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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Acceptance Criteria (Implied by 510(k))	Reported Device Performance (from document)
Mechanical Performance	Equivalence to predicate devices in mechanical strength and stability under relevant biomechanical loads (e.g., as per ASTM F1717).	"The worst case components of the CASPIAN OCT/MESA Mini/ DENALI Mini System were previously tested in accordance with ASTM F1717 and determined to be equivalent to predicate devices."
	New components (03.5 contoured rods) do not represent a new worst-case scenario.	"The subject rods were determined not to represent a new worst case via finite element analysis and engineering rationale."
Material Biocompatibility	Use of biocompatible materials known to be safe for implantation.	"The subject devices are manufactured from Ti6Al4V Eli per ASTM and ISO standards."
Functionality	Ability to provide immobilization and stabilization of the posterior cervical and thoracic spine as an adjunct to fusion.	"The system functions as an adjunct to fusion to provide immobilization of stabilization of the posterior cervical and thoracic spine."
Intended Use	Alignment with established indications for use in spinal fixation.	The Indications for Use statement in the document specifies conditions like DDD, Spondylolisthesis, Fracture/dislocation, etc. The device is deemed substantially equivalent for these uses.
Design Characteristics	No significant differences from predicate devices that would adversely affect use.	"There are no significant differences between the CASPIAN OCT/MESA Mini/ DENALI Mini System and other systems currently being marketed which would adversely affect the use of the product."

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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