(27 days)
The New Era Orthopaedics Polyscrew Pedicle Screw System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for noncervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
The New Era Orthopaedics™ (NEO) Polyscrew Pedicle Screw System is designed to provide mechanical support while biologic fusion takes place. It has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.
The New Era Orthopaedics™ (NEO) Polyscrew Pedicle Screw System is designed to provide mechanical support while biologic fusion takes place. Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.
This document (K150647) is a 510(k) premarket notification for the "Polyscrew Pedicle Screw System" by New Era Orthopaedics. Based on the provided text, the device itself has not undergone new performance testing for this submission. Instead, this submission focuses on a modification to the surgical technique for an already cleared device (K141253). Therefore, much of the requested information regarding acceptance criteria and performance studies for the device itself is not present.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "Per the risk analysis, the safety and efficacy of the device was established in the previously cleared New Era Orthopaedics™ Polyscrew Pedicle Screw System (K141253) and additional performance testing is not necessary." This means that for this specific 510(k) submission, there are no new acceptance criteria or reported device performance data because the device itself is unchanged. The substantial equivalence is based on the previously cleared device and the modified surgical technique being cleared with another predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no new performance testing for the device was conducted as part of this submission. The safety and efficacy were established in the predicate device (K141253), but the details of that study are not included in this document.
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, as no new performance testing for the device was conducted as part of this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new performance testing for the device was conducted as part of this submission.
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 device is a pedicle screw system, a physical implant, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a pedicle screw system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new performance testing for the device was conducted as part of this submission. The substantial equivalence for the device itself was based on prior studies (K141253).
8. The sample size for the training set
Not applicable, as no new performance testing for the device was conducted as part of this submission.
9. How the ground truth for the training set was established
Not applicable, as no new performance testing for the device was conducted as part of this submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this document):
This 510(k) submission (K150647) is for an updated surgical technique for an already cleared device, the Polyscrew Pedicle Screw System. The core device itself (components, materials, technical characteristics) remains unchanged from the predicate device, K141253.
The study that "proves the device meets acceptance criteria" for this specific submission is essentially a demonstration of substantial equivalence to previously cleared devices, particularly regarding the added surgical technique.
- Device Performance: The document explicitly states: "Per the risk analysis, the safety and efficacy of the device was established in the previously cleared New Era Orthopaedics™ Polyscrew Pedicle Screw System (K141253) and additional performance testing is not necessary." This means the acceptance criteria and performance data for the physical device components would have been established and met in the K141253 submission.
- Surgical Technique Modification: The focus of K150647 is to "update the Surgical Technique to include in-situ assembly." The document further states that this modified surgical technique "has been previously cleared in the CREO™ Stabilization System (K124058) and raises no new types of safety or effectiveness questions."
- Conclusion: The regulatory decision is based on the "overall technological characteristics" leading to the conclusion that the Polyscrew Pedicle Screw System is substantially equivalent to the predicate devices (K141253 for the device itself, and K124058 for the specific surgical technique modification).
Therefore, this document does not contain new data on acceptance criteria or performance studies of the Polyscrew Pedicle Screw System as a standalone device. It leverages the existing clearances of its predicate devices to demonstrate substantial equivalence for a minor modification (surgical technique).
§ 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.