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MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is designed to be used at L5/S1 level. It is intended for use as anteriorly placed supplemental fixation device via the anterior surgical approach below the great vessel bifurcation. The device is intended as a temporary fixation device until fusion is achieved.

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate system is intended for anterior lumbar spine at L5/S1 level, for the following indications:

1. Degenerative Disc Disease (DDD) at L5/S1 level. (DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies)
2. Pseudoarthrosis
3. Spondylolysis
4. Trauma (i.e., fracture or dislocation)
5. Spinal stenosis
6. Deformities and or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
7. Tumor
8. Failed previous fusion.

MEDICREA® INTERNATIONAL anterior lumbo-sacral plate is intended to be used with autograft and or allograft as an adjunct to fusion.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage and a lumbo-sacral plate for degenerative conditions.

The MEDICREA® Anterior Lumbo sacral Plate system is a stabilization device for use as an adjunct to fusion. The implant is composed of :

• one lumbo sacral plate
• either 3 or 4 anterior lumbar screws , depending on the lumbosacral plate considered in the range

The anterior lumbar screw is manufactured from titanium alloy meeting ASTM F136 and ISO 5832-3 standards, and the lumbosacral plate is manufactured from titanium alloy meeting ASTM F136 and ISO 5832-3 and PEEK OPTIMA® meeting the ASTM F 2026.

Acceptance Criteria & Device Performance:

The provided document does not explicitly state "acceptance criteria" with numerical targets for device performance. Instead, it demonstrates substantial equivalence to predicate devices through a comparison of design, materials, and mechanical testing results. The "reported device performance" is essentially that it met the testing standards for spinal implants and performed comparably to predicate devices in those tests.

Therefore, the table below reflects what can be inferred as "acceptance criteria" (meeting the established standards and demonstrating equivalence) and the "reported device performance" (the device successfully underwent these tests).

Study Information:

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

   • No human-based test set was used for this 510(k) submission. The "test set" refers to the specific device samples that underwent the non-clinical mechanical testing. The document does not specify the exact number of device samples used for each test (Static axial Compression, Static torsion, Dynamic compression).
   • Data Provenance: The data provenance is from in vitro mechanical testing performed according to recognized ASTM standards. No human or animal data is involved. The testing was conducted by MEDICREA® INTERNATIONAL.

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

   • Not applicable. The ground truth for mechanical testing is established by engineering principles and adherence to standardized testing protocols (ASTM F1717). No human expert consensus was required for establishing "ground truth" in this context.

3. Adjudication method for the test set:

   • Not applicable. As this was non-clinical mechanical testing, there was no adjudication method in the sense of expert review of case outcomes. The results of the mechanical tests were directly measured and compared against the standards and predicate device characteristics.

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 device is a spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

   • Not applicable. This device is a physical medical implant, not a software algorithm.

6. The type of ground truth used:

   • Mechanical Performance Ground Truth: The ground truth for the mechanical testing was defined by the requirements and methodologies outlined in ASTM F1717, a recognized standard for spinal implant constructs.
   • Substantial Equivalence Ground Truth: The ground truth for demonstrating substantial equivalence was the characteristics and performance of the legally marketed predicate devices, as well as the established indications for use and material standards.

7. The sample size for the training set:

   • Not applicable. As this is not a machine learning or AI device, there is no "training set."

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

   • Not applicable, as there was no training set.

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