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The CCD™ Spinal System is limited to non-cervical use in the posterior spine. The CCD spinal screws, when used as pedicle screws with the CCD™ Spinal' System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-Sl) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and(d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and no lower than the sacrum. Otherwise, the CCD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CCD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-Sl vertebral joint, the specific indications for the CCD Spinal System (either stainless steel or titanium alloy versions) are the following:

1. Degenerative disc disease (as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and / or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule).
2. Pseudoarthrosis
3. Stenosis
4. Spondylolisthesis
5. Spinal deformities: scoliosis, kyphosis, and lordosis
6. Fracture
7. Unsuccessful previous attempts at spinal fusion
8. Tumor resection
   All of the CCD hooks are intended for posterior thoracic and/or lumbar use only. CCD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.

The CCD™ Spinal System consists of rods, hooks, screws, connectors, cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CCD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CCDTM Spinal System implant components are fabricated either from ASTM F138 or its ISO equivalent stainless steel or titanium alloy conforming to ASTM F136 or its ISO equivalent (non-pedicle screw indications only) and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implant components in a spinal construct.

This is a 510(k) summary for a medical device (Compact Cotrel-Dubousset (CCD™) Spinal System), which describes its intended use, components, and indications. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

The provided text focuses on:

• Device identification: Product name, manufacturer.
• Device classification: Spinal fixation system.
• Device description: Components (rods, hooks, screws, connectors), materials (ASTM F138/ISO stainless steel, ASTM F136/ISO titanium alloy), and whether they are sterile or non-sterile.
• Indications for use:
  • General non-cervical posterior spinal use for stabilization during fusion.
  • Specific pedicle screw indications: severe spondylolisthesis (Grade 3 and 4) at L5-S1, autogenous bone graft only, fixed to lumbar and sacral spine, device removal after fusion. Lumbar pedicle screw insertion no higher than L3.
  • Other pedicle screw uses: sacral/iliac attachment only.
  • General indications for both stainless steel and titanium alloy versions: degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fracture, unsuccessful previous fusion attempts, tumor resection.
  • Specific indications for hooks and cross connectors.

Therefore, I cannot answer your request for acceptance criteria and study details because the provided text does not contain that information. The document is a regulatory summary describing the device itself, not a performance study report.

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