(16 days)
FORTIFY™ and FORTIFY™-R Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
FORTIFY™ and FORTIFY™-R 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 heights and footprints to accommodate the anatomical needs of a wide variety of patients. The components can be preoperatively or intraoperatively assembled to best fit individual requirements. Each spacer has an axial hole to allow autogenous bone graft or allograft to be packed inside of 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™ Corpectorny Spacers are manufactured from titanium alloy per ASTM F67, F136, and F1295. FORTIFY™-R Corpectorny Spacers are manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F67, F136, F1295, and F560.
The provided document is a 510(k) Summary for the FORTIFY™ and FORTIFY™-R Corpectomy Spacers, which are vertebral body replacement devices. The purpose of this submission is to request clearance for these devices. The document describes the device, its intended use, and the basis of substantial equivalence to predicate devices. It relies on mechanical testing to demonstrate substantial equivalence, rather than a clinical study involving human or animal subjects.
Here's an analysis based on your request, focusing on what is stated and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as numerical targets in this summary) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Compliance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F2077 for demonstrating substantial equivalence. | Was conducted for: |
- Static compression
- Dynamic compression
- Static torsion
- Dynamic torsion
- Expulsion |
| Material Properties | Specification for materials (e.g., Titanium alloy per ASTM F67, F136, F1295; PEEK OPTIMA LT1 per ASTM F2026, F67, F136, F1295, F560) | FORTIFY™: Manufactured from titanium alloy per ASTM F67, F136, and F1295.
FORTIFY™-R: Manufactured from radiolucent PEEK OPTIMA LT1, with titanium alloy and tantalum components, per ASTM F2026, F67, F136, F1295, and F560. |
| Design Characteristics | Accommodation of anatomical needs, axial hole for bone graft, protrusions/spikes to resist expulsion. | Devices include a central core and endplates in a range of heights and footprints. Each spacer has an axial hole. Protrusions (teeth) on superior and inferior surfaces grip endplates. Additional spikes available on some implants. |
| Intended Use | Use in thoracolumbar spine (T1-L5) for vertebral body replacement due to tumor or trauma, with supplemental fixation, and ability to pack with bone graft. | Meets the stated Indications for Use. |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as Mechanical testing. This testing was performed in accordance with standards cited: "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004 and ASTM F2077. The purpose of this testing was to "demonstrate substantial equivalence to the predicate system(s)."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. For mechanical testing of medical devices, the "sample size" typically refers to the number of devices or components subjected to each test condition. This information is usually detailed in the full test report, not typically in the summary.
- Data Provenance: This is mechanical test data, not clinical data from patients. Therefore, concepts like "country of origin of the data," "retrospective or prospective" do not apply in the same way they would for a clinical study. The data would originate from the testing laboratory where the mechanical tests were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation relies on objective mechanical testing against engineering standards and material specifications, not on expert-adjudicated clinical data or "ground truth" derived from human experts in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on objective mechanical testing against engineering standards. Adjudication methods like 2+1 or 3+1 are used for human expert reviews, typically in clinical studies to establish a consensus ground truth, which is not the case here.
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 information is not applicable. The device is a physical spinal implant, not an AI diagnostic tool or system designed to assist human readers (e.g., radiologists) in interpreting medical images. Therefore, an MRMC study and AI assistance metrics are irrelevant.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. As previously mentioned, this is a physical medical device (spinal implant), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by validated engineering standards and guidance documents. For instance, ASTM F2077 defines test methods for spinal implants, and the "Guidance for Spinal System 510(k)s" provides the framework for demonstrating substantial equivalence through mechanical performance. The device's performance measured during mechanical testing is compared against the requirements and benchmarks implied by these standards for predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. This is mechanical testing for a physical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (not a machine learning model).
§ 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.