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When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.

The IST Pedicle Screw System includes pedicle screws. polyaxial screw heads, locking caps and rods. The components are fabricated from titanium alloy (ASTM F-136). The system can be used in either percutaneous or open surgery procedures. The system components are provided clean and nonsterile for steam sterilization at the user's facility.

This document is a 510(k) summary for the Innovative Spinal Technologies Pedicle Screw System. It provides information for marketing the device. However, it does not contain any performance data from a study used to prove the device meets specific acceptance criteria.

Here's why and what's missing:

• "PERFORMANCE DATA: Performance data were submitted." This line indicates that performance data was submitted to the FDA, but the document itself does not present or describe that data, nor does it list specific acceptance criteria.
• 510(k) Pre-market Notification: A 510(k) is a pre-market submission demonstrating that the device is "substantially equivalent" to a legally marketed predicate device. While this process may involve some performance testing, the 510(k) summary provided here focuses on the device description, intended use, and substantial equivalence, rather than detailed study results against acceptance criteria as requested in the prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance (for a study of performance).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document serves as a regulatory clearance document, not a detailed scientific study report.

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