Advanced UroScience InnerSheath consists of a cannula and a cap. The cannula is designed to fit easily within an endoscope and to permit easy alignment of an injection needle within to in easily within an endosope and to provide adequate gripping of the cannula and endoscope, and an adequate seal with the injection needle. Advanced UroScience InnerSheath is provided sterile and is intended for single use only.

AI/ML Overview

Here's an analysis based on the provided document, addressing the various points about acceptance criteria and device study.

It's important to note that this document is a 510(k) summary for a medical device (Advanced UroScience InnerSheath) submitted to the FDA for market clearance. 510(k) submissions typically rely on demonstrating "substantial equivalence" to a predicate device rather than presenting full-blown clinical trials with detailed acceptance criteria and statistical performance metrics in the same way a PMA (Pre-Market Approval) study would. Therefore, some of the requested information (especially around specific performance metrics, sample sizes for specific tests, and AI-related details) is unlikely to be found in this type of document because it wasn't required for this device's regulatory pathway.

Device Name: Advanced UroScience InnerSheath

Intended Use: To help position an injection needle within the center of an endoscope.

1. A table of acceptance criteria and the reported device performance

Based on the provided document, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated as they would be in a full clinical study report. The submission relies on "technological characteristics and performance" being "similar to or equivalent to the predicate device" and demonstrating safety and effectiveness through "Biocompatibility and bench testing."

Acceptance Criteria Category (Inferred)	Reported Device Performance
Material Biocompatibility	Demonstrated to be safe (via "Biocompatibility testing")
Functional Equivalence to Predicate	"Technological characteristics are similar to or equivalent to the predicate device." "performance is substantially equivalent to the predicate device."
Ease of Fit within Endoscope	"designed to fit easily within an endoscope"
Ease of Alignment of Injection Needle	"permit easy alignment of an injection needle"
Adequate Gripping (Cannula & Endoscope)	"provide adequate gripping of the cannula and endoscope"
Adequate Seal with Injection Needle	"an adequate seal with the injection needle"
Sterility	"provided sterile" (Implies meeting sterility standards)
Single Use	"intended for single use only"

Note: The acceptance criteria listed above are inferred from the device description and the claim of "safety and effectiveness" and "substantial equivalence." The document does not provide pass/fail thresholds or specific quantitative results from these tests.

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

Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions "bench testing" but does not provide details on the number of devices or iterations tested.
Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission, the testing would typically be conducted according to US or international standards accepted by the FDA. It would generally be prospective for bench testing and biocompatibility, but the exact study design details are absent.

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

Not applicable / Not specified. For a device like an endoscope accessory, "ground truth" (in the sense of expert radiological or pathological labels) is not typically established. The testing would focus on engineering and functional performance, and possibly biocompatibility by qualified lab personnel.

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

Not applicable / Not specified. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. For bench testing of a device's physical and functional properties, a formal adjudication process as described (e.g., 2+1 reader consensus) is not typically used.

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 device (Advanced UroScience InnerSheath) is a physical medical device (an endoscope accessory) and does not involve AI or human "readers" in the context of interpretation. Therefore, an MRMC study or AI assistance effect size is not relevant.

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

Not applicable. This device is a physical, non-AI medical device.

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

Not applicable in the conventional sense. For this device, "ground truth" would relate to the successful and safe mechanical/functional performance (e.g., proper fit, seal, alignment) as evaluated by engineering standards, and biological compatibility as evaluated by established lab tests. It's not about diagnosing or classifying medical conditions, so expert consensus, pathology, or outcomes data in a diagnostic context are not relevant.

8. The sample size for the training set

Not applicable / Not specified. This device does not use machine learning, so there is no "training set." The engineering and biocompatibility testing would not be described in terms of training data.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

Summary of Limitations due to 510(k) Regulatory Pathway:

This document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device rather than proving de novo safety and effectiveness through extensive, detailed clinical trials with explicit acceptance criteria and statistical endpoints in the way a PMA submission or an AI/software as a medical device (SaMD) study would. The focus is on showing that the new device is as safe and effective as a legally marketed predicate device through similar technological characteristics and performance. Therefore, many of the detailed quantitative and methodological questions provided in the prompt are not addressed in this type of regulatory filing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right, stacked on top of each other.

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

JUL 27 2015

Advanced UroScience, Inc. Ms. Karen E. Peterson Vice President of Regulatory, Clinical and Quality Affairs 1290 Hammond Road St. Paul, MN 55110

Re: K002573

Trade/Device Name: Advanced UroScience Innersheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated (Date on orig SE ltr): August 17, 2000 Received (Date on orig SE ltr): August 18, 2000

Dear Ms. Peterson,

This letter corrects our substantially equivalent letter of November 16, 2000.

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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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

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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EXHIBIT 3

Indications for Use Statement

L 30 25 73 510(k) Number (if known)_

Advanced UroScience InnerSheath Device Name

Indications for Use

Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.

(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109

・

Over the Counter Use_

(Optimal Format 1-2-96)

Daniel C. Heggem

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

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Advanced UroScience, Inc.

EXHIBIT 7 Koo2573

510(k) Summary

Submitter's Name, Address, and Date of Submission

Karen E. Peterson Vice President of Regulatory, Clinical, & QA Advanced UroScience, Inc. 1290 Hammond Road St. Paul, MN 55110

Phone:	651-762-2146
Fax:	651-407-1975

August 17, 2000 Submitted:

Device Name

Trade Name: Classification Name:

Advanced UroScience InnerSheath Endoscope and/or Accessories, 21 CFR 876.1500 Cannula .

Common/Usual Name:

Predicate Device

Bard Stabilizing Cannula (K930827)

Indication for Use

Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.

Device Description

Technological Characteristics and Performance

The technological characteristics are similar to or equivalent to the predicate device. Biocompatibility and bench testing have demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device.

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.