(65 days)
When intended to promote fusion of the cervical spine (Cl-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:
-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies)
-Spondylolisthesis
-Spinal Stenosis
-Fracture/dislocation
-Revision of previous cervical spine surgery
-Tumors
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.
The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and Hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium allov. The components will be provided non-sterile.
The provided document describes a 510(k) premarket notification for the "Sure Lok Mini Posterior Cervical/Upper Thoracic System," a spinal interlaminal fixation orthosis. However, this document does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device.
Instead, the document primarily focuses on establishing substantial equivalence for a physical medical device (spinal fixation system) to existing predicate devices.
Here's a breakdown of why it doesn't fit the requested criteria:
- Type of Device: The device described is a physical implant (polyaxial screws, rods, hooks) for spine stabilization, not an AI/ML algorithm or software.
- Performance Data: The "Performance Data" section explicitly states, "Risk analysis was conducted and led to the determination that additional mechanical testing is not required in order to establish the substantial equivalency of the subject devices to the predicate devices." This indicates that no new performance study (like a clinical trial or algorithm performance evaluation) was conducted or detailed in this document to assess specific acceptance criteria. Substantial equivalence was based on technological characteristics and mechanical engineering analysis, comparing it to existing, already approved devices.
- Missing Information: All points requested in your prompt (table of acceptance criteria, sample size, data provenance, expert numbers, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) are entirely absent because they are relevant to validating an AI/ML device, not a physical implant's substantial equivalence.
Therefore, I cannot extract the requested information from this document. This document is a regulatory submission for a traditional medical device, not an AI/ML product.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.