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

The Distal Radius Fracture Repair System (DRFRS) was previously cleared under 510(k) No. K030198. 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. K030198 in order to add accessories to the DRFRS.

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 drill guide, screw jig and screw guide.

A standard awl, which is a manual surgical instrument, used to enlarge t or tunnel by rotary movement is a catalog item manufactured by K-Medic (catalog no. KM-48-336).

This submission describes two accessories that are being added to the Distal Radius Fracture Repair Systems, fragment plates and a "K-Type" wire.

The fragment plates are essentially smaller implementations of the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates. The fragment plates are intended for the attachment of small bone fragment plates will be available in the four versions: right, left, straight, and "Y."

The fragment plates are made from the same titanium (ASTM F 136 - 96) as the existing Distal Dorsal Nail-Plates and Distal Volar Radius Plates cleared via K030198. The plates are intended to be fastened to bone using the 2.5 mm titanium screws that were cleared via K030198.

The K-Wires that will be supplied with the Distal Radius Fracture Repair System are primarily intended for intraoperative use to temporarily locate bone plates or for interfragmental fixation.

Even though the K-Wire is intended primarily for intraoperative use, if desired by the surgeon, the K-Wires may permanently implanted. The K-Wires are made from the same titanium (ASTM F 136 - 96) as the existing pins and screws.

Three variations of the right and left distal volar plates have been added to accommodate the anatomies of larger and smaller patients. The list of manual surgical instruments included in the Distal Radius Fracture Repair System has been updated.

The provided document describes a medical device, the "Distal Radius Fracture Repair System," and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets performance metrics via a machine learning algorithm or AI component.

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

• Device Type: The device is a surgical implant system (plates, screws, nails, etc.) used for fixing bone fractures, not a software or AI-driven diagnostic/detection system.
• Performance Data Focus: The "Summary of Performance Data" section explicitly states that the device complies with certain ASTM standards (related to material specifications and fixation pins/wires) and was found substantially equivalent to a predicate device through a "15-point technological comparison of features and a 3-parameter comparison of mechanical performance." This refers to traditional engineering and biomechanical testing, not AI performance metrics.
• No Mention of AI/ML: There is no mention of an algorithm, AI, machine learning, diagnostic performance (e.g., sensitivity, specificity), ground truth, training sets, test sets, or expert readers/adjudication.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML device performance. The document describes a traditional medical device clearance process focused on material standards, mechanical performance, and substantial equivalence to a predicate device.

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