PLC SUTURE ANCHOR

• K Number: K063726
• Device Name: PLC SUTURE ANCHOR
• Manufacturer: SMITH & NEPHEW INC., ENDOSCOPY DIV.
• Date Cleared: 2007-03-06 ( 81 days)
• Product Code: HRS , HWC
• Regulation Number: 888.3030
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K053344

Intended 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

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.

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.