(448 days)
FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated versions.
When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) 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 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 in the thoracolumbar spine (T1-L5), FORTIFY® and FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, 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 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, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include a central core and endplates, which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endplates can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autograft or allograft to be packed inside the spacer. Protrusions (teeth) on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. Additional spikes are available on some implants. FORTIFY® Integrated (FORTIFY® I) endplates have an integrated plate to accommodate screws for additional fixation and are assembled to the core.
This document is a 510(k) summary for Globus Medical Inc.'s FORTIFY® Corpectomy Spacers, requesting additional indications for use in the cervical spine. It does not describe a study that proves the device meets specific acceptance criteria in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC, human reader improvement).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through design, intended use, material composition, function, and range of sizes. The "performance data" section refers to mechanical testing and bacterial endotoxin testing, which are standard for implantable medical devices but not related to software/AI performance metrics. The "clinical literature" section indicates a review was performed to support safety, rather than a prospective clinical study with specific endpoints for the device itself.
Therefore, most of the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this 510(k) submission.
Here's a breakdown of what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | N/A (Guidance documents and ASTM standards followed) | Static and dynamic compression, torsion, subsidence, and expulsion testing conducted successfully. |
| Bacterial Endotoxin | N/A (ANSI/AAMI ST-72:2011 followed) | Bacterial endotoxin testing (BET) conducted successfully. |
| Clinical Safety/Effectiveness | N/A (Equivalence to predicate devices) | Clinical literature review determined the safety profile to be equivalent to predicate devices. |
| Substantial Equivalence | Equivalent design, intended use, materials, function, and dimensions to predicate devices. | Device possesses these characteristics relative to the predicate devices. |
Note: The document does not specify quantitative acceptance criteria (e.g., minimum compression strength, endotoxin limits) but rather states that tests were conducted in accordance with relevant standards and guidance, implying successful completion.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document describes mechanical and bacterial endotoxin testing, not a clinical test set with human subjects or a dataset for an AI model.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. Mechanical testing data would be generated in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., clinical diagnosis) is not relevant here.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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:
- No. This is a submission for an implantable medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Testing & Bacterial Endotoxin Testing: The "ground truth" would be established by the specifications in the relevant ASTM standards (F2077, F2267) and ANSI/AAMI ST-72:2011, which define acceptable performance parameters.
- Clinical Literature Review: The basis for demonstrating safety and efficacy is established through existing published clinical literature on similar devices and procedures.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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.