Shoulder
Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Foot and Ankle
Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Elbow
reconstructions Ulnar or radial collateral ligament Lateral epicondylitis repair Biceps tendon reattachment

Knee
Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis

Hip
Capsular repair Acetabular labral repair

Device Description

Preloaded 2.3 mm suture anchor manufactured from PLC incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.

AI/ML Overview

The provided text describes a medical device, the PLC Suture Anchor, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria, a study proving the device meets those criteria, or details about sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI/algorithm-based devices.

The document mainly focuses on:

Device Description: The PLC Suture Anchor, made from PLC with UHMWPE suture on a stainless steel inserter.
Indications for Use: A comprehensive list of shoulder, foot and ankle, elbow, knee, and hip soft tissue reattachment procedures.
Predicate Device: Smith & Nephew BioRaptor Suture Anchor (K053344).
Technological Comparison: The key difference is the material (PLC, an osteoconductive biodegradable material).
Summary Performance Data: States that "bench and animal testing that demonstrates substantial equivalence" was conducted. This is the closest the document comes to mentioning performance data.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Not specified	Bench and animal testing demonstrating substantial equivalence to the predicate device (Smith & Nephew BioRaptor Suture Anchor).

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: The general nature of "bench and animal testing" implies laboratory and animal study data, but specific countries or retrospective/prospective nature are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The performance data relates to material properties and mechanical performance, not diagnostic accuracy requiring human expert ground truth.

4. Adjudication method for the test set

Not applicable/Not specified.

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

No, this is not an AI/algorithm-based device.

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

No, this is not an AI/algorithm-based device.

7. The type of ground truth used

The ground truth would likely be based on objective measurements from the bench and animal tests (e.g., mechanical strength, degradation rates, tissue integration in animal models). The document does not specify the exact type of measurements or "ground truth" used, beyond stating "bench and animal testing."

8. The sample size for the training set

Not applicable/Not specified. 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/Not specified.

Summary

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K063726 page 1 of 2

SECTION IV MAR 06 2007 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.

PLC Suture Anchor

Date Prepared: March 5, 2007

A. Submitter's Name:

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

B. Company Contact

Deana Boushell Principal Regulatory Affairs Specialist Phone: (508) 337-4036 (508) 261-3620 FAX:

C. Device Name

Trade Name:	PLC Suture Anchor
Common Name:	Suture Anchor
Classification Name:	Fastener, Fixation,degradable, soft tissue

D. Predicate Devices

The PLC Suture Anchor is substantially equivalent to the Smith & Nephew BioRaptor Suture Anchor (K053344).

Description of Device E.

Preloaded 2.3 mm suture anchor manufactured from PLC incorporating ultra high molecular weight polyethelene suture on a stainless steel inserter.

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page 2 of 2

F. Indications for Use

The Smith & Nephew PLC suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP lesion repairs Capsular Shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff tear repairs Biceps tenodesis

Foot and Ankle

Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Elbow

reconstructions Ulnar or radial collateral ligament Lateral epicondylitis repair Biceps tendon reattachment

Knee

Extra-capsular repairs: medial collateral ligament lateral collateral ligament posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement Iliotibial band tenodesis

Hip

Capsular repair Acetabular labral repair

G. Comparison of Technological Characteristics

The Smith & Nephew PLC Suture Anchor is substantially equivalent to the Smith & Nephew, Inc BIORAPTOR Suture Anchor. The only major difference is the material of the anchor which is PLC, an osteoconductive biodegradable material.

H. Summary Performance Data

The performance testing conducted includes bench and animal testing that demonstrates substantial equivalence to the Smith & Nephew, Inc BIORAPTOR Suture Anchor.

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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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. Endoscopy Division c/o Ms. Deana Boushell Principal Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

MAR 0 6 2007

Re: K063726

Trade/Device Name: PLC Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 14, 2006 Received: December 15, 2006

Dear Ms. Boushell:

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

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Page 2 -- Ms. Deana Boushell

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

[signature]

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

Enclosure

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Ko6376

§I.D

Indications for Use

510(k) Number (if known):

Device Name: PLC Suture Anchors

Indications For Use:

The Smith & Nephew PLC suture anchors are intensed for use for the reattachment of soft tissue to bone for the following indications:

Shoulder

Foot and Ankle Hallux valgus repairs Medial or lateral instablility repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Elbow

Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee

Hip

Capsular repair Acetabular labral repair

Prescription Use __ x_

(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ Yo

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Davice Evaluation (ODE)

Db. Tho

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

510(k) Number

Page 7

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.