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510(k) Data Aggregation
(70 days)
Fixone Biocomposite Anchor
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, SLAP Lesion 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 following indications are for the S and SL type anchors only:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Hip: Capsular repair, Acetabular Labral repair
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-TCP). A nonabsorbable UHMWPE suture is inserted into the anchor. The anchor is implanted using a provided driver.
B,N,BN type(Knotted suture anchors) are 'screw-in' anchors used alone or in combination with Kc,KcN type(Knotless suture anchors) for soft-tissue repair.
Kc,KcN type(Knotless suture anchor) are used for a soft-tissue repair in combination with the B,N,BN type.
SL type 'push-in' anchors that are ideal for soft-tissue repair in narrow or deep areas.
S type are 'push-in' anchors that are ideal for soft-tissue repair in the foot, ankle, hand and wrist
The Fixone Biocomposite Anchor consists of cannulated anchors with an eyelet. They are pre-loaded on an insertion device. The Fixone Biocomposite Anchor is intended to provide secure reattachment of the soft tissue to bone.
Devices are provided sterile. Single use only.
The provided text describes a medical device, the "Fixone Biocomposite Anchor," and its 510(k) submission to the FDA. This submission aims to demonstrate substantial equivalence to previously cleared devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document discusses:
- Device Description: What the Fixone Biocomposite Anchor is, its components (PLGA copolymer and β-TCP anchor, UHMWPE suture), and how it's implanted.
- Intended Use: Fixation of suture (soft tissue) to bone in various anatomical locations (shoulder, foot/ankle, knee, elbow, hand/wrist, hip).
- Predicate Device Comparison: A detailed table comparing the subject device to several predicate devices (K171299, K192032, K192484, K213008) across various attributes like indications for use, materials, dimensions, fixation mechanism, suture characteristics, and sterilization.
- Performance Data: Mentions "Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues, shelf-life testing, pyrogenicity testing and endotoxin monitoring. The tests demonstrated that the device performs in a substantially equivalent manner to the prior related devices."
Crucially, there is no mention of:
- AI/ML components: The device is a physical biocomposite anchor, not a software algorithm.
- Clinical study or diagnostic performance metrics: The performance data refers to bench testing for physical and material properties, not clinical outcomes, sensitivity, specificity, or AUC for a diagnostic tool.
- Ground truth, expert readers, sample sizes for AI models, or MRMC studies. These are concepts relevant to evaluating AI/ML diagnostic or predictive devices, which the Fixone Biocomposite Anchor is not.
Therefore, I cannot fulfill the request as the provided input does not contain the necessary information about acceptance criteria and a study proving an AI/ML device's performance. The device described is a traditional medical implant, and its evaluation focuses on physical and biological equivalence, not AI performance.
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(183 days)
Fixone Biocomposite Anchor
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.
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(113 days)
Fixone Biocomposite Anchor
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.
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