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When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws

The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Connectors

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX® Reconstruction System is a posterior svstem, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi), Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopaedic and neurosuraical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The provided document describes a 510(k) summary for the VERTEX® Reconstruction System, which is a spinal interlaminal fixation orthosis. The purpose of this 510(k) is to add additional components to the existing system. The document does not describe a study involving device performance metrics such as sensitivity, specificity, accuracy, or any form of clinical trial with human subjects where these metrics would be relevant.

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing (mechanical testing) and by showing that the new components are identical in terms of material, indications for use, and intended use, and that performance specifications are met. Therefore, many of the requested elements about clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new components are based on demonstrating mechanical equivalence to existing predicate devices under specific ASTM standards.

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

• Sample Size: The document does not specify the exact number of test samples (e.g., number of tapered rods) used for the mechanical tests. However, ASTM standards typically outline the minimum number of samples required for such testing.
• Data Provenance: The tests were performed by Medtronic, likely in a laboratory setting, in accordance with ASTM (American Society for Testing and Materials) standards. This is a non-clinical, in-vitro study. Country of origin for data is not explicitly stated but Medtronic Sofamor Danek is based in Memphis, TN, USA.

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

• Not Applicable. This submission is based on mechanical performance testing against established engineering standards (ASTM 1717-12) and comparison to predicate devices, not on clinical outcomes or expert interpretation of patient data. Therefore, no "experts" in the sense of clinical reviewers or diagnosticians were used to establish ground truth for a test set.

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

• Not Applicable. As this is non-clinical mechanical testing, there is no need for adjudication as typically understood in clinical or imaging studies. Mechanical test results are objective measurements.

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 not a study of AI or a diagnostic device involving human readers or cases. It is a 510(k) for a spinal implant system based on substantial equivalence through mechanical testing and comparison to predicate devices.

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

• Not Applicable. This is not an algorithm or AI device. It's a medical implant system.

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

• For the mechanical testing, the "ground truth" is defined by the performance specifications and criteria outlined in the ASTM 1717-12 standard for spinal implant assemblies. The device's performance is compared against these engineering benchmarks. For demonstrating substantial equivalence for other components, the "ground truth" is the established safety and performance of the predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI models.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

Ask a specific question about this device

When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
Occipitocervical constructs require bilateral fixation to C2 and below.
Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX SELECT Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.
The VERTEX Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. The VERTEX Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.
To achieve best results, do not use any of the VERTEX Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document.
As with all orthopaedic and neurosurgical implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.

This document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal interlaminal fixation orthosis. It's a regulatory submission affirming substantial equivalence to previously cleared devices, not a study reporting on the device's performance in detail against specific acceptance criteria. Therefore, the information requested about acceptance criteria and study details for device performance is largely not present in this document.

However, based on the context of a 510(k) submission for a spinal implant, we can infer some general aspects.

Here's an analysis of the provided text in relation to your request:

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

This document does not contain a table of acceptance criteria nor does it report specific device performance data in a quantitative manner as typically found in clinical studies or performance testing reports. This 510(k) submission focuses on demonstrating substantial equivalence to predicate devices, which implies that the new device meets the same safety and effectiveness standards as the predicate devices.

The "PERFORMANCE DATA" section states:

• "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*": "N/A" for characteristic, standard/test/FDA guidance, and results summary.
• "Comparative Performance Information Summary": "N/A" for characteristic, requirement, new device, and predicate device.
• "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION": "Not Applicable"
• "CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA": "Not Applicable; the system did not change. The surgical techniques were only updated to provide more detail. The overall implant process did not change."

This explicitly states that no new performance data (clinical or non-clinical) was generated or submitted for this particular 510(k). The purpose of this submission was to consolidate several cleared surgical techniques into two concise documents, implying that the device itself, and its performance characteristics, are considered unchanged from previously cleared versions.

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

As indicated above, there was no new test set used for a performance study described in this 510(k) submission. Therefore, information regarding sample size, data provenance, retrospective/prospective nature, or country of origin is not available in this document.

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)

Since there was no new test set or clinical study conducted, there's no information on experts establishing ground truth.

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

Not applicable, as no new test set or study was performed.

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 submission for a spinal implant system, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis would be part of this type of submission.

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

Not applicable, as this is not an algorithm-based device.

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

Not applicable, as no new performance study generating ground truth was described.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that would require a training set.

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

Not applicable, as this is not an AI/machine learning device.

Summary of what can be inferred from the document:

The VERTEXT® Reconstruction System is a spinal implant system. This 510(k) submission (K110522) by Medtronic Sofamor Danek USA, Inc. primarily served to:

• Consolidate existing surgical techniques for the device into updated documentation.
• Affirm that the device itself and its indications for use remain substantially equivalent to previously cleared predicate devices (listed in the document, e.g., K003780, K062447, etc.).

The "study" that proves the device meets acceptance criteria referred to by the applicant (Medtronic) is the accumulated body of evidence and prior clearances for the predicate devices and earlier versions of the VERTEX® Reconstruction System. This 510(k) is essentially a declaration that the changes (consolidation of surgical techniques) do not alter the substantial equivalence to those previously cleared devices, and therefore, no new performance data or clinical studies were deemed necessary by the FDA.

Ask a specific question about this device

When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine. In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations. The purpose of this submission is to add an adjustable Occipitocervical plate to the system. The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel. To achieve best results, do not use any of the VERTEX® Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The provided text is a 510(k) summary for the VERTEX® Reconstruction System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary for a spinal fixation orthosis like the VERTEX® Reconstruction System does not typically include clinical study data with acceptance criteria for device performance based on human reader studies, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies in the way one might expect for a diagnostic AI device.

Instead, for devices like these, "acceptance criteria" and "device performance" are primarily demonstrated through mechanical testing to prove that the new device component (the adjustable Occipitocervical plate) is mechanically equivalent to the predicate device and meets established safety standards for implantable medical devices.

Therefore, many of the requested categories for AI/diagnostic studies are not applicable to this document. I will fill in the relevant information as much as possible based on the provided text.

Acceptance Criteria and Device Performance Study for VERTEX® Reconstruction System (K091365)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of clinical data for AI/diagnostic performance. For mechanical testing, specific sample sizes (number of constructs or components tested) would have been used, but these exact numbers are not detailed in the 510(k) summary. These would be found in the full 510(k) submission, not the summary.
• Data Provenance: Not applicable for clinical study data. Mechanical testing data would be generated internally by the manufacturer.

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

• Not Applicable. This is a medical device, not a diagnostic AI system requiring expert consensus on image interpretation or disease diagnosis for a test set. Ground truth for mechanical testing is based on engineering standards and measurements.

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

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

7. The type of ground truth used

• For mechanical testing: The ground truth is based on established engineering standards, biomechanical principles, and predicate device performance data. The performance of the new component is compared against these benchmarks and the predicate device to demonstrate equivalence. This would include measurements of parameters like yield strength, ultimate tensile strength, fatigue strength, and stiffness.

8. The sample size for the training set

• Not Applicable. This device is not an AI model that requires a training set of data.

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

• Not Applicable. See point 8.

Summary of Relevant Information from the K091365 Document:

The K091365 document is a 510(k) summary for a Class II spinal implant. The primary method for demonstrating "acceptance criteria" and "device performance" relies on proving substantial equivalence to existing predicate devices.

The key statement regarding performance is:
"The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."

This indicates that the "study" demonstrating performance was mechanical testing of the device components (specifically, the added adjustable Occipitocervical plate). The "acceptance criterion" was that these mechanical test results had to be equivalent to those of previously cleared predicate devices or established standards for such implants. The document does not provide details on the specific test parameters, sample sizes, or numerical results of these mechanical tests within this summary, as is typical for 510(k) summaries. These details would be part of the full 510(k) submission to the FDA.

Ask a specific question about this device

When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

To achieve best results, do not use any of the VERTEX Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical. implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.

The presented document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal fixation device. This type of document is a premarket notification for a medical device submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary focuses on demonstrating "substantial equivalence" rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be seen for AI/ML-driven devices.

Therefore, many of the requested criteria for AI/ML device studies are not applicable to this document. The study described is primarily a mechanical testing comparison to predicate devices.

Here's an breakdown of the information that can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

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: This document describes mechanical testing for substantial equivalence, not a clinical study or an AI/ML model's test set on human data. The "sample size" would refer to the number of components tested mechanically, which is not specified in this summary.
• Data provenance: Not specified, as it's mechanical test data, not patient data.

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 for AI/ML models or clinical diagnostic studies is not relevant here. The "ground truth" for mechanical testing would be established by engineering standards and validated testing protocols, not expert consensus on medical images or patient outcomes.

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

• Not applicable: Adjudication methods are used in clinical studies or AI/ML model evaluations where there might be disagreement in expert interpretation. This is not how mechanical testing is assessed.

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 surgical implant system, not an AI-assisted diagnostic tool or a system that involves "human readers." No MRMC study was conducted.

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

• Not applicable: This device is a physical surgical implant. There is no algorithm or standalone performance in the context of AI/ML.

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

• For mechanical testing: The "ground truth" is defined by established engineering and biomechanical standards for spinal implant performance, typically involving load-to-failure, fatigue testing, and other mechanical property assessments. It's not a clinical "ground truth" like pathology or outcomes.
• For substantial equivalence: The "ground truth" is the performance and characteristics of the predicate devices.

8. The sample size for the training set

• Not applicable: This involves mechanical testing for substantial equivalence, not an AI/ML model with a training set.

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

• Not applicable: See above. There is no "training set" in the context of this 510(k) submission.

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