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The VICTORY™ Lumbar Plate System is indicated for use through an anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels, or through an anterior surgical approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

The VICTORY™ Buttress Plate is intended to stabilize allograft at one level (L1-S1), aiding in spinal fusion and to provide temporary stabilization and augment of a spinal fusion. The device is not intended for load bearing applications.

The VICTORY™ Lumbar Plate System consists of 3- and 4-screw plates, buttress plates, and bone screws in various sizes to accommodate varying patient anatomy and surgical needs. The plates attach to the anterior, anterolateral portion of the lumbar or lumbosacral spine. The plates are used with variable angle screws. The implants are manufactured from titanium alloy.

This is a 510(k) Pre-market Notification for a medical device called the VICTORY™ Lumbar Plate System. It is not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and training/test set specifics for AI/ML performance is not applicable to this document.

The document describes the device, its indications for use, and confirms that mechanical testing was conducted to demonstrate substantial equivalence to predicate devices, in accordance with relevant ASTM standards and FDA guidance documents.

Here's what can be extracted from the document regarding the performance evaluation, even though it's not an AI/ML study:

1. A table of acceptance criteria and the reported device performance:

Since this is a mechanical device, the "acceptance criteria" are typically defined by the performance standards outlined in the referenced ASTM F1717 and FDA guidance documents for spinal plating systems. The document states that "Performance data demonstrate substantial equivalence to the predicate devices." This implies that the device met or exceeded the performance characteristics of the legally marketed predicate devices, as evaluated through the specified mechanical tests. Specific numerical acceptance criteria and reported performance values are not provided directly in this summary, as they would be contained within the full mechanical test reports submitted to the FDA.

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

• Sample Size: Not explicitly stated in this summary. For mechanical testing of medical devices, "sample size" typically refers to the number of device units tested for each specific mechanical property (e.g., how many plates were subjected to static compression bending). This detail would be in the full test reports.
• Data Provenance: The data is generated from controlled laboratory mechanical testing of the VICTORY™ Lumbar Plate System. There is no patient data involved.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. "Ground truth" in this context refers to established mechanical engineering principles and standardized testing methodologies as defined by ASTM and FDA guidance. The "experts" would be the engineers and technicians conducting the tests and interpreting the results against these established standards.

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

Not applicable. Adjudication methods are typically for human interpretation of data, such as in clinical trials or AI model evaluations. Mechanical testing is objective and relies on scientific measurement.

5. 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/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for mechanical testing is derived from established engineering standards and physical laws, as outlined in documents like ASTM F1717 and FDA guidance for spinal systems. It's about meeting quantifiable physical performance metrics.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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