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 (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Device Description

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. The Stryker Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera).

The Stryker Arthroscopes come in various diameters including 1.9mm, 2.7mm, and 4.0mm. Larger size arthroscopes are used for general viewing, while smaller diameter arthroscopes are used for restricted surgical sites. The Stryker Arthroscopes come in several directions of view including, 0°, 30°,45°, 70°. The direction of view enables viewing of different parts. Materials of the Arthroscope include stainless steel, titanium, PEEK, Glass, and Sapphire.

AI/ML Overview

The provided text describes a 510(k) summary for the Stryker Arthroscope, focusing on establishing substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific performance acceptance criteria based on clinical outcomes or diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or cannot be extracted from this document, as it concerns a medical device (an arthroscope) that's primarily a viewing instrument for internal examination. The "performance testing" mentioned refers to engineering and safety standards, not clinical performance in terms of diagnostic accuracy or reader improvement.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, AUC) or diagnostic accuracy. Instead, it demonstrates compliance with voluntary safety and performance standards and highlights technological characteristics compared to a predicate device.

Category	Acceptance Criteria (Implied by Standards & Equivalence)	Reported Device Performance
Biocompatibility	Conformity to ISO 10993-1 (Evaluation and Testing), 10993-10 (Irritation and Delayed-Type Hypersensitivity). Implied acceptance: non-toxic, non-irritating materials.	Subjected to and passed biocompatibility testing requirements. Patient-contacting materials are identical to predicate device (Henke Sass Wolf Arthroscope K080560).
Electrical Safety	Conformity to IEC 60601-1 (General Requirements for Basic Safety and Essential Performance), IEC 60601-2-18 (Safety of endoscopic equipment). Implied acceptance: safe electrical operation.	Subjected to and passed electrical safety testing requirements.
Sterilization	Conformity to TIR 12 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing) and ISO 14937 (Sterilization of Health Care Products - General Requirements). Implied acceptance: device can be safely and effectively sterilized for reuse.	Subjected to and passed sterilization testing requirements.
Optical Performance	Conformity to ISO 8600-1 (General requirements for medical endoscopes), 8600-3 (Determination of field of view and direction of view), and 8600-5 (Determination of Optical Resolution). Implied acceptance: meets specified optical properties for visualization.	Met all specified design and performance requirements. Specific FOV values are 105°, 80°, 65°. Specific direction of view values are 0°, 30°, 45°, 70°. Outer Diameters: 4mm, 2.7mm, 2.3mm, 1.9mm. Working Lengths: 165mm, 140mm, 120mm, 75mm, 72mm, 58mm.
Overall Design	Substantial equivalence to predicate device (Henke Sass Wolf Arthroscopes K080560) in construction, materials, and technological characteristics (FOV, Direction of View, Outer Diameter, Working Length, Reusability, Light Guide End Adapter) such that no new questions of safety or effectiveness are raised.	The Stryker Arthroscopes are substantially equivalent to the predicate device. Differences in Field of View and Working Length do not affect safety and efficacy, as they are within acceptable ranges or do not pose new risks.

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

Sample Size for Test Set: Not applicable. The document discusses performance testing related to engineering standards (biocompatibility, electrical safety, sterilization, optics) and a comparison of technological characteristics to a predicate device. It does not describe a clinical "test set" in the context of diagnostic accuracy or clinical outcomes.
Data Provenance: Not applicable for clinical performance data. The data presented is from internal engineering tests and a comparison to a predicate device's specifications.

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

Number of Experts: Not applicable. This type of information is relevant for studies involving human interpretation or clinical judgment. The 510(k) pertains to the physical and functional characteristics of an arthroscope, not its interpretative output.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" of cases requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC study was not done. The device is an arthroscope, a visually guided surgical instrument, not an AI-powered diagnostic or interpretive tool.
Effect Size of Human Reader Improvement: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The Stryker Arthroscope is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. For the engineering performance tests, the "ground truth" would be defined by the specifications in the relevant ISO and IEC standards (e.g., a material is biocompatible if it passes ISO 10993 tests; an arthroscope meets optical resolution if it conforms to ISO 8600-5). The substantial equivalence claim is based on direct comparison of design and material specifications between the proposed device and the predicate device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/ML device.

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

Ground Truth for Training Set: Not applicable.

Summary

{0}------------------------------------------------

5900 Optical Court San Jose, CA 95138 1: 408 754 2000 f: 408 754 2521

K093677

MAR - 5 2010

stryker®

Endoscopy

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name Proprietary Name: Common and Usual Names: Classification Name:

Stryker Arthroscope Stryker Arthroscope Arthroscope (21 CFR § 888.1100, Product Code HRX)

Intended 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 (carpel tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release).

Device Description: 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. The Stryker Arthroscope is a long tube containing a series of lenses. At the distal end, an objective lens captures the image of the object. Lens along the rod relay the image. At the proximal end, a proximal coupling lens relays the image to a CCD (Camera).

Technological Characteristics: The Stryker Arthroscopes are substantially equivalent in construction and materials to the predicate Henke Sass Wolf Arthroscopes (K080560).

	Proposed Device	Predicate Device	Equivalence	Impact onSafety andEffectiveness
Device	Stryker Arthroscope	HSW Arthroscope
Technological Characteristics (Design)
Field of View(FOV),Degrees	105°, 80°, 65°	85°, 105°	Different	The differencesin the Field ofview do notaffect thesafety andefficacy of thedevice.
Direction ofView	0°, 30°, 45°, 70°	0°, 30°, 45°, 70°, 110°	Same	N/A

1/3

{1}------------------------------------------------

OuterDiameter	4mm, 2.7mm, 2.3mm,1.9mm	4mm, 2.3mm-2.9mm,1.7-1.9mm	Same	N/A
WorkingLength	165mm, 140mm, 120mm,75mm, 72mm, 58mm	195mm, 185mm,140mm, 70mm, 60mm	Different	The lengths arewithin therange of thepredicate. Thedifferences inthe length donot affect thesafety andefficacy of thedevice.
Single Use orReusable	Reusable	Reusable	Same	Equivalent
Light GuideEnd Adapter	Storz and Olympus	ACMI, Storz, Olympus,Wolf & Dyonics	Same	N/A

Voluntary Safety and Performance Standards: The Stryker Arthroscopes conform to the voluntary standards including but not limited to (Refer to Section 5.1):

Biological Evaluation of Medical Devices

10993-1: Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing

10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Delayed-Type Hypersensitivity

Electrical Safety Requirements Per 60601

IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-2-18: Medical Electrical Equipment - Part 2: Particular Requirements for the safety of endoscopic equipment

AAMI/ISO Standards for Sterilization of Medical Devices

TIR 12: Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities

ISO 14937: Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices

Optics

ISO 8600-1: Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements

ISO 8600-3: Optics and optical instruments: Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics

ISO 8600-5: Optics and photonics-Medical Endoscopes and Endoscopic Accessories-Part 5: Determination of Optical Resolution of rigid endoscopes with optics.

{2}------------------------------------------------

Performance Testing: The subject device has been subjected to and passed electrical safety, sterilization, and biocompatibility testing requirements. The patient contacting materials are identical to the materials used in the predicated device (Henke Sass Wolf Arthroscope K080560). The Stryker Arthroscopes met all specified design and performance requirements.

Predicate Devices: The Stryker Arthroscopes are substantially equivalent in terms of safety and effectiveness to the currently marketed device, Henke Sass Wolf Arthroscopes (K080560).

Substantial Equivalence: The technological differences between the Stryker Arthroscope and Henke Sass Wolf Arthroscopes do not raise new questions of safety or effectiveness. Therefore the Stryker Arthroscopes are substantially equivalent to the previously cleared Henke Sass Wolf Arthroscope (K080560). Refer to Section 7.0 for a detailed comparison.

Contact:

Signature

Feb. 25, 2010

Shibir Desai Stryker Endoscopy 5900 Optical Court San Jose, CA 92138 Phone: 408-754-2784 408-754-2521 Fax: Email: Shibir.Desai@stryker.com Date:

പ്ര

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features the HHS emblem, which includes a stylized depiction of an eagle with outstretched wings. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

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

MAR - 5 2010

Stryker Endoscopy % Shibir Desai Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95136

Re: K093677

Trade/Device Name: Stryker Arthroscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: February 25, 2010 Received: March 2, 2010

Dear Shibir Desai:

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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - Shibir Desai

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INTENDED USE

Device Name: Stryker Arthroscope

K093677 510(k) Number if known:

No known contraindications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nelkell
(Division Sign-Off) for nxim

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093677

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.