The Arthrex NanoScope system is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

Device Description

The Arthrex NanoScope System provides image processing and digital documentation for endoscopic procedures. The system comprises a camera control unit (CCU) and a handpiece that provides distal LED illumination to the surgical site using a fiber optic bundle surrounding a high-resolution camera sensor.

AI/ML Overview

This a 510(k) summary for the Arthrex NanoScope System, which is an endoscopic video camera system. The submission seeks to prove substantial equivalence to a predicate device, the Arthrex Synergy UHD4 System (K153218). The provided document does not contain specific acceptance criteria or a detailed study report with performance metrics for the Arthrex NanoScope System.

However, it does indicate that bench testing was performed to demonstrate equivalence to the predicate regarding environmental conditions, power requirements, image capture, and video output and resolution. This implies that the acceptance criteria would relate to these specific performance aspects, with the predicate device's performance serving as the benchmark.

Since detailed study results and acceptance criteria are not explicitly present in the provided text, I will answer based on the information implied by the document about the type of study and the areas of comparison.

Here's an attempt to answer the questions based on the available information and logical inference for a 510(k) submission of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and reported performance metrics are not provided in the document, this table is constructed based on the types of tests mentioned as being performed for equivalence. The acceptance criterion is implied to be "Matches or performs comparably to the predicate device."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Environmental conditions performance is comparable to predicate.	Bench testing demonstrated equivalence to predicate.
Power requirements are comparable to predicate.	Bench testing demonstrated equivalence to predicate.
Image capture performance is comparable to predicate.	Bench testing demonstrated equivalence to predicate.
Video output and resolution performance is comparable to predicate.	Bench testing demonstrated equivalence to predicate.
No significant differences raising safety/effectiveness concerns.	Differences are minor and do not raise safety/effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench testing." Typically, bench testing for a device like an endoscopic camera would involve a physical sample of the device rather than a "test set" of patient data.

Sample Size: Not explicitly stated, but for bench testing, it would generally involve one or more manufactured units of the Arthrex NanoScope System.
Data Provenance: Not applicable in the context of patient data. The "data" here would be the measurements and observations from the physical bench tests performed in a lab setting. It is not retrospective or prospective in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not directly applicable. Bench testing does not typically involve human experts establishing "ground truth" in the way a clinical study would (e.g., radiologists interpreting images). The "ground truth" for bench testing would be established by validated test equipment and objective measurements against predefined specifications or the predicate's performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for reconciling conflicting expert opinions on data. Bench testing relies on objective measurements and established test protocols.

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 MRMC study was done. This device is an endoscopic video camera system, not an AI-assisted diagnostic tool. The submission focuses on the performance of the camera itself, primarily through bench testing comparing it to a predicate device.

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

This question is not applicable. The Arthrex NanoScope System is a hardware device (video camera system), not a standalone algorithm. Its performance is measured directly through its physical output (image quality, resolution, etc.), not as an algorithmic output requiring a human-in-the-loop for interpretation of an algorithm's classification.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing would be the objective measurements obtained from testing the Arthrex NanoScope System against established engineering specifications or by directly comparing its performance characteristics (e.g., resolution, light output, power consumption) to that of the predicate device (Arthrex Synergy UHD4 System K153218) using calibrated equipment. It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This question is not applicable. The Arthrex NanoScope System is a hardware device; it does not involve machine learning or AI models that require a "training set" of data.

9. How the Ground Truth for the Training Set was Established

This question is not applicable, as there is no training set for this device.

Summary

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July 5, 2019

Arthrex Inc. Heli Chambi Infantas Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K190645

Trade/Device Name: Arthrex NanoScope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 24, 2019 Received: May 29, 2019

Dear Heli Chambi Infantas:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer R. Stevenson, MBE Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190645

Device Name

Arthrex NanoScope System

Indications for Use (Describe)

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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510(k) Summary

Date Prepared	March 12, 2019
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Heli F Chambi InfantasSenior Regulatory Affairs Associate1-239-643-5553, ext. 71263Heli.chambiinfantas@arthrex.com
Name of Device	Arthrex NanoScope System
Common Name	Endoscopic Video Camera System
Product Code	GCJ
Classification Name	21 CFR 876-1500: Endoscope and accessories
Regulatory Class	II
Predicate Device	K153218 – Arthrex Synergy UHD4 System
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain clearance for theArthrex NanoScope System as a line extension to the Arthrex Synergy UHD4 Systemcleared under K153218.
Device Description	The Arthrex NanoScope System provides image processing and digital documentationfor endoscopic procedures. The system comprises a camera control unit (CCU) and ahandpiece that provides distal LED illumination to the surgical site using a fiber opticbundle surrounding a high-resolution camera sensor.
Indications for Use	The Arthrex NanoScope System is intended to be used as an endoscopic video camerain a variety of endoscopic surgical procedures, including but not limited to:orthopedic, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. Thedevice is also intended to be used as an accessory for microscopic surgery.
SubstantialEquivalence Summary	The Arthrex NanoScope System is substantially equivalent to the predicate device inwhich the basic design features and intended use are the same. Any differencesbetween the Arthrex NanoScope System and the predicates are considered minorand do not raised questions concerning safety and effectiveness.There are no significant differences between the new device and predicate that raiseissue of safety or effectiveness. Bench testing was performed to demonstrateequivalence to the predicate regarding environmental conditions, powerrequirements, image capture, and video output and resolution.
Conclusion	Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed 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.