(205 days)
The Poseidon OCT Spinal Fixation 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 to 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 Poseidon OCT Spinal Fixation 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.
In order to achieve additional levels of fixation, the Poseidon OCT Spinal Fixation System may be connected to the Medyssey Zenius, Iliad or Kora Spinal Systems using parallel connectors and taper rods.
The Poseidon OCT Spinal Fixation System is a posterior fixation system designed for occipito-cervicalthoracic use for single and/or multilevel rigid fixation to treat occipital and/or cervical conditions of the spine.
Based on the provided text, the device in question is the Poseidon OCT Spinal Fixation System. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving novel acceptance criteria. Therefore, the information requested regarding acceptance criteria and a study proving the device meets them, especially in the context of AI/ML performance, is not present in this document.
For clarity, I will address each point based on what is available in the document, and explicitly state when the requested information is absent.
Here's an analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the manner typically associated with clinical studies or performance testing against specific numerical benchmarks for new or AI/ML-driven devices. Instead, it states:
| Criterion Type | Details from Document |
|---|---|
| Performance Standards Utilized | Pre-clinical testing was conducted per ASTM F2706 and ASTM F1798. This implies that the device's mechanical performance was evaluated against the standards outlined in these ASTM specifications. The "acceptance criteria" would implicitly be the passing requirements of these standards. |
| Tests Conducted | - Static and dynamic axial compression, static torsion and static tension per ASTM F2706. |
- Static and dynamic interconnection mechanism and subassemblies per ASTM F1798. |
| Stated Outcome | "These comparisons demonstrate substantial equivalence to the predicate devices." This is the primary "reported device performance" in the context of a 510(k), meaning its performance is considered comparable to the legally marketed predicates. |
| Specific Performance Values | Not provided in this document. |
| Acceptance Criteria Values | Not explicitly stated but are inherent to the ASTM standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The document describes pre-clinical mechanical testing, not a clinical study involving a test set of human data. Therefore, concepts like sample size for a test set, data provenance, or retrospective/prospective nature do not apply in the context of this 510(k) summary.
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)
This information is not applicable as the document describes pre-clinical mechanical testing, not a study requiring expert consensus or ground truth establishment from medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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 information is not applicable. The device is a spinal fixation system, a physical implant, not an AI/ML-driven diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical spinal fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the pre-clinical mechanical testing, the "ground truth" would be the expected mechanical behavior according to the ASTM standards (F2706 and F1798). This is determined by the specifications and measurement techniques defined within those engineering standards, rather than medical ground truth like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 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.