Search Results

True Tulip is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

When used for posterior non-cervical pediation in pediatic patients, the True Tulip is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idopathic scoliosis (AIS), neuromuscular scoliosis, and congental scoliosis. Additionally, the True Tulip is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True Tulip is intended to be used with autograft and/or allograft.

Not Found

This looks like regulatory correspondence for a medical device and does not contain information about the acceptance criteria or a study proving the device meets them. The document is primarily an FDA 510(k) clearance letter for a "Thoracolumbosacral Pedicle Screw System" and details the indications for use for the device. It does not include information about the performance of any AI/ML component, clinical study data, or acceptance criteria related to a study.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

True Tulip and True M.I.S. are intended for posterical (TI-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, sooliosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

When used for posterior non-cervical pediatic patients, True Tulip and True M.I.S. are indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. Additionally, True Tulip and True M.I.S. are intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pedicle screw fixation is limited to a posterior approach. True Tulip and True M.I.S. are intended to be used with autograft and/or allograft.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (True Tulip, True M.I.S. pedicle screw system). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

However, the document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other data related to a clinical study or performance evaluation of the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

Ask a specific question about this device

True Tulip is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

When used for posterior non-cervical pediation in pediatic patients, the True Tulip is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the True Tulip is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True Tulip is intended to be used with autograft and/or allograft.

True M.I.S. is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization in skeletally mature patients as an adjunct to fusion for the following acute and chronic instabilities or deformities of the thoracic. lumbar. and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

When used for posterior non-cervical pediatic patients, the True M.I.S. is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idionathic scoliosis (AIS), neuromuscular scoliosis. Additionally, the True M.I.S. is intended to treat pediatric patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma. pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach. The True M.I.S. is intended to be used with autograft and/or allograft.

Not Found

The provided text is an FDA 510(k) clearance letter for two medical devices, "True Tulip" and "True M.I.S.", which are Thoracolumbosacral Pedicle Screw Systems. This document outlines the FDA's determination of substantial equivalence to predicate devices and provides information about the intended use of the devices.

However, this document does NOT contain any information regarding: acceptance criteria, device performance testing data, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request using the provided text. The requested information pertains to performance studies and validation, which are not detailed in this FDA clearance letter.

Ask a specific question about this device