(55 days)
The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
- Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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
- Spondylolisthesis
- Trauma (i.e. fracture or dislocation)
- Spinal stenosis
- Deformities or curvatures (i.e. scoliosis, kyphosis)
- Spinal tumor
- Pseudoarthrosis, and/or
- Failed previous fusion
The X-spinesw Cortical Bone Screw System consists of pedicle screws, rods, cross connectors, and associated instruments. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system implant components are manufactured from Ti6Al4V ELI, a titanium based alloy which complies with ASTM F136. Alternatively, rods are also offered manufactured from cobalt chromium alloy which complies with ASTM F1537. The single use only implants are provided non-sterile, and should not be reused under any circumstances.
The system does not contain software/firmware or electrical equipment.
This document is a 510(k) premarket notification for a medical device called the "X-spine Cortical Bone Screw System." It seeks to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than establishing new acceptance criteria or proving effectiveness through a traditional clinical study.
Therefore, many of the requested points regarding acceptance criteria and performance studies are not directly applicable or available in this type of submission. This 510(k) summary focuses on equivalence to existing devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not present specific acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) for a diagnostic or therapeutic AI device. Instead, it describes mechanical testing to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" here are implied to be meeting or exceeding the mechanical performance of the predicate device.
| Criteria/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| ASTM F1717 – Static and dynamic axial compression bending testing | Meets or exceeds performance of predicate device | "The X-spine Cortical Bone Screw System was subjected to the following testing ... The results of these studies show that the subject device meets or exceeds the performance of the predicate device" |
| ASTM F1717 - Static torsion testing | Meets or exceeds performance of predicate device | "The X-spine Cortical Bone Screw System was subjected to the following testing ... The results of these studies show that the subject device meets or exceeds the performance of the predicate device" |
| Overall Equivalence | No new risks introduced, substantially equivalent to predicate devices based on design, intended use, material composition, technological and functional characteristics, and mechanical performance. | "does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing described is mechanical, not clinical, and typically involves a specific number of devices or components. Details on the number of samples tested are not included. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical testing.
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. This is a submission for a spinal implant, not an AI device or a diagnostic tool requiring expert ground truth for a test set. The "ground truth" for mechanical testing is established by standard laboratory procedures and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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 device or a diagnostic tool that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing of devices like this, the "ground truth" is typically defined by standardized physical measurements and engineering specifications, often established by ASTM standards (e.g., ASTM F1717). There is no "expert consensus" or "pathology" in the context of mechanical performance.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it.
§ 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.