Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist Indications: Scapholunate ligament reconstruction.

Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

Knee Indications: Extra-capsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.

This product is preloaded with suture for use at the discretion of the physician.

Device Description

The device is a resorbable screw and washer assembly. The screw measures 12.5mm in length and 2.25mm in diameter. The washer is oval shaped and measures 7mm along the long axis with two spikes to hold the soft tissue in place. The device is fully cannulated to accommodate the driver mechanism. The device may be used with any legally marketed suture (size 1 or 2) for secondary reattachment of soft tissue.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: "Soft Tissue Screw and Washer". This type of submission focuses on proving substantial equivalence to existing legally marketed devices, rather than conducting new clinical trials to establish safety and effectiveness from scratch.

Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies, is largely not applicable or not present in this document.

Here's an breakdown based on the document:

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

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for clinical outcomes. The overarching acceptance criterion for a 510(k) is substantial equivalence to predicate devices. This means the device must be as safe and effective as a legally marketed device.
Reported Device Performance: The document states: "Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices." No specific quantitative performance data from this mechanical testing (e.g., tensile strength, fixation strength relative to predicates) is provided in this summary.

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

Clinical Test Set Sample Size: Not applicable. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, there was no clinical test set in the traditional sense.
Data Provenance: Not applicable for clinical data. For non-clinical (mechanical) testing, the provenance of materials or internal laboratory data is not specified.

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)

Not applicable as no clinical testing was performed and therefore no ground truth based on expert review of clinical data was established for a test set.

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

Not applicable as no clinical testing was performed and therefore no adjudication of clinical outcomes was necessary.

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

Not applicable. This device is a physical resorbable screw and washer, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance, typically for imaging devices or software.

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

Not applicable as this is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for substantial equivalence in this context would be the established safety and effectiveness of the predicate devices, which were approved based on their own data or prior substantial equivalence. For the mechanical testing performed, the "ground truth" would be the performance characteristics of the predicate devices against which the new device was compared. However, details of these comparisons are not provided in this summary.

8. The sample size for the training set

Not applicable as no machine learning algorithm was involved.

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

Not applicable as no machine learning algorithm was involved.

In summary, this 510(k) submission relied on non-clinical (mechanical) testing and comparison to predicate devices to demonstrate substantial equivalence, rather than new clinical trials or AI performance studies.

Summary

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K012572/51

page 1 of 2

DEC 03 2001

CORPORAT ARTERS

SUMMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:	Arthrotek, Inc.(A wholly owned subsidiary of Biomet, Inc.)56 East Bell DriveP.O. Box 587Warsaw, Indiana 46581-0578Establishment Registration No.:1825034
Contact Person:	Sara B. ShultzBiomet Manufacturing, Corp.P.O. Box 587Warsaw, Indiana 46581-0578Phone: (219) 267-6639FAX: (219) 372-1683
Proprietary Name:	Soft Tissue Screw and Washer
Common or Usual Name:	resorbable screw and washer
Classification Name:	Fastener, Fixation, Biodegradable soft tissue
Device Product Code:	87MAI

Legally Marketed Devices To Which Substantial Equivalence is Claimed: Mini Harpoon® Suture Anchor (Biomet, Inc., K973775), Acufex's Suretac® (Acufex, K931519), Resorbable Bone Pin (Biomet, Inc., K011522), Mitek Gll Anchor (Mitek Surgical Products, Inc., K953877), Quick Anchor Plus (Mitek Surgical Products, Inc., 510(k) number unknown).

Indications for Screw and Washer:

Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist Indications: Scapholunate ligament reconstruction.

Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

.

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@biomet.com

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K01257251
page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in large, bold, black letters. Below that, the words "CORPORATE HEADQUARTERS" are in smaller, thinner, black letters.

This product is preloaded with suture for use at the discretion of the physician.

Device Description: The device is a resorbable screw and washer assembly. The screw measures 12.5mm in length and 2.25mm in diameter. The washer is oval shaped and measures 7mm along the long axis with two spikes to hold the soft tissue in place. The device is fully cannulated to accommodate the driver mechanism. The device may be used with any legally marketed suture (size 1 or 2) for secondary reattachment of soft tissue.

Summary of Technologies: The Soft Tissue Screw and Washer technological characteristics (material and design) are similar to the predicate devices.

Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

0

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

트

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

Ms. Sara B. Shultz Regulatory Specialist Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K012572

Trade/Device Name: Soft Tissue Screw and Washer Regulation Number: 888.3040, 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC, HTN Dated: October 24, 2001 Received: October 25, 2001

Dear Ms. Shultz:

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. Sara B. Shultz

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Mark N Milbersm

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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K012572 S1

Page _ of _.

kol2572 510(k) NUMBER (IF KNOWN):_

DEVICE NAME: Soft Tissue Screw and Washer

INDICATIONS FOR USE:

Indications for Screw and Washer:

Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Wrist Indications: Scapholunate ligament reconstruction.

Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.

The Soft Tissue Screw and Washer is preloaded with suture for use at the discretion of the physician.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use
(Optional Format 1-2-96)

Mark M

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

510(k) Number_

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.