(22 days)
The 8.5mm diameter Xia Polyaxial Screws are intended to be used with the other components of the Xia Spine System.
The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the XIA Spine System is also 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
The 8.5mm diameter Xia Polyaxial Screws are available in lengths ranging from 30 mm to 90 mm (in 5 mm increments). The top portion of the screw is threaded to accept a closure screw. The subject 8.5mm diameter Polyaxial Screw is identical to the 7.5 mm diameter Xia Polyaxial Screws except for the following differences: larger diameter bone thread and tapered screw tip. The subject screws are manufactured from titanium alloy.
This 510(k) Premarket Notification is for a line extension to an existing medical device, the Xia Spine System. Specifically, it introduces an 8.5mm diameter polyaxial screw, which is a larger version of an already approved 7.5mm diameter polyaxial screw within the same system.
Because this is a line extension and the manufacturer claims substantial equivalence to an existing predicate device (the 7.5mm diameter Xia Polyaxial Screw), the provided document does not contain independent clinical study data to demonstrate efficacy or safety for the new 8.5mm screw. Instead, the acceptance criteria and proof of meeting those criteria are based on engineering analysis and comparison to the predicate device.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: The 8.5mm diameter Xia Polyaxial Screw must demonstrate similar design concepts and comparable properties to the predicate 7.5mm diameter Xia Polyaxial Screws. | "The 8.5 mm diameter Xia Polyaxial Screws share the same design concepts as that of the currently available 7.5 mm diameter Xia Polyaxial Screws. An engineering analysis demonstrated the comparable properties of the subject 8.5mm diameter Xia Polyaxial Screw to the predicate Xia Polyaxial Screws." |
| Intended Use: The 8.5mm screws must be compatible with the existing Xia Spine System and its intended uses. | "The 8.5mm diameter Xia Polyaxial Screws are intended to be used with the other components of the Xia Spine System." The expanded indications for use for the overall Xia Spine System are listed and apply to the system which now includes the 8.5mm screw. |
| Indications for Use: The expanded Xia Spine System (including the 8.5mm screw) must be suitable for specific spinal conditions and procedures as outlined in the indications. | The document explicitly outlines various indications for use for the Xia Spine System as a pedicle screw fixation system and as an anterior/posterior fixation system. These indications are accepted for the system which now incorporates the 8.5mm screws. |
| Material: The device must be manufactured from an appropriate, biocompatible material. | "The subject screws are manufactured from titanium alloy." (This implies it's the same or a similar material to the predicate, which is generally accepted for spinal implants). |
| Dimensional Specifications: The device must meet specified dimensions. | "The 8.5mm diameter Xia Polyaxial Screws are available in lengths ranging from 30 mm to 90 mm (in 5 mm increments)." (The increase in diameter from 7.5mm to 8.5mm is the primary difference and is explicitly stated.) |
Study Information (Based on a Substantial Equivalence Submission)
Given that this is a 510(k) submission for a line extension demonstrating substantial equivalence, a traditional "study" in the sense of a clinical trial proving efficacy or safety of the new device was not performed or required as per the documentation.
- Sample size used for the test set and the data provenance: Not applicable. No distinct "test set" from a patient population was used for the 8.5mm screw's performance evaluation as described. The evaluation was based on engineering analysis comparing the new screw to the predicate. Data provenance would be from internal engineering testing and design specifications.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an engineering analysis comparing a new component to a predicate, "ground truth" establishment by a panel of clinical experts for a test set is not typically involved in the same way as for a novel device. The "truth" is established by adherence to design specifications, material properties, and mechanical testing standards by engineering and regulatory personnel.
- Adjudication method for the test set: Not applicable. No clinical test set or adjudication process is described for this line extension.
- 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 spinal implant, not an AI-assisted diagnostic or imaging device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal implant, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for demonstrating substantial equivalence relied on engineering principles, material specifications, and comparative design analysis. The predicate device's existing regulatory approval and established safety/efficacy record served as the primary clinical "ground truth" reference.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.