Search Results

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.

Ask a specific question about this device