(80 days)
The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula.
The Newdeal TIBIAXYS Plates are fixed with the SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.
The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. All plates and screws are manufactured from titanium alloy and are provided either sterile or non-sterile.
The provided 510(k) summary for the Newdeal TIBIAXYS System describes a medical device, a bone plate fixation system, and does not involve AI/ML components typically associated with the requested criteria. Therefore, most of the requested information regarding AI/ML device performance, ground truth, and expert evaluation is not applicable.
However, I can extract the information related to the device's performance based on the general mechanical testing described.
Non-AI/ML Device Acceptance Criteria and Study Details:
The summary states that the device was tested for its mechanical properties to ensure compatibility with its intended uses and compared to predicate devices. The acceptance criteria are implicitly that the device's mechanical properties are compatible with its intended uses and substantially equivalent to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties compatible with intended uses | "All the results show that the Newdeal TIBIAXYS System has mechanical properties compatible with their intended uses." |
| Substantial equivalence to predicate devices | "The Newdeal TIBIAXYS System are substantially equivalent to predicate device." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size (number of mechanical tests or units tested) or the provenance (e.g., country of origin, retrospective/prospective) for the mechanical testing performed. This information is typically detailed in the full test reports, not usually summarized in this section of a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is a mechanical implant, and its performance is evaluated through engineering tests, not human expert interpretation of data or images. "Ground truth" in this context refers to engineering specifications and performance standards.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements and do not require expert adjudication in the way clinical diagnostic interpretations would.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with AI assistance. The Newdeal TIBIAXYS System is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The ground truth or performance standard for this device is based on engineering specifications and established mechanical performance criteria for bone fixation plates, along with comparison to the performance of legally marketed predicate devices. This includes properties like strength, fatigue resistance, and biocompatibility (though the summary only explicitly mentions "mechanical properties").
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI/ML training set, this question is not relevant.
§ 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.