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K Number
K092360
Device Name
ACP4 SPINAL IMPLANT SYSTEM
Manufacturer
X-SPINE SYSTEMS, INC.
Date Cleared
2010-01-22

(171 days)

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

The X-Spine ACP4 System is intended for anterior screw fixation to the cervical spine (C2-C7 inclusive). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

  • Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
  • Spondylolisthesis,
  • Trauma (i.e., fractures or dislocations),
  • Tumors,
  • Deformity (defined as kyphosis, lordosis, or scoliosis) .
  • Pseudoarthrosis, and/or
  • Failed previous fusions.
Device Description

The X-Spine ACP4 System includes titanium alloy anterior cervical plates and bone screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The implant components are provided clean and non-sterile.

AI/ML Overview

The request is about the acceptance criteria and study proving the device meets the criteria. Specifically, it requests:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size and data provenance for the test set.
  3. Number and qualifications of experts for ground truth establishment (test set).
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study details (if applicable).
  6. Standalone performance study details (if applicable).
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. Ground truth establishment for the training set.

Based on the provided documents for K092360, the device is the "ACP4™ Spinal Implant System," which is a traditional medical device (cervical plating system) and not an AI/ML-based device. Therefore, the requested information, which pertains to AI/ML device performance criteria, ground truth, and expert evaluation, is not applicable to this submission.

The "PERFORMANCE DATA" section states: "Biomechanical testing indicates that the ACP4 system is capable of performing in accordance with its intended use." This indicates that the device's performance was evaluated through biomechanical tests, rather than clinical studies involving human readers, ground truth, or training sets as relevant for AI/ML systems.

Therefore, I cannot fulfill the request for information specifically tailored to AI/ML device evaluations based on the provided document. The document describes a traditional medical device submission, which does not typically include these types of performance evaluations.

§ 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.