Search Results
Found 1 results
510(k) Data Aggregation
(26 days)
The Citrespline™ and Citrelock™ ACL Implants 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, 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 CITRESPLINE™ and CITRELOCK™ ACL Implants are soft tissue fixation devices ranging in diameter from 7 to 12 mm in 1 mm increments, and lengths of 23, 28, and 33 mm. There are two designs for the system: 1) a "twist-ribbed" cannulated, self-locking device (trade names CITRELOCK ACL and CITRELOCK) and 2) a "straight spline" style device (trade name CITRESPLINE). Both designs include a cannula through the central axis to allow for alignment into the surgically prepared site. Like the predicate devices, surgical placement of the implants in bone is facilitated with a reusable set of instruments. The CITRESPLINE and CITRELOCK ACL Implants are intended to attach soft tissue to bone for procedures in the foot/ankle, knee, shoulder, elbow, and hand/wrist.
The CITRESPLINE and CITRELOCK ACL Implants are made from CITREGEN biomaterial, which is a homogeneous biocomposite comprised of 60 wt. -% unsintered hydroxyapatite (HA) and 40 wt.-% polyester. CTREGEN'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 is a 510(k) premarket notification letter and supporting documentation for two medical devices, the Citrespline™ and Citrelock™ ACL Implants. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance through a clinical study with acceptance criteria in the manner typical for AI/ML device submissions.
Therefore, many of the requested details, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training and testing, are not applicable to this document. This document describes the mechanical testing and material properties of the implant devices, not an AI/ML algorithm.
However, I can extract information related to the performance data and "acceptance criteria" as presented within the context of mechanical and material testing for these implant devices, and present it in a similar structured format.
Here's the closest interpretation of your request based on the provided text:
Description of Acceptance Criteria and Device Performance (for Implant Devices)
The device in question, the Citrespline™ and Citrelock™ ACL Implants, are soft tissue fixation devices intended for surgical reattachment of ligaments and tendons. The documentation focuses on demonstrating their substantial equivalence to a legally marketed predicate device (K200725) through material composition, technological characteristics, and mechanical performance testing, specifically "pull-out" strength.
The "acceptance criteria" are implied by the phrase "possess similar or significantly higher pull out strengths relative to the primary predicate devices." The study described is a benchtop mechanical testing study, not a clinical study involving human subjects or an AI/ML algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar or significantly higher pull-out strengths relative to the primary predicate devices (K200725) | The worst-case subject devices (e.g., smallest diameter, shortest length) demonstrated similar or significantly higher pull-out strengths compared to the primary predicate devices. This was attributed to the larger diameter and longer engagement length of the subject devices. |
| Maintain satisfactory pull-out strength over time (aging) | Pull-out testing was performed at time-zero and after soaking in 37°C PBS through 26 weeks. Results supported the conclusion of substantial equivalence. |
| Maintain satisfactory pull-out strength after simulated physiological loading | Pull-out testing was performed after 5,000 cycles of simulated physiological loading. Results supported the conclusion of substantial equivalence. |
| Sterility | Validations for sterility of implants were adopted from previously performed activities and confirmed. |
| Packaging and Shelf Life | Packaging and shelf life tests using real and accelerated time aging were performed with passing results. The labeled shelf-life is one year based on analyzed stability data. |
| Endotoxin Limits | Bacterial endotoxin testing (BET) showed CITREGEN test articles to meet the set endotoxin limits ( |
Ask a specific question about this device
Page 1 of 1