(27 days)
The Libra Pedicle Screw System is intended for immobilization of the posterior thoracic, lumbar and sacral/iliac spine (T1-S1/Ilium) in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
The Libra Pedicle Screw System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
This document is a 510(k) premarket notification for the "Libra Pedicle Screw System," specifically for adding a cobalt chrome rod series. It does not contain information about a study proving the device meets acceptance criteria in the way a clinical trial or algorithm performance study would. The acceptance criteria and "study" are related to demonstrating substantial equivalence to a predicate device through non-clinical performance data (e.g., theoretical analysis).
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document only discusses "performance data" in the context of demonstrating substantial equivalence, not specific quantitative acceptance criteria with reported numerical performance values like sensitivity/specificity for a diagnostic device. The acceptance criterion is essentially "does not create a new worst case" or "maintains existing performance."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: The cobalt chrome rod, when integrated into the Libra Pedicle Screw System, should not create a new worst-case scenario compared to the previously cleared titanium alloy rods. This implies that the mechanical properties and system integrity should be maintained or improved, and not compromised. | Theoretical analysis of the proposed device modification was performed. The results demonstrate the cobalt chrome rod does not create a new worst case. |
| Material Biocompatibility: The new material (cobalt chrome) should be medically acceptable and suitable for implantation. | Rods are additionally manufactured from cobalt chrome (ASTM F1537). (This implies compliance with a recognized standard, which serves as an acceptance criterion for material safety/biocompatibility). |
| Technological Characteristics: The overall system should retain the same intended use, basic design, dimensions, and fundamental scientific technology as the predicate device. | The Libra Pedicle Screw System possesses the same technological characteristics as the predicate device, including intended use, basic design (rod and screw configuration), material (medical grade), and sizes. The fundamental scientific technology is the same as the previously cleared device. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of a clinical study. The "test set" here refers to the theoretical analysis performed on the design of the cobalt chrome rod and its integration into the system. It's a theoretical analysis, not a study involving human subjects or a large dataset. No data provenance in the sense of patient data is mentioned, as this is a materials/mechanical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would refer to established engineering principles, material science standards (e.g., ASTM F1537), and possibly expert engineering analysis to determine if the new component "does not create a new worst case." The document does not specify the number or qualifications of experts involved in this theoretical analysis, but it would typically be conducted by qualified engineers and material scientists within Spinal Balance, Inc. or their consultants.
4. Adjudication method for the test set
Not applicable. There's no mention of an adjudication method as would be used for image review or clinical assessments. The "adjudication" is inherent in the internal engineering review and FDA's assessment of the 510(k) submission.
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 system for spinal fusion, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related metrics are irrelevant.
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.
7. The type of ground truth used
The "ground truth" used for this type of submission would be established engineering principles, material science standards (e.g., ASTM F136 for titanium, ASTM F1537 for cobalt chrome), and biomechanical testing standards (though direct testing results are not detailed here, theoretical analysis relies on such principles). The "ground truth" for showing substantial equivalence is that the new material change does not negatively impact the safety and effectiveness profile of the already cleared device, as assessed through engineering analysis.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.