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The ICONN Answer II Suture Anchor is indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. Specific indications are as follows: Shoulder Indications: Rotator Cuff Repairs, Biceps Tenodesis Foot/Ankle Indications: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.

The ICONN Answer II Suture Anchor (P/N's 147501 and 155001) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-600L polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in two sizes (Diameter x Length): 4.75mm x 16mm and 5.5mm x 16mm.

The provided text is a 510(k) summary for the ICONN Answer II Suture Anchor, a medical device. It describes performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information about studies involving AI or human readers for diagnostic purposes.

Therefore, I cannot fulfill your request for information related to:

• A study proving the device meets acceptance criteria using an AI system.
• Number of experts establishing ground truth or their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Sample size and ground truth for training set.

The document focuses on mechanical and biocompatibility testing for a physical medical device (suture anchor), not a diagnostic AI system.

Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and performance, as appropriate for a physical implantable device:

Description of Device Testing and Acceptance Criteria

The ICONN Answer II Suture Anchor underwent performance testing to demonstrate its safety and effectiveness, and substantial equivalence to its predicate device (Arthrex PEEK Corkscrew FT (K061665)). The tests focused on mechanical properties, biocompatibility, and sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "side by side mechanical testing performed on the subject device and predicate" and "Bioburden – 3 Lots," but does not explicitly state the number of samples or devices tested for each mechanical or biocompatibility test. The data provenance is not explicitly stated as retrospective or prospective, but testing for device clearance typically occurs prospectively as part of product development. The country of origin of the data is implied to be within the US, given the FDA submission.

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

Not applicable. This device is a physical implant, and the "ground truth" for mechanical and biocompatibility testing is based on objective laboratory measurements and established biological assays, not expert interpretation of diagnostic images.

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

Not applicable. This concept is relevant for studies involving human interpretation or consensus, such as clinical trials or AI performance evaluations, not for basic device performance testing.

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. This document pertains to a physical suture anchor, not an AI-assisted diagnostic tool.

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

Not applicable. This document pertains to a physical suture anchor, not an algorithm.

7. The type of ground truth used:

• Mechanical Testing: Objective measurements (e.g., force, displacement, torque) against established engineering standards (e.g., FDA Draft Guidance, ASTM F543-2013). The "ground truth" is the physical behavior of the device under defined conditions.
• Biocompatibility Testing: Results of standardized biological assays (e.g., ISO 10993) against predefined acceptance criteria for cellular response, irritation, sensitization, and endotoxin levels. The "ground truth" is the biological reaction to the material.
• Sterilization Validation: Microbiological testing results against established sterility assurance levels and bioburden limits. The "ground truth" is the confirmed absence of viable microorganisms.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning study.

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

Not applicable. This is not an AI/machine learning study.

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