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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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The ICONIX All Suture Anchor System is 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, Iliotibial Band Tenodesis.
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The ICONIX All Suture Anchors are intended for single use only.

The ICONIX All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. As the anchor is deployed, the sheath bunches and fixates in bone.

The provided text describes the ICONIX All Suture Anchor System and its expanded indications for use. However, it does not include information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement. This is likely because the device is a medical implant (suture anchor) and not an AI-powered diagnostic or assistive tool, which typically have performance metrics and studies as detailed in the prompt.

The "study" mentioned here is confined to non-clinical comparative bench testing to support expanded indications, not a clinical study involving human performance or diagnostic accuracy.

Here's an analysis based on the provided document, addressing the prompt's questions where possible and noting where information is not applicable or unavailable:

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

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

• Sample Size for Test Set: Not explicitly stated in the document. The text only mentions "comparative bench testing" for "cyclic testing followed by ultimate tensile strength".
• Data Provenance: The study was "non-clinical comparative bench testing," implying it was conducted in a lab setting, likely within the United States where Stryker Endoscopy is based (San Jose, CA). It is prospective in nature for device validation.

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)

• This question is not applicable to this type of device and study. The testing involved mechanical properties (fixation strength, tensile strength) which are measured quantitatively, not subjectively assessed by human experts for ground truth.

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

• This question is not applicable as the "test set" involves physical device performance, not human interpretation or diagnostic assessment.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ICONIX All Suture Anchor System is a physical surgical implant.
• Therefore, an effect size of human improvement with/without AI assistance is not applicable.

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

• This question is not applicable. This device is a physical medical implant, not an algorithm, and does not have standalone "algorithm only" performance.

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

• The "ground truth" for this device's performance was established via objective mechanical measurements of fixation strength and ultimate tensile strength in a bench testing environment according to engineering principles. It was compared against the performance of predicate devices.

8. The sample size for the training set

• This question is not applicable as there is no "training set" in the context of mechanical bench testing for a physical medical device. This term is specific to machine learning and AI model development.

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

• This question is not applicable since there is no training set for this type of device validation.

Summary of the Study:

The "study" described in the document is a non-clinical comparative bench test. Its purpose was to demonstrate that the ICONIX All Suture Anchors, when used for Gluteal Tendon Repair of the Hip (an expanded indication), show equivalent mechanical fixation strength to predicate devices. This type of testing is standard for demonstrating substantial equivalence for physical medical devices, especially when expanding indications without significant design changes. Clinical testing was explicitly stated as "not required for this submission." The FDA's 510(k) clearance (K133671) acknowledges this bench testing as sufficient to support the claim of substantial equivalence.

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