(148 days)
The Innovasis Box™ peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella™ Pedicle Screw System. The interior of the Box™ system can be packed with allograft or autograft. Box™ implants are intended to be used in pairs.
The Innovasis Box™ Peek VBR System consists of polyetheretherketone(peek) implants meant to be used only in pairs and with supplemental fixation. The devices are offered in a variety of different shapes (i.e. curved, rectangular) and sizes, in order to better accommodate a patient's anatomy. The implants also feature holes located throughout their geometry in order to accommodate bone graft and maximize bone ingrowth.
Tantalum markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The ends of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.
The provided text describes a medical device, the Innovasis Box™ Peek VBR System, and its clearance through the FDA 510(k) process. This process focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with acceptance criteria as might be found for a novel drug or a high-risk medical device requiring a PMA.
Therefore, the Acceptance Criteria and associated study details as requested (such as sample size, expert qualifications, adjudication method, MRMC studies, effect size, standalone performance, training set details) are not applicable or not explicitly detailed in this type of submission. The "study" here refers to non-clinical bench testing to demonstrate performance in accordance with its intended use and a comparison to predicate devices, rather than a clinical trial with specific performance metrics against a pre-defined acceptance threshold.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Performance: Capable of performing its intended use as a vertebral body replacement. | "Performance testing indicates that the Box™ Peek VBR System is capable of performing in accordance with its intended use." (This is a general statement, specific quantitative metrics are not provided in this 510(k) summary). |
| Biocompatibility/Material Safety: Materials meet medical grade standards. | "The implants are machined from Medical Grade peek (Polyetheretherketone) OPTIMA (Invibio™) per ASTM F2026. Marker beads machined from Tantalum per ASTM F560." (Meeting ASTM standards implies adherence to material safety and quality). |
| Mechanical Strength/Integrity: Capable of withstanding forces in the thoracolumbar spine and preventing expulsion. | "The ends of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion." "Performance testing indicates that the Box™ Peek VBR System is capable of performing in accordance with its intended use." (Again, general statement. Specific biomechanical tests, e.g., compression, torsion, fatigue, are typically performed but quantitative results are not in this summary). |
| Visualization: Radiopaque markers for post-operative imaging. | "Tantalum markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery." |
| Substantial Equivalence: Device is as safe and effective as legally marketed predicate devices with the same indications for use and technological characteristics. | The device was found substantially equivalent to five predicate devices: K043316 (RabeaTM - Signus), K032064 (CPOD/LPODTM VBR System – Theken), K050553 (NovelTM VBR Spinal System - Alphatec), K031757 (Peek TetrisTM - Signus), K050449 (Quantum Vertebral Body Replacement – Quantum Orthopedics). This is the primary "acceptance criterion" for a 510(k) clearance. |
2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. The performance testing refers to "non-clinical (bench)" testing, not clinical studies on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant for this engineering-based substantial equivalence submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical bench testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM standards), and predefined engineering test protocols to demonstrate mechanical integrity and functional performance. It is not comparable to clinical ground truth.
8. The sample size for the training set: Not applicable. This refers to a medical device's engineering and materials, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
§ 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.