(217 days)
The Fixone Biocomposite Small Anchor are intended to be used fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers. Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
The Fixone Biocomposite Small Anchor is intended for reattaching soft tissue to bone with sutures. It consists of Driver, Anchor, Non-absorbable suture and needle. A needle was attached to the end of the suture so that it could penetrate the damaged soft tissue to enable it to be used for OPEN surgery without arthroscopy. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A non absorbable suture manufactured from co-braided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
The provided text is a 510(k) summary for the Fixone Biocomposite Small Anchor, a medical device intended for soft tissue to bone fixation. It details the device's characteristics, intended use, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Fixone Biocomposite Small Anchor are primarily based on demonstrating substantial equivalence to a predicate device (Arthrex SutureTak Suture Anchor) through a series of bench tests and biocompatibility evaluations. The "Requirements" column in the table implicitly defines the acceptance criteria, and the "Results" column indicates whether these criteria were met.
- Table of Acceptance Criteria and Reported Device Performance:
| Test Item / Category | Acceptance Criteria (Defined by Standard/Comparison) | Reported Performance / Result |
|---|---|---|
| Material Performance | ||
| External surface Measurement | Not explicitly stated (likely visual/dimensional inspection) | Pass |
| Insertion torque | ASTM F2502 and USP (implies meeting specified torque ranges) | Pass |
| Fixation strength | Not explicitly stated (implied to be equivalent to predicate or safe for intended use) | Pass |
| Tensile strength | Not explicitly stated (implied to be equivalent to predicate or safe for intended use) | Pass |
| Extractable color | Not explicitly stated (likely visual inspection for absence of unapproved color) | Pass |
| Extraction test | Not explicitly stated (general requirement for extraction testing) | Pass |
| pH | The difference should be 1.5 and less. | Pass |
| Potassium permanganate reducing substances | The difference of the consumption of potassium permanganate should be 2.0 mL and less. | Pass |
| Residue after evaporation | Record the weight of the residue should be 1.0mg and less. | Pass |
| Heavy metals | Any brown color produced within 10 minutes in the tube containing the extract of the prepared sample does not exceed that in the tube containing the standard lead solution | Pass |
| UV spectrum (250nm~350nm) | Maximum absorbance between 250 to 350 nm should be 0.1 and less. | Pass |
| Property | When observing it with the naked eye, test solution should be clear and have no foreign particles. | Pass |
| Performance Testing of Fixone® Biocomposite Anchor (Pull-out test) | ASTM F1839-08 (Standard for Rigid Polyurethane Foam, implies testing in a relevant bone model with expected retention) | Pass |
| Biocompatibility (Anchor) | ||
| Cytotoxicity | ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Acute systemic toxicity test | ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous (intradermal) reactivity test | ISO 10993-10(2013) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization test for delayed hypersensitivity | ISO 10993-10(2013) Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Bacterial reverse mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
| Mammalian erythrocyte micronucleus test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
| Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Bioabsorbable screws test | ASTM F2502 Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants | Pass |
| Subchronic toxicity test | ISO 10993-11 Biological Evaluation of Medical Devices Part 11- Test for systemic toxicity | Pass |
| Biocompatibility (Suture) | ||
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Systemic toxicity test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Genotoxicity test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
| Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
Study Details:
The provided document describes a bench testing and biocompatibility testing study conducted to demonstrate the substantial equivalence of the Fixone Biocomposite Small Anchor to its predicate device. This is a common approach for Class II medical devices seeking 510(k) clearance, where clinical trials are often not required if substantial equivalence can be demonstrated through non-clinical data.
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Sample Size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of units/samples used for each bench test (e.g., number of anchors for pull-out tests, number of extracts for chemical analysis). It simply states that "Bench test were performed." and "The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device." For biocompatibility, it states "Test result" for each test, implying a sufficient number of test articles were used as per the specified ISO/ASTM standards.
- Data Provenance: The tests were performed by AJU Pharm Co.,Ltd. in Korea, which is the manufacturer. The data is retrospective, as it's presented after the tests were conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of study (bench testing and biocompatibility) does not involve human experts establishing "ground truth" for a test set in the way an AI diagnostic study would where radiologists label images. The "ground truth" here is established by adherence to recognized international standards (ISO, ASTM, USP, OECD) and their inherent testing methodologies, which are designed to be objective and reproducible.
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Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1 or 3+1 by experts) are pertinent to studies involving human interpretation or clinical outcomes, typically in AI/diagnostic device evaluations. For bench testing and biocompatibility, the results are typically quantitative or qualitative "pass/fail" outcomes based on pre-defined standard criteria.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use the device to assist in interpretation. The Fixone Biocomposite Small Anchor is a physical implant, not a diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As a physical medical device (biocomposite anchor), the concept of "standalone algorithm only performance" does not apply. The device's performance is measured directly through physical and chemical properties and biological interactions, not through an algorithm.
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The type of ground truth used:
- The "ground truth" for this device is based on established industry standards and regulatory requirements for medical device safety and performance. This includes:
- Biocompatibility Standards: ISO 10993 series for biological evaluation of medical devices (e.g., cytotoxicity, systemic toxicity, irritation, sensitization, genotoxicity, implantation).
- Material and Mechanical Testing Standards: ASTM (e.g., F2502 for bioabsorbable devices, F1839 for foam testing) and USP (pharmacopeial standards).
- Comparison to Predicate Device: The performance and safety profile of the predicate device (Arthrex SutureTak Suture Anchor) acts as a de facto "ground truth" for establishing substantial equivalence in terms of intended use, principle of operation, and general safety/performance characteristics.
- The "ground truth" for this device is based on established industry standards and regulatory requirements for medical device safety and performance. This includes:
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The sample size for the training set:
- Not Applicable. There is no "training set" in the context of this device's evaluation. This is not an AI/machine learning device that requires training data. The device's design and manufacturing processes are established based on engineering principles and regulatory guidance, not learned from data.
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How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, there is no ground truth established for one.
§ 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.