(99 days)
When used as a vertebral body replacement device in the cervical spine (C2-T1), COLOSSEUM™M Mesh devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
When used as a vertebral body replacement device in the thoracolumbar spine (T1-L5), COLOSSEUM™ Mesh devices are intended for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The interior of the vertebral body replacement device spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
COLOSSEUM™ Mesh are devices that can be used as vertebral body replacement devices. The components of the implant include a preformed mesh cage and optional endcaps, which are available in a range of sizes and options to accommodate various surgical approaches and the anatomical needs of a wide variety of patients. The mesh and the endcaps are intraoperatively assembled to best fit individual requirements. Protrusions (teeth) on the superior and inferior surfaces of the endcaps grip the endplate of the adjacent vertebrae to resist expulsion.
COLOSSEUM™ Mesh implants are used to provide structural stability and as an adjunct to fusion in skeletally mature individuals following corpectomy or vertebrectomy in the cervical and thoracolumbar spine. Thoracolumbar mesh implants may be inserted using a posterior, transforaminal, anterior, anterolateral, or lateral approach. Cervical mesh implants are inserted using an anterior approach.
COLOSSEUM™ Mesh implants are manufactured from titanium alloy as specified in ASTM F136. All implants are single use only.
This document describes a spinal implant device, COLOSSEUM™ Mesh, and its clearance process through the FDA's 510(k) pathway. This pathway demonstrates substantial equivalence to legally marketed predicate devices, rather than requiring a device to meet specific acceptance criteria through a clinical study or a detailed performance study with a defined test set, ground truth independent validation.
Therefore, many of the requested details, such as the sample size for a test set, the number of experts used to establish ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this type of device submission. The FDA 510(k) process for this device focuses on demonstrating that it is as safe and effective as a legally marketed predicate device, primarily through mechanical testing and material characterization, rather than through a clinical performance study with a test set and ground truth in the way one would evaluate an AI/ML or diagnostic device.
Here's a breakdown of the requested information based on the provided document:
1. A table of Acceptance Criteria and the Reported Device Performance:
Since this is a 510(k) submission for a spinal implant, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for a diagnostic device. Instead, the acceptance criteria are adherence to recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to the successful completion of these tests.
| Acceptance Criteria (based on 510(k) requirements and listed standards) | Reported Device Performance |
|---|---|
| Mechanical Testing: | Successfully completed: |
| - Static Compression (ASTM F2077) | Devices demonstrated performance comparable to predicate devices. |
| - Dynamic Compression (ASTM F2077) | Devices demonstrated performance comparable to predicate devices. |
| - Static Torsion (ASTM F2267) | Devices demonstrated performance comparable to predicate devices. |
| - Dynamic Torsion (ASTM F2267) | Devices demonstrated performance comparable to predicate devices. |
| - Expulsion (Guidance for Spinal System 510(k)s) | Devices demonstrated performance comparable to predicate devices. |
| - Subsidence (Guidance for Spinal System 510(k)s) | Devices demonstrated performance comparable to predicate devices. |
| MRI Compatibility Testing: | Successfully completed: |
| - Magnetically Induced Displacement Force (ASTM F2052) | Tested and found acceptable. |
| - MR Image Artifacts (ASTM F2119) | Tested and found acceptable. |
| - Radio Frequency Induced Heating (ASTM F2182) | Tested and found acceptable. |
| - Magnetically Induced Torque (ASTM F2213) | Tested and found acceptable. |
| Biocompatibility Testing: | Successfully completed: |
| - Bacterial Endotoxin (ANSI/AAMI ST-72) | Complied with standards. |
| - Patient-contacting materials adherence to standards or prior 510(k) clearance | Materials met applicable standards or were used in previously 510(k) cleared devices, demonstrating biocompatibility. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective), (If applicable to a clinical study):
- Not Applicable. This submission details mechanical and material testing, not a clinical study on human subjects with a test set of clinical data (like images or patient records). The "samples" here are physical devices subjected to laboratory tests.
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), (If applicable to a clinical study):
- Not Applicable. Ground truth, in the context of this device, refers to established engineering standards (ASTM, ANSI/AAMI) for mechanical properties and material safety. Expert consensus in a clinical diagnostic sense is not involved in establishing the "ground truth" for these engineering tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set, (If applicable to a clinical study):
- Not Applicable. No human adjudication of clinical "ground truth" was performed as part of this submission. The "adjudication" is performed by satisfying the requirements of the specified engineering standards.
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 (If applicable):
- Not Applicable. COLOSSEUM™ Mesh is a physical implant, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (If applicable):
- Not Applicable. COLOSSEUM™ Mesh is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.), (If applicable to a clinical study):
- Engineered/Standardized Ground Truth. The "ground truth" for this device's performance is defined by established engineering and material standards (e.g., ASTM F2077 specifies how compression strength is measured, and success is defined by meeting certain load requirements or demonstrating equivalence to predicate devices). It's not clinical data, but rather mechanical and material properties verified in a lab setting.
8. The sample size for the training set (If applicable to an AI/ML device):
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set."
9. How the ground truth for the training set was established (If applicable to an AI/ML device):
- Not Applicable. This is a physical medical device, not an AI/ML algorithm.
§ 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.