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K Number
K964623
Device Name
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
Manufacturer
SOFAMOR DANEK USA,INC.
Date Cleared
1997-02-06

(80 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 Titanium CD HORIZON™ Anterior Spinal System is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops. The specific indications for the CD HORIZON" Anterior Spinal System are the following:

  1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
  2. Pseudoarthrosis
  3. Stenosis
  4. Spondvlolisthesis
  5. Spinal deformities: scoljosis, kyphosis, lordosis
  6. Fracture
  7. Unsuccessful previous attempts at spinal fusion
  8. Tumor resection

All components of the Titanium CD HORIZON™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.

Device Description

The Titanium CD HORIZON™ Anterior Spinal System consists of the following implants components:

  • CD HORIZON™ rod (commercially pure titanium), 6.35mm diameter
  • CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter .
  • TSRH® rod (titanjum alloy), 6.35mm diameter .
  • CD HORIZON™ screws (titanium alloy), 5.5mm, 6.5mm, and 7.5mm . diameters
  • CD HORIZON™ Break-Off Set Screw (titanium alloy) t
  • CD HORIZON™ Staples (titanium allov) .

The Titanium TSRH® rod can be used with the Titanium CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The Titanium CD HORIZON™ Anterior Spinal System implant components are fabricated from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, the Titanium CD HORIZON" Anterior Spinal System has a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. The implant components may be sold sterile or non-sterile. Titanium implants are not to be used with stainless steel implant components in a spinal construct

AI/ML Overview

This document is a 510(k) summary for a spinal implant device, not a study evaluating a device's performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not applicable.

Here's a breakdown of what can be inferred or stated based on the provided text:

  • Acceptance Criteria and Reported Device Performance: This document does not describe acceptance criteria for a device's performance in the sense of diagnostic accuracy or a specific measurable outcome from a clinical study. Instead, it describes the device itself and its intended use. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through mechanical testing and comparison of materials and indications.

    No specific performance metrics like sensitivity, specificity, or AUC are provided.

  • Study That Proves the Device Meets Acceptance Criteria: The document refers to "Mechanical test data were supplied in support of the Titanium CD HORIZON™ Anterior Spinal System 510(k) notification." This indicates a study was conducted (mechanical testing), and its results were used to support the claim of substantial equivalence. However, no details about the methods, sample size, or specific acceptance criteria for these mechanical tests are provided in this summary.

Let's address each point as best as possible, considering the context of the provided text:

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

    • Acceptance Criteria (Implied for 510(k) clearance): Substantial equivalence in terms of materials, intended use, and mechanical performance compared to predicate devices.
    • Reported Device Performance: The document states, "The Titanium CD HORIZON™ Anterior Spinal System was declared to be substantially equivalent to other commercially available devices." No specific performance metrics (e.g., strength in Newtons, fatigue cycles) from the mechanical tests are reported in this summary.

  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 specified. This refers to the number of implants or constructs tested for mechanical properties.
    • Data Provenance: Not specified, but likely from laboratory mechanical testing. This is not clinical data.

  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. Mechanical testing for spinal implants does not typically involve human experts establishing "ground truth" in the way a diagnostic study would. The "ground truth" for mechanical testing would be the physical properties measured.

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

    • Not Applicable. Adjudication methods are relevant for human interpretation or clinical outcomes, not for objective mechanical test results.

  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 document describes a physical medical device (spinal implant), not an AI/ML algorithm or a diagnostic imaging device.

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

    • Not Applicable. This is not an algorithm.

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

    • Not Applicable (in the diagnostic sense). For mechanical testing, the "ground truth" would be the measured physical properties of the materials and constructs under various loads, as determined by standardized laboratory methods (e.g., ASTM F1717 for spinal implant constructs).

  8. The sample size for the training set:

    • Not Applicable. There is no "training set" as this is not an AI/ML algorithm.

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

    • Not Applicable. As above, no training set.

In summary: The provided document is a regulatory 510(k) summary for a physical medical device. It focuses on the device's description, materials, indications for use, and a statement of substantial equivalence supported by mechanical test data. It does not contain the kind of performance data, study design details, or expert involvement typically associated with evaluating diagnostic or AI/ML device performance against specific "acceptance criteria" as implied by the prompt's structured questions.

§ 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.