(232 days)
No
The summary describes a mechanical implant (vertebral body replacement) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma and restore biomechanical integrity, which are therapeutic actions.
No.
The device description clearly states it is an implant (vertebral body replacement), not a diagnostic tool. Its purpose is to physically restore the spine, not to identify or assess medical conditions.
No
The device description clearly states it is comprised of physical components made of Titanium (frames, spacers, spikes) and is intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for replacing a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine. This is a surgical implant used directly within the body.
- Device Description: The description details a physical implant made of titanium components designed to be surgically placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the CPOD/LPOD is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Theken CPOD / LPOD VBR is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).
The Theken CPOD / LPOD VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.
The Theken CPOD / LPOD VBR System is designed to be constructed using two cage components in conjunction with an appropriate single spacer component. This combination of components creates an implantable construct. The use of a single cage as an implant has not been tested or approved.
The Theken CPOD / LPOD VBR is intended to be used with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622) or the DePuy Acromed ISOLA System (K980485).
Product codes
MQP
Device Description
The Theken CPOD / LPOD VBR is comprised of Titanium rounded rectangular and rectangular frames with fenestrations and radii on all sides and toothed spikes which are used in combination with Titanium spacer components. The frames and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular frames engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
A-2