Search Results

The Citregen Tendon Interference Screw (TIS) and Citrelock are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. More specifically:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tendon Reattachment, Acromion-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 Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist.

The Citregen TIS and Citrelock are fixation devices ranging in diameter from 4 to 9 mm and lengths from 10 to 23 mm to be used with reusable instruments. There are two designs for the system: 1) a traditional tapered, blunt threaded and cannulated screw that is screwed into the prepared bone and 2) a "twist-ribbed" cannulated, self-locking device (trade named Citrelock™) that is inserted into bone. The Citregen TIS and Citrelock system is intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist.

The Citregen TIS and Citrelock are made from Citregen biomaterial, which is a homogeneous biocomposite comprised of 60 wt.-% unsintered hydroxvapatite (HA) and 40 wt.-% polyester. Citregen's polymer component is a citrate-based network of completely amorphous polymer chains crosslinked together to form an elastomeric material. As water penetrates the subject device, surface erosion of the polymer phase occurs through hydrolysis of the ester bonds located between the monomers and at the crosslink sites.

The provided text focuses on the 510(k) premarket notification for the Citregen Tendon Interference Screw and Citrelock. This document primarily addresses the substantial equivalence of this medical device to a predicate device, rather than providing detailed acceptance criteria and study results in the context of an AI/ML powered medical device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment cannot be extracted from the provided text as it pertains to a traditional medical device (a physical screw) and not an AI/ML algorithm.

Here's what can be extracted based on the nature of the submission:

• Device Type: The device is a traditional medical implant (tendon interference screw).
• Study Purpose: The studies were conducted to demonstrate substantial equivalence to a predicate device, primarily focusing on safety and performance characteristics relevant to an orthopedic implant.

Here's a breakdown of what could be extracted related to performance data, even though it's not in the context of AI/ML acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance: This type of table is not present for acceptance criteria in the AI/ML sense. However, the document states that "performance characteristics... were established via comprehensive studies" and that results of these studies "demonstrated that the Citregen TIS performance was substantially equivalently to the predicate device."

   • Acceptance Criteria (Implied for a physical implant): Substantial equivalence to the predicate device in terms of "imaging, histological, histomorphometry, and biomechanical data."
   • Reported Device Performance: "The Citregen TIS performance was substantially equivalently to the predicate device."

2. Sample size used for the test set and the data provenance:

   • Test Set (for in-vivo animal studies): Ovine (sheep) model of ACL reconstruction.
   • Sample Size: Not explicitly stated as a number, but mentioned as a "GLP functional ovine model."
   • Data Provenance: Not specified, but likely from a laboratory conducting GLP (Good Laboratory Practice) studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an orthopedic implant's performance in animal models would typically be established through pathological examination, imaging analysis, and biomechanical testing by specialized researchers/veterinarians, not "experts" in the AI/ML sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to this type of device and study.

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 device is not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Ground Truth: Based on "imaging, histological, histomorphometry, and biomechanical data" from the ovine model, evaluated at 0, 3, 6, 12, and 24 months.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Text:

The provided document describes a traditional medical device (Citregen Tendon Interference Screw and Citrelock) and its 510(k) submission to the FDA, demonstrating substantial equivalence to a predicate device. The performance data presented refers to bench testing, biocompatibility tests, and animal studies (GLP ovine model) to assess the device's physical and biological performance over time, not the performance of an AI/ML algorithm. Therefore, the questions tailored for AI/ML device evaluations are largely not addressable from this document.

Ask a specific question about this device