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The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal 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 Spinal 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, 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® Spinal 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 stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 6mm diameter rods from the DIAPASON™ Spinal System and OPUS™ Spinal System are intended to be used with the other components of the Xia® Titanium Spinal System. The Titanium Multi-Axial Cross Connectors are intended to be used with the other components of the Xia Titanium Spinal System.

The Xia® Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). The components are manufactured from Titanium material (Ti alloy and CP Titanium). This submission is intended to address a line extension to Xia® Spinal System. The line extension includes a new range of offset and rod to rod Titanium alloy connectors.

This 510(k) Premarket Notification (K052181) describes a line extension to the Xia® Spinal System. The document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics, statistical analysis, or comparison to a pre-defined threshold.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through:

• Technological Comparison: Stating that the subject components (new range of offset and rod-to-rod Titanium alloy connectors) share the "same intended use, material, and basic design concepts" as the predicate Xia Spinal System (K013823).
• Mechanical Testing: Mentioning that mechanical testing "demonstrated comparable mechanical properties to the predicate device." However, no specific data, acceptance criteria for this testing, or detailed study methodology are provided in this summary.

Therefore, I cannot provide the requested information in the table or answer the specific questions related to acceptance criteria, sample sizes, ground truth, expert opinions, or comparative effectiveness studies based on the provided text. This type of 510(k) summary typically includes a high-level overview and directs the reviewer to the full submission for detailed testing results.

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The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal 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 Spinal 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 Spinal 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 stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The 6 mm diameter rods from the DIAPASONTM Spinal System and OPUS™ Spinal System are intended to be used with the other components of Xia " Titanium Spinal System. The Titanium Multi-Axis Cross-Connectors are intended to be used with the other components of Xia® Titanium Spinal System.

The Xia Titanium Spinal System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors, Multi-Axial Cross Connectors (MACs), and Staple. The components are manufactured from Titanium material (Ti alloy and CP Titanium). The purpose of this submission is to include cannulated polyaxial screws to the Xia Titanium Spinal System.

The provided document is a 510(k) premarket notification for a medical device (Xia® Spinal System with cannulated polyaxial screws), not a study report for an AI/ML powered device. Due to this, the document does not contain the information required to answer the prompt. The request asks for details like "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device, which involves specific sections such as performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and comparative effectiveness studies. None of this information is present in the provided special 510(k) summary, as it pertains to a traditional orthopedic implant modification. Hence, I cannot extract the requested information from the given text.

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The Rods from the Osteonics® Spinal System and Opus Spinal System are intended to be used with the components of the Xia Spinal System.

The Xia Spinal System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spinal 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 Spinal 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 Spinal 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 stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The submission involves no change to the components themselves. This submission covers use of predicate OSS and Opus 6 mm diameter Rods with the predicate Xia Spinal System.

This 510(k) submission (K013688) focuses on allowing the use of previously cleared Osteonics® Spinal System (OSS) and Opus Spinal System rods with the Xia Spinal System. It does not describe a study involving an "AI device" or "algorithm" in the conventional sense of machine learning or diagnostic imaging. Instead, the "device" in question is a medical implant (spinal fixation system components). Therefore, acceptance criteria and study details related to AI performance metrics (like sensitivity, specificity, F1 score, effect size of human readers with/without AI) are not applicable here.

However, I can extract the relevant information regarding the mechanical performance study conducted to demonstrate the safety and effectiveness of using these combined components, which serves as the "study that proves the device meets the acceptance criteria" in this context.

Here's the information structured to best fit your request, adapting the columns where necessary:

Acceptance Criteria and Reported Device Performance

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance: Not explicitly stated as a numerical sample size. The description refers to "Construct fatigue testing," implying multiple test specimens were subjected to fatigue loads. Data provenance is not applicable in the human subject or imaging sense; this is a laboratory-based mechanical test.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized testing protocols (e.g., ASTM standards for fatigue testing of medical implants) and measured physical properties by engineers. No human expert "ground truth" establishment in the diagnostic sense is mentioned.

3. Adjudication method for the test set: Not applicable. This is mechanical testing, not a clinical review of images or data requiring adjudication among experts.

4. 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 a submission for a physical medical device (spinal implant components), not an AI diagnostic or assistance tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm involved. "Standalone" performance here refers to the mechanical integrity of the device itself.

6. The type of ground truth used: For mechanical properties, the "ground truth" is typically defined by established engineering standards and material specifications that define acceptable performance limits (e.g., fatigue life, stiffness, strength) for spinal implants. The comparison is against predicate constructs (existing, legally marketed spinal systems). The phrase "comparable mechanical properties" indicates the tested construct's performance met or exceeded the performance of the predicate devices.

7. The sample size for the training set: Not applicable. This is a mechanical test for a physical device, not an AI or machine learning model that requires a training set.

8. How the ground truth for the training set was established: Not applicable, as no training set exists for this type of submission.

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