(97 days)
The Palisade Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
The Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. The system 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 the thoracic, lumbar, and sacral spine.
This document is a 510(k) premarket notification for a medical device called the "Palisade Pedicular Fixation System." It is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of submission. This document describes a mechanical device used in spinal surgery, not an AI/diagnostic device.
However, I can extract the relevant information from the document regarding the performance testing that was conducted to demonstrate the substantial equivalence of the device.
Here's an interpretation of the provided document in the context of your request, focusing on what is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for clinical performance, as it is a mechanical device. Instead, it relies on demonstrating mechanical equivalence to predicate devices through various ASTM standard tests. The "reported device performance" is essentially that the device passed these tests in accordance with applicable standards.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Summary) |
|---|---|
| Endurance, Strength, Durability | Device "passed" tests according to applicable ASTM standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated for each mechanical test. However, typically mechanical testing involves a specific number of samples (e.g., 6 or more) per test configuration as defined by the ASTM standards. This is for product samples, not patient data.
- Data provenance: Not applicable. The data is generated from laboratory mechanical testing of the device components, not from human or animal subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is mechanical testing, not a diagnostic or clinical study requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is mechanical testing.
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 mechanical spinal fixation system, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of clinical ground truth. The "ground truth" for these tests are the established performance requirements and methodologies outlined in the ASTM standards for spinal implant mechanical testing.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study Discussed in the Document (Performance and Biological Testing):
The document reports on performance tests conducted in accordance with applicable standards and test methods to determine the endurance, strength, and durability of the Palisade Pedicular Fixation System.
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Tests Performed:
- ASTM F1798
- ASTM F1717
- Static Compression Bending
- Flexural Grip
- Axial Grip
- Static Torsion
- Torsional Grip
- Dynamic Compression Bending
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Conclusion regarding these tests: Spineology states that the device "passed" these tests and demonstrated substantial equivalence to the predicate devices. The exact quantitative results (e.g., specific load values, cycles to failure) are not provided in this summary document but would have been submitted to the FDA separately.
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Biological Safety Testing: "Not required as there was no change in materials from the predicate device." This implies that the materials used in the Palisade system are identical to those of legally marketed predicate devices, for which biological safety has already been established.
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Packaging and Sterilization Testing: "Not required as there was no change to the sterile barrier system, sterilization method, sterilization parameters, or sterility assurance level (SAL) from the predicate device." This indicates that these aspects of the device delivery are the same as those previously cleared predicate devices.
In essence, this document demonstrates substantial equivalence of a new mechanical spinal fixation device to existing, legally marketed devices by showing it has the same intended use, indications for use, fundamental scientific technology, biological safety, packaging, and sterilization method, supported by mechanical testing that confirms similar performance characteristics as defined by international 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.