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MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device is designed individually for each patient and indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

UNID® IB3D ALIF device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

The MEDICREA® INTERNATIONAL UNiD® IB3D ALIF device consists of one single implant with specific heights, footprint, lordosis and coronal angle. Patient matched endplates can be added to the implant. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6AI-4V ELI following ASTM F3001 standard, a radio opaque material. As any orthopaedic implants should not be reused. For a complete quide of the system, please refer to the surgical technique manual for specific instructions.

The UNiD® IB3D ALIF cage is designed for a specific patient, it must not be used for another patient.

MATERIALS: Components are manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.

Function:
The UNiD® IB3D ALIF was developed as an implant:

• to provide immobilization and stabilization of posterior spinal segments .
• to augment the development of a solid spinal fusion ●
• . to provide stability to ease fusion
• to be mechanically resistant to allow the fusion of the operated level

I apologize, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (UNiD® IB3D ALIF), an intervertebral body fusion device.

It focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than an AI/ML-driven device's performance study against specific acceptance criteria.

The text does not include:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Details about sample sizes used for test sets or data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The document discusses mechanical testing (Finite Element Analysis - FEA) of the physical implant, concluding that no new worst-case implant was created, thus no additional physical testing was deemed necessary. This is typical for a physical medical device clearance, not an AI/ML software.

Therefore, I cannot fulfill your request based on the provided input.

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