(113 days)
The Exactech® Proliant™ Polyaxial Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Exactech Proliant Polyaxial Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
This submission proposes a new pedicle screw spinal fixation system. The proposed Proliant Polyaxial Pedicle Screw System is a top-loading spinal fixation system that comprises various sizes of polyaxial screws, rigid rods and cross connectors to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136). The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.
The Proliant Polyaxial Pedicle Screw System includes a complete instrumentation system to assist the surgeon in the implantation of each component according to a traditional open surgical procedure.
The provided text describes a 510(k) submission for the Exactech® Proliant™ Polyaxial Pedicle Screw System. This is a medical device for spinal fixation, and the summary focuses on demonstrating "substantial equivalence" to predicate devices rather than proving a new clinical benefit or performance against specific, quantifiable acceptance criteria in the way a diagnostic AI device might.
Therefore, many of the requested categories (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of document. The study described is a biomechanical engineering study, not a clinical study involving human patients or ground truth derived from expert review or pathology.
Here's a breakdown based on the available information:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a spinal fixation system, the "acceptance criteria" are not reported as specific performance metrics with thresholds (e.g., sensitivity, specificity thresholds for AI). Instead, acceptance is demonstrated by showing "substantial equivalence" to legally marketed predicate devices through biomechanical testing, indicating the device can withstand "clinically relevant biomechanical loads."
| Acceptance Criteria Category | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Intended Use/Indications for Use: | The Proliant Polyaxial Pedicle Screw System has the same indications for use and intended uses as the Hydralok System and similar indications for use and intended uses as VSS/Extended VSS Systems. |
| Materials: | Composed of titanium alloy (Ti-6Al-4V ELI per ASTM F136), which is a biocompatible material conforming to a recognized industry standard for permanent implants. This is the same as the predicate devices (Hydralok System and VSS/Extended VSS Systems). |
| Design Features: | The Proliant Polyaxial Pedicle Screw System has similar design features to the predicate devices. |
| Dimensions: | The Proliant Polyaxial Pedicle Screw System is dimensionally comparable to the predicate devices. |
| Packaging and Sterilization: | Provided non-sterile for single use only, and must be steam sterilized by the hospital prior to use, using the same method as the predicate systems. |
| Device Shelf Life: | Neither the Proliant Polyaxial Pedicle Screw System nor identified predicates have shelf-life expiration dating, indicating comparable shelf-life characteristics. |
| Performance Specifications / Biomechanical Loads (Physical): | The Proliant Polyaxial Pedicle Screw System withstands clinically relevant biomechanical loads. This was demonstrated through mechanical testing and engineering analysis, specifically: |
- Static Compression Bending, Static Torsion, and Dynamic Compression Fatigue testing per ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model).
- Biomechanical assessment comparing Proliant Polyaxial Pedicle Screw System mechanical performance to cited predicate systems. The results "demonstrate the proposed devices are substantially equivalent to cited predicates." |
Study Details
- 1. Sample sizes used for the test set and the data provenance: Not applicable. The "test set" in this context refers to mechanical test specimens (e.g., spinal implant constructs). The document does not specify the number of samples tested for each biomechanical test (Static Compression Bending, Static Torsion, Dynamic Compression Fatigue). The testing is laboratory-based mechanical testing, not a clinical study on human data.
- 2. Data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is biomechanical laboratory testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance is established by the physical testing results against engineering standards and comparison to predicate devices, not by expert human review.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the physical performance as measured by standardized mechanical testing (ASTM F1717) and engineering analysis compared to the established performance of predicate devices.
- 8. The sample size for the training set: Not applicable. This is not a machine learning/AI device.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.