(29 days)
The Bioknotless BR Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site; 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus; 5. Biceps tenodesis 6. Acromio-clavicular separation; 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment; 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction; 2. Lateral stabilization 3. Medial stabilization at the medial talus site; Foot: Hallux Valgus reconstruction; 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair; 2. Lateral collateral ligament repair; 3. Joint capsule closure to anterior proximal tibia; 4. Posterior oblique ligament or joint capsule to tibia repair; 5. Extra capsular reconstruction / ITB tenodesis; 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER; 1. Bankart repair 2. SLAP lesion repair; 3. Rotator cuff repair; 4. Capsule shift repair (glenoid rim) The Lupine Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair, 2. SLAP lesion repair 3. Rotator cuff repair, 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site, 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, 5. Biceps tenodesis, 6. Acromio-clavicular separation, 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment, 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction, 2. Lateral stabilization 3. Medial stabilization at the medial talus site, Foot: Hallux Valgus reconstruction, 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair, 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia., 4. Posterior oblique ligament or joint capsule to tibia repair, 5. Extra capsular reconstruction / ITB tenodesis, 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER:1. Bankart repair, 2. SLAP lesion repair, 3. Rotator cuff repair, 4. Capsule shift repair (glenoid rim)
Bioknotless BR Anchor / Lupine BR are a preloaded, disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus. The anchor material is changing from absorbable polylactic acid (PLA) in the predicate device to Biocryl Rapide a B-TCP/PLGA biocomposite material in the proposed devise. The anchor is a one piece suture anchor sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
The Bioknotless BR Anchor / Lupine BR Anchor is a medical device for soft tissue repair to bone. The acceptance criteria and supporting study details are as follows:
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | The device should demonstrate equivalent or superior mechanical properties compared to the predicate device, specifically regarding its ability to withstand forces during soft tissue to bone fixation. This would typically involve metrics such as pull-out strength, insertion torque, and degradation characteristics consistent with its intended use and duration of support. | The submission states: "Bench testing was performed demonstrating that the Bioknotless BR Anchor / Lupine BR Anchor met predetermined acceptance criteria." While specific numerical performance values are not provided in this summary, the FDA's clearance (K070925) indicates that the device's mechanical performance, derived from bench testing, was found to be acceptable and substantially equivalent to the predicate device. The change in material from absorbable polylactic acid (PLA) to Biocryl Rapide (a ß-TCP/PLGA biocomposite) implies that the new material's mechanical and degradation properties were thoroughly evaluated to ensure continued safety and effectiveness for soft tissue to bone fixation. The use of Biocryl Rapid in existing Mitek Milagro Screws (K032717, K060830) for similar indications further supports its proven mechanical suitability. |
| Biocompatibility | The device material must be biocompatible and elicit no unwarranted inflammatory or toxic response in vivo. | While not explicitly detailed as a separate "study" section, the fact that the material (Biocryl Rapid, a ß-TCP/PLGA biocomposite) is "currently used in the Mitek Milagro Screw (K032717, K060830)" implies that its biocompatibility has already been established and accepted by the FDA for similar applications in bone fixation. New biocompatibility testing specific to this device would likely have been conducted and reviewed as part of the overall bench testing, satisfying relevant ISO standards (e.g., ISO 10993 series). |
| Dimensional Equivalence | The dimensions of the anchor should be identical to the predicate device to ensure similar surgical handling and implantation. | The submission explicitly states: "The anchor is dimensionally identical anchor to that of the Bionotless Anchor Plus / Lupine Anchor Plus." This indicates that this criterion was met by design. |
2. Sample Size Used for the Test Set and Data Provenance
The summary states that "Bench testing was performed". This implies that the test set consisted of a number of physical anchor samples that underwent mechanical and potentially other laboratory tests. However, the specific sample size (e.g., number of anchors tested for pull-out strength, number of samples for degradation studies) is not specified in the provided 510(k) summary.
Regarding data provenance, the testing was performed as bench testing, meaning it was conducted in a laboratory setting. This is a form of prospective data collection specifically designed to evaluate the physical and mechanical properties of the device before clinical use. The country of origin of the data is not explicitly stated but would typically be the location of the manufacturing and R&D facilities of DePuy Mitek (USA, as inferred from the submitter's address).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of medical device (suture anchor) does not typically involve "experts" establishing a "ground truth" for a "test set" in the way an AI diagnostic algorithm would. For a mechanical device, the "ground truth" is established by objective engineering specifications, material science standards, and established biomechanical testing protocols.
The "experts" involved would be:
- Engineers and material scientists employed by DePuy Mitek who designed the product and established the design specifications and testing protocols.
- Laboratory technicians who conducted the bench tests according to established procedures.
- Regulatory specialists who ensure the testing meets regulatory requirements and standards.
Their qualifications would be relevant engineering, material science, or biological science degrees and experience in medical device development and testing.
4. Adjudication Method for the Test Set
As this is bench testing of a physical device, an "adjudication method" in the context of human interpretation (like 2+1 or 3+1 for imaging studies) is not applicable. The "adjudication" for bench test results involves:
- Comparison to predetermined acceptance criteria: Test results are directly compared against established numerical thresholds (e.g., minimum pull-out strength).
- Verification of methodology: Ensuring that the testing was performed according to validated protocols and standards.
- Statistical analysis: Results are typically analyzed statistically to confirm reliability and meet acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this device. This type of study is typically used for diagnostic devices or AI algorithms where human interpretation of data (e.g., medical images) is involved, and the goal is to assess the impact of the device on human reader performance. The Bioknotless BR Anchor / Lupine BR Anchor is a surgical implant, not a diagnostic tool requiring human interpretation for its primary function.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an "algorithm only without human-in-the-loop performance" is not applicable. This phrasing refers to the performance of artificial intelligence or computational algorithms. The Bioknotless BR Anchor / Lupine BR Anchor is a physical medical implant, not an algorithm. Its performance is assessed through bench testing (mechanical, material, and biocompatibility studies) and potentially clinical outcomes for previously approved similar products.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective engineering and material science metrics derived from:
- Established mechanical properties defined by industry standards and internal design specifications (e.g., minimum tensile strength, maximum degradation rate).
- Biocompatibility standards (e.g., ISO 10993 series) for the material.
- Dimensional specifications for the physical anchor.
In short, the ground truth is based on physical and chemical measurements against predefined, objective standards.
8. Sample Size for the Training Set
There is no explicit "training set" mentioned or implied for this device in the context of machine learning or AI. The term "training set" is relevant for AI algorithms that learn from data.
If interpreted loosely as the historical data and experience informing the device's design, then:
- The predicate device (Bioknotless Plus Anchor / Lupine Anchor Plus) serves as a "trained" entity from which the new device derives its substantial equivalence. The design and performance data from this predicate, and other similar devices, implicitly "trained" the design choices for the Bioknotless BR Anchor / Lupine BR Anchor.
- The material Biocryl Rapid has prior use in "Mitek Milagro Screw (K032717, K060830)," which means clinical and bench data from those devices provided a "training set" for the material's properties and safety profile.
9. How the Ground Truth for the Training Set Was Established
Given the interpretation above:
- For the predicate device, its ground truth would have been established through its own bench testing, potentially animal or clinical studies, and successful marketing and clinical use, all demonstrating its safety and effectiveness.
- For the Biocryl Rapid material, the ground truth would have been established through extensive material science testing (mechanical, chemical, degradation), biocompatibility studies (in vitro and in vivo), and documented clinical use in other FDA-cleared devices like the Mitek Milagro Screw.
In essence, the "ground truth" for the "training set" (prior devices and materials) was established through comprehensive scientific and regulatory evaluation over time.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.