Search Results

The Titan Ti Suture Anchor System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

• Shoulder· Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction,
• Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
• Hip: Capsular Repair, Acetabular Labral Repair

The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor

This document is a 510(k) summary for the ArthroCare Corporation Titan™ Ti Suture Anchor System. It describes a medical device, its intended use, and its substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device is a "Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)" and the submission is for a modification to an existing device, specifically the addition of polyethylene tubing to improve shaft design.

Crucially, this document does not describe a study to prove the device meets acceptance criteria. Instead, it is a regulatory submission for a medical device seeking clearance based on substantial equivalence to predicate devices. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC comparative effectiveness specific to the current submission's modification. The FDA's clearance is based on the argument that the modification (the addition of polyethylene tubing) does not raise new questions regarding safety and effectiveness, implying that the performance characteristics of the device remain largely consistent with the predicate.

Therefore, I cannot provide the requested information from the given text as the information is not present. The document focuses on regulatory clearance, not on a detailed performance study as would be conducted for a new or significantly modified device requiring extensive clinical or analytical validation.

Ask a specific question about this device

The Titan Ti Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction;
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
• Hip: Capsular Repair, Acetabular Labral Repair

The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver. The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor.

The provided text describes a 510(k) summary for the ArthroCare Corporation Titan™ Ti Suture Anchor System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study with a test set.

Therefore, many of the requested sections about acceptance criteria, test set details, expert ground truthing, and AI-specific studies are not applicable or cannot be extracted from this type of regulatory submission.

Here's the information that can be extracted, along with explanations for the missing details:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) submission like this, the primary "acceptance criterion" is often substantial equivalence to a predicate device. This means the new device performs as intended and is as safe and effective as a device already on the market. Specific quantitative performance acceptance criteria (e.g., "Device must achieve X N/mm of pull-out strength with no more than Y% failure rate") are not typically stated or summarized in this part of the document, as the focus is on comparative safety and effectiveness. The "efficacy in cadaver shoulder bone" is presented as support for this equivalence, not as a direct measurement against a pre-defined numerical performance threshold.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a "test set" in the context of an algorithm or human reader study. The study mentioned is "cadaver shoulder bone" for efficacy.
• Data Provenance: Cadaver shoulder bone (unspecified country of origin or number of cadavers).
• Retrospective or Prospective: Unspecified, but implied to be a laboratory study rather than a clinical one.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The study involved biomechanical testing on cadaver bone, not clinical interpretation requiring expert consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical imagery or diagnostic interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This document describes a medical device (suture anchor), not an AI algorithm for diagnostic imaging or a system for interpreting data. Therefore, an MRMC study is not relevant.
• Effect Size of Human Readers with/without AI: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: Not applicable. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

• Ground Truth: For the "efficacy in cadaver shoulder bone" mention, the "ground truth" would be the biomechanical performance metrics (e.g., pull-out strength, failure mode) measured directly from the cadaveric specimens under controlled laboratory conditions. This is a form of direct experimental measurement rather than expert consensus or pathology in a clinical sense.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device does not involve a "training set" like an AI algorithm would.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The key "study" referenced in the 510(k) for the Titan™ Ti Suture Anchor System is a demonstration of efficacy in cadaver shoulder bone. This testing was conducted to support the claim that the device is substantially equivalent to the predicate device (ArthroCare Titan Ti Suture Anchor, K092133). The document explicitly states: "The Titan Ti Suture Anchor design and technology is identical to the existing Titan Ti Suture Anchor devices cleared in K092133. The addition of ancillary instruments does not raise new questions regarding the safety and effectiveness of the Titan Ti Suture Anchor system. Efficacy of the device was shown in cadaver shoulder bone. The proposed system is safe and effective as the predicate device."

This statement implies that biomechanical testing was performed on cadaveric shoulder bone to assess the performance of the suture anchor, likely focusing on properties like pull-out strength or fixation stability. The results of this testing were deemed sufficient to demonstrate that the device performs comparably to the predicate device and meets its intended purpose. The acceptance criteria in this context are implicitly that the device performs at least as well as the predicate device in relevant biomechanical tests to establish substantial equivalence for regulatory clearance.

Ask a specific question about this device