(169 days)
The Stryker XCEL Anchor is intended for use in securing soft tissue to bone in such procedures as:
Shoulder: Bankart repair, SLAP lesion repair, Rotator cuff repair, Capsular shift repair, Biceps tenodesis, Acromio-clavicular separation
Elbow: Biceps tendon reattachment
Foot & Ankle: Achilles tendon repair/reconstruction, Lateral stabilization, Medial stabilization
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Joint capsule closure to anterior proximal tibia, Posterior oblique ligament or joint capsule to tibia repair, Extra capsular reconstruction/ITB tenodesis, Patellar ligament and tendon avulsion repairs
The Stryker XCEL Anchor is intended for single-use only.
The Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with nonabsorbable, braided polyester surgical suture, and pre-assembled on a disposable inserter. Stryker instrumentation, drill and soft-tissue guide/drill guide, will be used to install the Stryker XCEL Anchor. The Stryker XCEL Anchor System will be provided pre-assembled, sterile for single-use applications (ASTM 4169). The device will be sterilized by Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO 10993 and G95-1.
The provided text is a 510(k) premarket notification summary and a letter from the FDA regarding the Stryker XCEL Anchor System. This document does not contain the kind of detailed information requested about acceptance criteria and a study proving a device meets them, especially in the context of AI/ML performance (e.g., sample sizes for test/training sets, expert consensus, MRMC studies).
Instead, it describes a medical device (Stryker XCEL Anchor System) for securing soft tissue to bone and states its substantial equivalence to a predicate device (Mitek Panalok 3.5mm Absorbable Anchor System). The safety and effectiveness are established by demonstrating this substantial equivalence, not through a performance study against specific acceptance criteria as you've outlined for AI/ML devices.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on:
- Device Name and Classification: Stryker XCEL Anchor System, Class II, Smooth or Threaded Metallic Bone Fixation Fasteners.
- Predicate Device: Mitek Panalok 3.5mm Absorbable Anchor System.
- Intended Use: Securing soft tissue to bone.
- Device Description: Poly L-lactic acid (PLLA) anchor with non-absorbable, braided polyester surgical suture, pre-assembled on a disposable inserter.
- Substantial Equivalence: Claimed based on intended use, safety, efficacy, and performance compared to the predicate device.
- Sterilization and Biocompatibility: Information provided (Ethylene oxide, ISO 10993).
- Indications for Use: Specific surgical procedures (e.g., Bankart repair, rotator cuff repair, Achilles tendon repair).
There is no mention of:
- Acceptance criteria in the form of performance metrics (like sensitivity, specificity, F-score, etc.).
- A specific "study" with test sets, training sets, ground truth establishment, expert readers, or AI/ML components.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
§ 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.