The Arc EndoCuff and Arc Endocuff Vision have short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.

The Arc EndoCuff and Arc Endocuff Vision are designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.

The Arc EndoCuff and Arc Endocuff Vision are cylindrical shaped all polymer products. They utilise the combined properties of two polymer materials to self-retain to the designated endoscope(s). The products feature a number of flexible "hairs" that fold within the structure of the product during intubation and forward movement when in use, and open out when drawn backward to control field of view.

Both the Arc EndoCuff and Arc Endocuff Vision devices are manually pushed onto the tip of the endoscope. It is designed to grip the endoscope sufficiently so as to prevent dislodgment during the procedure but without causing damage to the endoscope. At the end of the procedure, the device is removed either manually or with a purpose designed disposable tool before the endoscope is reprocessed.

The endoscope fitted with the Arc EndoCuff or Arc Endocuff Vision is inserted into the intestine either through the anus or a stoma and is used in the standard manner. The EndoCuff stabilizes the tip of the instrument in the bowel lumen enabling the shaft of the Arc endoscope to be more easily straightened on pulling back so avoiding excessive looping. This is because the cuff maintains the position of the tip without having to angle it acutely against the bowel wall to gain purchase. The device does not hinder forward motion or cause trauma.

During extubation, the device enables tip withdrawal in a more controlled fashion and provides improved visualisation by opening up the intestinal lumen for careful examination. Mucosal folds are everted and flattened enabling a more complete view of the areas of the bowel wall that were hidden behind mucosal folds.

AI/ML Overview

This document is a 510(k) Summary for the Arc EndoCuff and Arc Endocuff Vision devices, which are accessories for endoscopes. It describes the device, its indications for use, and technological characteristics. The main purpose of this submission is to add additional marketing claims, which are supported by non-clinical performance testing, clinical data, or device design.

The document does NOT describe the acceptance criteria or a study that proves the device meets the acceptance criteria for an AI/ML medical device.

Instead, it pertains to a physical medical device (an endoscope accessory) and focuses on demonstrating substantial equivalence to previously cleared predicate devices and supporting additional marketing claims for these physical devices.

Therefore, many of the requested elements for describing the acceptance criteria and a study for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to the content of this 510(k) summary.

However, I can extract information relevant to the device's claims and their supporting documentation as provided in the document.

Based on the provided document, here's what can be inferred about the device's claims and supporting evidence, noting that the context is a physical medical device, not an AI/ML system:

The document describes marketing claims for the Arc EndoCuff and Arc Endocuff Vision, and the supporting documentation for each claim. This is the closest equivalent to "acceptance criteria" and "proof" in the context of this 510(k) submission, even though it's not a formal set of quantitative acceptance criteria for an AI/ML model's performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI/ML device, there are no specific quantitative acceptance metrics like sensitivity or specificity. Instead, the "acceptance criteria" are the marketing claims, and the "reported device performance" is the type of documentation (clinical data, device design, in-vitro testing) that supports these claims.

No.	Marketing Claim (Proxy for "Acceptance Criteria")	Supporting Documentation (Proxy for "Reported Device Performance")
1	Arc EndoCuff assisted colonoscopy results in a statistically significant and clinically relevant improvement in adenoma detection rate in screening, surveillance, and diagnostic populations, as compared with unassisted colonoscopy.	Based on Clinical Data (Specifically, a "Meta-Analysis of the Clinical literature supports the improvement of Adenoma Detection Rate claims.")
2	Arc EndoCuff and Arc Endocuff Vision are designed to increase ADR by manipulating folds to maximize the viewable mucosa.	Based on Device Design & In addition, based on Clinical Data
3	The Arc EndoCuff and Arc Endocuff Vision allows for controlled withdrawal.	Based on Device Design
4	The Arc EndoCuff and Arc Endocuff Vision have been designed to minimize the difficulties in loop reduction.	Based on Device Design
5	The Arc EndoCuff and Arc EndoCuff Vision are designed with an outer diameter to provide increase wall apposition in the colon.	Based on Device Design
6	The hinged arms of the Arc EndoCuff and Arc Endocuff Vision collapse into the body to minimize intubation force and insertion resistance.	Based on Device Design and In-vitro testing.
7	The internal ridges provide a tight grip on the distal end of the colonoscope and minimize risk of dislodgement.	Based on Device Design and Clinical Data.
8	The design is intended to minimize the risk of mucosal trauma.	Based on Device Design and In-vitro testing.
9	The Arc Endocuff Vision reduces the likelihood of red-out.	Based on Device Design.

Regarding the other requested information, these are largely not applicable as the document describes a physical medical device, not an AI/ML system:

2. Sample sized used for the test set and the data provenance:

The document mentions "Clinical Data" and "Meta-Analysis of the Clinical literature supports the improvement of Adenoma Detection Rate claims." It does not specify the sample sizes of the individual studies included in the meta-analysis, nor details about data provenance (e.g., country of origin, retrospective/prospective nature of the meta-analyzed studies). This information would typically be in the full clinical study reports, not a 510(k) summary.

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 physical device; no "ground truth" establishment in the context of an AI/ML model's output for analysis by experts is described. Clinical studies would involve physician assessments, but this document does not detail the number or qualifications of clinicians involved in the meta-analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept pertains to establishing ground truth for AI model performance evaluation, which is not what this document is about.

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. MRMC studies are for evaluating diagnostic performance of systems (often AI) with human readers. The clinical data cited is likely related to the device's impact on Adenoma Detection Rate during colonoscopy, which is a clinical outcome, not a reader study of diagnostic interpretation. The document states the device results in a "statistically significant and clinically relevant improvement in adenoma detection rate," but does not provide specific effect sizes.

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

Not applicable. This is a physical device that assists human clinicians, not a standalone AI algorithm. It's used with an endoscope, not independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the clinical claim (ADR improvement), the "ground truth" would be the pathology results of detected polyps/adenomas and the patient outcome of Adenoma Detection Rate as determined in the clinical studies included in the meta-analysis.

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

January 23, 2017

Boddingtons Plastics Ltd Sarah Gibson Regulatory Compliance Manager Unit 6 Pattenden Lane, Marden Tonbridge, Kent TN12 9QJ United Kingdom

Re: K162205

Trade/Device Name: Arc EndoCuff and Arc Endocuff Vision Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated (Date on orig SE ltr): November 10, 2016 Received (Date on orig SE ltr): November 14, 2016

Dear Sarah Gibson:

This letter corrects our substantially equivalent letter of December 9, 2016

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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.

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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 801); medical device 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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 Industry and Consumer Education 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

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

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Indications for Use

510(k) Number (if known) K162205

Device Name

Arc EndoCuff and Arc Endocuff Vision

Indications for Use (Describe)

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
· Keeping the suitable depth of endoscope's view field
· Helping the endoscope with being inserted into the gastrointestinal tract

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

Summary of Safety and Effectiveness

510(k) number _K162205

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Summary

Submitter's Identification:	Boddingtons Plastics LtdUnit 6 Wheelbarrow Park EstatePattenden LaneTonbridgeKentTN12 9QJUnited Kingdom
Contact:	Sarah Gibson
Telephone:	+44 1622 833700
Fax:	+44 1622 833701
Email:	Sarah.gibson@boddingtons.co.uk
Date of Summary:	01st August 2016
Device Name:	Arc EndoCuff and Arc Endocuff Vision
Proprietary Name:	Arc Endocuff Vision ARV110; ARV120; ARV130and ARV140Arc EndoCuff AEC110, AEC120, AEC130 andAEC140
Classification:	Endoscope and/or accessories
Product Code:	FED
Product Class:	II
Code of Federal Regulation:	21 CFR 876.1500
Panel	Gastroenterology and Urology

Substantial Equivalence:
Manufacturer	Trade Name	Model	510(k) Number
Boddingtons Plastics Limited	Arc EndoCuff	AEC110, AEC120,AEC130, AEC140	K122565
Boddingtons Plastics Limited	Arc Endocuff Vision	ARV110, ARV120,ARV130, ARV140	K151801

Description

Description of Device

The Arc EndoCuff and Arc Endocuff Vision have short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.

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Arc EndoCuff Vision

The Arc EndoCuff and Arc Endocuff Vision are designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.

Indications for Use:

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

Keeping the suitable depth of endoscope's view field
Helping the endoscope with being inserted into the gastrointestinal tract

Technological Characteristics

The purpose of this notification is to add additional marketing claims to the Arc EndoCuff and Arc Endocuff Vision, there are no new technological features incorporated in the devices.

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Conclusion

lt is concluded that the Arc EndoCuff and Arc Endocuff Vision remain safe and effective as the product design, materials and sterilisation methods remain unchanged from the original Premarket Notifications.

The expanded marketing claims are substantially equivalent and do not change fundamental scientific technology and intended use of the market cleared device. A Meta-Analysis of the Clinical literature supports the improvement of Adenoma Detection Rate claims.

Marketing Claims

The marketing claims were supported via non-clinical performance testing, clinical data, or were based on the device design, will be included within the advertising and promotional materials for Arc EndoCuff and Arc Endocuff Vision, and are as follows;

No.	Marketing Claims	Supporting Documentation
1	Arc EndoCuff assisted colonoscopy resultsin a statistically significant and clinicallyrelevant improvement in adenomadetection rate in screening, surveillance,and diagnostic populations, as comparedwith unassisted colonoscopy.	Based on Clinical Data
2	Arc EndoCuff and Arc Endocuff Vision aredesigned to increase ADR by manipulatingfolds to maximize the viewable mucosa.	Based on Device DesignIn addition, based on Clinical Data
3	The Arc EndoCuff and Arc Endocuff Visionallows for controlled withdrawal.	Based on Device Design
4	The Arc EndoCuff and Arc Endocuff Visionhave been designed to minimize thedifficulties in loop reduction.	Based on Device Design
5	The Arc EndoCuff and Arc Endocuff Visionare designed with an outer diameter toprovide increase wall apposition in thecolon.	Based on Device Design

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boddingtons Arc EndoCuff Vision

No.	Marketing Claims	Supporting Documentation
6	The hinged arms of the Arc EndoCuff andArc Endocuff Vision collapse into the bodyto minimize intubation force and insertionresistance.	Based on Device Design and In-vitrotesting.
7	The internal ridges provide a tight grip onthe distal end of the colonoscope andminimize risk of dislodgement.	Based on Device Design and ClinicalData.
8	The design is intended to minimize the riskof mucosal trauma.	Based on Device Design and In-vitrotesting.
9	The Arc Endocuff Vision reduces thelikelihood of red-out.	Based on Device Design

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.