(108 days)
The SpineSelect Polyscrew Pedicle Screw System is intended for immobilization and stabilization of the spine. The SpineSelect Polyscrew Pedicle Screw System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The SpineSelect Polyscrew Pedicle Screw System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 5.5-7.5 mm and in lengths from 30-55 mm. Rods are available in 5.5mm diameter either straight or precurved. The straight rods range in lengths from 30-400 mm, whereas the pre-curved rods range in length from 30-150mm. The system includes a screw assembly which includes a polyscrew (solid or cannulated), a saddle and tulip head, Rods are locked in place with a set screw. Associated instrumentation to complete the procedure are provided.
The provided text is a 510(k) summary for the SpineSelect Polyscrew Pedicle Screw System, a medical device. It details the device's indications for use, description, and comparison to predicate devices, but does not describe a study involving an AI/algorithmic device or human readers interpreting data. Instead, it focuses on the mechanical performance of a physical implantable device.
Therefore, I cannot provide information on:
- Acceptance criteria and reported device performance related to an algorithm's output. The acceptance criteria discussed are for the mechanical performance of the pedicle screw system, not an algorithm's performance.
- Sample size used for the test set and data provenance. No such test set is described for an AI device.
- Number of experts used to establish ground truth and their qualifications. Not applicable to a mechanical device submission.
- Adjudication method for the test set. Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable.
- Standalone (algorithm only) performance. Not applicable as this is a physical device.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an algorithm. Not applicable.
- Sample size for the training set and how ground truth was established for the training set. Not applicable.
Based on the provided text, the relevant information regarding acceptance criteria and the study that proves the device meets those criteria is as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Pre-clinical static compression bending | "SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance) |
| Pre-clinical dynamic compression bending | "SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance) |
| Pre-clinical static torsion bending | "SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance) |
2. Study that Proves the Device Meets Acceptance Criteria:
- Study Type: Pre-clinical mechanical testing.
- Methods: The testing performed includes "static and dynamic compression bending and static torsion bending per ASTM F1717-10." ASTM F1717-10 is a standard specification for spinal implant constructs in a corrosive environment intended for internal fixation.
- Conclusion: SpineSelect concluded that the SpineSelect Polyscrew Pedicle Screw System is "substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness." This implies that the device's mechanical test results were comparable to or better than those of the predicate devices.
Missing Information (as per the prompt's request for AI-related details):
As this submission is for a physical pedicle screw system and not an AI or algorithmic device, the specific details requested regarding test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not available and not applicable to this document.
§ 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.