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The Stryker ICONIX XBraid TT with Needles devices are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament 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 Joint 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

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

The NanoTack TT Suture Anchor is intended for the fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/ wrist, elbow, and knee in the following procedures:

Hip: Hip capsule repair, acetabular labrum reattachment

Shoulder: Capsular stabilization (Bankart repair, anterior shoulder instability, SLAP lesion repair, capsular shifts or capsulolabral reconstructions), acromioclavicular separation repair, deltoid repair, rotator cuff tear repair, biceps tenodesis

Foot and Ankle: Hallux valgus repair. Medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, Metatarsal ligament/tendon repair/reconstructions, bunionectomy

Elbow, Wrist, and Hand: Biceps tendon reattachment, ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair

Knee: Extra-capsular repair (medial collateral ligament, lateral collateral ligament, posterior oblique ligament), patellar realignment and tendon repairs (vastus medialis obliquous advancement), Iliotibial band tenodesis

The ICONIX XBraid TT with Needles devices are soft-tissue fixation devices consisting of an all suture anchor with a push-in design, preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures. Fixation is achieved by the polyester sheath bunching when the anchor is deployed. The suture "tape" is composed of 100% ultra-high molecular weight polyethylene (UHMWPE). These devices include needles, which are housed in a compartment within the inserter handle. These needles are swaged to the free ends of all working sutures for use at the discretion of the surgeon. The devices are provided in a sterile state; the anchor and inserter assembly will be packaged in a single-use sterile barrier system (SBS) containing a disposable drill and drill guide to aid in bone hole creation and anchor implantation.

There are two proposed configurations of The ICONIX XBraid TT with Needles device:

• 1.4mm suture anchor with 1.2mm XBraid TT suture tape, and
• . 2.3mm suture anchor with 2.0mm XBraid TT suture tape.

The NanoTack TT Suture Anchor is a non-degradable implant device consisting of a suture anchor with attached non-degradable, flat suture tape preassembled on an insertion device. This device is provided sterile, and is intended for single use only. The anchor is manufactured from polyether ether ketone (PEEK), and the suture tape is composed of 100% ultra-high molecular weight polyethylene (UHMWPE). The anchor and inserter assembly will be packaged in a single-use sterile barrier system (SBS).

There is one proposed configuration of the NanoTack TT Suture Anchor:

• . 1.4mm anchor with 1.2mm XBraid TT suture tape.

The provided document is a 510(k) Premarket Notification from the FDA regarding two medical devices: the ICONIX XBraid TT with Needles and the NanoTack TT Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable or present in this type of regulatory submission.

However, I can extract information related to the device performance testing conducted to support substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a standalone section. Instead, it describes various "non-clinical verification and validation testing" performed to assess the efficacy and substantial equivalence of the proposed devices to their predicate devices. The implicit acceptance criterion for these tests is that the new devices perform comparably to or better than the predicate devices, or that they meet established engineering or biological safety standards.

Below is a summary of the types of tests conducted and the general conclusion, as specific numerical acceptance criteria and performance metrics are not detailed in this high-level summary.

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

• Sample Size: The document does not specify the exact sample sizes used for each of the non-clinical tests (e.g., how many devices were tested for tensile strength, how many were subjected to cyclic loading, etc.).
• Data Provenance: The tests are described as "non-clinical verification and validation testing." This implies laboratory-based or benchtop testing, not data derived from patients or clinical studies. Therefore, it's not applicable to discuss country of origin or retrospective/prospective nature in the typical sense of clinical data.

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

This information is not applicable. The evaluations described are "non-clinical verification and validation testing," which refers to product performance and safety testing (e.g., mechanical testing, biocompatibility). These types of tests do not involve human experts establishing "ground truth" in the way a clinical study would (e.g., radiologists interpreting images). The "ground truth" for these tests would be the measured physical properties or biological safety outcomes as defined by engineering standards or biological assessments.

4. Adjudication Method for the Test Set

This is not applicable as there is no "test set" in the context of expert review or clinical evaluation that would require adjudication. The testing described is objective, non-clinical performance data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. The devices are surgical suture anchors used for soft-tissue to bone fixation. They are physical implants, not AI-powered diagnostic or assistive technologies. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to these devices.

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

This is not applicable. As mentioned, these are physical medical devices, not algorithms or AI.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests is based on objective measurements against engineering specifications, material properties, and established biological safety standards. For example:

• Tensile Strength: Measured force at failure, compared against a predefined standard or predicate device performance.
• Biocompatibility: Results of biological assays (e.g., cytotoxicity, sensitization, irritation) compared against ISO 10993 standards.
• Sterilization Validation: Confirmation of sterility assurance levels (SAL) according to recognized standards.
• Pyrogen Testing: Measurement of pyrogen levels, compared against recommended limits.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of non-clinical device performance and safety testing for these physical implants. The testing performed is to validate the device's design and manufacturing, not to train an algorithm.

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

This is not applicable as there is no training set for these devices.

In summary, the document details non-clinical verification and validation activities demonstrating that modifications to existing suture anchors (ICONIX XBraid TT with Needles and NanoTack TT Suture Anchor) result in devices that are substantially equivalent in performance and safety to their predicate devices. It does not contain information about clinical studies, AI algorithms, or expert ground-truthing as typically found in submissions for diagnostic or AI-based devices.

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The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the shoulder. They are indicated for use in rotator cuff repair.

The Self-Punching ICONIX Anchors are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures, which are folded over and mounted on the forked tip of the inserter. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone. The anchor pre-loaded on the inserter is packaged in a singleuse sterile barrier system (SBS).

The provided text is a 510(k) summary for the Stryker Self-Punching ICONIX device. It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical benchtop testing. The document explicitly states that clinical testing was NOT required for this submission. Therefore, it does not describe a study that proves the device meets specific acceptance criteria based on human or clinical performance, nor does it provide information related to AI or a multi-reader multi-case study.

However, based on the non-clinical benchtop testing described, here's an attempt to extract relevant information for the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for the benchtop tests (e.g., number of anchors tested for fixation strength or insertion effort). The data provenance is from non-clinical benchtop testing, meaning it's laboratory-generated data, not from human subjects or clinical settings.

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

Not applicable. This was non-clinical benchtop testing, not involving expert consensus on images or medical findings. The "ground truth" was established by objective physical measurements (e.g., force, strength, material testing results) against predefined engineering specifications and comparison to the predicate device.

4. Adjudication method for the test set

Not applicable. As this was non-clinical benchtop testing, there was no need for adjudication by experts. Results were likely determined by instrument readings and comparisons.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence for this submission."

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

No, this pertains to a physical medical device (suture anchor), not an algorithm or AI.

7. The type of ground truth used

The ground truth used for these non-clinical tests was based on objective physical measurements (e.g., force, strength values) and material testing results against established engineering specifications and comparison to the predicate device's performance.

8. The sample size for the training set

Not applicable. This is a physical medical device submission, not an AI/algorithm where training sets are relevant.

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

Not applicable.

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The Stryker Self-Punching ICONIX Anchors are intended to be used for soft-tissue to bone fixation in the elbow, shoulder, knee and hip. See indications 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

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 Self-Punching ICONIX Anchors (herein referred to as the proposed device(s)) are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures, which are folded over and mounted on the forked tip of the inserter. The anchor is inserted into the bone using a self-punching mechanism, and the polyester sheath bunches as the anchor is deployed to allow for fixation in bone. The anchor preloaded on the inserter is packaged in a single-use sterile barrier system (SBS).

The provided text is a 510(k) summary for the Stryker Self-Punching ICONIX, a medical device for soft-tissue to bone fixation. It does not describe a study involving acceptance criteria and a device's performance against them in the context of an AI/algorithm-based diagnostic or prognostic device.

Instead, this document describes and demonstrates the substantial equivalence of a new medical device (Stryker Self-Punching ICONIX Anchors) to existing predicate devices based on non-clinical benchtop testing. The performance data presented focuses on fixation strength and insertion effort, not on diagnostic accuracy, sensitivity, specificity, or reader performance in an AI context.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not addressed in this document for the described device.

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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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

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

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

The Stryker ICONIX TT All Suture Anchors are a line extension of the legally marketed Stryker ICONIX All Suture Anchors. The ICONIX TT 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. The sheath bunches as the anchor is deployed to fixate in bone.

The provided text is related to a 510(k) premarket notification for a medical device called the "Stryker ICONIX TT All Suture Anchor." This document describes the device's technical characteristics, its intended use, and a comparison with a predicate device to establish substantial equivalence.

Based on the information provided, no acceptance criteria or studies proving a device meets acceptance criteria related to AI/algorithm performance are present. This document is for a physical medical device (suture anchor) and the "performance data" section refers to non-clinical verification and validation testing for mechanical properties and biocompatibility, not an AI algorithm.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI device meets them using this input. The questions you've asked (about sample sizes, ground truth, experts, MRMC studies, standalone performance) are specific to the evaluation of AI/ML-driven medical devices, which is not the subject of this document.

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