(87 days)
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System consists of one 2 Hole Syndesmosis Buttress Plate (titanium alloy), two Knotless TightRopes (titanium alloy buttons and UHMWPE braid suture) and various ancillary instruments to aid in insertion. The proposed Arthrex Buttress Plate is a metal plate is manufactured from either titanium alloy or stainless steel. The implantable devices are packaged with various ancillary instruments to aid in insertion. The implantable devices and various ancillary instruments are provided sterile and are single use.
The provided text describes the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System, a medical device for fracture repair. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies typical for AI/software devices.
Therefore, many of the requested details regarding acceptance criteria for AI software, human reader studies, and large-scale ground truth establishment for training and test sets are not applicable to this type of medical device submission.
However, I can extract information related to the acceptance criteria and performance data as presented for this specific orthopedic implant system.
Acceptance Criteria and Reported Device Performance (based on provided text):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Equivalent cyclic fatigue to predicate device. | Cyclic fatigue testing demonstrated that the proposed Arthrex Syndesmosis TightRope XP Buttress Plate Implant System performs statistically equivalent to the predicate device cleared under K043248. |
| Ultimate tensile strength equivalent to predicate device. | The submitted mechanical testing data demonstrates that the ultimate tensile strength of the proposed device is substantially equivalent to that of the predicate device for the desired indications. | |
| MRI Compatibility | Safety in Magnetic Resonance (MR) Environment. | MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance and ASTM standards (F2052, F2119, F2182, F2213). The device has been evaluated for MR Conditional labeling. |
| Biocompatibility | Meets pyrogen limit specifications. | Bacterial Endotoxins Test (BET) utilizing the Kinetic Chromogenic Method (in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP, EP 2.6.14) demonstrated that the device meets pyrogen limit specifications. |
| Biocompatibility ISO 10993-1:2018. | Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted in accordance with ISO 10993-1:2018. (Implies all sections were successfully met). | |
| Substantial Equivalence | Basic design features, intended use, materials, fundamental scientific technology, indications for use, sterility, and shelf-life are identical or minor differences do not raise different questions of safety or effectiveness compared to predicate. | The device is substantially equivalent to the predicate device (K043248) in which basic design features and intended uses are the same. Differences (preloaded inserter, buttress plate, MR conditional labeling) are considered minor and do not raise different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It mentions "Cyclic fatigue testing was conducted" and "MRI force, torque, and image artifact testing were conducted," which typically implies a statistically relevant number of samples for each specific test, but the exact count is not disclosed.
- Data Provenance: The studies were conducted by the manufacturer (Arthrex Inc.) for regulatory submission to the FDA. The data provenance is internal testing performed by the company or by contract labs on their behalf. Specific country of origin for data generation (beyond "Naples, FL 34108" for the submitter) is not detailed. All studies were prospective in the sense that they were designed and executed specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This submission is for an orthopedic implant (hardware), not an AI/software device that requires expert human interpretation of medical images. Ground truth for device performance is established through internationally recognized and standardized laboratory testing (e.g., ASTM, ISO standards) conducted by qualified engineers and scientists in a controlled environment, not by clinical expert consensus on patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. As explained above, this is not an AI/software device involving human review and adjudication of medical imaging. Performance is assessed through objective physical and chemical testing.
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:
- N/A. This device is an implant, not an AI software. No human reader study was conducted, nor would it be relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical implant, not an algorithm. Its performance is inherent to its physical properties and mechanical behavior, which are tested directly.
7. The type of ground truth used:
- For mechanical performance: The "ground truth" is defined by established engineering and material science principles, measured by standardized test methods (e.g., cyclic loading to failure limits, ultimate tensile strength measurements).
- For MRI compatibility: The "ground truth" is adherence to established safety thresholds for magnetic field interactions (displacement, torque, heating) and acceptable levels of image artifact as defined by reference standards (ASTM, FDA guidance).
- For biocompatibility: The "ground truth" is compliance with international biological evaluation standards (ISO 10993) and pharmacopoeial methods (USP, EP) for pyrogenicity, cytotoxicity, and other biological effects, which rely on defined thresholds and observation of biological responses.
8. The sample size for the training set:
- N/A. This is not an AI/machine learning device; therefore, there is no "training set" in the computational sense. The device design and manufacturing processes are informed by accumulated engineering knowledge and prior predicate device designs, not by a data-driven training process.
9. How the ground truth for the training set was established:
- N/A. No training set as per AI/ML terminology. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science data, and validated manufacturing processes (Quality Systems Regulation 21 CFR Part 820).
§ 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.