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The Centurion POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and cables (Titanium).

This document is a 510(k) premarket notification for a medical device called the Centurion POCT System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving the device meets specific acceptance criteria through a clinical or algorithmic performance study.

The submission is for additional components (new rods) to an already cleared system (K180025). The manufacturer explicitly states:

"The subject devices being added to the previously cleared Centurion POCT System (K180025) specify the same rod diameter, material, surface finish, and intended use as the previously cleared devices and therefore are substantially equivalent in design and performance. There are no significant differences between the new subject devices and the predicate devices that would introduce a new worse case for performance testing. Therefore, no additional performance testing is required."

This means they are not presenting a study with acceptance criteria and performance data for a new device's efficacy or accuracy. Instead, they are arguing that because the new components are so similar to already approved ones, they don't need new performance studies.

Therefore, for your specific requests, I cannot extract the information because the provided document does not contain an acceptance criteria table or details of a study proving device performance against such criteria. There is no mention of AI/ML, human readers, or expert consensus analysis related to performance.

Here's why each point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on mechanical equivalence to predicate devices, not performance criteria for a clinical outcome or diagnostic accuracy.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance mentioned for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a performance study.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML or diagnostic device requiring such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical orthopedic implant system, not a software algorithm.
7. The type of ground truth used: Not applicable.
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.

In summary, the provided document is a regulatory submission for device modifications based on substantial equivalence, not a study report demonstrating clinical or algorithmic performance against predefined acceptance criteria.

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The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 - T3): traumatic spinal fraumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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 allov or Cobalt Chrome allov, that allow the surgeon to build a spinal implant construct. The Centurion POCT System consists of an assortment of rods, set screws, cross connectors, parallel and axial connectors, lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

This FDA 510(k) K180025 submission describes a modification to an existing device, the Centurion POCT System, specifically a design change to the set screw component of the cross connector to include a retention feature. It is a Special 510(k) submission, meaning it relies on previously established substantial equivalence and focuses on the impact of the modification.

Therefore, the submission does not contain a new study to prove the device meets acceptance criteria in the traditional sense of a clinical trial or a performance study to establish new clinical efficacy or safety. Instead, the focus is on demonstrating that the modification does not negatively impact the device's performance compared to its predicate device, which was already cleared.

Here's a breakdown of the requested information based on the provided document, much of which will be listed as "Not Applicable" for this type of submission:

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)

• Sample Size for Test Set: Not specified in the document. For static mechanical testing, the "sample size" would typically refer to the number of test articles (modified set screws/cross connectors) tested to meet the ASTM F1798-13 standard.
• Data Provenance: Not specified, but generally, such engineering tests are conducted in a laboratory environment, likely within the manufacturer's R&D or QA facilities, or third-party testing labs.

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. This submission details engineering performance, not interpretative medical decisions. Ground truth in this context is based on physical measurements and compliance with engineering standards.

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

• Not Applicable. This is an engineering verification of a physical device component, not a diagnostic or interpretative study.

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 spinal fixation 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 device is a spinal fixation system, not an algorithm.

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

• Engineering Standards: The "ground truth" for the mechanical testing is defined by the requirements and methodologies outlined in the ASTM F1798-13 standard ("Standard Test Method for Static and Fatigue Bending Properties of a Spinal Rod with Transverse Connectors"). Compliance with these standardized performance metrics constitutes the ground truth for this type of evaluation.

8. The sample size for the training set

• Not Applicable. This is a physical device modification, not a machine learning model.

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

• Not Applicable. This is a physical device modification, not a machine learning model.

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The Centurion POCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 – T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Centurion POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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, cross connectors, parallel and axial connectors, lateral offset adapters, multi-axial screws, hooks, occipital plates, bone screws, and cables.

This document is a 510(k) premarket notification for the Orthofix Centurion POCT System, which is a spinal fixation system. It expands the indications for use of an existing device (K131833) to include the use of posterior screws in the cervical region of the spine.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not specify quantified acceptance criteria (e.g., specific tensile strength values, fatigue limits). Instead, the performance assessment relies on demonstrating equivalence to predicate devices through mechanical testing standards.

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

The document mentions "mechanical testing" and "published literature". It does not specify a human "test set" or explicit sample sizes for the mechanical tests themselves.

• Sample Size: Not explicitly stated for specific tests, but implicitly refers to the number of test articles (implants) tested to meet the ASTM standards.
• Data Provenance: The document does not specify the country of origin. It relies on "mechanical testing per ASTM F1717 & F2706" and "published literature". These are laboratory tests, not data from human subjects. The data is likely prospective in the sense that the tests were performed specifically for this submission, although the standards themselves are established.

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 for a spinal implant fixed via mechanical testing, not a diagnostic or prognostic device requiring expert interpretation of human data.

4. Adjudication Method for the Test Set:

• Not applicable. No human test set or adjudication process is 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 device is a mechanical spinal implant, 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 device, not an algorithm.

7. The Type of Ground Truth Used:

• Mechanical Testing Standards: The "ground truth" for the device's performance is its ability to meet the established mechanical testing criteria outlined in ASTM F1717 and ASTM F2706. These standards define the acceptable mechanical properties (e.g., static and dynamic strength, torsion resistance) for spinal implant assemblies.
• Predicate Device Equivalence: The ultimate ground truth for this 510(k) submission is substantial equivalence to the legally marketed predicate devices, meaning it performs as safely and effectively as a device already on the market.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device submission based on mechanical testing and predicate device comparison, not an AI or machine learning model that would require a training set.

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

• Not applicable. As above, there is no training set for this type of device submission.

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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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