Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis.

Foot/Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstruction. Achilles tendon repairs/reconstruction, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/recontructions and Bunionectomy.

Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,

Knee: Extra-capular repairs -Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement and Illoiotibial band tenodesis.

Device Description

The 2.0 PK Suture Anchor T and the 2.0 PK Suture Anchor S consist of a non-absorbable suture anchor with attached non-absorbable suture(s) preassembled to a stainless steel insertion device, and is provided sterile, for single use only. Both anchor models achieve fixation via ribbed/threaded design characteristics that are consistent with the repair of soft tissue to bone.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, specifically the "2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S." This is a premarket notification for a traditional medical device, not an AI/ML powered device. Therefore, many of the requested criteria such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only) performance," "ground truth establishment," and "training set sample size" are not applicable.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through performance testing. This means the acceptance criteria are largely based on showing comparable performance in defined mechanical tests rather than clinical accuracy studies.

Here's an interpretation of the available information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format, nor does it provide detailed raw performance data. Instead, it makes a general statement of equivalency to predicate devices. The "acceptance criteria" are implicitly met if the device's performance in the Summary Performance Data demonstrates substantial equivalence to the predicate devices.

Acceptance Criteria Category	Reported Device Performance
Insertion Properties	Substantially equivalent to Smith & Nephew 2.3 BIORAPTOR and Arthrex Mini BioSuture Tak™ anchors.
Fixation Properties	Substantially equivalent to Smith & Nephew 2.3 BIORAPTOR and Arthrex Mini BioSuture Tak™ anchors.
Safety and Efficacy	Differences from predicate devices do not raise new issues of safety and efficacy.
Clinical Indications	Intended for the same range of soft tissue to bone reattachment indications as predicate devices (Shoulder, Foot/Ankle, Elbow/Wrist/Hand, Knee).

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

The document does not explicitly state the sample size for the performance tests. It refers to "performance testing conducted" for insertion and fixation properties. The data provenance is not specified beyond being "conducted" by Smith & Nephew. It is certainly prospective testing, as it's performed to validate the new device. It is not clinical data but rather bench testing.

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

Not applicable. This is a mechanical device, and "ground truth" for the test set would be objective measurements from engineering tests rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a diagnostic device involving expert review.

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 a medical implant/fastener, not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical implant/fastener, not an AI-powered algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be established by objective engineering measurements (e.g., pull-out strength, insertion force, material properties) during performance testing in a lab setting, compared against established standards or the performance of predicate devices. It is not pathology, outcomes data, or expert consensus in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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K0815" pyf 'f2

AUG 2 6 2008

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S

Date Prepared: May 23, 2008

A. Submitter's Name:

SECTION IV

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact

Janice Haselton Sr. Regulatory Affairs Specialist Phone: 978-749-1494 Fax: 978-749-1443

C. Device Name

Trade Name:	2.0 PK Suture Anchor T2.0 PK Suture Anchor S
Common Name:	Fastener, fixation, non-degradable, soft tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener
Product Code:	MBI
Regulation Number:	21 CFR §888.3040

D. Predicate Devices

The 2.0 PK Suture Anchor T and the 2.0 PK Suture Anchor S are substantially equivalent to the following legally marketed device in commercial distribution: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor cleared in K071586 and Arthrex Mini BioSuture Tak™ cleared in K050749/K061863.

Smith & Nephew, INC 2.0 PK Anchors Pg. 25 of 54

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E. Description of Device

F. Intended Use

The 2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S is intended for use for the reattachment of soft tissue to bone for the following indications:

Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,

G. Comparison of Technological Characteristics

The performance testing conducted demonstrates substantial equivalence to the Arthrex Mini BioSuture Tak™suture anchor, cleared in K050749/K061863. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy

H. Summary Performance Data

The performance testing conducted demonstrates that the insertion and fixation properties of the 2,0 PK Suture Anchor T and the 2.0 PK Suture Anchor S are substantially equivalent to the Smith & Nephew 2.3 BIORAPTOR and the Arthrex Mini BioSuture TakTM anchors.

Smith & Nephew INC 2.0 PK Anchors Pg. 26 of 54

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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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2008

Smith & Nephew, Inc. Endoscopy Division % Ms. Janice Haselton Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K081511

Trade/Device Name: 2.0 PK Suture Anchor "S" and 2.0 PK Suture Anchor "T" Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC, JDR Dated: May 28, 2008 Received: May 29, 2008

Dear Ms. Haselton:

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. Janice Haselton.

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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millican

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):

K0815-11

Device Name: ____2.0 PK Suture Anchor S and 2.0 PK Suture Anchor T

Indications For Use:

The 2.0 PK Suture Anchor S and 2.0 PK Suture Anchor T is intended for use for the reattachment of soft tissue to bone for the following indications:

Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,

Prescription Use

AND/OR

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brown

Division of Ger and Neurological Devices

510 k) Number_

Smith & Nephew, INC 2.0 PK Anchors Pg. 16 of 54

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.