(226 days)
The XENON Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.
The system is comprised of XENON standard polyaxial screws, hightop polyaxial screws, set screws, rods. The XENON polyaxial screw features a dual lead thread, 3 prong drive instrument interface and is self tapping. The polyaxial screws are offered in various diameters ranging from 4.5mm to 8.0mm and lengths ranging from 25mm and 80mm. The polyaxial screws range of motion is 50 degrees Medial/Lateral and 50 degrees Inferior/superior. The 5.5mm diameter rods are offered in lengths 35mm to 600mm. The rods are also offered in two profiles, straight and precontoured. The adjustable bridges are offered in 4 different sizes. The implants are manufactured from surgical grade titanium alloy (Ti6AI-4V).
Here's a breakdown of the acceptance criteria and the study that proves the XENON™ Pedicle Screw System meets them, based on the provided document:
This document is a 510(k) summary for a medical device (XENON™ Pedicle Screw System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results against predefined acceptance criteria for a novel device. Therefore, much of the requested information regarding sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies of AI/diagnostic devices, is not present in this type of submission.
The "acceptance criteria" here are implicitly the performance standards set by recognized consensus standards for spinal implant mechanical testing, and the "proof" is that the device met these standards and was substantially equivalent to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (XENON™ Pedicle Screw System) |
|---|---|
| ASTM F1717 for Spinal Implants | Demonstrated substantial equivalence to the predicate Zodiac Polyaxial Spinal Fixation System device. Performance testing covered: |
| - Dynamic Compression Bending | |
| - Static Torsion | |
| - Static Compression Bending | |
| Substantial Equivalence | Similar in terms of general design, intended use, and technological characteristics to the predicate devices (Zodiac® 4.0 Polyaxial Spinal Fixation System, Zodiac® Polyaxial Spinal Fixation System, Apelo™ Pedicle Screw System). |
Note: The document states that the testing "demonstrated that XENON Pedicle Screw System is substantially equivalent to the predicate Zodiac Polyaxial Spinal Fixation System device." This implies that the XENON system met or exceeded the performance of the predicate device when tested against ASTM F1717. Specific numerical thresholds for these tests are not provided in this summary but would be part of the full test reports.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/not specified in this 510(k) summary. The "test set" here refers to the device specimens used for mechanical testing, not patient data. The number of physical units tested to satisfy ASTM F1717 standards is not disclosed in this summary.
- Data Provenance: Not applicable. This study involves mechanical testing of physical device components, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth as typically defined for AI or diagnostic devices (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for mechanical testing is established by the specifications and outcomes of the standardized tests (ASTM F1717) and the performance of the predicate device.
- Qualifications of Experts: Not applicable. Material scientists, engineers, and technicians would be involved in conducting and interpreting the mechanical tests according to industry standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Mechanical testing results are typically objective measurements, not subject to human adjudication in the same way clinical diagnoses or image interpretations are. Calibration and adherence to test protocols ensure consistency.
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 device is a pedicle screw system, not an AI or diagnostic tool that requires human interpretation of medical cases. The study was mechanical testing of physical hardware.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Yes, in a broad sense. The "standalone" performance here refers to the mechanical performance of the device itself, without human intervention once the tests begin. However, this terminology typically applies to AI algorithms. For this device, it implies that the mechanical tests measured the intrinsic properties and performance of the pedicle screws and system components independent of surgical implantation technique (which would involve human-in-the-loop aspects).
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission is established by recognized consensus standards (ASTM F1717) for mechanical testing of spinal implants and the demonstrated performance of the predicate device when subjected to these same standards. The "truth" is that the XENON system's mechanical capabilities are equivalent to a device already deemed safe and effective.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This submission describes mechanical testing, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of 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.