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When used as a pedicle screw fixation system in skeletally mature patients, the Cadence™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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).

In addition, when used as a pedicle screw fixation system, the Cadence Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine; and
d) who are having the device removed after the development of a solid fusion mass
When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

When used as a hook and sacral screw system, the Cadence Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Cadence Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Cadence™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. The implants in this system are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F-136.

The Cadence™ Spinal Fixation System is a medical device, and the provided document is a 510(k) premarket notification. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving performance through extensive clinical studies with acceptance criteria in the same way a novel AI algorithm might. Therefore, many of the requested fields about AI-specific study design (e.g., sample size for training/test sets, expert ground truth, MRMC studies, standalone performance) are not applicable or directly addressed in this document.

Here's an analysis based on the provided text, focusing on the evidence presented to support the device's acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated. The study involved mechanical testing of components, not human patient data in the context of this 510(k) summary. The "test set" here refers to the actual physical components tested.
• Data Provenance: Not applicable in the context of a clinical test set. The data originates from laboratory mechanical testing.

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

• Number of Experts: Not applicable. Ground truth for mechanical properties is established by adherence to standardized testing protocols (ASTM F 1717-96 and ASTM F 1798-97), not expert consensus on clinical findings.
• Qualifications of Experts: Not applicable. The "ground truth" is defined by the physical properties measured according to the ASTM standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Mechanical testing results are objective measurements based on standardized methodologies, not subject to human interpretation requiring adjudication in this context.

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:

• MRMC Study: No. This is a spinal fixation system, not an AI or imaging diagnostic device. MRMC studies are not relevant to its evaluation.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Performance: No. This is a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for the device's performance is based on standardized mechanical performance metrics outlined in ASTM F 1717-96 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model) and ASTM F 1798-97 (Standard Guide for Evaluation of Spinal System Constructs in a Vertebrectomy Model). These standards define the expected biomechanical behavior and material characteristics for such devices.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence for a physical medical device. The "training" in manufacturing comes from established engineering principles and quality control processes.

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

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of the Study and How the Device Meets Acceptance Criteria:

The study that proves the Cadence™ Spinal Fixation System meets acceptance criteria is a series of mechanical tests conducted according to established industry standards: ASTM F 1717-96 and ASTM F 1798-97.

The acceptance criteria are implicitly derived from the performance of the predicate device, the Silhouette™ Spinal Fixation System, and the requirements of the ASTM standards themselves. The core acceptance criterion for this 510(k) submission is "substantial equivalence" in mechanical properties to the predicate device.

The study demonstrated that the Cadence™ Spinal Fixation System's components exhibited "substantially equivalent mechanical properties" when compared to the previously cleared Silhouette™ Spinal Fixation System components. This means that the Cadence™ system passed the mechanical tests (likely involving dynamic and static loading, fatigue, and material strength) at levels comparable to, or better than, the predicate device. The use of titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 further supports its material suitability and biocompatibility, aligning with established standards for implantable medical devices.

The FDA's clearance (K022374) confirms that based on this mechanical testing and comparison, the device is considered substantially equivalent to the predicate device for its stated indications for use.

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The Sulzer Spine-Tech RPX™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

The RPX™ Cement Restrictor is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

The RPX™ Cement Restrictor Device is a hollow, tapered block that is titanium. This device is intended to be used in conjunction with PMMA cement.

The provided text describes a 510(k) premarket notification for a medical device, the Sulzer Spine-Tech RPX™ Titanium Cement Restrictor. This submission is for regulatory clearance based on substantial equivalence to predicate devices, not for demonstrating clinical efficacy or performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, expert consensus, ground truth, and sample sizes is not applicable to this type of regulatory submission as presented in the provided document.

Here's a breakdown of what can be extracted and what is not available:

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

• Not applicable. This document is a 510(k) summary, which focuses on substantial equivalence based on intended use, design, and physical characteristics comparison to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical study. Performance data, if any, for mechanical or functional aspects would typically be presented in the full 510(k) submission, not in this summary, and would usually relate to bench testing rather than clinical performance against acceptance criteria.

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. No test set or clinical study data is mentioned in this 510(k) summary. This submission relies on a comparison to predicate devices.

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. No test set requiring expert-established ground truth is mentioned.

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

• Not applicable. No test set requiring adjudication is mentioned.

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 device is a cement restrictor, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

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

• Not applicable. No ground truth data is established or used for this 510(k) submission.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set and therefore no ground truth for it.

In summary: The provided document is a 510(k) submission for substantial equivalence. It does not contain information about clinical studies with acceptance criteria, test sets, training sets, ground truth establishment, or expert reviews, as these are typically part of a different type of regulatory submission (e.g., PMA for novel devices or specific clinical studies for efficacy claims). The basis for clearance here is the similarity to existing, legally marketed predicate devices.

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When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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).

In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine
d) who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral illiac attachment only. Hook and transverse of the Silhouette Spinal Fixation System are intended for posterior thoracic only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws and are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths; fixed screws of varying diameters and lengths; rods in varying lengths; hooks in varying designs; and transverse connectors in the various configurations of fixed, adjustable, variable angle offset and axial. All implant components are either top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

The provided text is a 510(k) Summary for the Silhouette™ Spinal Fixation System, which is a medical device. This type of regulatory submission in the United States focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study or extensive analytical testing.

Therefore, the supplied document does not contain the information requested regarding acceptance criteria and a study demonstrating that the device meets those criteria. The 510(k) summary primarily addresses:

• Device Description: What the device is and what it's made of.
• Intended Use: The medical conditions and anatomical locations for which the device is designed.
• Statement of Technological Comparison: A qualitative comparison to a legally marketed predicate device, highlighting that the new device has "similar mechanical properties" based on ISO mechanical testing (not clinical or human-in-the-loop studies).
• Regulatory Classification and Predicate Device: Identifies the classification and the previous devices it is substantially equivalent to.

Based on the provided text, here's an analysis of why the requested information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This information is not found in the summary. The summary mentions "mechanical testing carried out according to ASTM 1717-96 to validate the Variable Angle Connector and the Axial Connector." It states that this testing "demonstrated similar mechanical properties to the previously cleared Silhouette™ Spinal Fixation System components." However, specific acceptance criteria (e.g., minimum tensile strength, maximum displacement) and the exact reported performance values are not detailed.

2. Sample size used for the test set and the data provenance: Not applicable for the type of information provided. The "test set" in this context refers to mechanical test samples, not a clinical data set. The document does not specify the number of components tested for the mechanical validation. Data provenance (country, retrospective/prospective) is relevant for clinical studies, not for internal mechanical testing of device components.

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. "Ground truth" and "experts" are terms related to clinical or diagnostic accuracy studies, not mechanical component testing for spinal implants. The ground truth for mechanical testing would be the physical properties measured against industry standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies in expert opinions, 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. MRMC studies, AI, and human reader performance are entirely unrelated to the mechanical performance of a spinal fixation system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance, which is not part of this device's evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing mentioned, the "ground truth" would be established engineering standards (ASTM F-136 for material, ASTM 1717-96 for mechanical testing).

8. The sample size for the training set: Not applicable. Training sets are relevant for machine learning algorithms, which are not involved here.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through a comparison of device design, materials, and mechanical properties (using ASTM standards) to a predicate device, rather than reporting on clinical performance criteria, diagnostic accuracy, or AI system validation.

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When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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).

In addition, when used as a pedicle screw fixation system, the Silhouette Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine
d) who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F-136.

The provided text is a 510(k) summary for the Silhouette™ Spinal Fixation System, a medical device for spinal fixation. It describes the device, its intended use, and indicates that it has been found substantially equivalent to predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

This type of 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical trial or performance study data with specific acceptance criteria as might be seen for novel devices or those requiring a PMA.

Therefore, I cannot fulfill your request for the tables and information regarding acceptance criteria and performance studies based on the provided text. The document is essentially a regulatory clearance notice, not a detailed technical or clinical study report.

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The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

The Trinica Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter. Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

The provided text describes a 510(k) submission for the Trinica™ Anterior Cervical Plate System, focusing on its substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.

Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, and expert involvement cannot be extracted directly from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance; instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" assessment is based on non-clinical tests.

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

Not applicable. This document refers to non-clinical tests which are typically bench tests (e.g., mechanical testing) and do not involve patient data or test sets in the context of clinical performance. The data provenance would be laboratory testing.

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

Not applicable. Ground truth in this context would generally refer to a clinical diagnosis or outcome, which is not part of this non-clinical testing summary. Expert involvement would be in the design and interpretation of the non-clinical tests themselves, but this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" in the sense of clinical data requiring 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

Not applicable. This is a medical device (spinal plate system), not an AI imaging or diagnostic algorithm.

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

Not applicable. This is a medical device, not an algorithm. Performance assessment is based on the physical device itself.

7. The Type of Ground Truth Used

For non-clinical performance testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM F136), and biomechanical performance criteria. The document states "appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria."

8. The Sample Size for the Training Set

Not applicable. This is not a study involving a training set for an algorithm.

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

Not applicable. This is not a study involving a training set for an algorithm.

Summary from the document:

The 510(k) submission for the Trinica™ Anterior Cervical Plate System relies on demonstrating substantial equivalence to a predicate device (Michelson Anterior Cervical Plate System K974435). The "study" referenced is a series of non-clinical tests (likely mechanical, material, and design verification tests) that assessed the impact of design changes. The document explicitly states:

• "Results of the testing demonstrated that the modified device meets established criteria."
• "Testing of the Trinica Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435) and that the design modifications do not affect device safety and effectiveness."

The primary "acceptance criterion" articulated in the document is satisfying the FDA's requirement for substantial equivalence to a legally marketed predicate device, especially regarding safety and effectiveness, which was confirmed through these non-clinical tests.

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When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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).

In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:

• having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
• who are receiving fusions with autogenous graft only
• who are having the device fixed or attached to the lumbar or sacral spine, and
• who are having the device removed after the development of a solid fusion mass

When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varving diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed and adjustable widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.

Here's a breakdown of the acceptance criteria and study information for the Sulzer Spine-Tech Silhouette™ Spinal Fixation System, based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the test set. It mentions "Fatigue Testing of Silhouette™ Spinal Fixation System/adjustable transverse connector construct." The data provenance is not specified beyond being generated by Sulzer Spine-Tech for regulatory submission. It is a non-clinical, in-vitro test.

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

This information is not applicable. The study is a non-clinical, in-vitro device performance test against a predefined engineering standard (ASTM Provisional Standard PS 5-94), not a clinical study involving expert interpretation of data or patient outcomes. Therefore, there's no "ground truth" in the sense of expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically relevant for clinical studies where there may be disagreements among human reviewers. This was a physical performance test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes non-clinical engineering performance testing of a spinal fixation system.

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

Yes, in a sense, a "standalone" test was performed. The device, specifically the adjustable transverse connector and the system construct, was subjected to a standalone physical performance test without human involvement in its operation or interpretation during the test itself. The test was to evaluate the physical properties of the device against an established standard.

7. The Type of Ground Truth Used

The ground truth used was based on an established engineering standard: ASTM Provisional Standard PS 5-94, Test Method for Static and Dynamic Spinal Implant Assembly in a Corpectomy Model. The acceptance criteria (no failures, 156 N run-out load, 5,000,000 cycles) are derived directly from this standard.

8. The Sample Size for the Training Set

This information is not applicable. This document describes performance testing of a physical medical device, not an AI/ML algorithm that would require a training set.

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

This information is not applicable, as there is no training set for an AI/ML algorithm.

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When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments 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).

In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:

• having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint a)
• who are receiving fusions with autogenous graft only b)
• who are having the device fixed or attached to the lumbar or sacral spine c)
• who are having the device removed after the development of a solid fusion mass d)

When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine. loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation. pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and to facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar, and sacral areas of the spine. Implants in this system consist of hooks and/or screws connected to rods that are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, and transverse connectors in fixed widths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F-136.

The provided text describes a 510(k) submission for the Silhouette™ Spinal Fixation System. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of a typical AI/medical device performance evaluation.

Instead, this document focuses on demonstrating substantial equivalence of the Silhouette™ Spinal Fixation System to a predicate device (K980288), primarily based on design, operating principle, materials, shelf life, packaging materials/process, and sterilization. The key change is a modification of labeling to include expanded indications for use, an additional warning, and an additional precaution.

Therefore, many of the requested categories for a typical AI device study are not applicable to this 510(k) submission.

Here's an attempt to extract relevant information and note where the requested information is not present:

1. Table of acceptance criteria and the reported device performance

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

• Not applicable / Not specified for human subject data. The "test" in this context refers to biomechanical testing of components, not a clinical trial with a "test set" of patients or data for an AI algorithm.
• The provenance of data for biomechanical testing is not detailed (e.g., country of origin).

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

• Not applicable. This submission focuses on hardware equivalence and biomechanical properties, not diagnostic or interpretive tasks where expert ground truth would be established.

4. Adjudication method for the test set

• Not applicable. See point 3.

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 device.

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

• No. This is not an AI device.

7. The type of ground truth used

• Biomechanical testing results: The "ground truth" for this device's performance is based on the results of biomechanical tests comparing its components to other commercially available systems. The specific metrics (e.g., stiffness, fatigue strength) are not detailed but are implied by "equivalent mechanical performance."
• Predicate device's established safety and effectiveness: The ultimate "ground truth" for the overall device approval is its substantial equivalence to a legally marketed predicate device (K980288), which has already established its safety and effectiveness.

8. The sample size for the training set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. This is not an AI device.

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