(280 days)
The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is internal fixation. Specific indications for the plates included in the system as follows:
The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is inticated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.
The ITVAL Foot & Ankle VAL System is internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.
The Distal Fibular VAL Plate is indicated for internal fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.
Advanced Bone Plate is mainly used for internal fixation of hand, wrist, foot, ankle and distal fibular fractures. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends.
Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Advanced Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
Disclaimer: This document is a 510(k) summary for a medical device (Advanced Bone Plate) and primarily focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo efficacy or setting new acceptance criteria. Therefore, the information provided will reflect this context.
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly define quantitative "acceptance criteria" in the traditional sense of a performance study with numerical targets. Instead, it aims to demonstrate "substantial equivalence" in terms of characteristics and performance to legally marketed predicate devices. The "reported device performance" is described through the successful completion of various non-clinical tests that show the device functions similarly to the predicate devices.
| Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for biological contact. | Evaluation conducted in accordance with ISO 10993-1, indicating compliance. |
| Mechanical Performance (Plates): Bending stiffness, bending strength of plates consistent with predicate devices. | Performed mechanical tests per ASTM F382-17 (Standard Specification and Test Methods for Metallic bone plate and Three-point Bending Test Method) to determine Bending Stiffness, Bending Strength, and Bending Structural Stiffness, demonstrating substantial equivalence. |
| Mechanical Performance (Screws): Torsion, insertion/removal, and pullout strength of screws consistent with predicate devices. | Performed mechanical tests per ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) to determine Torsion Test, Insertion/removal Test, and Pullout Test, demonstrating substantial equivalence. |
| Sterilization: Device can be effectively sterilized by the user to a sterility assurance level (SAL) of 10^-6. | Sterilization via Overkill Approach (Half-Cycle method) validated per ISO 17665-1:2006. (Device is non-sterile). |
| Reprocessing (Cleaning): Reusable instruments and implants can be effectively cleaned. | Cleaning instructions validated per FDA guidance AAMI TIR30:2003. |
| Technological Characteristics: Similar design features, materials, and indications for use as predicate devices. | Design Features: Variable angle locking technology, limited contact profiles, anatomic contours, and similar size ranges. Materials: Titanium alloy (plates per ASTM F1472, screws per ASTM F136). Both found to be substantially equivalent. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each mechanical test (e.g., number of plates or screws tested). It refers to standard ASTM methods (F382-17, F543-17) which would prescribe sample sizes.
- Data Provenance: The tests are non-clinical, conducted in a laboratory setting by the manufacturer (Double Medical Technology Inc.) or a contracted lab. The data is thus prospective experimental data generated for the purpose of this submission.
- Country of Origin: Likely China, given the submitter's address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical mechanical testing is established by the specifications in the relevant ASTM standards (e.g., ASTM F382-17, ASTM F543-17) and successful execution according to those methods, rather than expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers where there's a need to resolve discrepancies in expert interpretations of data (e.g., imaging scans). For mechanical testing, the results are quantitative and objective, based on physical measurements and adherence to standard protocols.
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
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a passive internal fixation device like a bone plate. The document explicitly states: "No clinical performance data was provided to demonstrate substantially equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm or AI device was not done. This device is a physical implant, not a software algorithm.
7. The type of ground truth used
The "ground truth" for this device, within the scope of this 510(k), is established by:
- Accepted Industry Standards: Primarily ASTM F382-17 and ASTM F543-17 for mechanical properties, and ISO 10993-1, ISO 17665-1:2006, and AAMI TIR30:2003 for biocompatibility, sterilization, and reprocessing. These standards define the acceptable methods and performance benchmarks for such devices.
- Comparison to Predicate Devices: The core of a 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device. The "ground truth" for substantial equivalence is met if the new device's characteristics and performance fall within the established safety and efficacy profile of the predicates.
8. The sample size for the training set
This section is not applicable. This device is a physical bone plate, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.