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510(k) Data Aggregation
(77 days)
MONDEAL DISTAL RADIUS SYSTEM
The Mondeal® DISTAL RADIUS 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® Distal Radius 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 configurations. Manual reusable surgical instruments may be supplied to facilitate implantation.
This submission describes a medical device, the Mondeal® Distal Radius System, which is a set of plates and screws for fixing distal radius fractures. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a previously cleared device. Therefore, the "study" conducted is a comparison to a predicate device, rather than a clinical trial or a performance study with acceptance criteria in the typical sense for an AI/software device.
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Acceptance Criteria and Study for Mondeal® Distal Radius System
The "acceptance criteria" and "study" for the Mondeal® Distal Radius System are based on demonstrating substantial equivalence to a predicate device (Mondeal® Radius HO System, K050655), as per 510(k) requirements. There is no performance study against specific, quantified acceptance criteria in the context of an AI/software device. Instead, the "performance" here refers to material and mechanical properties, as well as intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Demonstrates Equivalence to Predicate) | Reported Device Performance (Mondeal® Distal Radius System) |
|---|---|---|
| Indications for Use | Identical to predicate device | The Mondeal® DISTAL RADIUS System is intended to be used for the fixation of fractures and osteotomies involving the distal radius applied to the volar and dorsal aspect. (Identical to predicate) |
| Technology | Identical to predicate device | Titanium plates and screws (Identical to predicate) |
| Application | Identical to predicate device | Internal Fixation of small bones of hand and foot (Identical to predicate) |
| Design / Components | Comparable to predicate device | CP Titanium Grade 2 plates and Ti-6Al-4V ELI screws (Predicate uses Ti-6Al-4V ELI Anodized Type II plates and screws) |
| Corrosion Resistance | Identical to predicate device | Identical |
| Mechanical Properties | Similar to predicate device | Similar hardness, yield and tensile strength, elongation, reduction in area, chemical content |
| Sterilization Method | Identical to predicate device | Steam Autoclave (Identical to predicate) |
| Packaging | Identical to predicate device | Tempered plastic and/or stainless steel trays for steam sterilization; plates and screws also packaged individually, all non-sterile (Identical to predicate) |
Note: The "acceptance criteria" are implied by the 510(k) process, which requires demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This means the new device must have the same intended use, and the same technological characteristics, or, if different, any differences must not raise new questions of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This is not a study involving a "test set" of patients or data in the typical sense. The evaluation is a comparison of device specifications and characteristics against a predicate device.
- Data Provenance: Not applicable. The data is descriptive information about the device's design, materials, and performance specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. There is no "ground truth" in the context of expert consensus on patient data or images. The "ground truth" for this submission would be industry standards for material properties and manufacturing, as well as the specifications of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. There is no test set or adjudication process as described in the context of clinical studies or AI algorithm evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an MRMC study. It is a comparison of a new medical device to a predicate device based on its physical and mechanical properties.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" is based on accepted engineering and material science standards, as well as the specifications and regulatory clearance of the predicate device (Mondeal® Radius HO System, K050655). The submission relies on the established safety and effectiveness of the existing predicate device as the benchmark for comparison.
8. Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
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