Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair

Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction

Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair

Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement

The PEEK Knotless Anchors are single-use devices.

Device Description

The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "PEEK Knotless Anchors" by Biomet Sports Medicine, Inc. As such, it focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria for a new device and proving its attainment through a dedicated study.

Therefore, many of the requested elements (acceptance criteria, study details, expert involvement, specific ground truth methods, sample sizes for training/test sets, MRMC study details) are not applicable or not explicitly provided in this type of regulatory submission.

Here's an attempt to answer the questions based on the available information:

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

The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating that the new device's technological characteristics are "similar or identical" to predicate devices, and that non-clinical testing showed it to be "functional within its intended use."

Acceptance Criteria (Implicit)	Reported Device Performance
Functional within intended use	Non-clinical testing indicated the devices were functional within their intended use.
Similar/Identical technological characteristics (material, design, sizing, indications) to predicate devices	"The technological characteristics (material, design, sizing, indications) of the PEEK Knotless Anchors are similar or identical to the predicate devices."

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

Sample Size for Test Set: Not applicable. The submission states "Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence." This refers to bench testing, not clinical studies with a 'test set' of patient data. The number of samples for the non-clinical tests is not specified.
Data Provenance: Not applicable. This was non-clinical laboratory testing, not human data.

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. No clinical test set or human ground truth was established, as it was non-clinical testing.

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

Not applicable. No clinical test set or human adjudication was involved.

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 is not an AI-based device, and no MRMC study was conducted.

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

Not applicable. This is a physical medical device (suture anchors), not an algorithm or AI system.

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

For the non-clinical testing, the "ground truth" implicitly refers to established engineering and biomechanical principles and design specifications to demonstrate functionality and equivalence. No human-based "ground truth" (like pathology or expert consensus) was used.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a stylized, blocky font. Above the word, there is a sequence of numbers and letters: K070389. The letters and numbers are handwritten and appear to be part of a code or identifier. The word "BIOMET" is the most prominent feature of the image.

P. 1/2

510(k) Summary

AUG - 9 2007

Preparation Date:	February 8, 2007
Applicant/Sponsor:	Biomet Sports Medicine, Inc. (formerly known as Arthrotek, Inc.)
Contact Person:	Susan Alexander
Proprietary Name:	PEEK Knotless Anchors
Common Name:	Soft tissue anchor
Classification Name:	Smooth or threaded metallic bone fixation fastener (21 CFR §888.3040), HWC

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

• ALLthread™ PEEK Suture Anchors	K060693	Arthrotek, Inc.
• Resorbable Interference Screw	K041274	Arthrotek, Inc.
• Soft Tissue Screw and Washer	K012572	Arthrotek, Inc.

Device Description: The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.

Indications for Use:

Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair

Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction

Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair

The PEEK Knotless Anchors are single-use devices.

Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the PEEK Knotless Anchors are similar or identical to the predicate devices.

5-1 MAHING ADDRESS SHIPPING ADDRESS 1:0. Box 587 56 F. Bell Drive Warsaw, IN 46581 0587 Warsaw, IN 46582 ()FFICIE PAN E-MAII. 574.267.66.39 574.367.8147 biomet@blomet.com

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070389

p. 2/2

510(k) Summary 510(k) Notification: PEEK Knotless Anchors Biomet Sports Medicine, Inc.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. unless otherwise noted. PEEK-OPTIMA® is a registered trademark of Invibio, Inc.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, which is the department's symbol. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Sports Medicine, Inc. % Ms. Susan Alexander Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

AUG = 9 2007

Re: K070389

Trade/Device Name: PEEK Knotless Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 4, 2007 Received: June 5, 2007

Dear Ms. Alexander:

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.

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. Susan Alexander

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or at Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Babare Buchem

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: PEEK Knotless Anchors

Indications For Use:

Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair

Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valqus Reconstruction; and Mid and Forefoot Reconstruction

Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair

The PEEK Knotless Anchors are single-use devices.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Senbere Budu

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

510(k) Number_ 4 - 1 R070389

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.