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The Deltaloc Anterior Cervical Plate System is indicated for use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.

The Deltaloc Anterior Cervical Plate System consists of plates and screws that are used for attachment to the anterior cervical spine. Plates are offered in a variety of sizes with varying numbers of screw holes to accommodate single to quadruple level fusions. Plates are shaped with both radial and lordotic curvature and contain a deformable tab at each screw hole to capture the screws to the plate, preventing screw digression. Screws are offered in two diameters and four lengths per diameter. All screws are also available so that their angle relative to the plate is fixed or variable.

The plates of the Deltaloc Anterior Cervical Plate System are manufactured from commercially pure titanium and the screws are manufactured from titanium alloy (Ti-6Al-4V).

This document is not a study; it is a 510(k) premarket notification for the Deltaloc Anterior Cervical Plate System. A 510(k) notification aims to establish substantial equivalence to a predicate device already on the market, rather than proving device performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document.

However, I can extract the information that is available:

1. A table of acceptance criteria and the reported device performance
This document, being a 510(k) notification, does not provide specific performance criteria or a table comparing them to reported device performance. It focuses on demonstrating substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a premarket notification for a medical device (cervical plate system), not a study involving a test set of data.

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. This is a premarket notification for a medical device (cervical plate system), not a study involving expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 device is a physical implant (cervical plate system), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Information that is available from the document:

• Device Name: Deltaloc Anterior Cervical Plate System
• Manufacturer: Alphatec Manufacturing, Inc.
• Intended Use/Indications: For use in the anterior cervical spine (C2-C7) in patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.
• Predicate Device: Synthes CSLP (Cervical Spine Locking Plate) System
• Basis for Approval: Substantial equivalence to the predicate device in design, function, materials used, and indications for use.
• Materials: Plates from commercially pure titanium, screws from titanium alloy (Ti-6Al-4V).

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