(11 days)
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:
- 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.
- Sample sized used for the test set and the data provenance: Not applicable. No test set or data provenance mentioned for performance evaluation.
- 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.
- Adjudication method for the test set: Not applicable.
- 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.
- 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.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. No training set for an algorithm.
- 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.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are 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.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.