(259 days)
The antero-lateral plate Sphynx™ is designed for use during surgery on the thoraco-lumbar area of the spine (T1-L5). The device is to be used only on one side and placed in such a manner as to be as far away from blood vessels and nerve roots as possible.
This implant is intended to provide stabilization until a solid spinal fusion develops, in the treatment of the following indications:
- Tumor of the vertebral body
- Fracture of the anterior spine (trauma)
- Degenerative disc disease, compatible with a ventral approach (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.)
- Pseudoarthrosis
- Spondylolysis
- Spondylolisthesis
- Scoliosis
- Lordotic deformities of the spine
- Spinal stenosis
- Failed previous spine surgery
The Sphynx is an implant device made from a titanium alloy Ti-6AI-4V ELI. It is to be implanted from the anterior-lateral approach. The Sphynx™ implant is an antero-lateral plate aimed at performing internal fixation of the thoraco-lumbar area of the spine (T1-L5), in addition to a solid intervertebral arthrodesis. The Sphynx™ instrumentation is composed of plates with anatomical conformation for cyphosis and lordosis. These plates are available in lengths 45-135mm increasing increments of 10mm. The fixation screws also consist of a variety of lengths and diameters. The safety screw is a 5mm diameter screw available in lengths starting at 24mm increasing in increments of 5mm to an overall length of 55mm. The two other fixation screws are available in diameters of 6mm and 7mm starting at 25mm and increasing in increments of 5mm to an overall length of 60mm.
This document describes the premarket notification (510(k)) for the Sphynx™ antero-lateral plate device, intended for spinal fixation. It establishes its substantial equivalence to previously marketed predicate devices primarily through mechanical testing.
Here's an analysis of the provided text in relation to the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Static Compression Bending per ASTM F1717-14 | Met |
| Static Torsion Bending per ASTM F1717-14 | Met |
| Dynamic Compression Bending per ASTM F1717-14 | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample size (number of devices/tests) used for the mechanical testing.
Data provenance: The testing was performed according to ASTM F1717-14, which is a standard specifying in-vitro mechanical testing methods for spinal implant devices. There is no information provided regarding the country of origin of the data, and it is in-vitro mechanical testing, not clinical data, so 'retrospective or prospective' does not apply.
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)
This section is Not Applicable as the study involved mechanical testing of a medical device, not a diagnostic algorithm that requires expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is Not Applicable as the study involved mechanical testing, not human-read diagnostic interpretation.
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 section is Not Applicable. The submission is for a physical spinal implant device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is Not Applicable. The submission is for a physical spinal implant device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the standards set by ASTM F1717-14 for static compression bending, static torsion bending, and dynamic compression bending. The device's performance was measured against these engineering standards.
8. The sample size for the training set
This section is Not Applicable. This is an evaluation of a physical medical device based on mechanical testing, not a machine learning model.
9. How the ground truth for the training set was established
This section is Not Applicable. As above, this is not a machine learning model requiring a training set with established ground truth.
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as mechanical testing.
- Study Name/Type: Mechanical testing
- Standards Met: ASTM F1717-14 (Static Compression bending, Static Torsion bending, and Dynamic Compression bending).
- Conclusion: The tests demonstrated that the Sphynx™ device's mechanical performance and fatigue endurance meet the original performance requirements of the specified ASTM standard, leading to the conclusion of "substantial equivalence" to predicate devices.
- Clinical Testing: The document explicitly states: "No clinical testing was performed."
§ 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.