(52 days)
The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
The EXTREMITY MEDICAL Midfoot Screw System
This document is a 510(k) Premarket Notification for the Extremity Medical Midfoot Screw System. It declares substantial equivalence to predicate devices and describes the intended use and technological comparison. However, it does not contain information about specific acceptance criteria or a study proving that the device meets such criteria because it's a submission for a medical device, not an AI/ML algorithm.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Summary of available information from the provided text:
Device: EXTREMITY MEDICAL Midfoot Screw System
Intended Use: Fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal joints.
Basis for Clearance: Substantial equivalence to predicate devices (EXTREMITY MEDICAL Midfoot Screw System K082934 and 3.5 Fully Threaded Screw, Synthes K050683). The statement of technological comparison notes that the device and its predicate devices have the same indications for use, similar design, similar materials, and equivalent mechanical properties. The conclusion is based on indications for use, materials, design, test data, and principles of operation.
Note: While "test data" is mentioned, the specific details regarding what tests were performed, what the acceptance criteria for those tests were, and the results of those tests are not included in this summary document. This 510(k) summary focuses on demonstrating substantial equivalence, not on detailing a performance study against specific acceptance criteria in the way one would for an AI/ML 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.