(266 days)
SFC™ has been designed to be used in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). SFC.10 is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in thoracic and/or lumbar spine such as posterior pedicle screw and rod system, anterior plate systems, and anterior screw and rod systems. The SFCTM may be used with autograft or allograft.
The SFCTM acts as an expandable spacer to maintain proper vertebral body spacing and angulation following vertebrectomy. The SFCTM VBR is manufactured from Ti6Al4V.
The provided text describes a medical device submission (K110153) for the Spinal Fusion Carrier (SFC™) VBR. It details the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ASTM F2077: Standard Test Methods for Intervertebral Body Fusion Devices | All applicable requirements met |
| ASTM F2267: Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | All applicable requirements met |
| Specific mechanical tests mentioned: | |
| - Static axial compression | All applicable requirements met |
| - Static axial torsion | All applicable requirements met |
| - Static compression shear | All applicable requirements met |
| - Dynamic axial compression | All applicable requirements met |
| - Dynamic axial torsion | All applicable requirements met |
| - Subsidence | All applicable requirements met |
| - Expulsion | All applicable requirements met |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical in-vitro mechanical testing. This means there was no human "test set" or patient data involved. The tests were performed on the device itself.
- Sample size for the test set: Not applicable for patient data. The number of devices tested for each mechanical test is not specified in the summary, but it would typically involve multiple units to ensure statistical robustness according to the ASTM standards.
- Data provenance: Not applicable as it's non-clinical in-vitro testing. It would be conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. For non-clinical mechanical testing, "ground truth" is established by the specified parameters and methodologies of the ASTM standards, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. As non-clinical testing, there's no diagnostic output or interpretation requiring expert adjudication. The "results" are quantitative measurements of mechanical properties compared against standard-defined acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic imaging or AI-assisted diagnostic devices where human readers interpret cases. The SFC™ VBR is a spinal implant, and its evaluation focuses on mechanical performance and biocompatibility, not diagnostic accuracy.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone study was performed, but it was a standalone non-clinical mechanical study of the device itself, not a standalone algorithm performance study. The tests described (ASTM F2077, ASTM F2267, and various mechanical stress tests) represent the performance of the device without human interaction during the test procedure, demonstrating its physical capabilities.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by:
- Performance standards: The quantitative pass/fail criteria and methodologies outlined in the ASTM F2077 and ASTM F2267 standards.
- Material properties and design specifications: The inherent characteristics of the device (e.g., manufactured from Ti6Al4V) and its engineering design.
- Predicate device performance: The performance characteristics of the previously cleared predicate devices (Innovotec SEC VBR, K091743; Aesculap Hydrolift VBR, K083186; Synthes Synex II, K061891) against which the SFC™ VBR was shown to be substantially equivalent.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of 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.