The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.

Hip diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondromatosis Unresolved hip pain Labral tears

Device Description

Arthrex Arthroscopes are rigid, fixed arthroscopes with a wide-angle view. Arthrex Arthroscopes have surgical stainless steel shafts and lens housings for durability and are available with a 30 or 70 degree angle view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surqical site and surgeon preference.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, an arthroscope. The information provided heavily emphasizes substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria.

Therefore, many of the requested details about specific acceptance criteria and a study proving the device meets them are not explicitly present in the provided text. The document acts as a regulatory submission demonstrating similarity, not an independent efficacy study.

Here's a breakdown of what can be inferred or is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" for K030096 are based on substantial equivalence to predicate devices, meaning the Arthrex Arthroscopes are considered safe and effective if they are similar in design, materials, and intended use to already legally marketed devices.
Reported Device Performance: No specific quantitative performance data (e.g., optical resolution, illumination strength, durability test results) is provided in this summary. The performance is implicitly "similar to predicate devices."

Feature/Criterion	Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Inferred/Stated)
Design	Similar to predicate devices	Rigid, fixed arthroscopes; Wide-angle view
Materials	Similar to predicate devices	Surgical stainless steel shafts and lens housings
Intended Use	Similar to predicate devices	Illumination and visualization of shoulder, knee, elbow, ankle, wrist, jaw, and hip.
Durability	Similar to predicate devices	Optical components sealed to provide durability
Safety	No new issues of safety raised compared to predicate	Considered safe by Arthrex, Inc.
Effectiveness	No new issues of effectiveness raised compared to predicate	Considered effective by Arthrex, Inc.

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

Sample Size for Test Set: Not applicable/Not mentioned. No independent test set of patients or cases was used for a performance study. The evaluation is based on comparison to existing devices.
Data Provenance: Not applicable. There is no specific data from clinical or performance testing detailed in this document. The "provenance" of the equivalence argument is the legal framework of 510(k) substantial equivalence.

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

Not applicable/Not mentioned. Since no independent performance study requiring a "test set" and "ground truth" was conducted and described in this summary, there is no mention of experts establishing ground truth. The safety and effectiveness are established by the FDA's acceptance of the substantial equivalence claim.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. No test set was used in the context of an efficacy study as described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a MRMC comparative effectiveness study was not done (or at least not described in this 510(k) summary). The document focuses on demonstrating substantial equivalence to predicate devices, not on a comparative effectiveness study involving human readers and AI.

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

Not applicable. This device is an arthroscope, a physical medical instrument for visualization, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.

7. The Type of Ground Truth Used

Not applicable/Not mentioned in the context of a performance study. The "ground truth" for the 510(k) process is the established safety and effectiveness of the predicate devices to which the new device is being compared.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. This is not an AI/algorithm-based device requiring a training set or ground truth for training.

Summary

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K030096

MAR 1 8 2003

PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Arthroscopes

NAME OF SPONSOR:	Arthrex, Inc.2885 S. Horseshoe DriveNaples, Florida 34104
510(K) CONTACT:	Sally Foust, RACRegulatory Affairs SpecialistArthrex, Inc.Telephone: (239) 643-5553 extension 1251FAX: (239) 430-3494
TRADE NAME:	Arthrex Arthroscopes
COMMON NAME:	Arthroscope
CLASSIFICATION:	Arthroscope21 CFR 888.1100
DEVICE PRODUCT CODE:	HRX

DEVICE DESCRIPTION AND INTENDED USE:

SAFETY AND EFFECTIVENESS

The Arthrex, Inc. Arthroscopes are similar to the predicate devices in design, materials, and intended use and as such are considered by Arthrex, Inc. to be substantially equivalent to devices currently available in U.S. distribution. The expansion of the indications of the Arthrex, Inc. Arthroscopes to include elbow and hip, those of the Smith & Nephew predicate device, does not raise new issues of safety and effectiveness.

000007

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 2003

Ms. Sally Foust, RAC Regulatory Affairs Specialist Arthrex, Inc. 2885 S. Horsehoe Drive Naples, Florida 34104

Re: K030096

Trade/Device Name: Arthrex Arthroscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscopes and accessories Regulatory Class: II Product Code: HRX Dated: January 9, 2003 Received: January 10, 2003

Dear Ms. Foust:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Sally Foust, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

uriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

INDICATIONS FOR USE:

Hip diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondromatosis Unresolved hip pain Labral tears

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Prescription Use

_ OR

Over-The-Counter

Use

(Per 21 CFR 801.109)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

000006

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.