(335 days)
The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static and dynamic axial compression bending testing per ASTM F1717 | Performed; results demonstrate substantial equivalence to predicate devices. |
| Static torsion testing per ASTM F1717 | Performed; results demonstrate substantial equivalence to predicate devices. |
| Use of titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 | Device manufactured from this material, consistent with predicates. |
| Same intended use as predicate devices | Confirmed. |
| Similar primary implant design as predicate devices | Confirmed. |
| Equivalent material of manufacture as predicate devices | Confirmed. |
| Overall substantial equivalence to predicate devices | Concluded based on non-clinical testing and shared characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical mechanical testing of the device components. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable to this type of study as described. The testing involves physical samples of the pedicle screw system components.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Given this is a non-clinical mechanical performance study rather than a clinical study evaluating diagnostic or treatment outcomes, there were no experts used to establish ground truth in the way one would for clinical data interpretation. The "ground truth" for this study is defined by the established standards of ASTM F1717 for mechanical testing. Compliance with these standards is objectively measured.
4. Adjudication Method
Since no experts were establishing ground truth for a clinical test set, an adjudication method is not applicable. The testing involves objective physical measurements against established engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical substantial equivalence of a medical implant, not the effectiveness of a diagnostic or treatment method involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone "algorithm only" performance study was not done. This is a physical medical device, not a software algorithm. The "standalone performance" here refers to the mechanical integrity of the device components in isolation (i.e., without being implanted in a patient, but using standardized test fixtures). The study conducted was precisely that – standalone mechanical testing of the device components.
7. The Type of Ground Truth Used
The "ground truth" used for this study is based on established engineering standards (ASTM F1717) for mechanical performance and material specifications (ASTM F136). The performance of the Athena Pedicle Screw System was compared directly against these standards and to the mechanical performance of predicate devices that previously met these standards.
8. The Sample Size for the Training Set
Since this is a non-clinical mechanical study rather than a machine learning or clinical study, the concept of a "training set" is not applicable. The device's design is developed through engineering principles, not through training on a dataset.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" does not apply to this type of study, the question of how ground truth was established for a training set is not applicable. The design and manufacturing processes are validated against engineering specifications and industry standards.
§ 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.