(142 days)
The Wiltrom Spinal Fixation System is intended to provide immobilization 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; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided non-sterile, and the implants are for single use only.
This document is a 510(k) premarket notification for a medical device called the Wiltrom Spinal Fixation System. It focuses on establishing substantial equivalence to a predicate device, the Fortex Pedicle Screw System (K090224). The information provided is primarily related to mechanical testing for safety and effectiveness, rather than a clinical study evaluating diagnostic or prognostic performance based on specific acceptance criteria for AI or algorithmic output. Therefore, many of the requested sections about AI/algorithm performance and ground truth establishment cannot be directly answered from this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document discusses mechanical testing criteria for the physical device, not for an AI or algorithm.
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance |
|---|---|
| Static Torsion Testing (ASTM F1717-15) | Conducted |
| Static Axial Compression Bending Testing (ASTM F1717-15) | Conducted |
| Dynamic Axial Compression Bending Testing (ASTM F1717-15) | Conducted |
| Overall Goal: Evaluate safety and effectiveness, demonstrate performance in stabilizing the operative site, and mechanical safety. | Overall Outcome: "The performance of Wiltrom spinal implants in stabilizing the operative site and the mechanical safety was demonstrated." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is for mechanical testing of the physical device, not an AI test set. The sample size would refer to the number of implants/constructs tested. The document states "mechanical testing including static torsion testing, static and dynamic axial compression bending testing were conducted," but does not specify the number of samples for each test or the provenance of the data in the context of clinical or image data.
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)
Not applicable. Ground truth, in this context, would relate to the physical integrity and performance of the device under stress, measured through engineering standards, not expert evaluation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical or imaging studies where expert consensus is needed. The testing here is mechanical.
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
Not applicable. This is not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" would be established by the engineering standards themselves (e.g., ASTM F1717-15) and the objective measurements of force, deformation, and failure points taken during the tests.
8. The sample size for the training set
Not applicable. This document does not pertain to the development of an AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not pertain to the development of an AI algorithm with a training set.
§ 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.