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The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The Spinal Edge TITAN Pedicle Screw System consists of longitudinal rods, polyaxial screws, and transverse connectors. The Spinal Edge TITAN Pedicle Screw System components are available in titanium alloy conforming to ASTM F-136 specifications.

The provided text describes the regulatory clearance of the Spinal Edge TITAN Pedicle Screw System. Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a table format. Instead, it relies on demonstrating comparable function and performance characteristics to the predicate device as the primary acceptance criterion. The performance is reported in relation to relevant industry standards.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document mentions "Representative samples of the device" were tested. However, the exact sample size (e.g., number of screws, number of constructs) used for the mechanical testing is not specified.
• Data Provenance: The testing methodology ("ASTM F1717 'Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model'") describes a laboratory-based, ex-vivo (or simulated in-vitro) test. Therefore, it's not applicable to "country of origin of the data" or "retrospective/prospective" in the clinical sense, as it's a mechanical performance study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device and study. The "ground truth" here is objective mechanical performance measured against a standard, not expert interpretation of clinical data. The ASTM F1717 standard itself defines the "ground truth" in terms of physical properties and behaviors under specified loads.

4. Adjudication Method for the Test Set:

This information is not applicable. Mechanical testing against a standard does not involve an adjudication method in the way clinical studies or image interpretations do. The results are typically quantitative measurements compared directly to specified limits or benchmarks.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. The TITAN Pedicle Screw System is a physical implant, and its performance is assessed through mechanical testing, not through human reading of cases.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a surgical implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used:

The ground truth used for this study is based on engineering standards and established material science properties. Specifically, the ASTM F1717 standard defines the appropriate testing methodology and expected performance characteristics for spinal implant constructs in a vertebrectomy model. The "ground truth" is therefore objective mechanical strength, stiffness, and fatigue resistance as measured against the parameters defined by this engineering standard.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this type of device.

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