(46 days)
DSI Pins and Wires are non-sterile, single-use pins and wires intended to be used for the fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices.
DSI Pins and Wires consist of various pins and wires for use in the fixation of bone fractures, bone reconstruction, or as a guide/aid for insertion of other medical devices. All DSI Pins and Wires included in this submission are manufactured of implant grade stainless steel. All DSI Pins and Wires included in this submission will be marketed non-sterile. Kirschner Wires, Steinmann Pins and Cerclage Wires are included in this submission.
This looks like a 510(k) summary for a medical device that does not involve AI or machine learning. The device, "DSI Pins and Wires," is described as a physical product (implant grade stainless steel pins and wires for bone fixation), not a software algorithm or diagnostic tool.
Therefore, the prompt's request for information related to AI/ML device studies (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets, etc.) cannot be answered from the provided text.
The document focuses on:
- Device Description: Physical characteristics and materials.
- Intended Use: Clinical applications.
- Regulatory Classification: Class II medical device.
- Substantial Equivalence: A comparison to existing, legally marketed predicate devices, which is the standard regulatory pathway for similar physical devices.
There is no mention of any software, AI, or performance studies that would generate the kind of data requested in the prompt. The "performance" for such a device would typically relate to mechanical strength, biocompatibility, and sterilization validation, not the diagnostic accuracy of an algorithm.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.