(108 days)
The Preference Elite Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:
The Preference Elite System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (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 failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Preference Elite Pedicle Screw System is indicated for skeletally matures patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (15-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.
The Preference Elite Pedicle Screw System is a spinal fixation system consisting of a variety of components including screws, various types and sizes of rods, cross-connectors and accessories, as well as implant components from the Preference Pedicle Screw System. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient.
Implant components from the Preference Pedicle Screw System including the curved and straight rods, set-screws, and cross-connectors are compatible with the Preference Elite Pedicle Screw System.
The Preference Elite Pedicle Screw System implants and components are made from titanium alloy (Ti-6A1-4V) per ASTM F136 and Cobalt-28 Chromium-6 Molybdenum Alloy (Co-28Cr-6Mo) per ASTM F1537.
The provided document is a 510(k) Pre-market Notification from the FDA regarding the "Preference Elite Pedicle Screw System." This document is not a study that proves a device meets acceptance criteria in the context of an AI/ML medical device, but rather a regulatory submission for a traditional medical device (a pedicle screw system).
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, and AI-specific performance metrics (MRMC, standalone algorithm performance) is not applicable to this document. This document primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of design, materials, and intended use.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported performance in the context of an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it states that "Testing and analyses were completed in accordance with the applicable standards" and "The testing results demonstrate that the new system, Preference Elite Pedicle Screw System, is substantially equivalent to the predicates."
The applicable standards mentioned are:
- ASTM F1717 Static Axial Compression Bending
- ASTM F1717 Static Torsion
- ASTM F1717 Dynamic Axial Compression Bending
- ASTM F1798 Static Pull-off
The "acceptance criteria" here would be meeting the established performance requirements set by these ASTM standards for spinal implant systems, which are intended to ensure mechanical integrity and safety. The reported "performance" is that the device did meet these standards and was found substantially equivalent.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet performance requirements of ASTM F1717 | Testing results demonstrated substantial equivalence |
| Meet performance requirements of ASTM F1798 | Testing results demonstrated substantial equivalence |
| Substantial equivalence to predicate devices (K081883, K073430) | Demonstrated for intended use/indications for use, function, materials, sizes, and sterilization |
2. Sample sized used for the test set and the data provenance
- Sample size for the test set: Not stated in terms of patient data. The testing mentioned (ASTM standards) refers to mechanical testing of the device components, not human subject data. The "sample size" would relate to the number of devices or components tested, which is not specified in this summary.
- Data provenance: Not applicable in the context of clinical data. The "data" pertains to mechanical test results of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving human interpretation or ground truth establishment by experts for clinical data.
4. Adjudication method for the test set
Not applicable. There is no expert adjudication for mechanical testing of a medical device like a pedicle screw system.
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/ML device, and no MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
Not applicable in the context of clinical data. For mechanical testing, the "ground truth" is typically defined by the objective physical measurements and established parameters of the ASTM standards themselves.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or ground truth in that context.
Summary relevant to the document provided:
The document describes a regulatory submission for a pedicle screw system, not an AI/ML device. The "acceptance criteria" and "study" refer to mechanical testing performed according to ASTM standards to demonstrate the device's mechanical integrity and its substantial equivalence to previously cleared predicate devices. The study concludes that the Preference Elite Pedicle Screw System is substantially equivalent based on these tests and comparison of its characteristics.
§ 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.