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When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

The occipital bone screws are limited to occipital fixation only.

The use of pedicle screws, is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.

The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. This submission is a line extension to Altius OCT System to add CoCr rods and alternate styles of rods, and screws, as well as other system components to the system and to update the indications for use for the system as a whole.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

This 510(k) summary is for a spinal fixation system, which falls under the category of a medical device and not an AI/ML algorithm. Therefore, many of the requested points related to AI/ML studies (like MRMC, standalone algorithm performance, AI improvement over human readers, training set details) are not applicable to this document. The study described is a series of mechanical tests to demonstrate substantial equivalence to existing predicate devices.

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: This information is not explicitly stated in the summary. For mechanical tests, the "sample size" would refer to the number of constructs tested for each configuration.
• Data Provenance: The data is generated from mechanical laboratory testing of the device components, not from patient data. Therefore, concepts like "country of origin" or "retrospective/prospective" studies are not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. As this is a mechanical testing study for a physical device, expert-established ground truth (in the clinical sense, e.g., for image interpretation) is not relevant. The "ground truth" here is adherence to established mechanical testing standards (ASTM standards) and the comparison of performance metrics against predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert clinical assessments or diagnostic interpretations. This study involves objective mechanical performance measurements, not subjective expert reviews.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of an AI/ML system on human reader performance. This document describes mechanical testing of a spinal fixation device, which does not involve human readers for diagnostic interpretation.

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

• No. This is not an AI/ML algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

• The "ground truth" in this context is based on established mechanical testing standards (ASTM F2706, F1717, F1798) and performance characteristics of legally marketed predicate devices. The goal is to demonstrate that the new device's components meet these engineering and regulatory benchmarks, indicating that they are at least as safe and effective as existing devices.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of mechanical testing for a spinal fixation system. This concept applies to the development of AI/ML algorithms.

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 one.

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The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis. .
• trauma (i.e., fracture or dislocation), .
• . spinal stenosis.
• atlantoaxial fracture with instability, .
• occipitocervical dislocation, .
• revision of previous cervical spine surgery, and/or
• . spinal tumor.

The occipital bone screws are limited to occipital fixation only.

The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

Rod connectors, crossbars and set screws are being added to the Sierra spinal system. All products are fabricated from titanium alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

This document describes a 510(k) premarket notification for the Sierra™ spinal system, specifically referring to the addition of rod connectors, crossbars, and set screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or safety. Therefore, the provided information does not include details on acceptance criteria, a study proving performance against those criteria, or specific metrics like sensitivity, specificity, or reader improvement with AI.

Here's an analysis based on the provided text, highlighting the absence of the requested information due to the nature of a 510(k) submission:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the provided document. For 510(k) submissions, the “acceptance criteria” typically revolve around demonstrating substantial equivalence in terms of functionality, technological characteristics, and safety to a predicate device. This is often achieved through comparative testing (e.g., mechanical, material) and analysis rather than clinical performance metrics.
• Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the new components have "substantially equivalent technological characteristics to the predicate devices."

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

• Sample Size for Test Set: Not applicable/not provided. This document does not describe a clinical study in the traditional sense involving a "test set" of patients or data for performance evaluation. The "testing" likely involved mechanical and material characterization of the new components against established standards or predicate device specifications.
• Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/not provided. Ground truth establishment by medical experts is typically part of clinical performance studies, which are not detailed in this 510(k) submission.

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

• Not applicable/not provided. Adjudication methods are relevant for clinical studies that involve expert review of cases, which is not the focus of this document.

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 document concerns a conventional medical device (spinal fixation system components), not an AI-powered diagnostic or assistive tool.
• Effect size of human reader improvement with AI: Not applicable, as no AI component is described.

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

• Not applicable, as no algorithm or AI component is described.

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

• Not applicable. The "ground truth" for a 510(k) submission like this would involve demonstrating that the new components meet established engineering and material standards, and perform comparably to predicate devices in mechanical and functional tests. It is not about clinical ground truth derived from patient data.

8. The sample size for the training set

• Not applicable. There is no mention of an algorithm or AI requiring a training set.

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

• Not applicable. There is no mention of an algorithm or AI requiring a training set or ground truth establishment in this context.

Summary of what the document does provide:

• Predicate Devices: SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229).
• Basis for Equivalence: "The overall designs of the rod connectors, crossbars and set screws in this submission are substantially equivalent to the predicate devices." and "The devices in this submission have substantially equivalent technological characteristics to the predicate devices."
• Materials: All products are fabricated from titanium alloy.
• Intended Use: Promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for various conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and spinal tumor).
• Limitations: Occipital bone screws limited to occipital fixation; polyaxial screws limited to T1-T3 for thoracic conditions only, not for cervical spine.

In conclusion, this document is a 510(k) summary for a conventional medical device modification, which focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting clinical study results with performance metrics or AI algorithm validation.

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The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:

• degenerative disc disease (DDD) as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies,
• spondylolisthesis. .
• trauma (i.e., fracture or dislocation), .
• spinal stenosis, .
• atlantoaxial fracture with instability, .
• occipitocervical dislocation, .
• revision of previous cervical spine surgery, and/or .
• . spinal tumor.
  The occipital bone screws are limited to occipital fixation only.
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

A new occipital plate design is being added to the Sierra spinal system. All products are fabricated from titanium alloy and cobalt alloy. All products are supplied "NON-STERILE" and must be sterilized prior to use.

This document is a 510(k) premarket notification for the Sierra™ OCT Spinal System, specifically for the addition of a new occipital plate design. It is a submission to the FDA (Food and Drug Administration) for regulatory clearance. Since this is a submission for a Special 510(k) and the information provided points to substantial equivalence with existing predicate devices, the focus is on design and material equivalency, rather than clinical performance studies involving a test set, ground truth, or human-in-the-loop assessments as would be done for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The "acceptance criteria" here refer to satisfying FDA's requirements for substantial equivalence based on design, materials, and intended use.

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

1. A 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 (N/A). This submission is for a medical device (occipital plate) and relies on substantial equivalence to predicate devices, not clinical performance data from a test set of patients in the way an AI/ML device would. No patient data or test set in the traditional sense was used.

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)

• N/A. Ground truth establishment is not relevant for this type of submission, which focuses on engineering and design equivalency.

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

• N/A. No test set or human adjudication process as described is relevant.

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

• N/A. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was conducted.

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

• N/A. This is not an algorithm or AI system.

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

• N/A. The "ground truth" equivalent in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness. The new device is deemed safe and effective because its characteristics are substantially equivalent to those already cleared devices.

8. The sample size for the training set

• N/A. No training set is relevant for this device.

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

• N/A. No ground truth for a training set was established.

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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.

Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), 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.
The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

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

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion.
The VERTEX® Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct.

The VERTEX® Reconstruction System is a medical device and its "performance" is based on mechanical testing demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not a software or AI-driven system; its "performance" is demonstrated through mechanical testing to show substantial equivalence to already marketed devices. There are no specific acceptance criteria percentages (e.g., sensitivity, specificity) for device performance in this 510(k) summary, as it's a hardware device.

2. Sample Size for Test Set and Data Provenance

Not applicable. This device's clearance is based on mechanical testing (benchtop) rather than a clinical "test set" of patient data. Therefore, there's no data provenance in terms of country of origin or retrospective/prospective nature.

3. Number of Experts for Ground Truth and Qualifications

Not applicable. Ground truth for a hardware device in mechanical testing is typically defined by engineering specifications and objective measurements, not expert consensus.

4. Adjudication Method

Not applicable. There's no adjudication method mentioned as it's not a clinical study involving human assessment of device outcomes or image interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a hardware device submission, not an AI/software device that would involve human readers. Therefore, no MRMC study was performed, and there is no effect size of human readers improving with AI assistance.

6. Standalone Performance Study

In a sense, the mechanical testing is a "standalone" performance evaluation of the device components themselves, independent of human interaction in a diagnostic or interpretive capacity. However, it's not "standalone (i.e. algorithm only without human-in-the loop performance)" as understood in AI contexts. The testing determines if the components meet strength, fatigue, and other biomechanical criteria comparable to predicate devices.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be engineering specifications, biomechanical standards, and comparative data from predicate devices. This involves objective measurements of strength, durability, and other physical properties.

8. Sample Size for Training Set

Not applicable. This is not a machine learning or AI device that requires a training set of data.

9. How Ground Truth for Training Set was Established

Not applicable. No training set was used.

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