(54 days)
The Lineum OCT Spine 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. pseudarthrosis); 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 Lineum OCT Spine 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 Lineum OCT Spine System can also be connected to the Biomet Polaris System via transitional rods or using the Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
The Lineum OCT Spine System consists of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusions. The system can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The implants are designed for the occiput, cervical, and/or upper thoracic spine (Occiput – T3) and consist of medical grade titanium alloy and CoCrMo alloy, similar to the predicate device.
The provided document is a 510(k) premarket notification summary for a medical device called the "Lineum OCT Spine System." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data focusing on mechanical and material properties, rather than clinical efficacy studies often seen with AI/ML devices. As such, the information required for a detailed AI/ML device study description (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.
The document discusses mechanical performance data, not AI/ML algorithm performance. Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, the study proving it meets them, sample sizes for AI/ML tests, ground truth details, expert qualifications, or MRMC studies, as these concepts are not applicable to the content of this regulatory submission.
Here's what the document does provide regarding performance data:
Performance Data (Mechanical)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria, but implied to meet or exceed. | The modified device functions as intended. The observed test results demonstrate that the device performs as well as or better than the unmodified system. |
Study Details (Mechanical Testing):
- Study Type: Non-clinical mechanical construct and component testing.
- Standards Used: Based on ASTM F2706 (Standard Test Method for Static and Fatigue Testing of a Spinal Orthosis for the Occiput-Cervical-Thoracic Spine) and ASTM F1798 (Standard Guide for Evaluation of Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Anterolateral Cervical Spine Fusion Constructs).
- Purpose: To support the substantial equivalence of the modified Lineum OCT Spine System to its predicate device.
- Conclusion: The mechanical testing provided demonstrates the substantial equivalence of the subject Lineum OCT Spine System.
Missing Information (Not applicable to this type of device submission):
- Sample size used for the test set and data provenance (e.g., country of origin, retrospective or prospective) for an AI/ML algorithm.
- Number of experts used to establish ground truth for a test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human readers with/without AI assistance.
- Standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML algorithm.
- Sample size for the training set (for an AI/ML algorithm).
- How the ground truth for the training set was established (for an AI/ML algorithm).
§ 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.