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The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

The SmartLoc™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.

The provided text describes the SmartLoc™ spinal fixation system, a Class II medical device. However, the information available is limited to its regulatory clearance, intended use, and mechanical testing results. It does not present a study with acceptance criteria and reported device performance in the context of an AI/algorithm-based device and its clinical performance metrics.

Therefore, I cannot provide the specific details requested in your prompt regarding:

• A table of acceptance criteria and reported device performance (in the context of AI/algorithm performance)
• Sample sizes and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results
• Standalone (algorithm only) performance
• Type of ground truth used (clinical outcomes, etc.)
• Training set details (sample size, ground truth establishment)

Based on the provided text, the device is a physical spinal implant system, not an AI or algorithm-based diagnostic or assistive device. The "Performance Data" section describes mechanical testing of the physical components.

Here's what I can extract related to acceptance criteria and performance for this physical medical device:

Acceptance Criteria and Device Performance (for a Physical Spinal Fixation System)

The SmartLoc™ spinal fixation system underwent mechanical testing to demonstrate its performance. The acceptance criteria are implicitly tied to demonstrating performance "as well as or better than" predicate devices according to established industry standards.

Study Information (Mechanical Testing):

1. Test Set Sample Size & Data Provenance: Not explicitly stated as a "test set" in the context of clinical data. The study was a mechanical test (laboratory-based) performed on a "worst case SmartLoc™ construct." The data provenance is from the manufacturer's testing in support of their 510(k) submission.
2. Number/Qualifications of Experts (Ground Truth): Not applicable for mechanical testing. Performance is evaluated against engineering standards.
3. Adjudication Method (Test Set): Not applicable for mechanical testing.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is a mechanical test of a physical device, not an AI-assisted diagnostic tool.
5. Standalone (Algorithm Only) Performance: Not applicable. This is a physical device.
6. Type of Ground Truth Used: The "ground truth" for mechanical performance is adherence to the specified ASTM F1717 standard and comparison against the performance of legally marketed predicate devices.
7. Training Set Sample Size: Not applicable. This is not a machine learning device.
8. How Ground Truth for Training Set Was Established: Not applicable.

Summary regarding your specific questions:

The provided document describes the regulatory clearance of a physical medical device (spinal fixation system), not an AI-based system. Therefore, most of the questions pertaining to AI/algorithm performance, training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "Performance Data" provided is solely about the mechanical integrity of the implant system.

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