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The APEX-DL Spine System with APEX Spine System Components is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).

The APEX-DL Spine System with APEX Spine System Components 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The APEX-DL Spine System with APEX Spine System Components is also a sacraliliac screw fixation system of the non-cervical spine 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 (pseudo-arthrosis).

When used in a percutaneous posterior approach with AIM MIS instrumentation, the APEX-DL Spine System with APEX Spine System Components is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pediatic patients, the APEX-DL Spine System implants with APEX Spine System Components are indicated as an adjunct to treat adolescent idiopathic scoliosis. The APEX DL Spine System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The APEX-DL Spine System includes Monoaxial, Uniplanar, and Polyaxial Double Lead Thread Screws in the cannulated and non-cannulated versions and in regular and reduction (extended tab) versions. APEX-DL Spine System is a low profile thoracolumbar implant for use with wide range of patient statures. The APEX-DL Spine System Polyaxial screws feature a friction head, which is designed to provide precise reduction mechanism as a result of easier rod capturing. The APEX-DL Spine System also includes Lordosed Percutaneous Rods. The APEX-DL Spine System is compatible with the APEX Spine System 5.5mm and 6.0mm rods, hooks, side-by-side connectors, iliac connectors, cross connectors, and washers.

The APEX-DL Spine System is a spinal implant for immobilization and stabilization of spinal segments. The document indicates that no clinical studies were performed. The acceptance criteria and testing are based on non-clinical (mechanical) tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly defined as demonstrating mechanical properties that are "equal or higher" than the identified predicate devices, based on the testing standards.

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

• Sample Size: Not explicitly stated in the provided document. For each of the ASTM tests listed, a specific number of samples (implants/constructs) would have been used, but this detail is not provided.
• Data Provenance: The data is from non-clinical (mechanical) testing conducted presumably by SpineCraft, LLC or a contracted testing facility. It is not patient or human data; therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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

Not applicable. This is a non-clinical, mechanical testing study, not a study requiring expert clinical assessment or ground truth establishment in a medical imaging or diagnostic context. The "ground truth" here is the objective measurement of mechanical properties according to established ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or imaging studies.

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

No. An MRMC study is a clinical study involving multiple human readers interpreting medical cases. The provided document explicitly states, "No clinical studies were performed."

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

Not applicable. This device is a physical spinal implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective mechanical measurements according to recognized industry standards (ASTM F1717 and ASTM F1798). The performance is then compared to "predicate systems" as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device undergoing mechanical testing, not a machine learning model that requires a training set.

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

Not applicable. As described in point 8, there is no "training set" for this type of device evaluation.

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The ASTRA System is 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:
Titanium alloy
CoCr alloy

Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.

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

This is a physical device, and the "test set" refers to the tested device components.

• Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.

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

• Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.

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 physical spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.

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

• Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.

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When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal 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 neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

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

• Who are receiving fusions with autogenous graft only; a)
• b) Who are having the device fixed or attached to the lumbar or sacral spine; and
• c) Who are having the device removed after the development of a solid fusion mass.

The DYNESYS® Spinal System consists of four pedicle screws, two cords and two spacers in a symmetric, bilateral arrangement. The pedicle screws are placed lateral to the facet joints with two screws in the cephalad position and two screws in the caudad position. The superior-inferior distance between the pedicle screws is maintained with the spacers. The cord passes through the eye of the pedicle screw heads and through the centers of the spacers.

This document is a 510(k) Pre-Market Notification for the DYNESYS® Spinal System. It is an application for regulatory clearance, claiming substantial equivalence to a predicate device, rather than a clinical study report describing acceptance criteria and device performance. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria or report performance metrics from a study designed to meet such criteria. It states that "Establishment of equivalence is based on similarities of intended use, design, and performance characteristics" to the predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document does not describe a clinical study with a ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This document does not describe a clinical study with 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 document is for a medical device (spinal system), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a medical device (spinal system), not for an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. This document does not discuss a clinical study with ground truth. The basis for clearance is substantial equivalence to a predicate device.

8. The sample size for the training set:
Not applicable. This document describes a medical device, not a machine learning model that would have a training set.

9. How the ground truth for the training set was established:
Not applicable. This document describes a medical device, not a machine learning model.

Additional relevant information from the document:

• Device Name: DYNESYS® Spinal System
• Intended Use: "When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal 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 neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis)."
• Predicate Device: Silhouette™ Spinal Fixation System (K980288)
• FDA Limitation: The FDA added a limitation to the labeling: "The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established." This indicates that while the device was found substantially equivalent for specified uses, potential broader uses were explicitly excluded without further proof.

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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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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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