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STGC-Lordotic is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). STGC-Lordotic is intended to be used with autograft in combination with supplemental fixation indicated for use in the thoracolumbar spine.

STGC-Lordotic is a vertebral body replacement device manufactured from titanium allov (Ti-6Al-4V), and is available in a variety of sizes to suit the individual anatomic and clinical circumstances of each patient. STGC-Lordotic is a single-piece device manufactured using electrical discharge machining, having a trapezoidal cross section with a hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior approach, STGC-Lordotic is to be used in combination with supplemental fixation indicated for use in the thoracolumbar spine. STGC-Lordotic is provided with 8.2° to 11.5° of endplate angulation (lordosis). STGC-Lordotic is provided non-sterile to the end user.

This document describes a 510(k) premarket notification for the STGC-Lordotic device, a vertebral body replacement. The focus is on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not directly available from this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria or detailed performance metrics against those criteria. Instead, it states that "performance testing to demonstrate substantial equivalence included methods described in the standards ASTM F2077 Test Methods for Intervertebral Body Fusion Devices (static compression, dynamic compression, static torsion, dynamic torsion) and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression (subsidence). Static expulsion testing also was performed."

The conclusion is that "The performance data included in this submission demonstrate substantial equivalence to the predicate device K121176 and K003043." This implies that the device performed comparably to, or within acceptable ranges of, the predicate devices for these mechanical tests. Specific numerical performance values or defined acceptance thresholds are not presented in this document.

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

This document describes non-clinical performance testing (mechanical testing), not a clinical study involving human patients or data. Therefore:

• Sample size for test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of device units tested, which is not specified in this summary.
• Data provenance: Not applicable in the context of human data. The data originates from laboratory mechanical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as no clinical study involving human assessment of ground truth is described. The "ground truth" here is the physical performance of the device against established mechanical standards.

4. Adjudication Method

This is not applicable as no clinical study with human readers/assessors or their adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done or reported in this document. The device is a physical implant, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, a form of standalone performance was done in the sense of non-clinical bench testing of the device's mechanical properties (static compression, dynamic compression, torsion, subsidence, expulsion). This testing was against recognized ASTM standards. However, this is "algorithm only" performance, given the device is mechanical.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluation was the established mechanical testing standards (ASTM F2077 and ASTM F2267) and the performance of the predicate devices. The device's performance was compared against these standards and the known performance of the predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set

This is not applicable. The device is a physical implant assessed through mechanical testing; there is no "training set" in the context of an algorithm or AI.

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

This is not applicable for the reasons stated above.

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