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The Transcorp Trans-Plate Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, or failed previous fusion.

The Transcorp Trans-Plate Anterior Cervical Plate System includes The Transoorp Trans Fivical plates and bone screws. The anterior cervical plate system includes a cover plate that covers the bone screws and the "window" of the plate. The cover plate is manufactured from implant grade PEEK conforming to ASTM F2026na. The plates, screws, and cover plate locking blade are manufactured from Titanium Alloy conforming to ASTM F136-08. The plate is fixated by attaching screws through holes in the plate to The plate is fixution of the vertebral body of the cervical spine (C2-C7).

Here's an analysis of the provided information regarding the Transcorp Trans-Plate Anterior Cervical Plate System's acceptance criteria and studies:

Key Takeaway: This 510(k) submission does not involve a study related to AI or any medical imaging device. It is for a mechanical spinal implant (plate and screws) and relies solely on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested points regarding AI/imaging studies, ground truth, expert consensus, and human reader performance are not applicable.

Acceptance Criteria and Reported Device Performance

The "reported device performance" for this submission is consistently stated as demonstrating equivalence to the predicate devices based on the test results. Specific numerical results are not provided in this summary document.

Further Information (Addressing all points, noting applicability)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided document. For mechanical testing of medical devices, sample sizes are typically determined by statistical requirements for engineering studies (e.g., to achieve a certain confidence level in material properties or fatigue life) rather than patient data.
   • Data Provenance: The testing was "performed on the Transcorp Trans-Plate Anterior Cervical Plate System," implying in-house or contract lab testing. It is not patient data (e.g., country of origin is not applicable). It is not retrospective or prospective clinical data. It is laboratory-based mechanical test data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This submission is for a mechanical implant and relies on standardized engineering tests (ASTM F1717, F1877). "Ground truth" in the context of expert consensus on medical findings is not relevant here. The "truth" is determined by the physical properties and performance measured against the standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication methods are used for resolving disagreements in expert interpretations, typically in clinical studies or when establishing ground truth from imaging. For mechanical testing, the results are typically directly measured and analyzed according to the specified ASTM standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This is not an AI or imaging device. There were no human readers involved in evaluating the performance of this mechanical implant, nor was there any AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. As noted, this is a mechanical device. The "ground truth" for its performance is derived from measurements of physical properties and mechanical behavior compared against accepted engineering standards (ASTM F1717, ASTM F1877) and against the performance of legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not Applicable. There is no "training set" for this mechanical device.

Summary of the Study:

The "study" conducted for the Transcorp Trans-Plate Anterior Cervical Plate System was a series of non-clinical performance tests aimed at demonstrating the mechanical equivalence of the new device to established predicate devices already on the market. These tests included:

• Static Torsion (per ASTM F1717): Measures the device's resistance to twisting forces.
• Static Bending Compression (per ASTM F1717): Measures the device's resistance to forces that would bend and compress it.
• Dynamic Bending Compression (per ASTM F1717): Measures the device's fatigue life and performance under repetitive bending and compression forces.
• Wear Testing Analysis (per ASTM F1877): Assesses the generation of particulate and wear debris, which can be critical for biocompatibility and long-term implant function.

The fundamental principle behind this 510(k) submission is that if the new device demonstrates similar mechanical properties and performance characteristics to previously approved predicate devices, it can be considered "substantially equivalent" and thus safe and effective for its intended use without requiring new clinical trials or evaluations of diagnostic accuracy.

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