(125 days)
The VEOS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (from T1 to S1).
The VEOS Spinal Fixation System is intended for noncervical pedicle fixation for the following indications : degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor: pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VEOS Spinal Fixation System is intended for noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, The VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. Pediatric pedicle screw fixation is limited to a posterior approach.
This system is intended to be used with autograft and/or allograft.
The Spineway VEOS Spinal Fixation System is composed of implant devices made from a titanium alloy Ti6Al4V-ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. All implants are provided sterile or non-sterile. The implants are to be implanted from the posterior approach. The screws are available as monoaxial reduction screws in multiple diameters and length. Titanium rods are available in two diameters and multiple lengths. CoCr rods are available in one diameter and two length. CoCr rods are only available non-sterile. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided. Screws for MS applications are available as polyaxial cannulated screws in multiple diameters and lengths. Rods for MS applications are available as pre-bent rods and straight rods. Associated instrumentation to complete the procedure is provided.
The provided text is an FDA 510(k) clearance letter for a medical device called the "VEOS Spinal Fixation System." This document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting a performance study of an AI/ML powered medical device against specific acceptance criteria.
Therefore, the requested information about acceptance criteria and a study proving a device meets acceptance criteria (especially in the context of AI/ML performance) is not present in the provided text. The document clearly states:
- "Clinical testing was not performed." (Page 5)
The tests summarized are non-clinical, mechanical tests (ASTM F1717 and ASTM F1798) to evaluate the structural competence of the spinal fixation system, which are physical properties of the implant, not performance metrics of an AI/ML algorithm.
Therefore, I cannot provide the requested table and details because the provided document does not contain information about:
- A table of acceptance criteria and reported device performance (in the context of AI/ML).
- Sample sizes for a test set or data provenance for AI/ML.
- Number of experts, their qualifications, or adjudication methods for ground truth establishment.
- MRMC studies or standalone AI performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Sample size for a training set or how its ground truth was established.
This document describes the clearance of a physical medical implant, not an AI/ML-driven diagnostic or treatment device.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.