(53 days)
The Distal Radius Locking Plating System is intended for the fixation of intra and extra-articular fractures as well as distal radius osteotomy.
The Distal Radius Locking Plating System consists of plates designed for various fracture modes of the radius. The system is used with locking screws, locking pegs, locking threaded pegs and cortical screws. Each device is manufactured from titanium alloy (Ti-6Al-V4 ELI - ASTM F 136-02a) and can be supplied color anodized or notanodized. The Distal Radius Locking Plating System will be provided non-sterile for steam sterilization by health care professionals prior to use.
Here's a breakdown of the requested information based on the provided text, though it's important to note that this document is an FDA 510(k) clearance letter and not a detailed study report. Therefore, much of the requested information regarding study specifics and performance metrics for a device with an algorithm will not be present as this is a medical device (bone plating system), not an AI/software device.
Acceptance Criteria and Device Performance
This document is for a Distal Radius Locking Plating System, a physical medical device. It does not involve AI or algorithms for diagnosis or analysis. Therefore, traditional "acceptance criteria" related to algorithm performance (e.g., sensitivity, specificity, AUC) and a "device performance" table in that context are not applicable.
The "acceptance criteria" for this type of device typically revolve around demonstrating substantial equivalence to predicate devices in terms of intended use, materials, design, and performance through mechanical testing (e.g., fatigue, static strength, torsional strength). The FDA's acceptance is based on the submission demonstrating that the device is as safe and effective as the predicate devices.
Table of Acceptance Criteria and Reported Device Performance (as inferred for a mechanical device):
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from Substantial Equivalence Determination) |
|---|---|
| Intended Use Equivalence | Intended for fixation of intra/extra-articular fractures and distal radius osteotomy, similar to predicate devices. |
| Material Equivalence | Manufactured from titanium alloy (Ti-6Al-V4 ELI - ASTM F 136-02a), a widely accepted and used material in predicate devices. |
| Design Equivalence | Consists of plates, locking screws, locking pegs, locking threaded pegs, and cortical screws, similar to predicate device systems. |
| Biocompatibility | Implied to meet biocompatibility standards through material choice and comparison to predicate devices. |
| Sterilization | Provided non-sterile for steam sterilization by healthcare professionals, a common practice for similar predicate devices. |
| Mechanical Performance (e.g., Strength, Fatigue) | Implied to have undergone testing to demonstrate equivalent mechanical performance as predicate devices, but specific results are not provided in this summary. |
| Labeling | Complies with FDA labeling requirements for similar devices. |
Study Details (Not applicable for this type of device and document)
Since this is a physical implantable device (a bone plating system) and not an AI/software diagnostic tool, the following questions are not directly applicable to the provided 510(k) summary. The FDA clearance is based on a demonstration of substantial equivalence to already cleared predicate devices, primarily through engineering testing and material characterization, not clinical studies with "test sets" or "ground truth" as described for AI.
Therefore, for questions 2 through 9, the answer is largely "Not applicable" or "Information not available in this 510(k) summary."
1. A table of acceptance criteria and the reported device performance
- See table above. This is inferred from the nature of a 510(k) submission for a mechanical device. Specific numerical performance data (e.g., fatigue cycles, static load limits) are not included in this high-level summary but would have been part of the full 510(k) submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This summary does not describe a clinical study or a "test set" in the context of an algorithm or diagnostic performance. Mechanical testing would involve a sample size of devices, but details are not provided here.
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)
- Not applicable. No ground truth establishment for a diagnostic test set is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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
- Not applicable. This device is a mechanical implant; it does not involve human readers or AI assistance in diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth for diagnostic purposes is not relevant for this device. For mechanical devices, "ground truth" is established by engineering standards and accepted mechanical testing (e.g., ASTM standards for material properties and device performance).
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it.
In summary: The provided document is for the FDA 510(k) clearance of a physical medical device (bone plating system) and therefore does not contain the kind of information typically associated with AI/software device performance studies, test sets, or ground truth establishment. The clearance is based on demonstrating substantial equivalence to predicate devices through design, materials, intended use, and mechanical performance (though specific mechanical results are not included in this summary).
§ 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.