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The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:

• Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• . Spondylolisthesis
• . Trauma (fracture or dislocation)
• . Spinal stenosis
• Deformities or curvatures (scoliosis, kyphosis, lordosis) ●
• . Tumor
• . Pseudarthrosis
• . Failed previous fusion

The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from The screws are available in three configurations: 4mm diameter self 103-128mm. tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring The elastic ring is inserted into a (made titanium alloy Ti-6AI-4V as well). circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.

The provided text describes a medical device, the Sintea Plustek Anterior Cervical Plate System, and its 510(k) summary for FDA clearance. It focuses on the device's physical properties, indications for use, and a comparison to predicate devices, but does not describe an AI/ML-driven device or study parameters related to AI/ML performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to acceptance criteria and studies for an AI/ML device, which are not present in the provided document.

The document only states:

1. Acceptance Criteria and Device Performance (Mechanical Testing):
The study for this device was a mechanical performance test to demonstrate substantial equivalence, not an AI/ML performance study.

2. Sample size and data provenance (for AI/ML test set): Not applicable, as this is a mechanical medical device, not an AI/ML device.

3. Number of experts and qualifications (for AI/ML ground truth): Not applicable.

4. Adjudication method (for AI/ML test set): Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study (for AI/ML): Not applicable.

6. Standalone performance (for AI/ML algorithm): Not applicable.

7. Type of ground truth used (for AI/ML): Not applicable. The "ground truth" in this context refers to established mechanical testing standards (ASTM F1717-09) and performance of legally marketed predicate devices.

8. Sample size for the training set (for AI/ML): Not applicable.

9. How ground truth for the training set was established (for AI/ML): Not applicable.

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