(58 days)
The Stabilizer Soft Tissue Anchor is a titanium alloy implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
The Stabilizer Soft Tissue Anchor is a titanium alloy (Ti 6A1-4V ELI Alloy for Surgical Implant Applications per ASTM F136-92) implant intended for use with or without USP Sutures as an attachment means for soft tissue and bone in Anterior Cruciate Ligament (ACL) repair or reconstruction. The Stabilizer is 8 mm in diameter. Stabilizer instruments must be used to install the Stabilizer Soft Tissue Anchor.
Stabilizer placement is accomplished by drilling an appropriately sized hole in uncompromised bone with a specifically designed drill, inserting the soft tissue anchor into the bone, expanding the stabilizer teeth of the implant to secure the anchor into bone using the anchor inserter, and optionally securing the ACL to the implanted anchor by using three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures to the implant site if required during the implantation procedure.
The provided 510(k) Premarket Notification for the Stabilizer™ Soft Tissue Anchor for ACL Repair/Reconstruction does not contain information about acceptance criteria or a study proving that the device meets such criteria.
This 510(k) submission, dated 1999, focuses on demonstrating substantial equivalence to existing predicate devices based on design, material, and function. The 510(k) summary provides:
- Device Description: Details on the titanium alloy implant, its diameter, and the installation procedure.
- Indications for Use: Specifies its application in ACL repair or reconstruction.
- Contraindications, Warnings, Precautions, and Complications: Important safety information.
- Comparison of Technological Characteristics: A statement asserting substantial equivalence to predicate devices.
- FDA Response Letter: Confirming substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment. The document does not describe performance targets, test results, sample sizes, ground truth establishment, or expert involvement in a study designed to meet specific performance criteria.
In summary, the provided document does not contain the information necessary to fulfill your request, as it pertains to a regulatory submission demonstrating substantial equivalence rather than a detailed performance study with defined acceptance criteria.
§ 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.