(128 days)
The ODALYS™ Pedicle Screw System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system ODALYS™ Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.
The ODALYS™ Pedicle Screw System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.
The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. Two sizes of connectors are available, short and long. The long is used in cases of spondylolisthesis where the short connector would not be able to engage the rod. The rods are available in multiple lengths.
Materials: The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
Function: The ODALYS™ Pedicle Screw System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.
The provided text describes the ODALYS™ Pedicle Screw System, a medical device, and its acceptance criteria as determined by the FDA's 510(k) clearance process.
Here's an analysis of the acceptance criteria and the "study" (non-clinical tests) used to prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (ODALYS™ Pedicle Screw System) |
|---|---|
| Mechanical Performance (Static Compression Resistance) | Met or exceeded the performance of predicate devices: Moss Miami (K000536) and PWB Lumbosacral Spine System (K920116) as evidenced by ASTM F1717 testing. |
| Mechanical Performance (Dynamic Compression Resistance) | Met or exceeded the performance of predicate devices: Moss Miami (K000536) and PWB Lumbosacral Spine System (K920116) as evidenced by ASTM F1717 testing. |
| Mechanical Performance (Static Torsion Resistance) | Met or exceeded the performance of predicate devices: Moss Miami (K000536) and PWB Lumbosacral Spine System (K920116) as evidenced by ASTM F1717 testing. |
| Material Composition | The device is manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136, which is equivalent to materials used in predicate devices. |
| Intended Use (Immobilization and stabilization of spinal segments for fusion) | The ODALYS™ Pedicle Screw System is intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for specific conditions (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion), and for severe spondylolisthesis (Grades 3 and 4) of L5-S1. This matches the intended use of predicate devices. |
| Design and Function (Top-loading pedicle screws, rod connectors, rods to provide spinal stabilization) | The ODALYS™ Pedicle Screw System has a similar design (variety of color-coded top-loading pedicle screws, rod connectors, and rods) and function (immobilization and stabilization of spinal segments until fusion takes place) compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of human data. The testing performed was non-clinical, involving mechanical tests of the device. The sample size for these mechanical tests (e.g., number of screws or constructs tested for each configuration) is not provided in the summary.
- Data Provenance: The data provenance is from non-clinical laboratory testing (mechanical testing per ASTM standards). There is no information regarding country of origin or whether it's retrospective or prospective, as it pertains to physical device testing, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The "ground truth" for this device, in the context of the 510(k) submission, is its mechanical performance and material properties. This is established by adherence to recognized ASTM standards for medical devices, rather than expert consensus on a dataset. The results are compared to predicate devices.
4. Adjudication Method for the Test Set
This section is not applicable. There was no human "test set" requiring adjudication. The assessment was based on objective mechanical testing results comparing the device to accepted standards and predicate device performance.
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
No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted devices that involve human interpretation of medical images or data. The ODALYS™ Pedicle Screw System is a physical implant, not an AI-based diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a physical implant; there is no AI algorithm associated with it.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Compliance with recognized industry standards (ASTM F1717 and ASTM F136).
- Substantial equivalence to legally marketed predicate devices in terms of intended use, design, materials, and function, as demonstrated by meeting or exceeding the mechanical performance and material specifications of those predicates.
8. The Sample Size for the Training Set
This section is not applicable. The ODALYS™ Pedicle Screw System is a physical pedicle screw system, not an AI or machine learning device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as point 8. There is no training set for this 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.