(183 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: Rotator 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 β-ΤCP). 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 provided text describes a medical device, the "Fixone Biocomposite Anchor," and its 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than presenting a study of AI/algorithm performance. Therefore, many of the requested criteria related to AI studies (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this document.
However, I can extract information related to the acceptance criteria and the studies performed for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established international standards (ASTM, ISO, USP) and predefined limits for specific tests. The reported device performance for all listed tests is "Pass," indicating that the device met the established criteria.
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing - Anchor Performance | ||
| External surface / Measurement | ASTM F2502 and USP | Pass |
| Insertion torque | N/A (implied to meet predicate performance) | Pass |
| Fixation strength | N/A (implied to meet predicate performance) | Pass |
| Tensile strength | N/A (implied to meet predicate performance) | Pass |
| Extractable color | N/A (implied to meet predicate performance) | Pass |
| Extraction test - pH | The difference should be 1.5 and less. | Pass |
| Extraction test - Potassium permanganate reducing substances | The difference of the consumption of potassium permanganate should be 2.0 mL and less. | Pass |
| Extraction test - Residue after evaporation | Record the weight of the residue should be 1.0mg and less. | Pass |
| Extraction test - 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 |
| Extraction test - UV spectrum (250nm~350nm) | Maximum absorbance between 250 to 350 nm should be 0.1 and less. | Pass |
| Extraction test - Property | When observing it with the naked eye, test solution should be clear and have no foreign particles. | Pass |
| Performance comparison test (Fixone vs. Arthrex) - Insertion force | N/A (implied to demonstrate substantial equivalence to predicate) | Pass |
| Performance comparison test (Fixone vs. Arthrex) - Insertion torque | ASTM F2502 | Pass |
| Performance comparison test (Fixone vs. Arthrex) - Pull-out test | N/A (implied to demonstrate substantial equivalence to predicate) | Pass |
| Performance comparison test (Fixone vs. Arthrex) - Fatigue test | The anchor shall be inserted into the pilot hole. Apply the load 50% of Pull-out test (offset 10%, Sine shape) - 30° (worst case) | Pass |
| Performance Testing of Fixone® Biocomposite Anchor (Pull-out test) - Short Immersion (5min - 24hr) | Pull-out test by immersion time of saline solution to evaluate two bioabsorbable suture anchors. ASTM F1839-08, Standard specification for RGID Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. (Specific quantitative criteria not explicitly listed but implied successful comparison). | Pass |
| Performance Testing of Fixone® Biocomposite Anchor (Pull-out test) - Long Immersion (4 weeks - 26 weeks) | Pull-out test by immersion time of saline solution to evaluate two bioabsorbable suture anchors. ASTM F1839-08, Standard specification for RGID Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments. (Specific quantitative criteria not explicitly listed but implied successful comparison). | Pass |
| Shelf-life testing | Real-time equivalent (RTE) and Accelerated aging temperature, Taa as per AAMI TIR17 and ASTM F 1980-02. Aging temperature: 55±2℃, aging time: 225 days. (Specific quantitative criteria not explicitly listed but implied successful demonstration of 5-year shelf-life). | 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 OECE 471, Bacterial reverse mutation test | Pass |
| Mammalian erythrocyte micronucleus test | ISO 10993-3, Genotoxicity test OECE 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 OECE 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 |
| Biocompatibility - Final Product | ||
| LAL test (Bacterial Endotoxin test) | USP 38 NF 33 Bacterial Endotoxin test "Gel clot method" | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for each particular bench test. It indicates that "Bench test were performed" and "The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device." These tests are typically conducted in a laboratory setting.
- Sample Size: Not explicitly stated as a number of individual anchors or sutures. Each test would have involved a specific number of samples as per the relevant ASTM or ISO standard.
- Data Provenance: The document states "AJU Pharm Co.,Ltd. / Korea" as the manufacturer. The testing was likely conducted in a laboratory setting, presumably in Korea or by a certified testing facility contracted by the manufacturer. This is prospective data generation through controlled laboratory experiments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/algorithm study involving expert review of medical images or patient data. The "ground truth" for this device's performance is established by adhering to widely accepted engineering, biocompatibility, and material testing standards (ASTM, ISO, USP).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/algorithm study involving expert adjudication. The "adjudication" is inherent in the pass/fail criteria defined by the standardized testing 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
Not applicable. This is a medical device for orthopedic fixation, not an AI diagnostic or assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is defined by the technical specifications and performance requirements established by recognized standards organizations (ASTM, ISO, USP) for medical devices of this type. For example:
- Bench Tests: Mechanical properties (e.g., insertion torque, pull-out strength, fatigue) are measured against predefined engineering limits or compared directly to a predicate device's performance.
- Biocompatibility Tests: Biological response (e.g., cytotoxicity, systemic toxicity, irritation, implantation response) is assessed against criteria specified in ISO 10993 series for acceptable biological safety.
- Shelf-life Tests: Stability over time is assessed against physical, chemical, and functional criteria at accelerated and real-time aging conditions according to AAMI TIR17 and ASTM F 1980-02.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set as this is not an AI/machine learning device.
§ 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.