(385 days)
Fixone Biocomposite Interference Screws are indicated for fixation of bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery. This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 6 models. It provide non-sterile (user must sterilization before use).
The provided text describes a medical device called "Fixone Biocomposite Interference Screw" and outlines its clearance process with the FDA. It includes a 510(k) summary focusing on bench testing and biocompatibility.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| External surface | ASTM F2502 and USP (Implied: device meets these standards) | Pass |
| Measurement | When tested by vernier calipers, the tolerance should be within ±5% | Pass |
| Tensile strength | The average strength of 10 stands is not less than 100N. | Pass |
| Extractable color | Compare with the matching solution: any color present is not more intense than of the appropriate matching solution. | MD2014-00216 (Implied: Pass) |
| Insertion torque | Tested with ASTM F2502-Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants (Implied: meets specified performance within this standard) | Pass |
| Fixation strength (Push-out test) | Tested with ASTM F2502-Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants; Tested subject and predicate device under same condition for the comparison (Implied: comparable to predicate) | AJU-M20201006-01 (Implied: Pass or equivalent to predicate) |
| Extraction test 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. | MD2014-00132 (Implied: Pass) |
| UV spectrum (250nm~350nm) | Maximum absorbance between 250 to 350 nm should be 0.1 and less. | Pass |
| Property (Visual inspection) | 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) | Pull-out test by immersion time of saline solution to evaluate two bioabsorbable suture anchors. [Absorption time (soaking time) : 4 weeks, 6 weeks, 12 weeks and 26 weeks] (Implied: comparable to predicate, within acceptable limits) | Ajum20170428-01 (Implied: Pass or equivalent to predicate) |
| ASTM F1839-08 (Polyurethane Foam for Orthopaedic Devices) | (Implied: Compliance with this standard for material properties) | Pass |
| Biocompatibility Tests: | ||
| Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity | Pass |
| Acute 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 (intradermal) reactivity test | ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization test for delayed hypersensitivity | ISO 10993-10 Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Bacterial reversion 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 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily details bench testing for mechanical, physical, and biocompatibility properties. It does not mention a clinical test set or human subject data.
- Sample Size (for bench tests): The "Tensile strength" test mentions an "average strength of 10 stands," indicating a sample size of at least 10 for that specific test. Other tests, such as those related to "Extractable color" and "Residue after evaporation," refer to "a quantity of suture, equivalent to not less than 250mg" and standard protocols, but specific sample counts for each bench test are generally not provided.
- Data Provenance: The bench tests were conducted by AJU Pharm Co., Ltd. in Korea (per the applicant information). These are laboratory tests, not clinical data from patients. They are inherently retrospective in the sense that they are conducted on manufactured devices in a controlled environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device approval is based on bench testing and biocompatibility assessments, not on studies requiring human experts to establish "ground truth" for diagnostic or clinical performance. The "ground truth" for the tests performed are the defined standards and specifications (e.g., ASTM, ISO standards, quantified limits for chemical properties).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is not a diagnostic or clinical performance study that would involve expert adjudication of results. The results are quantitative measurements against predefined criteria.
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 (an interference screw for ACL/PCL reconstruction) and not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
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 the device's performance is established by:
- Industry Standards: ASTM F2502, ASTM F1839-08, various ISO 10993 series for biocompatibility.
- Pharmacopoeial Standards: USP (for external surface).
- Defined Quantitative Limits: Specific values for pH difference, potassium permanganate consumption, residue after evaporation, maximum absorbance, and tensile strength (e.g., "not less than 100N").
- Comparison to Predicate Device: The fixation strength (push-out test) directly compares the subject device to the predicate device under the same conditions. This implies the predicate device's established performance serves as a comparative ground truth.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.