Search Results

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.

Ask a specific question about this device

The Xia Spinal System and the Xia Stainless Steel System are intended for use in the noncer spine. When used as a pedicle screw fixation system, the Xia Spinal System and Xia C Steel Systems are intended for patients: (a) having severe spondylolisthesis (Grades the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusion 'Iı, autogenous bone graft only; (c) who are having the device fixed or attached to the .nbar 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 and Xia Stainless Steel Systems are 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 and Xia Stainless Steel Systems are 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, tumor, pseudoarthrosis or revision of failed fusion attempts.

This submission is intended to address a line extension to both the Xia Spinal System and the Xia Stainless Steel System. The line extension includes a Dual Staple and modified cross connectors. The new components will be used for anterior fixation.

The provided text describes a Special 510(k) Premarket Notification for a line extension to the Xia Spinal System and Xia Stainless Steel System. This regulatory submission is for medical devices, specifically spinal fixation appliances. For such devices, acceptance criteria and performance are typically demonstrated through mechanical testing and comparison to a predicate device, rather than clinical studies involving human patients, especially for line extensions that introduce minor modifications.

Therefore, many of the typical questions asked for AI/software-based medical devices regarding clinical study design are not applicable here.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The primary acceptance criterion for this line extension, which includes new components (Dual Staple and modified cross connectors), is to demonstrate mechanical equivalence to the existing predicate Xia Spinal System and Xia Stainless Steel System.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable in the context of this device and submission type. The "test set" here refers to the new components (Dual Staple and modified cross connectors) and their mechanical performance. The "data provenance" would relate to the specific mechanical testing methods and standards used, but this level of detail is not provided in the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth for mechanical properties is established through standardized engineering tests, not expert consensus in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically for subjective clinical assessments, not objective mechanical tests.

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 a hardware medical device (spinal fixation system), not an AI/software device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a hardware medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is the mechanical performance of the predicate devices as established through engineering testing. The new components must demonstrate mechanical properties comparable to these established devices.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a hardware medical device, not a machine learning model.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a mechanical testing study. The summary states:

• "Mechanical testing demonstrated comparable mechanical properties to the predicate devices."

This indicates that the new components (Dual Staple and modified cross connectors) underwent a series of standardized mechanical tests designed to assess their strength, durability, and other relevant physical characteristics. The results of these tests were then compared against the established mechanical performance data of the predicate Xia Spinal System and Xia Stainless Steel System components. By demonstrating "comparable mechanical properties," the manufacturer has shown that the new components are mechanically equivalent to the already approved devices, thus meeting the acceptance criteria for this line extension. The specific details of these mechanical tests (e.g., types of tests, number of samples, test parameters, specific standards followed) are not provided in this summary but would have been part of the full 510(k) submission.

Ask a specific question about this device

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.

Ask a specific question about this device

The Xia Spinal System and the Xia Stainless Steel System are intended for use in the noncervical spine. When used as a pedicle screw fixation system, the Xia Spine System and Xia Stainless Steel Systems are 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 and Xia Stainless Steel Systems are 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 and Xia Stainless Steel Systems are 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 Spinal System consists of Monoaxial and Polyaxial Screws, Hooks, Blockers, Rods, and Connectors. This submission is intended to address a material modification to the Xia Spinal System as well as dimensional changes to the components. The subject device, named the Xia Stainless Steel System, is a line extension of the Xia Spinal System. The predicate Xia Spinal System is fabricated from titanium alloy. The subject Xia Stainless Steel System is fabricated from stainless steel.

This document describes a Special 510(k) submission for a line extension to the Xia Spine System, introducing the "Xia Stainless Steel System." The submission focuses on demonstrating substantial equivalence to the predicate device (Xia Spinal System, made of titanium alloy) by addressing a material change to stainless steel and dimensional adjustments.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Mechanical testing." However, it does not specify the sample size for this testing, nor does it provide details about the data provenance (e.g., country of origin or whether it was retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document describes a safety and effectiveness summary for a medical device (spinal fixation system) based on a line extension with a material change. It does not involve expert review for image interpretation or diagnosis. Therefore, the concepts of "experts to establish ground truth" related to diagnostic accuracy are not applicable here. The "ground truth" for this type of submission is the mechanical performance of the device.

4. Adjudication Method for the Test Set

As this submission does not involve clinical data or diagnostic tests, adjudication methods like 2+1 or 3+1 are not applicable. The assessment of whether the mechanical testing meets the acceptance criteria (comparable properties) would be performed by the manufacturer and reviewed by regulatory bodies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a physical medical device (spinal implant).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study relevant to an algorithm's performance was done. This is a hardware device.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on objective mechanical properties of the device components, measured through established engineering tests. The acceptance criteria essentially dictate that the mechanical properties of the new stainless steel components must be comparable to those of the predicate titanium alloy components.

8. Sample Size for the Training Set

As this is a mechanical device and not an AI/ML algorithm or diagnostic tool, the concept of a "training set" is not applicable.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set, this question is not applicable. The mechanical properties are inherent to the materials and design, and their measurement follows standardized testing protocols.

Summary of Key Findings:

The submission confirms the new Xia Stainless Steel System has "comparable mechanical properties" to the predicate Xia Spinal System. However, it provides limited detail on the specifics of the mechanical testing:

• Acceptance Criteria: "Comparable mechanical properties to the predicate components."
• Study: "Mechanical testing demonstrated comparable mechanical properties..."
• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified.
• Experts for Ground Truth: Not applicable (not a diagnostic study).
• Adjudication Method: Not applicable.
• MRMC Study: Not applicable.
• Standalone Study: Not applicable.
• Type of Ground Truth: Objective mechanical properties.
• Training Set Sample Size: Not applicable.
• Training Set Ground Truth Establishment: Not applicable.

Ask a specific question about this device