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The CASPIAN OCT/MESA Mini/ DENALI Mini Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and indicated for the following:

· DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• Spinal stenosis
• · Fracture/dislocation
• · Revision of previous cervical spine surgery
• · Tumors
• · Atlantoaxial fracture with instability
• · Occipitocervical dislocation

The occipital bone screws are limited to occipital fixation only

The rod and hook components are in the cervical/upper thoracic (CI-T3) spine. The pedicle screws are limited to placement in the TI-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The CASPIAN OCT/MESA Mini/ DENALI Mini System can also be linked to the Range Spinal System using rod connectors or transitional rods.

The CASPIAN OCT/MESA Mini/ DENALI Mini System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system. The purpose of the current submission is to add 03.5 contoured rods to expand the rod offerings for the system.

Materials: The subject devices are manufactured from Ti6Al4V Eli per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of stabilization of the posterior cervical and thoracic spine.

The provided document is a 510(k) summary for a spinal fixation system, not a study report for a medical device that uses AI or reports on acceptance criteria and performance data in the typical sense of a diagnostic or screening device.

Therefore, many of the requested categories for acceptance criteria and study design elements (such as sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission.

This 510(k) summary focuses on demonstrating substantial equivalence to previously marketed devices based on design, function, materials, and intended use, particularly for adding new rod sizes. The "acceptance criteria" here are implicitly related to mechanical testing and engineering rationale to ensure the new components maintain the same safety and effectiveness profile as the predicate devices.

Here's a breakdown of the relevant information from the document in relation to your request:

1. Table of Acceptance Criteria and 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 submission relies on mechanical testing standards (ASTM F1717) and engineering rationale/finite element analysis, not clinical 'test sets' of patient data in the context of AI or diagnostic devices. There is no mention of "patient data" test sets.

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" in this context would relate to defining mechanical testing parameters and interpreting engineering analyses, handled by biomechanical engineers and regulatory specialists, rather than clinical experts establishing ground truth for diagnostic imaging.

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

• Not Applicable: This relates to clinical data adjudication, which is not part of this 510(k) submission.

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, not an AI-powered diagnostic or screening device, so MRMC studies are irrelevant.

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

• Not Applicable: This is a medical device (spinal implant), not an algorithm.

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

• For the mechanical performance, the "ground truth" is established by adherence to recognized biomechanical testing standards (e.g., ASTM F1717) and engineering principles/ finite element analysis (FEA), indicating that the device meets defined physical strength and durability criteria. The overall ground truth for regulatory clearance is substantial equivalence to existing, legally marketed devices.

8. The sample size for the training set

• Not Applicable: This is a spinal implant, not a machine learning model, so there is no training set.

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

• Not Applicable: No training set exists for this type of device.

In summary, the provided document is a regulatory submission for a spinal fixation system, cleared based on substantial equivalence demonstrated through mechanical testing and engineering rationale, not clinical study data in the context of diagnostic performance.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following :
(a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
(b) spondylolisthesis,
(c) spinal stenosis
(d) trauma (i.e., fracture or dislocation).
(e) Atlanto-axial fracture with instability;
(f) Occipito-cervical dislocation:
(g) Tumors:
(h) Revision of previous cervical spine surgery
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1 - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1 - T3). The hooks are intended to be placed from C1 to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wire/cable attachment to the posterior cervical spine.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.

The Centurion POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium alloy or Cobalt Chrome alloy, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, parallel axial connectors, and lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

The Orthofix Centurion POCT System is a spinal fixation system intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction. The system's acceptance criteria are based on its substantial equivalence to predicate devices, demonstrated primarily through mechanical strength testing as per relevant ASTM standards.

Here's an overview of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify exact sample sizes for each mechanical test. However, "Mechanical testing" implies multiple units were tested to demonstrate performance against the specified ASTM standards.
• Data Provenance: The mechanical testing was conducted to support the substantial equivalence claim for the Centurion POCT System. This is typically done prospectively as part of product development and regulatory submission by the manufacturer (Orthofix Inc., a US company). The data would be considered prospective in the context of demonstrating performance for regulatory approval. The country of origin for the data is implicitly the United States as Orthofix Inc. is a US-based sponsor and the submission is to the FDA.

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

• This information is not applicable to this type of submission. The "ground truth" for medical device mechanical performance is established by standardized testing protocols (ASTM standards) and engineering principles, not by human expert consensus or clinical pathology. The "experts" are the engineers and testing laboratory personnel who conduct and analyze these mechanical tests, adhering to the specified standards.

4. Adjudication Method for the Test Set:

• This is not applicable to mechanical testing. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving human interpretation or subjective assessments. Mechanical tests yield objective, quantitative results directly comparable to established standards.

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:

• This is not applicable. The device described is a spinal implant for mechanical fixation, not an AI-powered diagnostic or interpretive tool that would involve human readers or image analysis.

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

• This is not applicable. The device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used:

• For mechanical testing, the "ground truth" is defined by the established performance criteria within the specified ASTM standards and the "Guidance for Industry and FDA Staff Spinal System 510(k)s" document. The device components must meet or exceed these predetermined mechanical thresholds to be considered substantially equivalent and safe/effective. This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set:

• This is not applicable. As a physical implant, this device does not utilize a "training set" in the context of machine learning or AI development. The design and manufacturing processes are informed by engineering principles and prior device knowledge, rather than a data training set.

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

• This is not applicable for the reasons stated in point 8.

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