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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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