Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device