(209 days)
The Titanium CD HORIZON" Spinal System, when using screws for pedicle fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) 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 secral spine; and (d) who are having the device removed after the development of a solid fusion mass.
Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a Titanium CD HORIZON™ construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the Titanium CD HORIZON™ Spinal System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scoliosis, kyphosis, lordosis
- Fracture
- Unsuccessful previous attempts at spinal fusion
- Tumor resection
NOTA BENE: The Titanium CD HORIZON" Spinal System Is limited to noncervical use. The titanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Scrows, when used as pedicle screws with the Titanium CD HORIZON™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) 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 not lower than the sacrum. Otherwise the tifanium alloy CD HORIZON" screws and the titanium alloy TSRH® Variable Angle Screws, when used with the Titanium CD HORIZON® Spinal System, are intended for sacral/iliac attachment only. All of the titanium alloy CD HORIZON" hooks are intended for thoracic and/or lumber attachment only. The titanium alloy TSRH® Low Profile CROSSLINK® Officet Plate, the titanium alloy TSRH® Low Profile CROSSLINK® plates, and the titanium alloy CD HORIZON™ Low Profile MULTI-SPAN" CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use only.
The Titanium CD HORIZON™ Spinal System consists of the following implant components which can be assembled in a variety of configurations, with each resulting spinal implant construct being tailor-made for the individual case.
CD HORIZON® rod (commercially pure titanium), 8.35mm diameter
CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter
CD HORIZON™ hooks (titanium alloy)
CD HORIZON™ screws (titanium alloy): 5.5mm, and 7.5mm diameters
CD HORIZON™ Break-Off Set Screw (titanium alloy)
CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates (titanium alloy)
In addition, the following Titanium TSRH® Spinal system implants can be used with the Titanium CD HORIZON™ Spinal System.
TSRH® rod (titanium alloy), 6.35mm diameter
TSRH® Variable Angle Screws (titanium alloy): 6.5mm and 7.5mm diameters
TSRH® Top Tightening Variable Angle T-Botts with Locking Screw (titanium alloy): small, medium, and large
TSRH® Low Profile CROSSLINK® Offset Plate (titanium alloy)
TSRH® Low Profile CROSSLINK® Plates (titanium alloy)
TSRH® Low Profile CROSSLINK® Plate Set Screws (titanium alloy)
The Titanium CD HORIZON™ Spinal System components and the others mentioned above are made out of titanium alloy described by ASTM Standard F136 or its ISO equivalent. The Titanium CD HORIZON" Spinal System also features a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium CD HORIZON™ implant components must not be used with implant components fabricated from stainless steel or any other alloy in a construct. The Titanium CD HORIZON™ implants may be sold sterile or nonsterile.
Instruments are available to facilitate the use of the device.
This is a 510(k) premarket notification for a medical device, the Titanium CD HORIZON™ Spinal System. As such, it reports on mechanical testing to establish substantial equivalence to predicate devices, rather than clinical studies demonstrating diagnostic performance or effectiveness in a patient population. Therefore, many of the requested fields are not applicable.
Here's an analysis of the provided text with respect to your questions:
1. A table of acceptance criteria and the reported device performance
The document states: "The Titanium CD HORIZON™ Spinal System was declared substantially equivalent to other predicate or preamendments devices. Mechanical test data were provided in the application."
This indicates that the acceptance criteria are related to meeting or exceeding the performance characteristics of predicate devices through mechanical testing. The specific acceptance criteria (e.g., specific load endurance, fatigue limits) and the detailed reported device performance are not explicitly provided in this summary. They would typically be found in the full 510(k) submission, which includes detailed test reports.
Without the full mechanical test report, a specific table of acceptance criteria and reported output cannot be generated from the provided text.
2. Sample size used for the test set and the data provenance
The document refers to "Mechanical test data." For mechanical testing, the "sample size" typically refers to the number of device components or constructs tested. This information is not provided in this summary.
Data provenance (country of origin, retrospective/prospective) is not applicable as this concerns material and device mechanical properties, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. Mechanical testing for substantial equivalence does not involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" in this context would be the physical properties derived from standardized mechanical tests.
4. Adjudication method for the test set
This question is not applicable for mechanical testing.
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 question is not applicable. This is a spinal implant system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a spinal implant system, not an algorithm.
7. The type of ground truth used
For mechanical testing, the "ground truth" would be established by:
- Standardized testing protocols: (e.g., ASTM or ISO standards for material properties, fatigue, and strength).
- Predicate device performance data: The benchmarks set by the devices to which substantial equivalence is being claimed.
The summary does not specify the particular standards or predicate device data used as "ground truth."
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of mechanical testing for a spinal implant. This is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
This question is not applicable.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.