(113 days)
The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:
Shoulder: Rotor Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A nonresorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 18 models. It provide non-sterile (user must sterilization before use).
The document provided describes the Fixone Biocomposite Anchor, a medical device intended for fixation of suture (soft tissue) to bone. The information primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a novel study evaluating the device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.
The "acceptance criteria" in this context refer to the successful completion of a series of bench tests and biocompatibility tests to ensure the device meets established safety and performance standards for similar orthopedic implants, and demonstrates substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests performed and their results. The "Requirements" column implicitly serves as the acceptance criteria for each test, with the "Results" column indicating "Pass" for all listed tests.
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Bench Tests | ||
| Fixation strength | Meets ASTM F2502 and USP standards | 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 (Visual inspection) | Test solution should be clear and have no foreign particles. | Pass |
| Biocompatibility Tests (Anchor) | ||
| Cytotoxicity | Meets ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Acute systemic toxicity test | Meets ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | Meets ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous (intradermal) reactivity test | Meets ISO 10993-10(2013) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization test for delayed hypersensitivity | Meets ISO 10993-10(2013) Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Bacterial reverse mutation test | Meets ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Mammalian erythrocyte micronucleus test | Meets ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Implantation test | Meets ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Bioabsorbable screws test | Meets ASTM F2502 Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants | Pass |
| Subchronic toxicity test | Meets ISO 10993-11 Biological Evaluation of Medical Devices Part 11- Test for systemic toxicity | Pass |
| Biocompatibility Tests (Suture) | ||
| Cytotoxicity | Meets ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Systemic toxicity test | Meets ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | Meets ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous reactivity test | Meets ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization sensitization | Meets ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Genotoxicity test | Meets ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Implantation test | Meets ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Hemolysis test | Meets ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria consists of a series of bench tests and biocompatibility tests. The document states:
"Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device."
This means the device was subjected to physical, chemical, and biological evaluations according to recognized international and national standards (e.g., ASTM, USP, ISO). Each test had specific pass/fail criteria (as indicated in the "Requirements" or "Test method / Test criteria" columns of the tables), and the device successfully "passed" all of them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test set sample size: This information is not provided in the document. For bench and biocompatibility testing, sample sizes are typically determined by the specific test standards (e.g., number of test specimens for mechanical tests, number of animals for in vivo biocompatibility).
- Data provenance: The testing was conducted by AJU Pharm Co., Ltd. (company address in Korea) or subcontracted labs, according to international standards. The document does not specify the country of origin for each specific test report, but the manufacturer is based in Korea. These are prospective tests performed on the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the evaluation involved objective physical, chemical, and biological testing against established standards, not interpretation by human experts to establish a "ground truth" in the clinical AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. As stated above, the evaluation was based on objective laboratory measurements and adherence to specified test methods.
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:
- This information is not applicable. This document describes the regulatory submission for a physical medical implant (biocomposite anchor), not an AI/diagnostic software device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by objective measurements and results from standardized bench tests and biocompatibility assays against predefined limits and criteria specified in the relevant ASTM, USP, and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the context of clinical efficacy studies.
8. The sample size for the training set:
- This information is not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable. This is a physical medical device, not an AI model that requires a training set with established ground truth.
§ 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.