(30 days)
The ISOLA Spinal System is a pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation. scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ISOLA Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The ISOLA Spinal System is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The ISOLA Polyaxial Washer construct will allow the current monoaxial screws of the ISOLA Spinal System to exhibit properties similar to those of polyaxial screws.
The provided document, K013441, is a 510(k) summary for the ISOLA Polyaxial Washer, a component of the ISOLA Spinal System. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria.
The document primarily describes the device, its intended use, and materials, and mentions that "Performance data were submitted to characterize the ISOLA Polyaxial Washer." However, it does not include:
- A table of acceptance criteria and reported device performance values.
- Details of a standalone algorithm performance study.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Data provenance for a test set (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for a training set.
- How ground truth for a training set was established.
This is typical for 510(k) submissions for spinal fixation devices, which often rely on mechanical testing rather than AI-driven clinical performance studies.
Therefore, based solely on the provided text, I cannot extract the information required to populate the table or answer the specific questions about acceptance criteria and study details as they pertain to AI or diagnostic performance.
The "Performance Data" mentioned likely refers to mechanical testing (e.g., fatigue, static strength, torsion) to ensure the device meets engineering specifications and functions as intended, rather than clinical efficacy or diagnostic accuracy as would be relevant for an AI/diagnostic device.
To answer your request, if this were a device requiring clinical performance or AI evaluation (which it is not), the information would typically be presented in a much more detailed clinical study report section, which isn't present in this 510(k) summary.
§ 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.