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The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Stainless Steel 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 Stainless Steel 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 Stainless Steel 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, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Staples, Connectors and Multi-Axial Cross Connectors (MACs). This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors.

This document is a 510(k) summary for a line extension to the Xia Stainless Steel System, a spinal fixation appliance. It explicitly states that the submission is for "a line extension to the Xia Stainless Steel System. The line extension includes a new range of offset and rod to rod connectors."

This means the device in question is a mechanical component, and the regulatory approval process for such devices typically relies on mechanical testing to demonstrate performance and substantial equivalence to a predicate device, rather than clinical studies involving human or even observational data.

Therefore, the requested information regarding acceptance criteria and studies would primarily focus on the results of mechanical testing. The document does support this by stating: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."

However, the provided text does not contain specific details about the acceptance criteria or the study that proves the device meets those criteria, such as numerical thresholds, sample sizes, or a detailed breakdown of the mechanical tests performed and their results. It only makes a general statement about comparable mechanical properties.

Given the information provided, I cannot populate the requested table or sections related to a study with specific data as it is not present in the document.

Based on the provided text, here's what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated with numerical values. It would likely relate to mechanical properties such as strength, fatigue life, and corrosion resistance, benchmarked against the predicate device.
• Reported Device Performance: Not explicitly stated with numerical values. The text only mentions "comparable mechanical properties to the predicate device."

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. For mechanical testing, this would refer to the number of components tested for each property.
• Data Provenance: Not specified. It can be assumed to be from a laboratory setting as part of product development and regulatory submission, typically conducted by the manufacturer or contracted labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable for a mechanical device. Ground truth for mechanical testing is established by material and engineering standards, not expert consensus in the medical diagnostic sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable for a mechanical device. This pertains to clinical studies involving human interpretation or subjective assessments. Mechanical testing involves objective measurements against predefined engineering standards.

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 type of study is relevant for AI or diagnostic imaging devices, not for mechanical spinal implants.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This refers to AI algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For mechanical devices, the "ground truth" often refers to established engineering standards, material specifications, and the performance of the predicate device under specific test conditions. The document implies comparison to these without detailing them.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence. This term is used for machine learning.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set.

In summary: The provided 510(k) summary is for a mechanical device (spinal implant components). It relies on demonstrating "comparable mechanical properties to the predicate device" through mechanical testing for substantial equivalence. However, it lacks the detailed quantitative results and specific acceptance criteria typically found in detailed test reports or studies. The questions provided are largely tailored for diagnostic or AI-driven medical devices, which operate under a different type of evaluation.

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The Xia Stainless Steel System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Stainless Steel 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 Stainless Steel 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 Stainless Steel 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, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.

The Xia Stainless Steel System consists of Monoaxial and Polyaxial Screws, Washer, Hooks, Blocker, Rods, Connectors and Multi-Axial Cross Connectors (MACs). This submission is intended to address a line extension to the Xia Stainless Steel System. The line extension includes 4.5 mm diameter Polyaxial Screws and longer length rods.

The provided document is a 510(k) Premarket Notification for a line extension to the Xia Stainless Steel System, a spinal fixation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it is not a clinical study report.

Here's why the requested information is absent and what the document does provide:

1. A table of acceptance criteria and the reported device performance:

   • Absent. This document doesn't define specific clinical acceptance criteria (e.g., a certain reduction in pain, a specific fusion rate, or a particular performance statistic like sensitivity/specificity for a diagnostic device).
   • What is present: The document states that "Mechanical testing demonstrated comparable mechanical properties to the predicate device." This is the basis for demonstrating substantial equivalence for this type of device modification (a line extension with different screw diameters and rod lengths). The acceptance criteria for this would be defined by the mechanical testing standards used (e.g., ASTM standards for spinal implants) comparing the new components to the predicate, demonstrating that they perform similarly or better under defined load conditions. However, the specific results or table of these criteria/performance are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Absent. There is no clinical test set in the context of a prospective or retrospective study for a diagnostic or therapeutic effect. The "test set" here would refer to the samples of the new device components used for mechanical testing. The document does not specify the number of samples used for these mechanical tests.
   • What is present: The device itself is manufactured by Howmedica Osteonics Corp based in Allendale, NJ, USA.

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):

   • Absent. Ground truth establishment by experts is relevant for diagnostic devices or those with subjective outcome measures. For spinal fixation hardware, the "ground truth" is typically defined by engineering standards for mechanical performance, biocompatibility, and material properties, not by expert medical evaluation of a patient test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Absent. Adjudication methods are used for resolving disagreements in expert ground truth establishment for clinical or diagnostic studies. This is not applicable here.

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:

   • Absent. This is a hardware device (spinal implant), not a diagnostic algorithm or AI-assisted system. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Absent. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • What is present: For a spinal implant, the "ground truth" for demonstrating safety and effectiveness in a 510(k) submission is typically established through:
     • Mechanical Integrity/Performance: Compliance with recognized ASTM or ISO standards for spinal implants, demonstrating equivalent or superior strength, fatigue life, and other mechanical properties compared to the predicate device.
     • Biocompatibility: Confirmation that the materials (stainless steel) are appropriate for implant use and have known biocompatibility profiles (often addressed by referencing predicate devices or established material standards).
     • Intended Use Compatibility: The new components fit within the intended use of the existing system and predicate.
   • The document implies that mechanical testing was the primary evidence for this line extension.

8. The sample size for the training set:

   • Absent. Spinal implants do not have a "training set" in the sense of machine learning algorithms or clinical trials.

9. How the ground truth for the training set was established:

   • Absent. Not applicable.

In summary, the provided document is a regulatory submission for a device modification (line extension) that demonstrates substantial equivalence to a legally marketed predicate device. It primarily relies on design comparison and mechanical testing to establish comparable safety and effectiveness, rather than a clinical study with specific acceptance criteria and detailed performance metrics as would be found for a novel therapeutic or a diagnostic device.

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