(107 days)
The use of the Palladian™ Lumbar Pedicle Screw System is indicated as an adjunct to fusion of the L5-S1 vertebra for the treatment of; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.
The Palladian™ Lumbar Pedicle Screw System is a non-cervical spinal fixation system, and intended for use with autograft and/or allograft. Pedicle screw fixation is limited to skeletally mature patients.
The Palladian™ Lumbar Pedicle Screw System is a multiple component, top-loading, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.
This document is a 510(k) Premarket Notification summary for the Palladian™ Lumbar Pedicle Screw System. It describes the device, its indications for use, its technological characteristics compared to predicate devices, and the performance data that supports its substantial equivalence.
Here's an analysis of the provided information, focusing on the acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds. Instead, it describes performance testing that aims to demonstrate substantial equivalence to legally marketed predicate devices. The reported performance is implicitly that the device's strength is "sufficient for its intended use" and "substantially equivalent" to predicate devices.
| Performance Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Static axial compression bending per ASTM F1717-13 | Strength sufficient for intended use and substantially equivalent to predicate devices | Results show strength is sufficient and substantially equivalent |
| Static torsion per ASTM F1717-13 | Strength sufficient for intended use and substantially equivalent to predicate devices | Results show strength is sufficient and substantially equivalent |
| Dynamic axial compression bending fatigue per ASTM F1717-13 | Strength sufficient for intended use and substantially equivalent to predicate devices | Results show strength is sufficient and substantially equivalent |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical mechanical testing of the device components. For such tests, the "sample size" refers to the number of device samples tested, not a population of patients. The document does not specify the exact number of samples (e.g., screws, rods) tested for each mode. It solely states "The Palladian™ Lumbar Pedicle Screw System has been tested in the following test modes."
- Sample Size: Not specified (refers to device components for mechanical testing, not patients).
- Data Provenance: Not explicitly stated, but as mechanical testing of a medical device, it is typically conducted in a controlled laboratory environment. The country of origin for the data is not mentioned, nor is it explicitly retrospective or prospective, as these terms usually apply to clinical studies involving human 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)
This section is not applicable to this document. The provided text describes mechanical performance testing of a spinal implant, not a diagnostic or AI-driven device that requires expert-established ground truth from patient data. The "ground truth" here is the physical performance of the device under specific loads according to industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical studies or evaluations of diagnostic accuracy where human experts assess cases and resolve discrepancies. This document describes non-clinical 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
This section is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices, especially those involving human interpretation of data, often with AI assistance. This document is about the mechanical performance of a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This question pertains to the performance of an algorithm or AI system. The device in question is a physical spinal implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical testing is the physical properties and performance of the device components as measured against established engineering standards (ASTM F1717-13). There is no "expert consensus" or "pathology" in the sense of clinical diagnoses needed here. The standard itself defines the acceptable criteria for performance.
8. The sample size for the training set
This section is not applicable. The device is a physical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as 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.