(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 (<14 vs. ≥14 years) | At 1 and 2 years post-op, subjects <14 years had on average higher IKDC scores than subjects ≥14 years. This demonstrates a non-inferior outcome between the two age groups. A similar outcome was seen in the Lachman knee laxity test. |
| Safety - Age Group (<14 years vs. 14-18 vs. 19+ years) | Subjects in the youngest age group (<14 years) experienced rates of AEs, serious adverse events (SAE), and device-related AEs and SAEs that were similar to the oldest subjects (19+ years) and lower than 14-18-year-olds. |
| Effectiveness - Tear Type (Partial vs. Complete ACL tears) | There were no differences in effectiveness outcomes (IKDC Subjective, IKDC Physical Exam, Lachman) between subjects with partial ACL tears at baseline and those with complete ACL tears. |
| Safety - Tear Type (Partial vs. Complete ACL tears) | There were no differences in safety between subjects with partial ACL tears at baseline and those with complete ACL tears. |
| Overall Conclusion | The BEAR Implant is as safe and effective in patients under 14 years of age as those over 14 years and as safe and effective in patients with partial ACL tears as those with complete ACL tears. Only slight modifications to the BEAR procedure are required and do not present new or increased risks. These data support the substantial equivalence of the BEAR Implant for the expanded indications. |
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
- Subjects ≥ 14 Years Old:
-
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
- Subjects with Complete Tear:
-
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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 6, 2025
Miach Orthopaedics, Inc. % Julie Broderick Regulatory Consultant Broderick Regulatory Consulting, LLC 7 Kendall Street Winchester, Massachusetts 01890
Re: K243578
Trade/Device Name: BEAR® (Bridge-Enhanced ACL Restoration) Implant Regulation Number: 21 CFR 888.3044 Regulation Name: Resorbable Implant For Anterior Cruciate Ligament (ACL) Repair Regulatory Class: Class II Product Code: QNI Dated: February 5, 2025 Received: February 5, 2025
Dear Julie Broderick:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
{2}------------------------------------------------
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER EERREIRA -S
Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
BEAR® (Bridge-Enhanced ACL Restoration) Implant
Indications for Use (Describe)
The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagenbased 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information l.
- Company: Miach Orthopaedics, Inc. 69 Milk Street, Suite 100 Westborough, MA 01581 USA Phone No.: 800-590-6995 Fax No.: 508-986-9625
- Contact: Rita Paparazzo VP, Regulatory, Clinical Operations, Quality and Medical Education Miach Orthopaedics, Inc. Phone No.: 800-590-6995 Email: rpaparazzo@miachortho.com
Date Prepared: 5 February 2025
II. Name of Device
| Device Trade Name: | BEAR® (Bridge-Enhanced ACL Restoration) Implant |
|---|---|
| Classification Name: | Resorbable implant for anterior cruciate ligament (ACL) repair |
| Product Code: | QNI |
| Regulation Number: | 21 CFR 888.3044 |
| Device Class: | II |
| Panel Identification: | Orthopedics |
III. Predicate Device
| Predicate Manufacturer: | Miach Orthopaedics, Inc. |
|---|---|
| Predicate Trade Name: | BEAR® (Bridge-Enhanced ACL Restoration) Implant |
| Predicate 510(k) No.: | DEN200035 |
IV. Device Description
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 tom 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.
V. Indications for Use
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,
{5}------------------------------------------------
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.
| Characteristic | New DeviceBEAR Implant | Predicate Device*BEAR ImplantDEN200035 | Comparison |
|---|---|---|---|
| Manufacturer | Miach Orthopaedics, Inc. | Miach Orthopaedics, Inc. | Same |
| Regulation No. | 21 CFR 888.3044 | 21 CFR 888.3044 | Same |
| Regulation Name | Resorbable implant for anteriorcruciate ligament (ACL) repair | Resorbable implant for anteriorcruciate ligament (ACL) repair | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Classification Code | QNI | QNI | Same |
| Intended Use / Indications forUse | The BEAR® (Bridge-Enhanced ACLRestoration) Implant is a bovineextracellular matrix collagen-basedimplant for treatment of anteriorcruciate ligament (ACL) injuries.The BEAR® Implant is indicated foradults, adolescents and childrenwith a complete or partial ruptureof the ACL, as confirmed by MRI.Patients must have an ACL stumpattached to the tibia to constructthe repair. Children with openphyses must have sufficient bonein the femoral and tibial epiphyseson either side of the intendedtunnel locations to avoiddisruption of the growth plates. | The BEAR® (Bridge-EnhancedACL Restoration) Implant is abovine extracellular matrixcollagen-based implant fortreatment of anterior cruciateligament (ACL) injuries. TheBEAR® Implant is indicated forskeletally-mature patients atleast 14 years of age with acomplete rupture of the ACL, asconfirmed by MRI. Patientsmust have an ACL stumpattached to the tibia toconstruct the repair. | Same except for changes inIndications:Remove age limitation-(≥14 years)Remove requirement for-patient to be skeletallymatureReplace both with "adults,adolescents and children"Add requirement forepiphyseal bone inchildren to avoiddisruption of growthplatesAdd partial rupture of ACL-Same Intended Use; both newand predicate devices areintended for use in treatingACL injuries. |
| Device Description | The BEAR Implant (22 mm indiameter and 44mm in length) iscylindrical in shape and comprisedof collagen and extracellularmatrix derived from bovineconnective tissue, which has beencleaned, disinfected and processedby a proprietary manufacturingmethod. The implant is intendedto be used with up to 10 ml ofautologous blood drawn during | The BEAR Implant (22 mm indiameter and 44mm in length) iscylindrical in shape andcomprised of collagen andextracellular matrix derivedfrom bovine connective tissue,which has been cleaned,disinfected and processed by aproprietary manufacturingmethod. The implant is intendedto be used with up to 10 ml of | Same |
| Characteristic | New DeviceBEAR Implant | Predicate Device*BEAR ImplantDEN200035 | Comparison |
| the surgical implantationprocedure. | autologous blood drawn duringthe surgical implantationprocedure. | ||
| Operating Principle | The BEAR Implant stabilizes theblood in the gap between the tornligament ends, facilitatingrestoration of the ACL. The BEARImplant is resorbed within 8 weeksand replaced with a fibrovascularrepair tissue. | The BEAR Implant stabilizes theblood in the gap between thetorn ligament ends, facilitatingrestoration of the ACL. TheBEAR Implant is resorbed within8 weeks and replaced with afibrovascular repair tissue. | Same |
| Materials | Bovine-derived Type 1 collagenand extracellular matrix | Bovine-derived Type 1 collagenand extracellular matrix | Same - no changes |
| Biocompatibility | No new testing required | Testing completed per ISO10993-1 and FDA guidance | Same - no changes |
| Technical Specifications | No new testing required | As approved in DEN200035 | Same - no changes |
| In Vivo Animal Testing | No new animal testing required | Completed as described inDEN200035 | Changes to Indications did notrequire new animal testing tovalidate. |
| Human Clinical Testing | Confirmatory clinical datapresented in eSTAR Section:Performance Testing | BEAR II Study (see DEN200035) | De Novo approval based onBEAR II study data; this 510(k)includes confirmatory clinicaldata from the BEAR III study(G170156) and the BRIDGERegistry (post-market study). |
VI. Comparison of Technological Characteristics
{6}------------------------------------------------
VII. Performance or Clinical Testing
No non-clinical or animal performance testing was required to support this 510(k), as the change was limited to the indications for use.
Confirmatory clinical data from the BEAR III Study (IDE #G170156) and the BRIDGE Registry (post-market study) demonstrated that the BEAR Implant subject of this 510(k) is as safe and effective as the predicate device in patients less than 14 years of age and in patients with partial ACL tears.
The BEAR III Study was a prospective multicenter single-arm cohort study of the BEAR Implant that enrolled 151 subjects at 7 U.S. investigational sites. The study eligibility criteria included subjects ≥12 years of age and with partial or complete ACL tears. The two primary outcomes were the IKDC Subjective Knee Evaluation score and IKDC Objective Physical Exam score at post-operative year 2. Safety endpoints included the rate of adverse events (AE), serious adverse events (SAE), UADEs and device-related AEs and SAEs.
The ongoing BRIDGE Registry is a real-world observational registry, with prospective arms, of patients receiving the BEAR Implant at up to 30 U.S. sites. The two primary effectiveness endpoints are
{7}------------------------------------------------
IKDC Subjective Knee Evaluation score at year 2 and Lachman knee laxity at 1 year. Secondary endpoints include 7 patient-reported outcomes (PRO) and knee-related adverse events.
For purposes of this 510(k) submission, safety and effectiveness data for BEAR Implant patients under age 14 were compared to those ≥14 years from the pooled BEAR III and BRIDGE studies were analyzed; safety and effectiveness data for patients with partial ACL tears were compared to complete ACL tears using the BEAR III dataset alone. Refer to Table 1 for subject accountability by age group and Table 2 for subject accountability by tear type.
| Baseline | Surgery | 1 Year | 2 Years | |
|---|---|---|---|---|
| Visit Completed, Subjects≥ 14 Years Old, BEAR III | 167 | 148 | 136 | 89 |
| Visit Completed, Subjects<14 Years Old, BEAR III | 3 | 3 | 3 | 2 |
| Visit Completed, Subjects<14 Years Old, BRIDGE Registry [1] | 14 | 15 | 7 | 6 |
| [1] Includes the proportion of subjects who have an EDC entry for either IKDC, currentstatus questionnaire, or physical exam at that timepoint EXCLUDING where all assessmentswere marked as not done. |
Table 1: Subject Accountability by Age Group
| Table 2: Subject Accountability by Tear Type | |||
|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- |
| Baseline | Surgery | 1 Year | 2 Years | |
|---|---|---|---|---|
| Visit Completed, Subjects withcomplete tear, BEAR III | 124 | 124 | 114 | 79 |
| Visit Completed, Subjects withpartial tear, BEAR III | 27 | 27 | 25 | 12 |
| [1] Includes the proportion of subjects who have an EDC entry for either IKDC, currentstatus questionnaire, or physical exam at that timepoint EXCLUDING where all assessmentswere marked as not done. |
Of the 18 subjects under 14 years of age, the mean age was 12.4 ± 1.98 years with a range from 7.7 to 14.0 years, 61.1% were white, 33.3% Black, 5.6% Asian and 11.2% other/refused, and 6.3% were Hispanic/Latino. Of the 27 subjects with a partial tear, 81.5% were white, 7.4% Asian, 3.7% Native Hawaiian or Pacific Islander, and 11.2% other/refused, and 18.5% were Hispanic/Latino.
The analyses supporting this label change were pre-specified in a prospective statistical analysis plan (SAP).
Safety & Effectiveness by Age
IKDC was compared between subjects <14 years and subjects ≥14 years in a non-inferiority analysis, whereas knee laxity was assessed descriptively, as were AE/SAE data. At 1 and 2 years post-op, subjects <14 years had on average higher IKDC scores than subjects ≥14 years, demonstrating a non-inferior outcome between the
{8}------------------------------------------------
two age groups. A similar outcome was seen in the Lachman knee laxity test. AEs were analyzed in three age groups, <14 years, 14-18 years and 19+ years. Subjects in the youngest age group (<14 years) experienced rates of AEs, serious adverse events (SAE), and device-related AEs and SAEs that were similar to the oldest subjects (19+ years) and lower than 14-18-year-olds.
Safety & Effectiveness by Tear Type
There were no differences in effectiveness outcomes (IKDC Subjective, IKDC Physical Exam, Lachman) or safety between subjects with partial ACL tears at baseline and those with complete ACL tears.
In conclusion, the BEAR Implant is as safe and effective in patients under 14 years of age as those over 14 years and as safe and effective in patients with partial ACL tears as those with complete ACL tears. Furthermore, only slight modifications to the BEAR procedure are required to address these patient populations, and no data from this analysis suggest that those surgical modifications are difficult or present new or increased risks to the BEAR procedure. These data support the substantial equivalence of the BEAR Implant subject of this 510(k) with the predicate BEAR Implant.
VIII. Special Controls
The BEAR Implant subject of this 510(k) meets the Special Controls established for "Resorbable implant for anterior cruciate ligament (ACL) repair", product classification code QNI, classification regulation 21 CFR 888.3044.
IX. Conclusions
Miach Orthopaedics concludes that the BEAR Implant is substantially equivalent to its predicate, the BEAR Implant authorized in DEN200035, and does not raise any new issues or concerns of safety or effectiveness.
§ 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.