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The CastleLoc-P Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:

• · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
• · spondylolisthesis,
• · trauma (i.e. fractures or dislocations),
• · tumors,
• · deformity (defined as kyphosis, lordosis, or scoliosis),
• · pseudoarthrosis.
• · failed previous fusion,
• · spinal stenosis.

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

The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, four-level fusion configurations (13~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile.

The AccelFix Lumbar Plate System's implants are Lumbar Plate System intended for use as an aid in spinal fixation. They are made from titanium alloy per ASTM F136. The AccelFix Lumbar Plate System consists of a variety of shapes and sizes of plates and screws. The plate has been designed to include spikes for added stability and alignment during screw insertion. The plates feature a curvature for anatomic fit. The diameter of screw is available from 5.5 to 6.0 mm and the length from 20 to 55 mm.

This document is a 510(k) Pre-Market Notification from the FDA, which declares substantial equivalence for medical devices to legally marketed predicate devices. It typically does not contain acceptance criteria or study results demonstrating performance in the way a clinical trial or AI device validation would.

Instead, the FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that is not subject to pre-market approval (PMA).

Based on the provided text, here's what can be extracted and inferred regarding "acceptance criteria" and "study":

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

This document does not contain a table of acceptance criteria or reported device performance in the context of diagnostic accuracy or clinical outcomes for the CastleLoc-P Anterior Cervical Plate System or the AccelFix Lumbar Plate System. The submission is a 510(k) for spinal intervertebral body fixation orthoses, which are mechanical implants, not AI/diagnostic devices.

The "performance testing" section, specifically for the CastleLoc-P Anterior Cervical Plate System and AccelFix Lumbar Plate System, states:

"The additional components to be added through this submission do not require additional mechanical testing. None of the additional components is the worst case of the CastleLoc-P Posterior Anterior Cervical Plate System."
"Therefore, we substitute mechanical test data of CastleLoc-P Anterior Cervical Plate System (predicate devices K113509, K143279, K190425) and AccelFix Lumbar Plate System (predicate device K 192481) for additional components with the predicate device data."

This indicates that instead of new performance tests for the new components, the company relied on the existing mechanical test data of the predicate devices. Therefore, the "acceptance criteria" implied are that the new components perform no worse than the predicate devices' mechanical properties. However, these specific mechanical properties (e.g., fatigue strength, torsional rigidity) and their quantitative acceptance limits are not detailed in this document.

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

Not applicable. As explained above, no new performance study with a test set of data (e.g., patient cases) was conducted for these devices as part of this 510(k). The evaluation relies on the substantial equivalence to predicate devices, including their prior mechanical testing.

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

Not applicable. This is not a study involving ground truth established by experts for a diagnostic or AI device.

4. Adjudication method for the test set:

Not applicable. No such test set or adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Not applicable. This is not a diagnostic device for which an MRMC study would typically be performed.

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

Not applicable. This is a spinal implant, not an algorithm or AI device.

7. The type of ground truth used:

Not applicable. "Ground truth" in the context of diagnostic or AI studies is not relevant here. The evaluation instead relies on conformity to material specifications (ASTM F136) and the mechanical performance previously established for the predicate devices.

8. The sample size for the training set:

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

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

Not applicable. There is no "training set" or corresponding ground truth establishment process described.

In summary:

This 510(k) submission for the CastleLoc-P Anterior Cervical Plate System and AccelFix Lumbar Plate System focuses on demonstrating substantial equivalence to existing predicate devices. The "study" mentioned for performance is the reliance on prior mechanical test data of the predicate devices. The document does not provide details on specific acceptance criteria and detailed performance data from new studies in the manner typically expected for AI/diagnostic software.

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