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The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.

The Distal Radius Fracture Repair System was previously cleared under 510(k) No. K023007. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K023007 to update and standardize the sterilization cycle. The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s). The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw guide. A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336. The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Radius Fracture Repair System include Titanium TI-6AL-4V ELI and Stainless Steel 440C and SST-17-4. The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use. The system is packaged in a high tempered plastic sterilization tray.

This is a 510(k) summary for a medical device (Distal Radius Fracture Repair Kit/System), not an AI/algorithm-driven device. Therefore, the requested information about acceptance criteria and studies proving the device meets those criteria, particularly regarding performance metrics like those for AI, is not applicable in the context of this document.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K023007) based on material, intended use, manufacturing, and sterilization process.

Here's why the requested information cannot be provided from the given text:

• No Acceptance Criteria for AI/Performance: The submission is for a traditional surgical implant system (plates, screws, pegs). There are no performance metrics or acceptance criteria related to accuracy, sensitivity, specificity, or other AI-specific measures. The "performance" discussed is in the context of the physical properties and function of the orthopedic implants, not an AI algorithm.
• No Study Data for AI/Performance: Consequently, there are no studies detailed that would "prove the device meets acceptance criteria" in terms of AI performance. The focus is on demonstrating that the modified device (primarily changes to sterilization cycle) is as safe and effective as the predicate device.
• No AI, therefore no ground truth, training/test sets, or experts for AI: Because this is not an AI device, there are no concepts of "training set," "test set," "ground truth," "number of experts," or "adjudication methods" in the context of AI performance evaluation.
• No MRMC Comparative Effectiveness Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.
• No Standalone Algorithm Performance: This is a physical device, not an algorithm, so standalone algorithm performance is irrelevant.

Summary of what can be extracted from the document:

1. Device: Distal Radius Fracture Repair System (implants and instruments)
2. Intended Use: Fixation of fractures and osteotomies involving the distal radius.
3. Key Change in this Submission (K030198): Update and standardize the sterilization cycle.
4. Substantial Equivalence Claim: The modified device is substantially equivalent to the previously cleared Distal Radius Fracture Repair System (K023007) regarding intended use, materials, biocompatibility, and overall performance characteristics.
5. Study (Implicit): The "study" here is the demonstration of substantial equivalence, relying on:
   • Comparison to Predicate Device: A detailed comparison table (page 4) highlighting similarities in features like manufacturer, packaging, sterilization method (non-sterile, recommend steam), intended use, implant period (permanent), material of construction (Titanium, Stainless Steel), available configurations, number of pegs/screws, peg/screw lengths, and specialized instruments.
   • Sterilization Validation (Not detailed in the provided text, but implied by the "update and standardize the sterilization cycle" statement): The manufacturer would have conducted validation studies (e.g., microbial challenges, sterility assurance level (SAL) testing) to ensure the new sterilization cycle is effective, but these studies are not described in this summary.

In essence, this document is a regulatory submission for a physical medical device, not an AI/machine learning product. Therefore, the requested information tailored to AI evaluation is not present.

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