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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.

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The Stabilizer Soft Tissue Anchor is a stainless steel implant intended for use 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 316L stainless steel implant intended for use 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.

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 up to three sutures. The anchor inserter (which spreads the stabilizer teeth of the implant) also serves as a suture organizer for delivery of sutures, as may be required, to the implant site during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole. If sutures are not used, use of the crimper is optional.

This document is a 510(k) Premarket Notification for a medical device called the "Stabilizer™ Soft Tissue Anchor, 6 mm," intended for ACL repair/reconstruction.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a submission to the FDA for market clearance, stating that the device is substantially equivalent to previously cleared predicate devices.

Therefore, I cannot extract the requested information, as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results with acceptance criteria.

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The Stabilizer Soft Tissue Anchor is intended for use with USP Sutures as an attachment means for soft tissue and bone for the indications listed below: Shoulder (Bankart repair, SLAP lesion repair, Acromioclavicular separation, Rotator cuff repair, Capsule shift \capsulolabral reconstruction, Biceps tenodesis, Deltoid repair), Elbow (Tennis elbow repair, Biceps tendon reattachment, Medial and lateral repairs), Ankle (Lateral instability, Medial instability, Achilles tendon repair/ reconstruction), Knee (Extra-capsular repairs and attachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament and joint capsule to tibia, joint capsule closure to the anterior proximal tibia; Extra-capsular reconstruction, ITB tenodesis; Patellar ligament and tendon avulsions repairs)

The Stabilizer Soft Tissue Anchor is a 316L Stainless Steel implant designed to provide an attachment means for soft tissue to bone using USP grade surgical sutures in joint reconstruction procedures. It is available in two sizes: 5 and 8 mm diameter. Attachment 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 securing soft tissue 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 during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer and to prepare the stabilizer for entry into the predrilled hole.

This document is a 510(k) premarket notification for a medical device, the Stabilizer™ Soft Tissue Anchor. It describes the device, its indications for use, contraindications, and comparisons to a predicate device.

Unfortunately, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about any studies (clinical or non-clinical) that demonstrate the device's performance.
• Sample sizes used for test sets or data provenance.
• Information on experts used for ground truth establishment or adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information about standalone algorithm performance.
• The type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

This 510(k) summary is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, not on detailing a rigorous performance study with specific acceptance criteria and results. For a device like this (a mechanical anchor), performance data would typically involve biomechanical testing (e.g., pull-out strength, fatigue testing) rather than clinical studies with "ground truth" in the way an AI diagnostic device would. However, even for biomechanical testing, specific acceptance criteria and results would be presented.

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The Stabilizer Soft Tissue Anchor is a 316L stainless steel implant intended for use with 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 316L stainless steel implant intended for use with 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.

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 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 during the implantation procedure. A crimper is also included to help secure the suture of choice to the Stabilizer, and to prepare the Stabilizer for entry into the predrilled hole.

This submission does not contain the information required to complete the request. The provided text describes a medical device, its intended use, contraindications, and comparisons to a predicate device, but it does not include any details about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations. The document explicitly mentions "COMPLIANCE WITH PERFORMANCE STANDARDS" but states "Not applicable." Therefore, I cannot extract the requested information about device performance and the study proving it meets acceptance criteria.

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