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The Iconix® HA+™ anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis. Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

The Iconix® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M Anchors are available in common sizes and lengths and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

This document describes the validation study for the Iconix® HA+TM Anchor, a medical device used for soft-tissue to bone fixation. This is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and established performance benchmarks for such devices, rather than a clinical accuracy study for AI/software.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, not an AI/software device, the "acceptance criteria" and "reported device performance" are primarily based on meeting established standards and demonstrating comparable mechanical properties to a predicate device.

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

The provided document describes non-clinical performance testing and an animal study. It does not describe a clinical study with a human-derived test set in the way an AI/software device would.

• Non-clinical Mechanical Testing: The sample sizes for insertion, cyclic, and pullout testing are not specified. The studies were performed to compare against the predicate device.
• Animal Study: The sample size for the animal study is not specified. The purpose was to evaluate biological safety and in vivo performance.
• Data Provenance: The document implies these were prospective laboratory and animal studies conducted by the manufacturer, Riverpoint Medical, LLC. There's no mention of country of origin for the data or whether it was retrospective.

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

This question is not applicable in the context of this device and study type.

• For non-clinical mechanical testing, the "ground truth" is typically defined by engineering specifications and objective measurements (e.g., force, displacement), not expert interpretation.
• For the animal study, "ground truth" would be established through histological analysis, observation of biological responses, and potentially pathological evaluation, conducted by veterinary pathologists or researchers, but this is not explicitly detailed as "experts establishing ground truth" in the sense of a diagnostic interpretation task.

4. Adjudication Method for the Test Set

This is not applicable. There was no human "test set" requiring adjudication in the context of an AI/software performance study. Mechanical and biological test results are typically objectively measured against defined criteria.

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

This is not applicable. This device is a physical bone anchor, not an AI/software diagnostic tool. There were no human "readers" involved in interpreting findings from the device itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable. This device is a physical bone anchor, not an algorithm or software. The mechanical and biological tests assess the device's inherent function, which is a "standalone" evaluation of its physical properties.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth was based on objective engineering measurements (e.g., load-to-failure, displacement) and comparison to the predicate device's established performance and industry standards for bone anchors.
• Biocompatibility/Animal Study: Ground truth was based on biological responses and safety profiles observed in the animal model, likely through histological analysis, gross observations, and clinical pathology, evaluated against established safety benchmarks for implantable materials.
• Suture Testing: Ground truth was based on United States Pharmacopeia (USP) requirements for tensile strength.

8. The Sample Size for the Training Set

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

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

This is not applicable, as there was no training set.

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The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:

Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)

Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, 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 instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy

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

Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis

The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.

Here’s a breakdown of the acceptance criteria and study information for the SUTUREFIX Ultra Suture Anchor, based on the provided text:

Important Note: The provided text is a 510(k) premarket notification summary. This type of submission generally focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical efficacy studies against acceptance criteria like you'd find for novel therapies or AI-driven diagnostic tools. Therefore, much of the requested information (especially regarding AI, human readers, sample sizes for training/test sets, and expert details for ground truth) is not applicable or not present in this document. The document primarily discusses mechanical performance data.

Acceptance Criteria and Reported Device Performance

Explanation: The document states, "Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices." This implies that the 'acceptance criteria' were the successful demonstration of adequate insertion and pull-out strength, and the ultimate acceptance criterion was deemed 'substantially equivalent' to the predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document refers to "Performance data" but does not quantify the number of devices or tests performed.
   • Data Provenance: Not specified, but generally, such biomechanical testing would be conducted in a laboratory setting (e.g., in-vitro or ex-vivo testing). No information on country of origin for the data is provided, nor whether it was retrospective or prospective in a clinical sense.

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

   • Not Applicable. For a mechanical device like a suture anchor, ground truth is typically established through direct physical measurement and engineering standards, not through "expert consensus" in the medical diagnostic sense. There are no "experts" establishing a diagnostic ground truth.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation of medical images or data is involved to establish a consensus ground truth. This is a biomechanical performance study, not an interpretative one.

4. 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 device is a surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement data is relevant or provided.

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

   • Not Applicable. This is a physical medical device, not an algorithm or AI.

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

   • Biomechanical Performance Metrics: Ground truth for this device would be based on empirically measured physical properties, such as the force required for insertion and the force required to pull out the anchor from a test material (e.g., bone surrogate or cadaveric bone). This is determined by engineering and biomechanical testing standards.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. As above, no training set for an AI/ML model.

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