(30 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT® Spinal System provides additional support during spinal fusion. The PILOT® Spinal System consists of screws and rods in a variety of shapes and sizes. The PILOT® Spinal System is manufactured from medical grade titanium alloy and will be sold non-sterile. Modifications to the PILOT® Spinal System that are the subject of this submission are confined to the modification of the tightening mechanism of the body component.
The document describes design modifications made to the PILOT® Spinal System and demonstrates its substantial equivalence to previously cleared devices. The acceptance criteria and the study proving the device meets these criteria are related to biomechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (from Biomechanical Testing) |
|---|---|
| Meets ASTM F1717 | Conducted to demonstrate substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Biomechanical testing in accordance with ASTM F1717 was conducted." This implies that the 'test set' in this context refers to the samples of the PILOT® Spinal System components and constructs that were subjected to the specified biomechanical tests.
- Sample Size: Not explicitly stated in terms of a number of devices or constructs. ASTM F1717 generally specifies test setup and conditions, but the exact number of samples for each test type (e.g., static compression, static torsion, fatigue compression/torsion) is determined by the manufacturer to achieve statistically significant results.
- Data Provenance: The data is generated from laboratory biomechanical testing of the device itself. It is not patient data (retrospective or prospective). Therefore, there is no country of origin of data in the typical clinical study sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable in the context of this 510(k) submission. For mechanical devices like spinal systems, "ground truth" is established through standardized engineering and materials testing (e.g., ASTM F1717 for mechanical performance). The "experts" involved would be engineers and laboratory technicians experienced in biomechanical testing, rather than medical professionals establishing clinical ground truth.
4. Adjudication Method for the Test Set:
Not applicable. Biomechanical testing relies on objective measurements and established standards (ASTM F1717). There is no "adjudication" in the sense of multiple human evaluators reviewing results.
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 device is a pedicle screw spinal system, a physical medical implant. It is not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical implant, not an algorithm or software.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is established by the results of biomechanical testing conducted in accordance with ASTM F1717. This standard defines the methods for mechanical testing of spinal implant constructs, and the results (e.g., stiffness, strength, fatigue life) are compared against the requirements and performance of legally marketed predicate devices to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical implant, not a software or AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.