(195 days)
The BEAR® (Bridge Enhanced ACL Repair) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair.
The BEAR® Implant (22 mm in diameter and 45mm 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.
The provided text describes the clinical study (BEAR II) conducted to support the safety and effectiveness of the BEAR® (Bridge-Enhanced ACL Repair) Implant. It is important to note that this document is a regulatory submission for a medical device and not a study validating an AI-powered diagnostic device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., ground truth establishment for training, expert consensus for test sets, MRMC studies, standalone algorithm performance) are not applicable to this submission.
However, I can extract and present the acceptance criteria and the study results relevant to the BEAR® Implant's clinical performance, as described in the provided text.
Acceptance Criteria and Reported Device Performance for BEAR® Implant
The acceptance criteria for the BEAR® Implant are primarily demonstrated through non-inferiority testing against a control (ACLR – ACL Reconstruction with autograft) for primary effectiveness endpoints and superiority/non-inferiority for secondary effectiveness endpoints. Safety parameters are also assessed for comparable rates between the BEAR group and the control group.
1. Table of Acceptance Criteria and Reported Device Performance
The core of the clinical acceptance is based on the primary effectiveness endpoints of the BEAR II study: IKDC Subjective Score and Instrumented AP Knee Laxity.
| Acceptance Criteria (Endpoint) | Null Hypothesis (for non-inferiority) | Reported Device Performance (Mean ± SD) | p-value | Meets Criteria? |
|---|---|---|---|---|
| Primary Effectiveness Endpoints (24 Months Post-Surgery) | ||||
| IKDC Patient Reported Score | True difference in means (BEAR - Control) ≤ -11.5 (clinically significant difference) | BEAR: 88.6 ± 13.4 | Control: 84.6 ± 13.3 |
§ 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.