(101 days)
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
The Cure™ Lumbar Plates (Cure™ - LP IView and Cure™ - QMax ) are available in a range of sizes to coincide with the surgical approach. The Cure™ - LP IView is identical to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole and the inclusion of a central rib at the through hole location. The Cure™ - LP QMax is identical to the Cure™ Lateral Lumbar plate with the exceptions of plate width and number of screw holes allocations. All Cure™ Lumbar Plates are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The provided text describes a 510(k) premarket notification for the "Cure™ Lumbar Plate System." This document is a regulatory submission to the FDA, asserting substantial equivalence to an existing predicate device. It does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the context of AI/ML performance.
Medical device approvals like this typically focus on demonstrating safety and effectiveness based on similarity to previously approved devices (predicates) and mechanical testing for physical properties. They do not involve the kind of performance studies with ground truth, expert readers, or AI/ML metrics that your questions refer to.
Therefore, I cannot answer most of your detailed questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.
Here's what I can extract based on the document's content:
- Device Name: Cure™ Lumbar Plate System
- Predicate Device: K171538 (Cure™ Lumbar Plate System)
- Purpose of the Submission: To demonstrate substantial equivalence of the Cure™ Lumbar Plate System (specifically the Cure™ - LP IView and Cure™ - LP QMax models) to the predicate device.
- Basis for Equivalence: Identical intended use and consistency in fundamental scientific technology.
Regarding "Non-clinical Testing" (Section G):
The document mentions "An engineering analysis was performed on the previously cleared Cure™ Lumbar Plate System" which "included static compression bending, static torsion, and dynamic compression bending." It concludes that the new plates are "superior in mechanical function and properties to the predicate device."
This section describes mechanical testing of the physical implant, not performance of an AI/ML algorithm. These tests are typically defined by ASTM standards and have their own internal acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) but these are for the hardware and are not related to algorithm performance metrics like sensitivity, specificity, or reader improvement.
In summary, the provided document does not support answering the questions related to AI/ML device performance studies.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.