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K Number
K143350
Device Name
Nile Alternative Fixation
Manufacturer
K2M, Inc.
Date Cleared
2015-02-25

(93 days)

Product Code
OWI
Regulation Number
888.3010
Type
Traditional
Panel
OR
Reference & Predicate Devices
K110348,K091190,K081622,K060009,K133482,K132395,K112736,K121541,K120099
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.

The indications for use include the following applications:

  1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

  2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;

  3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

Device Description

The Nile Alternative Fixation System implants are comprised of bands, clamps and set screws designed to attach to titanium or cobalt chrome rods. The band is manufactured from polyethylene terephthalate (PET) and the clamps and set screws are made from titanium alloy in accordance with ASTM F136. Once the bands are secured the stainless steel tips are detached and are not intended to be implanted.

Function: The Nile Alternative Fixation system is a band (tether) and clamp device that is designed to be used in conjunction with spinal rods for attachment to the posterior vertebral structures.

AI/ML Overview

I apologize, but the provided text is a 510(k) summary for a medical device (Nile Alternative Fixation Spinal System) and does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device.

The document describes:

  • The device name, its intended use, and indications for use.
  • Its classification and predicate devices.
  • A brief description of its components and function.
  • A comparison to predicate devices.
  • A mention of non-clinical mechanical performance evaluation.

However, it does not discuss:

  1. A table of acceptance criteria and reported device performance for an AI/ML system.
  2. Sample sizes for test sets, data provenance, or training sets in the context of AI/ML.
  3. Number of experts, qualifications, or adjudication methods for establishing ground truth for AI/ML.
  4. MRMC studies, effect sizes for human readers with/without AI assistance.
  5. Standalone algorithm performance.
  6. Type of ground truth used for AI/ML models.

The "Non-clinical Performance Evaluation" section simply states that the device "performed equally to or better than these systems in static tensile strength, static and dynamic compression, dynamic tension/band pull-through, static band pull-through, axial gripping capacity and rotational gripping capacity." This refers to biomechanical testing of a physical implant, not the evaluation of an AI/ML algorithm.

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.