(240 days)
The New Era Orthopaedics Polyscrew Pedicle Screw System is intended to provide immobilization 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, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
The New Era Orthopaedics Polyscrew Pedicle Screw System is also intended for non-cervical 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, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.
The New Era Orthopaedics Polyscrew Pedicle Screw System is a 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.
Materials:
Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537
The provided document describes the New Era Orthopaedics Polyscrew Pedicle Screw System, a Class II medical device. As a Class II device approved through the 510(k) pathway, its approval hinges on demonstrating "substantial equivalence" to a predicate device, not necessarily on meeting specific numerical acceptance criteria in the same way a novel device might.
Therefore, the "acceptance criteria" for this device are implicitly tied to the performance of its predicate devices, as demonstrated through non-clinical testing. The study provided focuses on proving this substantial equivalence through mechanical testing.
Here's the breakdown of the information requested based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: For 510(k) submissions, explicit numerical "acceptance criteria" and "reported device performance" in the typical sense of a novel device study are often not stated. Instead, the performance is reported as meeting or being equivalent to the predicate device, which implies satisfying the predicate's established safety and effectiveness.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: The device system (New Era Orthopaedics Polyscrew Pedicle Screw System) must demonstrate equivalent or superior mechanical performance in terms of static and dynamic compression, static torsion, and dissociation compared to its predicate devices, as evaluated using recognized ASTM F1717 standards. This implies that the device should withstand similar forces and exhibit comparable stability and durability to established pedicle screw systems without premature failure or degradation. | Non-Clinical Test Summary: The New Era Orthopaedics Polyscrew Pedicle Screw System underwent the following tests: |
- Static and dynamic compression per ASTM F1717
- Static torsion per ASTM F1717
- Dissociation testing
The results of this testing indicate that the New Era Orthopaedics Polyscrew Pedicle Screw System is equivalent to predicate devices. |
| Material Compatibility: The materials used (Ti-6Al-4V per ASTM F136; CoCr per ASTM F1537) must be biocompatible and suitable for implantation in the human body, consistent with materials used in predicate devices. | Materials: Ti-6Al-4V per ASTM F136 and CoCr per ASTM F1537 were used, which are standard, biocompatible materials for such implants and are consistent with those found in predicate devices. |
| Functional Equivalence: The device's design, intended use, and general operational principles must be substantially equivalent to the predicate devices. | Substantial Equivalence Claim: The New Era Orthopaedics Polyscrew Pedicle Screw System is claimed to be substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety, and performances. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical mechanical tests (static/dynamic compression, static torsion, dissociation). For mechanical testing of medical devices, sample sizes are typically determined by statistical requirements to achieve confidence in the measurements, but are not usually reported as a single "test set sample size" in the same way as a clinical study. Instead, multiple units of each component or assembly configuration would be tested to derive statistical data (e.g., mean, standard deviation, and comparisons to predicate device performance limits).
- Data Provenance: The data provenance is from non-clinical laboratory testing. The document does not specify the country of origin for the testing, but it is typically conducted in controlled laboratory environments in accordance with international (ASTM) standards. This is not retrospective or prospective in a clinical sense, as it refers to laboratory experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: This question is not applicable to this type of submission. Ground truth, in the context of device performance, is established through standardized engineering tests (e.g., ASTM F1717) and comparison to established predicate device performance and regulatory standards, not through expert consensus on qualitative data.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: This question is not applicable. Mechanical tests are quantitative and objective; their outcomes are measured directly based on physical properties and responses to applied forces, not through an adjudication process like one might find in a clinical trial or image interpretation study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. The New Era Orthopaedics Polyscrew Pedicle Screw System is a physical implant, not a diagnostic tool requiring human interpretation of results in this manner.
- Effect Size of Human Readers: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: This question is not applicable. This device is a physical pedicle screw system, not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of an algorithm. Its performance is its mechanical integrity and function as a physical implant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is established by objective mechanical performance standards (e.g., ASTM F1717) and comparison to the established performance of legally marketed predicate devices. The implicit ground truth is that the device must be safe and effective, similar to existing devices, as demonstrated by meeting standardized mechanical testing requirements and being made of recognized biocompatible materials.
8. The Sample Size for the Training Set
- Sample Size for Training Set: This question is not applicable. This device is not an AI/algorithm that requires a "training set." The engineering and design process for such a physical device involves iteration and testing, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: This question is not applicable as there is no "training set" for a physical implant device in the context of this submission.
§ 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.