(30 days)
The Reli SP Spinous Plating System of Precision Spine, Inc. is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.
The Precision Spine Reli SP Spinous Plating System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The purpose of this submission is to offer an expanded size range for the Reli SP Spinous Plating System.
The provided text does not contain information regarding traditional acceptance criteria and device performance studies typically associated with AI/ML-driven medical devices. This document is a 510(k) premarket notification for a medical device called the "Reli SP Spinous Plating System," which is a spinal interlaminal fixation orthosis.
The document states that "Precision Spine has not conducted mechanical testing as part of this Special 510(k) Device Modification Premarket Notification." Instead, "An analysis was performed to determine the subject implants were substantially equivalent to the predicate devices, therefore no mechanical testing was conducted as part of this submission."
Therefore, I cannot provide the requested information in the format given, as the device is a physical implant and the regulatory submission relies on substantial equivalence to predicate devices rather than direct performance testing against specific acceptance criteria.
To answer your specific questions:
- A table of acceptance criteria and the reported device performance: Not applicable, as direct performance testing was not conducted. The submission is based on substantial equivalence.
- Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation was used.
- 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 test set was performed.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is a physical implant, not an AI/ML diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical implant, not a standalone algorithm.
- The type of ground truth used: Not applicable. The submission focuses on substantial equivalence based on manufacturing materials, indications for use, and design similarity to predicate devices.
- The sample size for the training set: Not applicable. No training set for an algorithm was used.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a regulatory submission for a physical medical device based on substantial equivalence, not on performance testing against specific acceptance criteria derived from a study involving data sets or expert analysis.
§ 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.