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K Number
K192096
Device Name
Omnia Medical Trauma Screws
Manufacturer
Omnia Medical, LLC
Date Cleared
2020-02-27

(206 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K161616
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Omnia Medical Trauma Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Device Description

The Omnia Medical Trauma screws are manufactured from Ti-6A1-4V ELI per ASTM F136. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy.

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML medical device.

The document pertains to the 510(k) premarket notification for Omnia Medical Trauma Screws, which are physical medical devices (metallic bone fixation fasteners), not an AI/ML software device.

Therefore, I cannot provide an answer that includes:

  1. A table of acceptance criteria and reported device performance (for an AI/ML device)
  2. Sample size and data provenance for a test set (for an AI/ML device)
  3. Number and qualifications of experts for ground truth (for an AI/ML device)
  4. Adjudication method (for an AI/ML device)
  5. Multi-reader multi-case (MRMC) comparative effectiveness study data (for an AI/ML device)
  6. Standalone performance data (for an AI/ML device)
  7. Type of ground truth (for an AI/ML device)
  8. Sample size for the training set (for an AI/ML device)
  9. How ground truth for the training set was established (for an AI/ML device)

The document focuses on the substantial equivalence of the physical trauma screws to a predicate device based on intended use, technological characteristics, and engineering rationale, rather than performance data from clinical studies in the way you'd expect for an AI/ML 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.