(56 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent fixation strength to predicate device at time zero. | Proposed devices provide equivalent fixation strength compared to the predicate device. |
| Equivalent fixation strength to predicate device following cyclic loading. | Proposed devices provide equivalent fixation strength compared to the predicate device. |
| Equivalent insertion effort to predicate device. | Proposed devices require equivalent insertion effort compared to the predicate device. |
| Material-mediated pyrogenicity within required limits. | Passing results below the required limits. |
| Bacterial endotoxins within required limits. | Passing results below the required limits. |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.