(17 days)
The Nexa Compression Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The Nexa Compression Screw is made of 316L Stainless Steel, per ASTM F138, and is intended to be implanted into the bones of the foot and hand, and bones appropriate for the size of the device. The screws are provided in three diameters of various lengths. No new materials are used in the development of this implant.
This document, K060076, is a 510(k) Summary for a medical device called the "Nexa Compression Screw." It does not describe an AI/ML medical device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, or reader improvement) is not applicable and not present in the provided text.
The information provided describes a traditional medical device (a surgical implant) and its substantial equivalence to predicate devices, which is the regulatory pathway for such devices.
Here's a breakdown of why the requested information about acceptance criteria and study proving performance cannot be extracted for an AI/ML device:
- AI/ML Device Implication: The request is designed for AI/ML devices that generate data, such as images, interpretations, or diagnostic aids.
- Device Type: The Nexa Compression Screw is a physical implant made of 316L Stainless Steel. Its performance is evaluated through material properties, mechanical testing, and clinical use cases, not through algorithmic output.
- Regulatory Pathway: The 510(k) pathway for this device focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, primarily through comparison of materials, design, indications for use, and mechanical characteristics. It does not typically involve clinical studies with performance metrics like those for AI/ML algorithms.
Therefore, I cannot provide the requested table or details about AI/ML performance for K060076 as it is not an AI/ML medical device.
§ 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.