifications), but details are absent.

4. Adjudication method for the test set

Not applicable/Not specified in the provided text. The evaluation appears to be direct performance assessment (bench tests) and expert observation/assessment (animal studies), rather than an adjudicated review for ground truth establishment.

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 not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

Bench Data: Objective measurements against engineering specifications and comparison to predicate device performance.
Animal Data: Direct observation and assessment of device performance by "surgeons familiar with the predicate device(s)" during a surgical procedure (porcine cholecystectomy), with the "clinical outcome" being a success. This can be considered expert observation/assessment and outcome data (no adverse effects).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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100180 PAGE 1 of (3)

SurgiQuest, Inc. 510(K) Notification SurgiQuest AnchorPort® Optical Trocar & Cannula SIL Kit

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

SUBMITTER	SurgiQuest, Inc.12 Cascade Boulevard, Suite 2BOrange, CT 06477Phone: 203.799.2400	MAY - 5 2016
CONTACT PERSON	Kourosh AzarbarzinFounder & C.E.O. - SurgiQuest, Inc.
DATE PREPARED	January 8, 2010
CLASSIFICATION	Laparoscopic trocar, GCJClass: II
COMMON NAME	Disposable Endoscopic Optical Trocar & Cannula Kit
PROPRIETARY NAME	SurgiQuest AnchorPort® SIL Kit
PREDICATE DEVICE	SurgiQuest Elastomeric Optical trocar & CannulaSurgiQuest, Inc. (Orange, CT)K 063859
	GelPOINT SystemApplied Medical (Rancho Santa Margarita, CA)K090275
	SILSTM PortCovidien LP (North Haven, CT)K082619
	Surgiport™ Blunt Tip TrocarU.S. Surgical Corp. (Norwalk, CT)K903419
	EndoPath III™ Trocar SystemEthicon Endo-Surgery, Inc. (Cincinnati, OH)K032676
DEVICE DESCRIPTION	The subject is a surgical trocar and cannula kit is composed ofbiosafe materials. The device incorporates an expandableelastomer sheath, which serves to hold the cannula vertically inplace during endoscopic surgery. The device is used to createand maintain a port of entry during endoscopic surgery. It isfully disposable and is intended for single use only.

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100180 Page 2 of (3)

SurgiQuest, Inc. 510(K) NOTIFICATION SurgiQuest AnchorPort® Optical Trocar & Cannula SIL Kit.

INDICATIONS

NONCLINICAL TESTS SUBMITTED, REFERENCED OR RELIED UPON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Nonclinical test protocols were designed in order to test the critical performance and safety features of the device. The following bench top tests were performed in order to prove substantial equivalence and test reports are included in the filing:

Bench Data:

Leak rate without trocars in place, after multiple trocars . in place and after vigorous manipulation of trocars.
. Device insertion and removal evaluation
Minimum size of skin incision .
. Device fixation
. Rigidity / Flexibility
Size / Dimension ●
Sealing Instrument for maintaining insufflation .
Deployment method .

In vitro bench top testing has confirmed that the device is substantially equivalent in all manner of operation to the predicate devices sighted in this filing. The tests performed and submitted are those tests sighted in the above section and include method of deployment, fixation, insertion and removal forces, and maintenance of pneumoperitoneum during ordinary use and severe manipulation and incision size. In each case, the device was at least as safe and effective as the predicate.

In vivo animal studies were performed, including a porcine cholecysectomy, by surgeons familiar with the predicate device(s). The in vivo testing with the AnchorPort® device demonstrates that the AnchorPort® is safe and effective. In each aspects of device performance the AnchorPort® performed as well as or better than the predicate(s) in the aspects of insertion and removal forces, anchoring and fixation and maintenance of pneumoperitoneum. The clinical outcome of the porcine cholecysectomy was a success with no adverse effects or complications.

Animal Data:

Ease of port insertion, suturing and time to insert .
. Ease of insertion and withdrawal
. Ability to maintain pneumoperitoneum

CONCLUSIONS DRAWN FROM THE NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE THAT THE DEVICE IS SAFE, AS EFFECTIVE AND PERFORMS AT LEAST AS SAFELY AND EFFECTIVELY AS THE PREDICATE(S)

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100180 Page 3. (3)

SurgiQuest, Inc. 510(K) NOTIFICATION SurgiQuest AnchorPort® Optical Trocar & Cannula SIL Kit

Ability to manipulate instruments for laparoscopic . surgery
. Ability to conduct a typical laparoscopic procedure: cholecystectomy
. Ability of anchoring plate to hold the ports in position

In conclusion, extensive in vivo (animal) testing and in vitro (bench top) testing demonstrates conclusively that the device is substantially equivalent. The device performance was validated using robust engineering test methods and living tissue models and performed at least as safely and effectively as the legally marketed devices sighted in this 510(k) submission.

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Public Health Service

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

SurgiQuest, Inc. % Mr. Kourosh Azarbarzin C.E.O. 12 Cascade Boulevard, Suite 2B Orange, Connecticut 06477

Re: K100180

Trade/Device Name: SurgiQuest AnchorPort® Single Incision Laparoscopic Kit (SILK) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 01, 2010 Received: April 02, 2010

MAY - 5 "010

Dear Mr. Azarbarzin:

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Kourosh Azarbarzin

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

for

Mark N. Melkerson
Director

Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SURGIQUEST, INC. 510(K) Notification SurgiQuest AnchorPort® Optical Trocar & Cannula SH. Kit

STATEMENT FOR INDICATIONS FOR USE

510(k) Number:

K 100180

Device Name: SurgiQuest AnchorPort® Single Incision Laparoscopic Kit (SILK)

Indications for Use: The AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures and specifically where the surgeon will make a single skin incision in order to facilitate the use of multiple trocars to establish a port of entry for operating endoscopic instruments.

Prescription Use: Yes

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

Concurrence of CDRH, Office of Device Evaluation

Neil R. Dylan Forman

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100180

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.