CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET by BIOMET, INC.

Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ are resorbable rivets made of Lactosorb® Copolymer. They are designed with ribbed legs that extend during actuation to hold the rivets in the desired position. The heads incorporate spikes to grip the soft tissue and hold it in place during the healing process.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided documents focus on establishing substantial equivalence for a medical device (Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™) to a predicate device (Lactosorb® Pop Rivet). The "acceptance criteria" in this context are not presented as numerical thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) but rather as demonstrable equivalence in materials, manufacturing, indications for use, and mechanical properties.

Acceptance Criteria Category	Specific Criteria/Comparison to Predicate Device	Reported Device Performance
Material Composition	Same materials as predicate device	Manufactured from Lactosorb® Copolymer, same as predicate.
Manufacturing Processes	Same manufacturing practices as predicate device	Utilizes the same manufacturing practices as the predicate devices.
Indications for Use	Same indications for use as predicate device	Indicated for soft tissue reattachment in specific shoulder procedures, implying equivalence to the predicate.
Mechanical Strength	Equivalent or greater fixation strength compared to the predicate device	Mechanical testing indicated equivalent or greater fixation strength of the Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ compared to the predicate device.

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

Sample Size: The document does not specify a distinct "test set" in the context of clinical performance data. The evaluation primarily relied on non-clinical mechanical testing. The sample size for this mechanical testing is not provided in the furnished information.
Data Provenance: The mechanical testing data would be generated in a laboratory setting, likely in the United States where Biomet Inc. is located. It is not clinical data, so terms like "retrospective" or "prospective" do not apply.

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

Number of Experts: Not applicable. The "ground truth" for mechanical testing is based on objective measurements of fixation strength, not expert interpretation of clinical data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. As the primary evaluation was via mechanical testing, there was no need for adjudication of human interpretations.

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:

MRMC Study: No. This is a medical device for orthopedic fixation, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This device is a physical implant, not an algorithm.

7. The type of Ground Truth Used:

Type of Ground Truth: For the non-clinical testing, the "ground truth" was objective measurements of mechanical fixation strength performed on the devices.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.

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

Ground Truth Establishment: Not applicable.

Summary of the Study:

The study proving the device met the acceptance criteria was a non-clinical mechanical testing study. This study compared the fixation strength of the Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ to that of the legally marketed predicate device, Lactosorb® Pop Rivet. The key finding was that the new devices demonstrated equivalent or greater fixation strength compared to the predicate. Based on this, and the use of the same materials and manufacturing processes, it was determined that no clinical testing was necessary to establish substantial equivalence with the predicate device.

Summary

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DEC - 5 2003

Kc33519 Pge 194

BIOMET

510(k) Summary

Applicant/Sponsor:	Arthrotek Inc.(A wholly owned subsidiary of Biomet Inc.)56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587FDA Registration #: 1825034
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Gary Baker Contact Person: 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Telephone: (574) 372-1568 Fax: (574) 372-1683
Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ Proprietary Name:
Resorbable Pop Rivet Common Name:
Fastener, Fixation, Biodegradable, Soft Tissue Classification Name:

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Lactosorb® Pop Rivet - 510(k) K981798 cleared on July 13, 1998.

Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™ are resorbable Device Description: rivets made of Lactosorb® Copolymer. They are designed with ribbed legs that extend during actuation to hold the rivets in the desired position. The heads incorporate spikes to grip the soft tissue and hold it in place during the healing process.
MAILING ADDRESS P:O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

571 206.2742
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Indications for Use:	These devices are indicated for soft tissue reattachment in the following shoulder procedures:
	1. Instability repairs in the shoulder (Bankart Procedures)
	2. SLAP lesion repair
	3. Acromio-clavicular separation repairs
	4. Rotator cuff tear repairs
	5. Capsular shift or capsulolabral reconstructions
	6. Biceps tenodesis
	7. Deltoid repairs
Summary of Technologies:	Cannulated Arthrorivet TM and Cannulated RC Arthrorivet TM are manufactured from the same materials and utilizing the same manufacturing practices as the predicate devices.
Non-Clinical Testing:	Mechanical testing indicated equivalent or greater fixation strength of the Cannulated Arthrorivet TM and the Cannulated RC Arthrorivet TM compared to the predicate device.
Clinical Testing:	No clinical testing was necessary for determination of substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 5 2003

Mr. Gary Baker Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581

Re: K033519

Trade/Device Name: Cannulated Arthronvet™ and Cannnulated RC Arthronvet™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple component Metallic Bonc Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS, JDR, MAI Dated: November 5, 2003 Received: November 7, 2003

Dear Mr. Baker:

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 accordunce 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

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Page 2 - Mr. Gary Baker

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. 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) 594-4639. 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,

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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Statement of Indications For Use

510(k) Number (IF KNOWN): _ K ω {} } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } }

Device Name: Cannulated Arthrorivet™ and Cannulated RC Arthrorivet™

Indications for Use: These devices are indicated for soft tissue reattachment in the following shoulder procedures:

1. Instability repairs in the shoulder (Bankart Procedures)
SLAP lesion repair 2.
Acromio-clavicular separation repairs 3.
Rotator cuff tear repairs 4.
1. Capsular shift or capsulolabral reconstructions
1. Biceps tenodesis
1. Deltoid repairs

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	√
OR Over-the-Counter Use (Optional Format 1-2-96)	No

Division Sign-Off

Division of Ge , Restorative

and Neurologi Devices

510(k) Number K033519

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.