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K Number
K102265
Device Name
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
LDR SPINE USA
Date Cleared
2010-09-29

(50 days)

Product Code
KWQ
Regulation Number
888.3060
Type
Special
Panel
OR
Reference & Predicate Devices
K061002
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The C-Plate™ Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications:

  • degenerative disc disease (DDD) (defined as neck pain of discogenic origin . with degeneration of the disc confirmed by history and radiographic studies),
  • spondylolisthesis, .
  • trauma (i.e., fracture or dislocation), .
  • spinal stenosis, .
  • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
  • . tumor,
  • · . pseudoarthrosis,
  • failed previous fusion. .
Device Description

The C-Plate Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and associated instruments.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the LDR Spine C-Plate™ Anterior Cervical Plate System:

Summary of Device and Submission Type:

The LDR Spine C-Plate™ Anterior Cervical Plate System is an anterior cervical plate intended for spinal fixation for various conditions. This 510(k) submission (K102265) is for transfer of ownership and name change of an already cleared predicate device, the MAXIMA™ Anterior Cervical Plate System (K061002).

Crucially, the document explicitly states:

  • "A section outlining the technological characteristics and specific performance tests is not applicable for this submission."
  • "The proposed LDR Spine C-Plate™ Anterior Cervical Plate System is exactly the same as the predicate MAXIMA™ Anterior Cervical Plate System (cleared via K061002) and the purpose of this submission is to transfer the ownership and name of the device."

Therefore, many of the requested details regarding acceptance criteria and performance studies are not present in this document because they were established and reviewed during the clearance of the predicate device (K061002), not this specific submission (K102265).

Based on the provided text, here's what can be answered:

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

    This information is not provided in the document. As stated in the submission, "A section outlining the technological characteristics and specific performance tests is not applicable for this submission" because the device is identical to a previously cleared predicate. The acceptance criteria and performance data would have been established and presented during the original clearance of the MAXIMA™ Anterior Cervical Plate System (K061002).

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

    This information is not provided in the document. No new testing was conducted or documented for this 510(k) submission.

  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)

    This information is not provided in the document. No new testing was conducted or documented for this 510(k) submission.

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

    This information is not provided in the document. No new testing was conducted or documented for this 510(k) submission.

  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

    This information is not applicable/provided in the document. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool.

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

    This information is not applicable/provided in the document. This device is a mechanical spinal fixation system, not an algorithm.

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

    This information is not provided in the document. No new testing was conducted or documented for this 510(k) submission.

  8. The sample size for the training set

    This information is not applicable/provided in the document. This device is a mechanical spinal fixation system, not a machine learning model requiring a training set.

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

    This information is not applicable/provided in the document. This device is a mechanical spinal fixation system, not a machine learning model requiring a training set.

§ 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.