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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.

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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.

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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.

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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.

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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.

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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.

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True Tulip and True M.I.S. are intended for posterior, noncervical (T1-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, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric 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, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, True Tulip and True M.I.S. are intended to treat pediatic 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.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the "True Tulip System" and "True M.I.S. System," which are thoracolumbar-sacral pedicle screw systems.

This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a study demonstrating the device meets specific performance acceptance criteria for an AI or imaging diagnostic device.

Therefore, I cannot extract the information required to populate the fields you requested, such as:

• A table of acceptance criteria and reported device performance: The document does not define performance acceptance criteria for an AI/imaging device, nor does it report any performance metrics against such criteria.
• Sample size and data provenance for the test set: There is no mention of a test set, its size, or data provenance.
• Number of experts and qualifications for ground truth: No expert involvement for establishing ground truth is mentioned.
• Adjudication method: Not applicable as there's no mention of expert review or ground truth adjudication.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is described.
• Standalone (algorithm only) performance: The device described is a physical surgical implant, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable (no AI/machine learning training involved).
• How ground truth for training set was established: Not applicable.

The document entirely pertains to the regulatory process for a physical medical device, highlighting its intended use and classification based on substantial equivalence to existing devices. It does not contain information about the development or validation of an AI/imaging diagnostic algorithm.

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Redi-Spine 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, syphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

When used for posterior non-cervical pediatic patients, the Redi-Spine 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. Additionally, the Redi-Spine is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach. The Redi-Spine is intended to be used with autograft and/or allograft.

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This document is a 510(k) clearance letter for the Redi-Spine Thoracolumbosacral pedicle screw system, indicating it has been found substantially equivalent to a legally marketed predicate device. This type of document describes the intended use and regulatory classification of the device, but it does not contain information about acceptance criteria or the study that proves the device meets specific performance criteria.

Therefore, I cannot extract the requested information from the provided text. The document does not include details on:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Results of a standalone algorithm-only performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a surgical fixation system, indicating that the device is substantially equivalent to a predicate device. It specifies the indications for use but does not delve into performance metrics or supporting studies.

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The True Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Not Found

This is an FDA 510(k) clearance letter for a spinal fixation system, which is a physical medical device, not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria, study details, ground truth, and human-in-the-loop performance is not applicable to this document. The letter simply states the device's substantial equivalence to a predicate device based on its indications for use.

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