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The Silhouette™ Spinal System is intended for posterior, noncervical pedicle fixation for the following indications: 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 and dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

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 turnors, 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 the hook and sacral screw fixation of this system are T1 to the sacrum.

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

The provided text is a 510(k) summary for a spinal fixation system, not a study evaluating a medical device based on acceptance criteria. Therefore, most of the requested information cannot be extracted from this document, as it pertains to a clinical study or performance evaluation with specific metrics.

Here's a breakdown of why and what little information can be gleaned:

Reasoning for inability to answer most questions:

• Type of Document: This is a 510(k) summary, which is a premarket notification for a medical device. Its primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to present the results of a detailed performance study against pre-defined acceptance criteria for a novel AI or diagnostic device.
• Focus on Equivalence: The document explicitly states "There are no technological differences between the Silhouette Spinal Fixation System and the previously cleared Silhouette Spinal Fixation System" and "The Silhouette Spinal System is substantially equivalent to the original Silhouette Spinal System based on materials, design, function and the supporting information included in the Class III Certification and Summary." This means the "study" is a comparison to a predicate, not a performance study against specific criteria for a new device.
• Device Type: The device is a "Spinal Fixation System," which is a physical implant (hooks, screws, rods). The concept of "acceptance criteria" and "device performance" in this context refers to mechanical properties (e.g., strength, fatigue, biocompatibility) rather than diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) typically associated with AI or imaging devices. This document does not detail those mechanical tests or their results.
• Missing Study Details: There is no mention of "test sets," "ground truth," "experts," "adjudication methods," "MRMC studies," "standalone performance," or "training sets," as these are all relevant to the evaluation of AI/diagnostic algorithms, not material equivalence for a physical implant.

Information that can be extracted (with caveats):

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

   • Cannot be provided directly. The document does not define specific "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the overall acceptance criterion for 510(k) clearance is "substantial equivalence" to a predicate device.
   • Reported Device Performance: The primary "performance" reported is its substantial equivalence to the predicate. The document states:
     • "There are no technological differences between the Silhouette Spinal Fixation System and the previously cleared Silhouette Spinal Fixation System."
     • "The Silhouette Spinal System is substantially equivalent to the original Silhouette Spinal System based on materials, design, function and the supporting information included in the Class III Certification and Summary."
     • This implies that the device performs the same as the predicate. The specific mechanical performance (e.g., strength, fatigue life) that would underpin this substantial equivalence is not detailed in this summary.

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

   • Not applicable. There is no "test set" in the context of an algorithm or diagnostic study. The "test" for this device involved demonstrating equivalence in materials, design, and function to a predicate device, likely through engineering analysis and potentially mechanical testing, not a dataset of patients or images.

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 ground truth was established for a "test set" as this is not a diagnostic device.

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

   • Not applicable. No test set or adjudication method described.

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 implant, not an AI or diagnostic tool.

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

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

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

   • Not applicable. No ground truth in the context of an AI/diagnostic study. The "ground truth" for this 510(k) application is essentially adherence to established standards for spinal implants and demonstrating equivalence to a previously cleared device.

8. The sample size for the training set:

   • Not applicable. No training set for an algorithm.

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

   • Not applicable. No training set described.

In summary, the provided document is a regulatory filing for a physical medical device (spinal implant) demonstrating substantial equivalence to a predicate device, rather than a clinical or performance study of an AI-powered or diagnostic device. Therefore, the specific questions regarding acceptance criteria, test sets, ground truth, and expert evaluation are not relevant to this document's content.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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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The Spine-Tech Silhouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using 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 Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined 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 sacral/iliac attachment only, screws of the Spin-Tech 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 Spine-Tech Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitates the biological process of the spine. This system is intended for posterior use in the thoracic, lumbar and sacral regions of the spine. Implants of this system consist of hooks and/or screws, 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, both fixed and variable. All implants in this system are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6A1-4V), conforming to ASTM F-136.

The implants of this system are for single use only. An implant should never be reused after being removed from the body or sterilized after coming into contact with body fluids or tissues.

The provided document is a 510(k) summary for the Spine-Tech Silhouette™ Spinal Fixation System. It describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, it does not contain information regarding specific acceptance criteria, a formal study demonstrating the device meets those criteria, or details about a test set, ground truth, or expert involvement typically associated with AI/software device evaluations.

Instead, this document focuses on a medical device (spinal implant system) rather than a software or AI-based diagnostic/predictive device. The "testing" mentioned refers to biomechanical testing of the physical implants.

Therefore, many of the requested categories are not applicable to the content provided.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not specify quantitative acceptance criteria in terms of performance metrics commonly associated with software/AI (e.g., sensitivity, specificity, AUC). The performance reported is that the physical device components showed "equivalent mechanical performance" to predicate devices.

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

• Sample Size for Test Set: Not applicable. The "testing" refers to biomechanical tests on device components, not a clinical test set from human data for an AI/software.
• Data Provenance: Not applicable. The biomechanical testing would have been conducted in a lab setting, not using human data from a specific country or in a retrospective/prospective manner.

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

• Number of Experts: Not applicable. Ground truth, in the context of AI/software, refers to clinically verified labels or outcomes. For biomechanical testing, the "ground truth" would be established by engineering standards and measurements, not clinical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no clinical test set or ground truth adjudication process described.

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

• MRMC Study: No, this type of study is typically conducted for diagnostic imaging devices where human readers interpret medical images, often with AI assistance. This document describes a physical spinal implant system.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the biomechanical testing, the "ground truth" would be the established engineering and materials science standards for spinal implants (e.g., ASTM F-136 for titanium alloy, specifications for load-bearing, fatigue, etc.). This is a physical or engineering "ground truth," not a clinical ground truth.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not about an AI/ML model, so there is no training set in that sense. The design and manufacturing processes are informed by engineering principles and possibly prior iterations, but not a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model. The design and manufacturing of the physical device components are based on established engineering and medical device standards.

Summary of Document's Focus:

The K980288 document is a premarket notification for a physical medical device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, primarily through comparison of materials, design, function, and biomechanical testing. It does not involve software or artificial intelligence, and therefore, the requested information pertaining to AI/software validation studies is not present.

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