(147 days)
The Mondeal® RADIUS HO System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect.
The Mondeal® Radius Hand Osteosynthesis System consists of titanium volar and dorsal plates with shapes and sizes designed for internal fixation of distal radius fractures and osteotomies, and screws of varying lengths from 8 to 38 mm and 2.7 or 3.0 mm in diameter, supplied non-sterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include dorsal and volar "T" shaped right and left hand configurations.. Manual reusable surgical instruments are supplied to facilitate implantation
This document describes a 510(k) submission for the Mondeal® RADIUS HO System, a bone fixation system. The information provided is primarily focused on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of device performance metrics often seen in AI/software device submissions.
Therefore, many of the requested fields cannot be directly answered from the provided text. The submission focuses on comparing physical attributes and intended use.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided text does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a study. Instead, it demonstrates substantial equivalence to predicate devices based on a comparison of design, materials, intended use, and other physical characteristics.
| Attribute | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (from comparison table) |
|---|---|---|
| Product Name | Be a bone fixation system for distal radius fractures. | Mondeal® RADIUS HO System (is a bone fixation system) |
| Use | Single Use, Permanent implant. | Single Use, Permanent |
| Plate and Screw Material | Bio-compatible material suitable for bone fixation, ideally Ti-6Al-4V ELI or similar titanium alloy. | Ti-6Al-4V ELI plates and screws |
| Sizes | Offer a range of screw diameters and lengths suitable for distal radius fixation. | 2.7 mm x 8 - 32 mm, 3.0 mm x 8 - 32 mm |
| Available configurations | Offer right and left volar and dorsal configurations. | Right and left volar and dorsal |
| Indications for use | Intended for the fixation of fractures and osteotomies involving the distal radius, applied to volar and dorsal aspects. | Intended for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect. |
| Recommended sterilisation method | Compatible with standard sterilization methods, such as steam. | Steam |
| Packaging | Packaged non-sterile, intended for sterilization by purchaser, potentially in tempered plastic or stainless steel trays. | Tempered plastic and stainless steel trays, non-sterile, intended for sterilization by purchaser. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. This type of detail is typical for software or AI device studies involving patient data, not for traditional mechanical devices like bone plates, where performance is often evaluated through bench testing and material characterization against established standards.
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)
This information is not applicable and not provided. Ground truth in the context of this device would involve engineering specifications, material properties, and mechanical testing, not expert interpretation of diagnostic data like images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in studies where human readers are making subjective interpretations of data, such as images, and their agreement needs to be reconciled.
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 and not provided. MRMC studies are specific to evaluating the impact of AI or other tools on human reader performance, which doesn't apply to a bone fixation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this type of device would be derived from:
- Material specifications and standards: Verification that the Ti-6Al-4V ELI material meets industry standards.
- Design specifications: Verification that the dimensions and geometry match the intended design.
- Mechanical testing data: (Implied, but not detailed in this summary) This would involve tests for strength, fatigue, bending, and torsion to ensure the plate and screws can withstand physiological loads, often compared against established ASTM or ISO standards for bone fixation devices.
The document does not elaborate on specific test results or ground truth methodology, focusing instead on descriptive comparison to predicates.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" for a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable and not provided.
In summary:
The provided document is a 510(k) summary for a traditional medical device (bone fixation system). The "study" proving the device meets acceptance criteria is fundamentally a comparison to predicate devices to demonstrate substantial equivalence in terms of design, materials, intended use, and general performance characteristics. It is not an AI/software performance study, and therefore, many of the requested details about statistical significance, reader studies, and AI-specific metrics are not present or applicable. The "acceptance criteria" are implicitly defined by the attributes and performance of the chosen predicate devices, which the Mondeal® RADIUS HO System is shown to match or be comparable to.
§ 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.