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K Number
K182418
Device Name
V3 Segmental Plating System
Manufacturer
Atlas Spine, Inc.
Date Cleared
2018-11-29

(85 days)

Product Code
KWQ
Regulation Number
888.3060
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The V3 Segmental Plating System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6) deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "V3 Segmental Plating System" does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device.

The document discusses:

  • The FDA's decision regarding substantial equivalence for the medical device.
  • Regulatory information, general controls, and compliance requirements.
  • The indications for use for the V3 Segmental Plating System, which is a spinal intervertebral body fixation orthosis.

It does not:

  • Define specific performance acceptance criteria for an AI/ML product.
  • Describe a study involving an AI algorithm, a test set, ground truth establishment, expert readers, or multi-reader multi-case (MRMC) studies.
  • Provide details on training sets or their ground truth.

Therefore, I cannot fulfill your request for the table of acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods, as this information is not present in the provided text.

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.