(57 days)
The Stryker PEEK Zip Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
- Rotator Cuff Repair
- Bankart Repair
- SLAP Lesion Repair
- Acromio-Clavicular Separation Repair
- Capsular Shift/Capsulolabral Reconstruction
- Biceps Tenodesis
- Deltoid Repair.
Knee:
- Extra Capsular Repairs
- Medial Collateral Ligament
- Lateral Collateral Ligament
- Posterior Oblique Ligament
- Illiotibial Band Tenodesis
- Patellar Tendon Repair.
Elbow, Wrist, Hand:
- Scapholunate Ligament Reconstruction
- Ulnar Collateral Ligament Reconstruction
- Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment.
Foot and Ankle:
- Medial Instability Repair/Reconstruction
- Lateral Instability Repair/Reconstruction
- Achilles Tendon Repair/Reconstruction
- Midfoot Reconstruction
- Hallux Valgus Reconstruction.
Pelvis:
- Bladder Neck Suspension Procedures.
The Stryker PEEK Zip Suture Anchor is intended for single-use only.
The Stryker PEEK Zip Suture Anchor is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder, Knee, Elbow, Wrist, Hand, Foot and Ankle, Pelvis. The Stryker PEEK Zip Suture Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc. The screw-in anchor is pre-threaded with non-absorbable braided sutures and pre-assembled on a disposable inserter. The suture will be offered in both non-absorbable USP braided polyester suture (#K953531) and non-absorbable USP braided polyethylene suture (#K033654 and #K040472.). The Stryker PEEK Zip Suture Anchor will be validated to a SAL of 10° using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7:1995.
This document is a 510(k) Summary of Safety and Effectiveness for the Stryker PEEK Zip Suture Anchor, a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically discussed for AI/ML medical devices.
The document focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for this type of device (a Class II orthopedic fastener). Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device. This is primarily established by showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this 510(k) submission.
Here's an analysis based on the information provided, highlighting why certain categories are not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Conformity to ISO 10993-1, Blue Book Memorandum G95-1. | The device uses PEEK-OPTIMA® (polyetheretherketone), a biocompatible polymer. It will be validated to a SAL of 10⁻⁶ using ethylene oxide, and EtO residuals will be tested according to ISO 10993-7:1995. The material differences between the Stryker PEEK Zip and Stryker BioZip (predicate) do not affect safety and efficacy. The device is considered substantially equivalent in material composition to the Arthrex PEEK Corkscrew FT (predicate). |
| Sterilization: Validation to a Sterility Assurance Level (SAL) of 10⁻⁶. | Validated to a SAL of 10⁻⁶ using ethylene oxide (EtO). EtO residuals tested per ISO 10993-7:1995. |
| Safety and Performance Standards: Conformity to EN 550, EN 556-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971. | The device "will conform" to these voluntary safety and performance standards prior to market introduction. (This is a statement of intent for future compliance, not a report of completed performance against these standards within the document). |
| Substantial Equivalence: Demonstration that the device is as safe and effective as legally marketed predicate devices. | The document states: |
- "The Stryker PEEK Zip Suture Anchor is considered substantially equivalent in performance, intended use, safety, and efficacy to the Stryker BioZip Suture Anchor."
- "The Stryker PEEK Zip Suture Anchor is considered substantially equivalent in material composition, intended use, safety and efficacy to the Arthrex PEEK Corkscrew FT." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document is a 510(k) submission focusing on substantial equivalence for a physical medical device (suture anchor), not an AI/ML device. There is no "test set" in the context of an algorithm's performance on a dataset. The "testing" involves biocompatibility, sterilization validation, and adherence to performance standards for the materials and manufacturing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth is not established in this context as there's no diagnostic or predictive algorithm being evaluated against a reference standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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 product is a physical suture anchor, not an AI-assisted diagnostic or treatment planning system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As a physical device, ground truth in the context of diagnostic or predictive accuracy is not relevant. The "ground truth" for this device relates to its material properties, biocompatibility, sterility, and mechanical performance (implicitly covered by adherence to standards and substantial equivalence claims).
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.