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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:

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

The "test set" here refers to the clinical data used to evaluate the expanded indications against the predicate. This comes from two studies: the BEAR III Study and the BRIDGE Registry.

• Sample Size by Age Group (Pooled BEAR III and BRIDGE studies):

  • Subjects ≥ 14 Years Old:
    • Baseline: 167
    • Surgery: 148
    • 1 Year: 136
    • 2 Years: 89
  • Subjects < 14 Years Old:
    • Baseline: 3 (BEAR III) + 14 (BRIDGE) = 17
    • Surgery: 3 (BEAR III) + 15 (BRIDGE) = 18
    • 1 Year: 3 (BEAR III) + 7 (BRIDGE) = 10
    • 2 Years: 2 (BEAR III) + 6 (BRIDGE) = 8

• Sample Size by Tear Type (BEAR III dataset alone):

  • Subjects with Complete Tear:
    • Baseline: 124
    • Surgery: 124
    • 1 Year: 114
    • 2 Years: 79
  • Subjects with Partial Tear:
    • Baseline: 27
    • Surgery: 27
    • 1 Year: 25
    • 2 Years: 12

• Data Provenance:

  • BEAR III Study: Prospective, multicenter, single-arm cohort study conducted at 7 U.S. investigational sites.
  • BRIDGE Registry: Ongoing real-world observational registry with prospective arms, conducted at up to 30 U.S. sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not directly applicable to this type of device and study. The "ground truth" for an ACL repair implant is the objective and subjective clinical outcomes of the patients (e.g., successful healing, knee stability, patient-reported function, absence of adverse events). These are measured through standardized clinical assessments (IKDC scores, Lachman test) and adverse event reporting, performed by the investigators and clinicians managing the patients in the studies. The study design does not involve independent experts adjudicating "truth" in the way an imaging AI algorithm might.

4. Adjudication method for the test set:

Not applicable in the typical AI/ML context. Clinical outcomes are assessed directly by the study investigators and clinicians, and adverse events are reported according to study protocols. There is no external adjudication process described for establishing "ground truth" as there would be for, say, an imaging diagnosis.

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 is not an AI/imaging device. The study is a clinical trial evaluating an implant, not a diagnostic or assistive AI tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" (or basis for effectiveness and safety) for this device and study comes from:

• Clinical Outcomes Data: Measured using established tools like the IKDC Subjective Knee Evaluation score, IKDC Objective Physical Exam score, and Lachman knee laxity test.
• Safety Data: Adverse Events (AEs), Serious Adverse Events (SAEs), Unanticipated Adverse Device Effects (UADEs), and device-related AEs and SAEs, reported during the clinical studies.

8. The sample size for the training set:

Not applicable in the AI/ML context. This is a clinical implant. The phrase "training set" is not used in the context of clinical trials for device clearance; rather, it refers to the data used to develop and validate the implant's design and manufacturing process, and prior clinical trials for its initial approval (like the BEAR II study mentioned for the predicate device DEN200035).

9. How the ground truth for the training set was established:

Not applicable in the AI/ML context. The "ground truth" for the predicate device (DEN200035) was established through the BEAR II Study, which was a clinical trial evaluating the implant's safety and effectiveness in its initially approved patient population (skeletally-mature patients ≥14 years with complete ACL tears), using similar clinical outcome measures and adverse event reporting.

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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.

Note: The table focuses on primary clinical endpoints. Other non-clinical (bench, animal) acceptance criteria are mentioned in the text for material characteristics, sterilization, and basic performance.

2. Sample Size and Data Provenance

• Test Set (Clinical Study - BEAR II):
  • Sample Size:
    • Modified Intent-to-Treat (mITT) population (primary analysis): 104 subjects (73 in BEAR group, 31 in Control group).
    • As-Treated (AT) population (safety analysis): Same as mITT (65 in BEAR group, 35 in Control group after accounting for those who didn't undergo surgery and different N for some comparisons).
  • Data Provenance: The BEAR II study was conducted at "one U.S. site" (United States). It was a prospective, randomized controlled trial.

3. Number of Experts for Ground Truth and Qualifications

• Not Applicable: This is a clinical trial for a medical implant, not an AI/ML diagnostic device requiring expert annotation for ground truth. Ground truth for clinical outcomes like IKDC score, laxity, safety events (e.g., re-tear, infection) is established directly through clinical assessments, patient-reported outcomes, and objective measurements in a controlled study environment.
• Clinicians Involved: Three surgeons performed the procedures in the BEAR II study. Their specific qualifications (e.g., years of experience) are not detailed in the provided text.

4. Adjudication Method for the Test Set

• Not Applicable in the traditional sense of AI/ML ground truth adjudication: Clinical trials follow detailed statistical analysis plans (SAPs) for handling data, missing values (e.g., multiple imputation used for primary effectiveness endpoints), and endpoint assessment. There isn't a "ground truth adjudication" process by multiple experts as would be seen for image annotations. Clinical events (e.g., graft failure) are defined by specific clinical criteria (e.g., pivot shift exam, Lachman exam, MRI findings, need for revision surgery).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: An MRMC comparative effectiveness study is typically performed for imaging-based diagnostic devices to assess how AI assistance affects human reader performance. This study is a direct clinical comparison of two surgical interventions, not an imaging diagnostic device.

6. Standalone Performance

• Not Applicable: The BEAR® Implant is a physical medical device (implant) used in a surgical procedure, not a standalone algorithm. Its performance is intrinsically linked to its surgical implantation and the patient's biological response, rehabilitation, and long-term outcomes. The clinical study is the standalone performance evaluation in humans.

7. Type of Ground Truth Used

• Clinical Outcomes and Objective Measurements: The ground truth for the effectiveness and safety of the BEAR® Implant was established through:
  • Patient-Reported Outcomes (PROs): IKDC Subjective Score, KOOS domains, ACL Return-to-Sport Index (RSI) score.
  • Objective Clinical Measurements: KT-instrumented AP knee laxity, hamstring strength (hand-held dynamometer), hamstring to quadriceps ratio.
  • Clinical Event Rates: Graft/repair failure (defined by objective examination findings, MRI, or revision surgery), infections, need for additional surgical procedures.
  • Histopathology and Biomechanical Testing (Animal Studies): Used for design validation, resorption rates, and mechanical properties.

8. Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" for optimizing the device and procedure occurred during pre-clinical development (bench and animal testing) and an early feasibility clinical study (BEAR I), which precedes the pivotal BEAR II study.
  • BEAR I (early feasibility): "x" patients, "x" of whom received the BEAR® Implant (specific numbers redacted as (b)(4) in the document).

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

• Not Applicable (see point 8). For pre-clinical development:
  • Bench Testing: Utilized standardized test methods with predefined acceptance criteria for material properties (e.g., collagen content, DNA content, density) and functional integrity (e.g., blood absorption, Keith needle test).
  • Animal Studies (VIV-003, VIV-004): Ground truth was established through direct observation (gross necropsy), histological examination, and biomechanical testing of harvested tissues according to study protocols.

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