(107 days)
The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.
The BEAR® Implant (nominal 22 mm in diameter and 44 mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam irradiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR® Implant stabilizes the blood in the gap between the torn ligament ends. The BEAR® Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.
Children with open physes must have sufficient bone in the femoral and tibial epiphyses to accommodate a 2.4 mm cannulated drill pin with at least 2-3 mm of bone on either side of the intended tunnel locations to avoid disruption of the growth plates.
The provided document is a 510(k) premarket notification for a medical device called the BEAR® (Bridge-Enhanced ACL Restoration) Implant. The submission aims to expand the indications for use of the device, rather than introduce a new device or a new AI/ML-based device. Therefore, the traditional acceptance criteria and study designs typically associated with AI/ML device evaluations (e.g., performance metrics like sensitivity/specificity, sample sizes for test sets in diagnostic tasks, expert ground truth adjudication) are not applicable in this context.
This 510(k) focuses on demonstrating that the expanded indications for the existing BEAR Implant (use in patients under 14 and with partial ACL tears) are as safe and effective as its original indications. The studies conducted are clinical trials comparing outcomes between different patient subgroups.
Here's an analysis based on the information provided, tailored to the context of a medical implant and expanded indications for use:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., a certain percentage improvement). Instead, the acceptance criterion for the expanded indications is to demonstrate non-inferiority or similar safety and effectiveness of the BEAR Implant in the new patient populations (under 14 years old and with partial ACL tears) compared to the currently approved population (14+ years old with complete ACL tears), for which the predicate device (the same implant under its prior clearance) was deemed safe and effective.
The provided document summarizes the findings as follows:
| Criteria/Comparison Segment | Reported Device Performance |
|---|---|
| **Effectiveness - Age Group ( |
§ 888.3044 Resorbable implant for anterior cruciate ligament (ACL) repair.
(a)
Identification. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Post-operative evaluation of knee pain and function; and
(ii) Durability as assessed by re-tear or re-operation rate.
(2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Device performance characteristics, including resorption and ligament healing at repair site; and
(ii) Adverse effects as assessed by gross necropsy and histopathology.
(3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Characterization of materials, including chemical composition, resorption profile, and mechanical properties; and
(ii) Simulated use testing, including device preparation, device handling, compatibility with other ACL repair instrumentation, and user interface.
(4) The device must be demonstrated to be biocompatible.
(5) Performance data must demonstrate the device to be sterile and non-pyrogenic.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(7) Labeling must include the following:
(i) Identification of device materials and specifications;
(ii) A summary of the clinical performance testing conducted with the device;
(iii) Instructions for use, including compatibility with other ACL repair instrumentation or devices;
(iv) Warnings regarding post-operative rehabilitation requirements; and
(v) A shelf life.