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The Iconix() 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 Valqus 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® 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 or more working sutures. Sutures supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved (K100006 and K190817). The standard and the self-punching 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 Iconix® Anchors size is 2.3mm. The anchors will be sold sterile for single use with no components or accessories. The product is intended to be used with the same accessories used to implant the predicate device. The device is intended for use in a hospital/clinic/surgical setting, and it is intended for adults only.

The provided text describes a 510(k) premarket notification for a medical device called "Iconix® Anchor." This document is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to a previously cleared predicate device.

It is crucial to understand that a 510(k) submission for a non-AI/ML device like the Iconix® Anchor typically does not involve the types of studies, acceptance criteria, multi-reader multi-case (MRMC) studies, or ground truth establishment that are relevant for AI/ML-driven diagnostic devices. The questions posed in your prompt are highly specific to AI/ML software as a medical device (SaMD) or AI-augmented medical devices.

The Iconix® Anchor is a physical medical device (a soft-tissue to bone fixation fastener), not an AI/ML diagnostic or therapeutic system. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are centered around mechanical performance, biocompatibility, sterilization, and substantial equivalence to a predicate device, rather than diagnostic accuracy, reader performance, or AI model metrics.

Based on the provided document, here's how the information relates to your questions, highlighting the differences for a physical device:

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

The document does not present a formal "table of acceptance criteria" with reported performance metrics in the way one would for an AI/ML algorithm (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicit in meeting the performance requirements for a bone anchor, and the reported performance is qualitative, stating that the device "met all requirements for its intended use" and "performed comparably to the predicate device."

Regarding AI-specific questions (2-9), the nature of this submission means most are not applicable or the information is not provided because it's not a software/AI device:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable in the AI/ML sense. The "test set" for a physical device refers to the physical samples tested for mechanical properties, biocompatibility, etc. The document does not specify the number of individual anchors tested, only the types of tests performed (insertion, cyclic, pullout testing) and that cadaveric models were used for usability.
• Data provenance (country of origin, retrospective/prospective) is not relevant for physical device testing in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable in the AI/ML sense. "Ground truth" for this device is established by physical measurements and engineering validation against established standards (e.g., ISO, USP) and comparison to a predicate device's performance, not by expert consensus on image interpretation. For usability, medical professionals might have been involved in the cadaveric testing, but their number and specific qualifications are not detailed.

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

• Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations of data, typically in diagnostic studies. This is not relevant for mechanical and biological testing of a physical device.

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

• Not applicable. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks. This device is not an AI diagnostic tool.

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

• Not applicable. This question pertains to the performance of an AI algorithm independent of human interaction. The Iconix® Anchor is a physical implant, not an algorithm.

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

• For the physical device: The "ground truth" is based on engineering standards, validated test methods (e.g., ISO, USP), and direct physical measurements of properties like tensile strength, insertion force, pullout strength, and biocompatibility. Usability was evaluated using simulated use in cadaveric models.

8. The sample size for the training set

• Not applicable. This question is for AI/ML algorithms. The Iconix® Anchor does not have a "training set" in the machine learning sense. Any design iterations or preliminary testing during development would be more akin to "training," but not in the data science context.

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

• Not applicable. As there is no AI/ML training set, this question is not relevant.

In summary: The provided document is a 510(k) for a physical medical device (a bone anchor), not an AI/ML-driven diagnostic or therapeutic device. The "acceptance criteria" and "study" described are focused on the mechanical, biological, and sterility performance of the physical product, and its substantial equivalence to a predicate device, rather than the performance metrics typically associated with AI/ML systems. Therefore, most of your specific questions related to AI/ML study design are not addressed in this type of regulatory submission.

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The Stryker ICONIX 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: Scaphulolunate 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, Illiotibial Band Tenodesis, Medial Patellofemoral Ligament (MPFL) Repair/Reconstruction, Quadriceps Tendon Repair.

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

The Stryker ICONIX Anchors are intended for single use only.

The ICONIX Anchors, ICONIX TT Anchors, and ICONIX Anchors with Needles are soft tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. ICONIX Anchors with Needles have needles attached to the free ends of all working sutures. All of the ICONIX All-Suture Anchors are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone. Once the anchor has been inserted in the bone, the working sutures are used to complete the soft tissue repair or reconstruction procedure, in accordance with the surgeon's preferred technique for procedures within the indications for use.

The provided text is a 510(k) summary for a medical device (ICONIX All-Suture Anchor) seeking to expand its indications for use. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria, study details, or performance metrics in the context of an AI/ML study.

Therefore, I cannot fulfill your request as it pertains to AI/ML device performance. The document focuses on demonstrating substantial equivalence to predicate devices for expanded surgical procedures, not on the performance of a new AI algorithm.

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