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The Iconix Knotless 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, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair

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 Collateral 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 Knotless Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one working suture, also referred to as the repair strand, and a shuttle strand that is used to shuttle the repair strand around tissue and through the braided anchor body.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The size of the anchor of the subject device is 1.4mm. Iconix Knotless Anchor will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided text pertains to an FDA 510(k) premarket notification for a medical device called the "Iconix Knotless Anchor." It outlines the device's description, intended use, and the basis for its substantial equivalence to a previously cleared predicate device.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The product is a physical medical device (knotless anchor for soft-tissue to bone fixation), not an AI/ML algorithm.

Therefore, I cannot provide the requested information related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device, as these concepts are not applicable to the physical medical device described in the document.

The document discusses non-clinical mechanical testing (insertion, cyclic, and pullout testing) and other validations (shelf-life, sterilization, biocompatibility, packaging stability, usability engineering) to demonstrate that the device performs comparably to its predicate and meets requirements for its intended use. This is typical for physical medical devices but does not align with the AI/ML-focused questions in your prompt.

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The Iconix Knotless 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, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repair

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 Collateral 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 Knotless Anchors are soft-tissue to bone fixation devices, provided preloaded on a disposable inserter. The device is composed of a braided polyester anchor body that contains one working suture, also referred to as the repair strand, and a shuttle strand that is used to shuttle the repair strand around tissue and through the braided anchor body.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserters are comprised of metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix Knotless 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.

The classification for the Iconix Anchor is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.

This document is a 510(k) Pre-market Notification for a medical device called the "Iconix Knotless Anchor." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving a device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and expert involvement is not applicable based on the provided text.

Here's an analysis based on the information available:

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

The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it describes comparative performance testing against a predicate device.

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

The document does not specify the sample sizes for the mechanical tests (insertion, cyclic, pullout). It mentions "simulated use in a cadaveric models" for usability engineering, but the number of cadaveric models is not provided, nor is the country of origin. The data provenance details are largely absent.

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

This is not applicable as the document describes engineering and biocompatibility testing, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication method for the test set

This is not applicable.

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. The device is a surgical anchor, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a surgical anchor.

7. The type of ground truth used

For mechanical testing (insertion, cyclic, pullout), the "ground truth" would be the measured mechanical properties of the device itself and the predicate. For biocompatibility, it's compliance with ISO standards. For packaging and sterilization, it's compliance with relevant ISO standards and validation protocols. For the usability engineering, it was simulated use in cadaveric models.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

This is not applicable.

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