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The Zavation Spinal System is a pedicle screw system intended to provide immobilization 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 neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The standard pedicle screws have various options in lengths and diameters as well as a sterile packaged Hydroxyapatite (HA) coated option. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The safety and effectiveness of the fenestrated screws have not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g., osteoporosis, osteopenia). The device is intended only to be used with saline or radiopaque dye.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. It does not describe any acceptance criteria or studies related to device performance in a clinical or diagnostic context (e.g., accuracy, sensitivity, specificity) involving AI, imaging, or human readers.

Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices, primarily through mechanical testing of the implant's physical properties.

Therefore, most of the requested information cannot be extracted from this document as it pertains to different types of device validation.

Here's what can be extracted and a clear statement regarding what cannot:

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

This document describes mechanical testing for the Zavation Spinal System. The "acceptance criteria" can be inferred as meeting or exceeding the performance of predicate devices according to established ASTM standards.

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

• Sample size for test set: Not explicitly stated in terms of number of devices or constructs tested for the mechanical evaluation.
• Data provenance: Not applicable in the context of mechanical testing of physical implants. The testing was conducted in a lab setting.

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):

Not applicable. This is mechanical testing of an orthopedic implant, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is mechanical testing, not a study involving human adjudication of results.

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 document does not describe a clinical study of diagnostic or AI-assisted performance, nor does it mention AI.

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

Not applicable. This document does not describe the performance of an algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM) and performance comparable to a predicate device.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning algorithm or a training set.

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

Not applicable. This document does not describe a machine learning algorithm or a training set.

In summary: The provided FDA 510(k) summary focuses on the mechanical and material properties of an orthopedic implant (Zavation Spinal System) to demonstrate substantial equivalence to existing predicate devices. It does not contain any information related to studies involving AI, diagnostic accuracy, human readers, clinical endpoints, or ground truth establishment in a clinical context.

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The Zavation Spinal System is a pedicle screw system intended to provide immobilization 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 neurological imparment, fracture, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The standard pedicle screws have various options in lengths and diameters as well as a sterile packaged Hydroxyapatite (HA) coated option. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

This submission describes a medical device, the Zavation Spinal System, which is a pedicle screw system. The provided text outlines the device's indications for use, materials, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain information about acceptance criteria or a study that typically proves a device meets acceptance criteria in the context of an AI/ML medical device.

In the context of the provided text, the "acceptance criteria" for this traditional medical device are primarily related to its mechanical performance and substantial equivalence to legally marketed predicate devices, not performance metrics for an AI/ML algorithm. The "study" refers to mechanical testing.

Here's the breakdown of the information based on the provided text:

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

The following information is NOT available in the provided text as it pertains to AI/ML device studies, which this submission is not.

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

• Not applicable/Not provided. This is a traditional medical device, not an AI/ML device relying on a test set of data. The "test set" here refers to the physical devices tested mechanically.

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)

• Not applicable/Not provided. The "ground truth" for this device's performance is established through mechanical testing standards (ASTM F1717) and comparison to predicate device characteristics, not expert consensus on medical images or diagnoses.

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

• Not applicable/Not provided. This method is used for resolving discrepancies in expert labeling of data, which is not relevant to mechanical testing.

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/Not provided. This is specific to AI-assisted diagnostic devices.

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

• Not applicable/Not provided. This is specific to AI/ML device performance.

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

• For the mechanical testing, the "ground truth" is defined by the established ASTM F1717 standard for spinal implant mechanical performance. For substantial equivalence, the "ground truth" is the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. This is a traditional medical device, not an AI/ML device requiring a training set.

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

• Not applicable/Not provided.

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The Zavation Spinal System is a pedicle screw system 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document describes the Zavation Spinal System, which is a medical device. The information presented is for the FDA 510(k) clearance process, which focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance metrics of a novel algorithm or AI system.

Therefore, many of the requested criteria (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, and AI-specific metrics) are not applicable or not provided in this type of regulatory submission. This document describes a traditional mechanical medical device, not an AI/ML-driven device.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This is a mechanical device, and performance was evaluated through physical mechanical testing, not a clinical test set with patient data.

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

• Not Applicable. Ground truth, in the context of clinical data, is not established for this type of mechanical device testing. Performance is measured against engineering standards (ASTM F1717).

4. Adjudication method for the test set

• Not Applicable. Mechanical testing does not involve adjudication.

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

• No. This is not an AI/ML device, so MRMC studies are not relevant.

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

• No. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• Mechanical Standards and Predicate Performance: The "ground truth" for this device's performance is its ability to meet or exceed the mechanical performance characteristics (e.g., strength, durability under various loads) of its predicate devices, as evaluated through established ASTM standards (specifically ASTM F1717 for static and dynamic mechanical testing).

8. The sample size for the training set

• Not Applicable. This is a mechanical device; there is no "training set" in the context of AI/ML or clinical data used for learning. The "training" in the engineering sense would be the design and manufacturing process, which is not quantified in terms of "sample size" here.

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

• Not Applicable. As there's no training set, there's no ground truth for it. The ground for mechanical performance is established by engineering principles and ASTM standards.

Summary of the Study:

The study proving the device meets the acceptance criteria is described under the "Performance Data" section. It states:

• Type of Study: Mechanical testing.
• Methodology: Static compression bending and torsion, and dynamic compression bending were performed.
• Standard: The testing was conducted "according to ASTM F1717."
• Construct: A "worst-case construct" was used, implying rigorous testing conditions.
• Results: The mechanical test results "demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates that the acceptance criteria for this mechanical device are defined by its ability to match or surpass the structural integrity and durability of already-cleared predicate devices when tested under standardized, rigorous conditions.

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The Zavation System is intended to provide immobilization and stabilization of spinal segments in sketally mature patients as an adjunct to fusion in the tollowing acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; tumor; pseudoarthrosis; and failed previous fusion.

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and rod connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors, offsets, and connectors.

This document is a 510(k) premarket notification for the Zavation Spinal System. It is primarily a regulatory submission for a medical device and therefore does not contain information about an AI/ML device, its acceptance criteria, or a study proving it meets them.

The document describes a spinal fixation system, which is a physical implant used in spinal surgery. The performance data section refers to "biomechanical testing including static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. Axial and torsional grip of rod connectors was tested according to ASTM F1798." These are standard mechanical engineering tests for implants to ensure their structural integrity and performance, not statistical or clinical studies for an AI/ML device.

Therefore, I cannot provide the requested information as it is not present in the provided text.

Ask a specific question about this device

The Zavation Spinal System is a pedicle screw system 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for an AI/ML medical device.

Instead, this document describes the Zavation Spinal System, its intended use, materials, predicate devices, and the basis for its substantial equivalence to those predicate devices. The "Performance Data" section specifically states:

"Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. The mechanical test results demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates a mechanical performance study for a spinal implant, which is a different type of evaluation from what is typically done for AI/ML devices regarding diagnostic accuracy or clinical effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the context of an AI/ML device from this document. The document primarily focuses on:

• Mechanical Safety/Performance: Comparing the mechanical strength of the Zavation Spinal System to predicate devices according to a specific ASTM standard (F1717). The acceptance criterion here is implicit: the device must perform "as well as or better than" the predicate devices in these mechanical tests.
• Substantial Equivalence: Arguing that the device is substantially equivalent to legally marketed predicate devices based on technological characteristics, performance, and intended use.

To answer your specific questions in the context of an AI/ML device, I would need a document detailing a clinical performance study or an AI algorithm validation study.

Ask a specific question about this device

The Zavation Spinal System is a pedicle screw system 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods and crosslinks. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided text describes the Zavation Spinal System, a medical device. This document is a 510(k) summary submission to the FDA, which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.

Therefore, the study described here is not a clinical study involving human patients or AI algorithms. It is a biomechanical performance study of a spinal implant system. As such, many of the requested fields related to clinical studies and AI are not applicable.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

• Note: The specific numerical acceptance criteria (e.g., maximum load, cycles to failure) are not provided in this summary. The comparison is made against the performance of the predicate devices.

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

• Sample Size: Not explicitly stated, but mechanical testing typically involves a sufficient number of constructs to ensure statistical validity for the specific tests performed (e.g., 5-6 samples per test arm). The text mentions "a worst-case construct," implying specific configurations were tested.
• Data Provenance: This is a retrospective comparison against existing data for the predicate devices. The tests were performed in a lab setting ("biomechanical test lab"). There is no mention of country of origin as it's a lab study.

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

• Not Applicable. This was a mechanical engineering study, not a clinical study involving expert interpretation of data. The "ground truth" is defined by the physical properties and performance metrics of the materials and constructs themselves, as measured by testing equipment.

4. Adjudication Method for the Test Set

• Not Applicable. As a mechanical performance study, there's no adjudication in the sense of clinical agreement or consensus. The results are quantitative measurements from standardized 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 study is not about AI or human reader performance. It's a mechanical device performance study.

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

• Not Applicable. This study is not about an algorithm.

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

• The "ground truth" for this study is the measured mechanical performance of the device components and construct under various load conditions, compared against the known mechanical performance of the predicate devices according to established ASTM standards (F1717).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this mechanical performance study. The study involves physical testing of the device.

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

• Not Applicable.

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