Stryker Arthroscopes are endoscopic devices into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).

Device Description

Stryker Arthroscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during arthroscopic procedures. The devices are available in a variety of outer diameters and working lengths.

The arthroscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process the device for initial use, as well as to reprocess the device after each use. The devices are available in an evepiece and a C-Mount design. The evepiece arthroscopes connect to the camera system through a separate coupler; the C-Mount arthroscopes connect directly to the camera system through an integrated coupler.

Stryker's arthroscopes achieve their intended use by guiding light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display by a separate camera system. The arthroscopes' optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.

AI/ML Overview

The provided document is a 510(k) Summary for the Stryker Arthroscopes. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies on AI algorithms or advanced performance metrics. As such, the document does not contain the information required to answer many of the questions asked, particularly those related to acceptance criteria, AI performance, ground truth, and sample sizes for AI studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document provides a table of tests performed and their results, but it does not explicitly state the acceptance criteria for each test. It only indicates "PASS" for all tests.

Test	Method	Reported Device Performance	Acceptance Criteria (Not provided)
Electrical Safety	IEC 60601-1, IEC 60601-2-18	PASS	Not explicitly stated
Packaging	ASTM D4169	PASS	Not explicitly stated
Visual Inspection	ISO 8600-1	PASS	Not explicitly stated
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11	PASS	Not explicitly stated
Cleaning and Disinfection	AAMI TIR 12, AAMI TIR 30, ISO 15883-5, ISO 15883-2	PASS	Not explicitly stated
Sterilization	AAMI ST79, AAMI ST58, ISO 17665-1, ISO 14937	PASS	Not explicitly stated
Performance - Bench (Needle Torque)	-	PASS	Not explicitly stated
Performance - Bench (Needle Torque - Dynamic Torque)	-	PASS	Not explicitly stated
Performance - Bench (Focus Ring Torque)	-	PASS	Not explicitly stated

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

This information is not provided in the document. The document describes tests primarily related to the physical and functional aspects of the arthroscope (electrical safety, packaging, biocompatibility, cleaning, sterilization, mechanical performance), not data-driven performance studies typically associated with AI/software devices.

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)

This information is not provided. The device is an arthroscope, a physical optical instrument. The tests mentioned are for its physical and functional characteristics, not for diagnostic accuracy that would require expert-established ground truth.

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

This information is not provided. As explained above, the tests are primarily for physical and functional performance, not diagnostic accuracy requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance in this document. The device is a traditional arthroscope, not an AI-powered diagnostic tool.

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

There is no mention of an algorithm or standalone performance in this document.

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

This information is not applicable/provided. The performance tests are for physical device characteristics, where "ground truth" would be defined by engineering specifications and standards, not clinical diagnostic outcomes.

8. The sample size for the training set

There is no mention of a training set as this is not an AI/machine learning device.

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

There is no mention of a training set or its ground truth, as this is not an AI/machine learning device.

Summary based on available information:

The provided document is a 510(k) summary for a traditional medical device (Stryker Arthroscopes) and demonstrates substantial equivalence to a predicate device based on design, intended use, operating principles, technological characteristics, and safety features. The performance testing focuses on standard engineering, safety, and reprocessing validations rather than AI-specific performance criteria or clinical diagnostic accuracy studies. Therefore, most of the questions related to acceptance criteria for AI performance, ground truth, and sample sizes for AI studies cannot be answered from this document.

Summary

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December 1, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Stryker Endoscopy Christie Samsa Principal Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K202659

Trade/Device Name: Stryker Arthroscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 30, 2020 Received: November 2, 2020

Dear Ms. Samsa:

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 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

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K202659 - Christie Samsa

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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.

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic 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) K202659

Device Name Stryker Arthroscopes

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

Submitter:

Applicant	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person	Christie Samsa, ME, RACPrinciple Regulatory Affairs SpecialistPhone: (978) 500-1303Email: christie.samsa@stryker.com
Date Prepared	September 11, 2020

Subject Device:

Name of Device	Stryker Arthroscopes
Common or Usual Name	Stryker Arthroscopes
Classification Name	Arthroscope, 21 CFR 888.1100
Regulatory Class	Class II
Product Code	HRX

Predicate Device:

Name of Device	Precision Ideal Eyes® 4K Arthroscopes, K093677 & K183470
----------------	----------------------------------------------------------

Note: The predicate device has not been subject to a design-related recall.

Device Description:

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Indications for Use:

Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).

Feature	Subject DeviceStryker Arthroscopes	Predicate DeviceStryker Arthroscopes
Manufacturer	Stryker Endoscopy	Same as subject device
Submission Reference	Current Submission	K093677
Indications for UseStatement	Stryker arthroscopes are endoscopicdevices introduced into a patient toprovide an internal view or image ofthe interior of a joint for examination,diagnosis, and/or therapy.Arthroscopes are indicated for use inarthroscopic procedures performed inthe hip, knee, shoulder, wrist (carpaltunnel syndrome), temporalmandibular joint, ankle elbow, andfeet (plantar fascia release).	Same as subject device
Operating principles	Transmission of light to illuminateand image an arthroscopic joint, thenrelaying the image out of the surgicalsite for processing and display.	Same as subject device
Outer diameter	4mm, 2.9mm, 2.7mm, 2.4mm, 1.9mm	Same as subject device
Working Length	200mm, 165mm, 140mm, 120mm,75mm, 72mm, 58mm	Same as subject device
DOV	0°, 30°, 45°, 70°, and 30° reverse cant	Same as subject device
FOV	105°, 80°, 65°	Same as subject device
C-mount coupler seal	U-cup seal	Quad ring seal
Key Patient-ContactingMaterials	Stainless Steel, Optical Glass,Glass Fibers	Same as subject device
Single Use or Reusable	Reusable	Same as subject device
Cleaning	Manual and Automated	Same as subject device
Disinfection	Manual and Automated	Same as subject device
SterilizationMethods	Autoclave, Steris VPRO, APS Sterrad	Same as subject device
Sterility AssuranceLevel	10-6	Same as subject device

			Comparison of Technological Characteristics with the Predicate Device:

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Performance Testing:

The following performance data were provided in support of the substantial equivalence determination.

Test	Method	Result
Electrical Safety	IEC 60601-1	PASS
	IEC 60601-2-18
Packaging	ASTM D4169	PASS
Visual Inspection	ISO 8600-1	PASS
Biocompatibility	ISO 10993-1	PASS
	ISO 10993-5
	ISO 10993-10
	ISO 10993-11
Cleaning and Disinfection	AAMI TIR 12	PASS
	AAMI TIR 30
	ISO 15883-5
	ISO 15883-2
Sterilization	AAMI ST79	PASS
	AAMI ST58
	ISO 17665-1
	ISO 14937
Performance - Bench	Needle Torque	PASS
	Needle Torque - Dynamic Torque	PASS
	Focus Ring Torque	PASS

Conclusions:

The Stryker Arthroscope is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the Stryker Arthroscope when used as instructed.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.