Search Results
Found 7 results
510(k) Data Aggregation
(22 days)
MODIFICATION TO XIA SPINE SYSTEM
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.
Ask a specific question about this device
(30 days)
XIA SPINE SYSTEM
Ask a specific question about this device
(51 days)
XIA SPINE SYSTEM
Ask a specific question about this device
(80 days)
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
Ask a specific question about this device
(27 days)
XIA SPINE SYSTEM HOOKS
Ask a specific question about this device
(21 days)
XIA SPINE SYSTEM
Ask a specific question about this device
(89 days)
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 which is fused; (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. Pedicle screw fixation is limited to L3 to S1 or the ilium.
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 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 of the thoracic, lumbar, which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts. When used in the posterior non-pedicle indication the Xia system is indicated for use in the thoracic to sacral spine. When used in the anterior indication the Xia system is indicated for use in the thoracic and lumbar spine.
The XIA Spine System is a spinal fixation device for the noncervical spine. It consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. The components are manufactured from titanium.
The provided text describes a 510(k) summary for the XIA Spine System. It focuses on the device's indications for use and its substantial equivalence to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because it is a regulatory submission for premarket notification (510(k)) and not a study report.
Here's what can be extracted based on the information given:
Acceptance Criteria and Device Performance (Based on the 510(k) Summary)
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Functional Requirements for Spinal Fixation Devices (as assessed by bench testing) | "Bench testing demonstrates that the device will meet its mechanical functional requirements." |
| Substantial Equivalence in Intended Use to legally marketed predicate devices | The device's intended use is described as spinal fixation for various conditions in the noncervical spine, including pedicle screw fixation (for severe spondylolisthesis, acute/chronic instabilities, deformities, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion) and anterior/posterior screw/hook fixation (for degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, spinal deformities, tumor, pseudoarthrosis, revision of failed fusion). This is explicitly stated to be equivalent to predicate devices. |
| Substantial Equivalence in Materials to legally marketed predicate devices | The XIA Spine System components are manufactured from titanium, which is stated to be substantially equivalent to predicate devices. |
| Substantial Equivalence in Designs to legally marketed predicate devices | The system consists of rods, monoaxial and polyaxial bone screws, different types of hooks, closure screws, axial and parallel rod to rod clamps, lateral connectors and cross link components. These design characteristics are stated to be substantially equivalent to predicate devices. |
| Substantial Equivalence in Operational Principles to legally marketed predicate devices | The operational principle (spinal fixation) is stated to be substantially equivalent to predicate devices. |
| Compliance with general controls provisions of the Act (e.g., annual registration, listing, GMP, labeling, prohibitions against misbranding/adulteration) | The FDA's letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." It also notes that a "substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
Missing Information from the Provided Text:
- Sample size used for the test set and the data provenance: Not applicable. The submission refers to "bench testing," not a clinical test set with patient data. No details about the number of devices or iterations tested are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing doesn't typically involve human experts establishing ground truth in this manner.
- Adjudication method for the test set: Not applicable.
- 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/imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/imaging device.
- The type of ground truth used: For the "bench testing," the ground truth would be the pre-defined mechanical functional requirements or engineering specifications that the device needed to meet.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to pre-existing devices through comparisons of intended use, materials, designs, operational principles, and bench testing to meet mechanical requirements. It does not describe a clinical study with patients that would typically involve many of the detailed inquiries above, especially those related to AI or clinical effectiveness.
Ask a specific question about this device
Page 1 of 1