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The BIOSURE HEALICOL PK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications: Knee (ACL repairs, PCL repairs, Extra-capsular repairs, Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquus advancement, Iliotibial band tenodesis), Shoulder (Acromioclavicular separation repairs, Biceps tenodesis), Foot and Ankle (Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Flexor hullucis longus (FHL), Tendon transfers), Elbow, Wrist, and Hand (Bicens tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers, Carpomedicarpal joint arthroplasty)

Smith & Nephew BIOSURE HEALICOIL PK interference screw is a non-absorbable, sterile, single-use, interference screw composed of Polyetheretherketone (PEEK). It has a fenestrated open design which allows for bone ingrowth. It is provided in size ranging from 6mm to 10 mm diameter. BIOSURE HEALICOIL interference screw minimizes the volume of material implanted into the body while providing equal fixation strength of a standard interference screw. The central channel of the screw can be packed with autologous bone.

The provided document describes the Smith & Nephew BIOSURE HEALICOIL PK Interference Screw, a non-absorbable, sterile, single-use interference screw made of PEEK. The document focuses on establishing substantial equivalence to legally marketed predicate devices rather than providing acceptance criteria for a novel device or AI algorithm. Therefore, many of the requested points related to AI performance, ground truth establishment, expert review, and sample sizes for training/test sets are not applicable.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing "substantial equivalence" to predicate devices, meaning it does not define specific acceptance criteria in the traditional sense of a performance metric to be met by a new device against a predefined threshold. Instead, it aims to demonstrate that its performance is comparable to already cleared devices.

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

The document refers to mechanical testing and an animal study.

• Mechanical Testing: The document does not specify the sample size for the mechanical testing (pull-out and insertion).
• Animal Study: The animal study used a sample size of n=11 for the BIOSURE HEALICOIL PK interference screw and n=11 for the control group. The provenance of this data (e.g., specific animal model, institution) is not detailed, but it is explicitly an animal study and not human data. It is a prospective study by nature of being conducted to evaluate the device.

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

Not applicable. This device is a physical medical implant, not an AI or diagnostic device that requires expert interpretation for establishing ground truth on a test set. The evaluation relies on mechanical and histological analysis.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" in the context of interpretation or diagnosis that would require an adjudication method like 2+1 or 3+1. The evaluation methods were mechanical testing and histological analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic device involving human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used:

• Mechanical Testing: The ground truth for mechanical performance (pull-out and insertion strength) would have been established by direct measurements using calibrated testing equipment, following established engineering standards.
• Animal Study (Bone Ingrowth): The ground truth for bone ingrowth was established through:
  • Micro computed tomography (µCT): Provides detailed 3D imaging of bone structure.
  • Histology: Microscopic examination of tissue samples to assess new bone formation.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning device that requires a training set. The device design and materials are based on established engineering principles and prior knowledge.

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

Not applicable. There is no training set.

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