(128 days)
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the R&D Innovation Pedicle Screw System is 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis, (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).
The R&D Innovation Pedicle Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which 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 thoracic, lumbar, and sacral spine.
The R&D Innovation Pedicle Screw System is a spinal implant for immobilization and stabilization of spinal segments. The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical performance testing.
1. Acceptance Criteria and Reported Device Performance:
| No. | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. | Sterilization: Compliance with ANSI/AAMI ST79:2006 and ANSI/AAMI ST79/A1:2009 for steam sterilization. | The device has been shown to these standards. |
| 2. | Biocompatibility: Compliance with ASTM F136:2008 for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy. | The device complies with this standard. |
| 3. | Mechanical Integrity: Static compression bending, static torsion, and dynamic compression bending testing per ASTM F1717–11. | Performance requirements were met through these tests. |
| 4. | Substantial Equivalence: Similar indications for use, intended use, principles of operation, materials, chemical, mechanical, and metallurgical properties to predicate devices. | The R&D Innovation Pedicle Screw System demonstrated functional equivalence to predicate devices based on material specifications and mechanical testing. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The primary evidence presented for substantial equivalence consists of mechanical and material testing, not a clinical test set with human subjects.
- Data Provenance: Not applicable. The data provenance is from laboratory testing of the device and its materials against specified ASTM and ANSI/AAMI standards. It is not from human clinical data or real-world usage.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a clinical test set is not relevant here as the study is based on non-clinical engineering and material standards. The "ground truth" is adherence to established engineering and material specifications.
4. Adjudication method for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
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 a medical device (pedicle screw system), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is adherence to established engineering and material standards (e.g., specific ASTM and ANSI/AAMI standards for material composition, sterility, and mechanical performance). It is not based on expert clinical consensus, pathology, or patient outcomes data.
8. The sample size for the training set:
- Not applicable. There was no machine learning algorithm involved, and therefore no training set.
9. How the ground truth for the training set was established:
- Not applicable. There was no training set. The ground truth for the device's performance relies on its compliance with established industry standards and mechanical testing results.
§ 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.