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K Number
K132244
Device Name
N-FORCE FIXATION SYSTEM
Manufacturer
INNOVISION, INC.
Date Cleared
2014-03-06

(231 days)

Product Code
HWC
Regulation Number
888.3040
Type
Traditional
Panel
OR
Reference & Predicate Devices
K102528
Predicate For
K142776,K151146
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:

  • . Beta-bsm (ETEX Corporation)
  • . CarriGen (ETEX Corporation)
Device Description

The N-Force Fixation System is a screw system fixation. It includes fully and partially cannulated screws in various diameters and lengths, and accompanying instruments.
The N-Force Fixation System implants are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136. The N-Force Fixation System screws are cannulated and/or fenestrated and can be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.

AI/ML Overview

The document describes a Special 510(k) submission for the N-Force Fixation System, a screw system intended for bone fracture fixation and reconstruction, which can also deliver bone void fillers. The submission seeks to add new sizes and components to the existing system. The key information is about demonstrating substantial equivalence to a predicate device (K102528).

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

  1. A table of acceptance criteria and the reported device performance:

    Acceptance Criteria (What was tested)Reported Device Performance (Results)
    Static three-point bendingDemonstrated substantial equivalence to the predicate N-Force Screw
    Static torsionDemonstrated substantial equivalence to the predicate N-Force Screw
    Extraction testingDemonstrated substantial equivalence to the predicate N-Force Screw
    Engineering analyses (non-fenestrated screws)Supported substantial equivalence
    Ability to deliver bone void filler material (with ETEX recommended instruments)Demonstrated substantial equivalence to the predicate N-Force Fixation System

  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

    • Sample Size: Not explicitly stated. The document mentions "Testing was performed on the modified N-Force Screw" without specifying the number of screws or tests conducted.
    • Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. The testing was performed by the manufacturer, InnoVision, Inc., which is based in Memphis, TN, USA.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

    • Not applicable. This device is a mechanical fixation system, and its performance testing involves mechanical stability tests (bending, torsion, extraction) rather than expert interpretation of images or clinical outcomes that would require a "ground truth" established by experts.

  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable. As explained above, the testing is mechanical and does not involve adjudication of expert opinions.

  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This is a medical device (screw fixation system), not an AI-powered diagnostic or assistive tool.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a medical device, not an algorithm. The "standalone" performance here refers to the device's mechanical properties. The studies described are essentially "standalone" device performance tests.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The "ground truth" for this device's performance is based on established mechanical engineering principles and standards for bone fixation devices. The tests (static three-point bending, static torsion, extraction testing) are designed to assess the physical properties and strength of the screws against predefined engineering requirements and in comparison to a predicate device.

  8. The sample size for the training set:

    • Not applicable. This is a mechanical device, not a machine learning algorithm. Therefore, there is no "training set."

  9. How the ground truth for the training set was established:

    • Not applicable, as there is no training set.

§ 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.