The Xenoscope™ is intended to be used in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.

Device Description

The Xenoscope™ System contains two separate functioning components. First, the Xenoscope™ Laparoscope Device is a 0° or 30°, 30 Fr (10mm), 10 - 36 cm long, singleuse, high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. Second, the Xenoscope™ Dongle (now termed as the Xenobox™), which converts the camera image onto the video display screen for the surgeon to use, is provided with the Xenoscope™. Together, the Xenoscope™ and the Xenobox™ comprise the Xenoscope™ Laparoscopic System and work synergistically together.

AI/ML Overview

This looks like a 510(k) summary for the Xenocor Xenoscope Laparoscopic System, which is a medical device. Based on the provided text, it's difficult to extract the type of detailed information requested about acceptance criteria and a study proving the device meets them because this document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific performance metrics.

However, I can extract the information that is present and note where specific requested details are not provided.

Here's an attempt to answer your questions based only on the provided text:

Acceptance Criteria and Study for Xenocor Xenoscope Laparoscopic System

The provided document describes a premarket notification (510(k)) for the Xenocor Xenoscope Laparoscopic System. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a de novo clinical study with detailed performance metrics and acceptance criteria as one might see for a novel device or a PMA application.

Therefore, the "acceptance criteria" discussed are largely related to functional and safety testing designed to show that the new device performs comparably to the predicate and meets its own design specifications, rather than clinical performance against a specific disease state.

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

Acceptance Criteria Category	Reported Device Performance / Outcome	Explanation/Context from Document
Biocompatibility	Met pre-determined acceptance criteria	Per ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours.
Software Verification	Met pre-determined acceptance criteria	Verification of modifications for image rotation feature of the 30° scope; software level of concern not changed.
Shaft Bending Inspection	Met pre-determined acceptance criteria	Inspection of the laparoscope shaft to confirm functionality after bending the shaft.
Overall Functional/Safety	Met all acceptance criteria	"All necessary verification steps met pre-determined acceptance criteria to confirm safety and efficacy."
Comparative Analysis	Comparable to predicate device	"It has been demonstrated that the Xenoscope™ Laparoscopic System is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations."

Missing Information: The document does not specify quantitative acceptance criteria (e.g., "imaging resolution must be X lines per mm" or "light output must be Y lumens") or the specific numerical results of these tests. It only states that "All data met pre-determined acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the tests mentioned (Biocompatibility, Software Verification, Shaft Bending Inspection, or Comparative Analysis). It's likely these were engineering or bench tests rather than patient studies with a "test set" in the clinical sense.
Data Provenance: Not specified. Given the nature of a 510(k) for an endoscope, these are typically laboratory-based engineering and functional tests conducted by the manufacturer (Xenocor, Inc., USA). The document does not mention any clinical data, patient studies, or geographical origin of data.
Retrospective/Prospective: Not applicable to the type of testing described. These were likely pre-market verification tests.

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 applicable/Not specified. The "test set" described consists of functional/safety tests performed on the device itself, not a clinical set requiring expert interpretation for ground truth.

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

Not applicable/None. This type of adjudication is relevant for clinical studies with subjective interpretations, which are not described here.

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

No. An MRMC comparative effectiveness study was not done. This device is a laparoscopic system (endoscope), not an AI-powered diagnostic tool. The document describes functional and safety testing, and a comparison to a predicate device's intended use and fundamental technology, not a study comparing human performance with or without AI assistance.

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

No. This is not an algorithm-only device. It's a physical medical instrument (laparoscope), and the "software verification" relates to an image rotation feature, not a standalone AI algorithm.

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

Not explicitly defined in the context of a clinical "ground truth." For the functional and safety tests, the "ground truth" would be established by engineering specifications, relevant ISO standards (like ISO 10993-1 for biocompatibility), and design requirements.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the machine learning sense. The software verification mentioned refers to modifications for an image rotation feature, not a trainable AI model.

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

Not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002

June 1, 2017

Xenocor, Inc Mr. Spencer Walker Director, Regulatory Affairs 630 Komas Dr. Suite 200 Salt Lake City, Utah 84108

Re: K171344

Trade/Device Name: Xenocor Xenoscope Laparoscopic System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, HET Dated: May 5, 2017 Received: May 8, 2017

Dear Mr. Walker:

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 Actinclude 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

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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 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" (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 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,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

Indications for Use

510(k) Number (if known): K171344

Device Name: Xenocor® Xenoscope™ Laparoscopic System

Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR Over-The-Counter Use_

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

Concurrence of CDRH, Office Of Device Evaluation (ODE)

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510(k) Summary
Submitter:	Xenocor®, Inc
Contact Person:	Spencer Walker, MSC - Director Regulatory Affairs630 Komas Dr. Suite 200Salt Lake City, UT 84108(801) 581-5080
Date Prepared:	May 05, 2017
Trade Name:	Xenocor® Xenoscope™ Laparoscopic System
Classification Name:	Endoscope/ Ureteroscope and Accessories21 CFR §876.1500, Product Code GCJ, FGB, Class II
Predicate Device(s):	Gynecologic Laparoscope and Accessories21 CFR §884.1720, Product Code HET, Class II
	● K161838 - Xenocor®, Xenoscope™ Laparoscopic System

Device Description:

Indications For Use:

Comparative Analysis:

It has been demonstrated that the Xenoscope™ Laparoscopic System is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The Xenoscope™

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Laparoscopic System has been fully assessed within the Xenocor® Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm safety and efficacy.

Functional/Safety Testing:

The following functional tests were performed. All data met pre-determined acceptance criteria.

o Biocompatibility - Per ISO 10993-1 for External communicating device, direct tissue contact, duration ≤ 24 hours.
Software Verification Verification of modifications for image rotation feature of . the 30° scope. The Xenoscope™ Laparoscope software level of concern is not changed.
Shaft Bending Inspection of the laparoscope shaft to confirm functionality after . bending the shaft.

Conclusion:

The Xenoscope™ Laparoscopic System is substantially equivalent to the cited predicate device. Additionally, the Xenoscope™ Laparoscopic System met all acceptance criteria to confirm safety and efficacy.

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.