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K Number
K150675
Device Name
Dorsal Spanning Plate
Manufacturer
SKELETAL DYNAMICS, LLC
Date Cleared
2015-05-12

(57 days)

Product Code
HRS
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K093761
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.

Device Description

The Skeletal Dynamics Dorsal Spanning Plate consists of a bone plate designed for fracture fixation of the distal radius and wrist arthrodesis. Included in the system are titanium bone screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Dorsal Spanning Plate is comprised of: Titanium alloy plate and screws; Stainless steel K-wires (for provisional fixation not for implantation); System specific instrumentation.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device (Dorsal Spanning Plate) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the text mentions:

  • Performance Testing: "Mechanical testing which established equivalency included static and dynamic testing." This indicates testing was performed but does not provide specific acceptance criteria or detailed results.
  • Conclusion: "The Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device identified in this premarket notification." This is the overall conclusion of the 510(k) submission, based on the comparison to the predicate.

The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Information on experts, ground truth establishment, or adjudication methods.
  4. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
  5. Details on training set sample size or ground truth establishment for a training set.

Therefore, I cannot extract the requested information from the provided text.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.