(30 days)
The MDS Distal Radius Plating System is intended for internal fixation of fractures of the distal radius.
This special 510(k) submission is intended to add the following device instruments and caddy as accessories to the Miami Device Solutions Distal Radius Plating System which was cleared in K161292:
- Polyaxial Drill Guide
- Polyaxial Drill Guide Sleeve for K-Wire
- Polyaxial Drill Guide Caddy
The polyaxial drill guide caddy holds polyaxial drill guides and polyaxial drill guide sleeves for Kwires. The polyaxial drill guide and the polyaxial drill guide sleeve for K-wire helps the user during drill and K-wire insertion. The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths.
Here's an analysis of the provided text regarding the acceptance criteria and study information:
Based on the provided document, the device in question (Distal Radius Plating System with added polyaxial drill guides and associated accessories) did not undergo a clinical study to establish acceptance criteria or performance relevant to clinical outcomes such as diagnostic accuracy or treatment effectiveness.
Instead, this submission (K162635) is a Special 510(k) application to add accessories to an already cleared device (K161292). The focus of this specific submission is on non-clinical performance and substantial equivalence to the predicate device.
Here's a breakdown of your requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compatibility with applicable implants and instruments | The additional instruments and caddy were shown to be compatible with applicable implants and instruments. |
| Biocompatibility | Verification testing showed that the system is biocompatible. |
| Cleanliness and Sterilizability | Verification testing showed that the system can be cleaned and sterilized. |
| Substantial Equivalence (overall) | The device is substantially equivalent in intended use, materials, and performance characteristics to the predicate device. The addition of accessories does not alter the technology. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "Verification testing," which typically involves bench testing of samples but does not provide specific numbers for components tested.
- Data Provenance: Not specified, but given it's non-clinical testing, it would be laboratory-based rather than patient-derived.
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)
- N/A. Since no clinical study or diagnostic/treatment outcome assessment was performed, there was no need for experts to establish ground truth in this context. The "ground truth" for non-clinical tests is typically defined by engineering standards or material science principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No clinical study involving expert interpretation or adjudication was conducted.
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
- N/A. No MRMC study was conducted. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device is a mechanical surgical system, not an algorithm or software. "Standalone" performance testing would refer to the mechanical properties and function of the components, which falls under "Non-Clinical Performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance (compatibility, biocompatibility, cleaning/sterilization), the "ground truth" would be established by engineering specifications, recognized standards (e.g., ASTM F136 for materials, sterilization validation standards), and laboratory test results demonstrating compliance with these standards.
8. The sample size for the training set
- N/A. No training set was used as this device is not a learning algorithm or AI system.
9. How the ground truth for the training set was established
- N/A. No training set was used.
Summary of Clinical Data (from the document):
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."
This explicitly states that no clinical studies were performed, and thus no clinical acceptance criteria or human-performance metrics (like those for AI/diagnostic devices) were established or reported for this specific submission. The approval is based on substantial equivalence and non-clinical performance testing of the added accessories.
§ 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.