(111 days)
The LEUCADIA™ Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: severe spondylolisthesis (grade 3 and 4) at L5-S1; degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The LEUCADIA™ Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LEUCADIA™ Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of length, ranging from 30 mm to 100 mm and in 5 mm, 7 mm. 8mm and 9 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. Pre-bent rods are available in 10 mm increments, ranging from 30 to 120 mm in length. The LEUCADIA™ Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
The document provided is a 510(k) summary for the LEUCADIA™ Pedicle Screw System. It details the device's indications for use and states that biomechanical performance tests were conducted to demonstrate substantial equivalence to a predicate device.
However, the provided text does not include an acceptance criteria table, reported device performance metrics against specific criteria, or details regarding studies that would involve human readers, ground truth establishment, or sample sizes related to clinical or image-based performance. The study described is a series of biomechanical tests.
Therefore, many of the requested items cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined in terms of specific pass/fail values in the document) | "The test results were equivalent to the predicate device and/or other similar implants and are sufficient for in vivo loading." |
2. Sample size used for the test set and the data provenance
- Sample Size for test set: Not applicable for biomechanical tests in the context of clinical or image-based studies. The "test set" here refers to the biomechanical testing of the device components.
- Data Provenance: The tests are biomechanical in nature, conducted on the device components themselves, not on patient data.
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 be related to biomechanical standards and measurements, not expert clinical assessment.
4. Adjudication method for the test set
- Not applicable. Biomechanical tests follow standardized protocols (e.g., ASTM F1717, F1798, F543). The "adjudication" is based on meeting the requirements of these standards or demonstrating equivalence to a predicate device.
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) study was not done. This device is a pedicle screw system, a physical implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This device is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the biomechanical tests would be the quantitative measurements dictated by the ASTM standards (e.g., force, displacement, torque values) and comparison to established predicate device performance or industry benchmarks for in vivo loading sufficiency.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
Study details (from the document):
The study to "prove the device meets the acceptance criteria" involved the following biomechanical tests:
- Static Compression Bending Tests per ASTM F1717
- Static Tension Bending Tests per ASTM F1717
- Static Torsion Tests per ASTM F1717
- Dynamic Axial Compression Bending Tests per ASTM F1717
- Static Axial Gripping Capacity Tests per ASTM F1798
- Static Axial Torque Tests per ASTM F1798
- Static A-P Screw Pull Tests per ASTM F1798
- Static Screw Pullout Tests per ASTM F543
The conclusion of these tests was that the results were equivalent to the predicate device (LAGUNA® Pedicle Screw System, K083826 and K050060) and/or other similar implants and were deemed "sufficient for in vivo loading."
§ 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.