(152 days)
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.
The VLP Wrist Fracture System is a radial plating system comprised of plates, screws, and device specific instrumentation. Plates, screws, and locking pegs are provided in sterile packaging. Volar plate design options are offered in 3 hole, 5 hole, and 10 hole plate configurations, with both standard and wide sizes available for all sizes except the 10 hole plate. The 10 hole plate is available in standard size only. All plate designs are available in left and right configurations. 1.8mm Locking Pegs are available in lengths ranging from 10mm to 30 mm and 3.5mm Cortex and Locking Screws are available in lengths ranging from 10mm to 30mm. The system uses existing Smith & Nephew 2.4mm locking and cortex screws.
This document is a 510(k) premarket notification for the "VLP Wrist Fracture System". It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving device performance against acceptance criteria in the sense of a clinical trial or algorithm validation study. Therefore, most of the requested information regarding acceptance criteria and study details for an AI/device performance study (like sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies) is not applicable to this type of regulatory submission because it relates to a surgical implant, not an AI system.
However, based on the document, I can extract the following relevant information regarding the pre-clinical mechanical testing conducted to support the substantial equivalence claim:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Finite Element Analysis (FEA) | Proposed designs do not represent a new worst-case compared to existing worst-case. | Results determined that the proposed line addition plates did not represent a new worst-case when compared against the existing designs. |
| Four-Point Bend Fatigue | Not explicitly stated, but leveraging existing data implies meeting prior established criteria. | Existing mechanical testing for a 4 Hole Wide Plate design (K132296) was leveraged, indicating the new design is considered equivalent. |
| Torque-to-Failure (3.5mm locking screws) | Ultimate torsional strength greater than the minimum value outlined in ASTM F543. | The screws met the acceptance criteria by achieving an ultimate torsional strength greater than the minimum value outlined in ASTM F543. |
| Pullout Testing (3.5mm screws) | Not explicitly stated for performance, but the rationale was based on dimensional equivalence. | An engineering rationale was leveraged; critical dimensions for pullout behavior were identical to existing predicate screws. No new testing was deemed necessary. |
| Bacterial Endotoxin Testing | Acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72. | Met the acceptable endotoxin limits as stated in relevant FDA Guidance and ANSI/AAMI ST72. |
Regarding the other points, they are generally not applicable to this type of 510(k) submission for a metallic bone fixation device:
- Sample sized used for the test set and the data provenance: Not applicable. For mechanical bench testing, "sample size" refers to the number of devices tested, which is typically described in the full test reports (not provided here). Data provenance would be from internal lab testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on ASTM standards or industry-accepted engineering principles, not expert medical consensus.
- Adjudication method: Not applicable to mechanical testing.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted diagnostic devices.
- Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This is for AI systems.
- The type of ground truth used: For mechanical testing, the "ground truth" is defined by the physical behavior of the materials and device components under specified test conditions, measured against established engineering standards (e.g., ASTM F543 for torsional strength). For sterility, it's defined by microbiological assay results against established endotoxin limits.
- The sample size for the training set: Not applicable. This is for AI/machine learning. FEA involves computational modeling, not a "training set" in the AI sense.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes the regulatory submission for a physical medical device (bone fracture system) and the pre-clinical mechanical and biological testing conducted to support its safety and effectiveness by demonstrating substantial equivalence to predicate devices, not an AI or diagnostic device that would require human reader studies or extensive ground truth establishment by medical experts.
§ 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.