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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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MEDICREA® INTERNATIONAL IB3D ALIF device is 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 or Retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. 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.

MEDICREA® INTERNATIONAL IB3D ALIF device consists of one single implant available in several heights, lengths, lordosis and footprints. It is intended for insertion between two adjacent vertebrae by an anterior approach. The MEDICREA® INTERNATIONAL implant is manufactured from titanium alloy Ti-6Al-4V ELI following standards ASTM F3001, a radio opaque material. As any orthopaedic implant, the lumbar interbody device must not be reused. The surgeon should strictly follow the recommendations provided in the surgical technique.

The provided text is a 510(k) premarket notification for a medical device called "IB3D ALIF," an intervertebral body fusion device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical trial with defined acceptance criteria and human reader studies (MRMC studies).

Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, and other specifics typically found in studies proving a device meets such criteria (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, training set details).

The requested information is not available in the provided text because this is a 510(k) submission for a physical implant (an intervertebral body fusion device), not a software or AI-driven diagnostic device.

Here's an explanation of why the requested information is absent and what is typically provided in a 510(k) for a physical device:

• Acceptance Criteria and Device Performance (Table): Not applicable in the context of AI software. For this device, "performance" relates to mechanical strength, biocompatibility, and intended function as an intervertebral body fusion device, which are tested against standards like ASTM F2077 and F2267. The document states "no new worse-case implant was created" by FEA, and expulsion testing was conducted, but specific pass/fail criteria or detailed results are not explicitly listed in this summary.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type (for test set), Training Set Details: These questions are specifically relevant to the evaluation of AI or imaging diagnostic software. The IB3D ALIF is a physical implant. Its evaluation for 510(k) clearance primarily involves:
  • Mechanical Testing: Such as finite element analysis (FEA) and expulsion testing to ensure the device can withstand forces and maintain placement.
  • Biocompatibility Testing: Ensuring the materials are safe for implantation in the human body.
  • Materials Comparability: Demonstrating the materials are the same as previously cleared predicate devices.
  • Indications for Use Comparability: Showing the device is intended for the same patient population and conditions as predicate devices.
  • Sterilization Validation: Ensuring the device can be sterilized effectively.

In summary, the provided document relates to a physical medical device (an implant) and not an AI or software-based diagnostic tool. As such, the concept of "acceptance criteria" and "studies" as understood for AI/software in the prompt are not relevant to this 510(k) submission.

Ask a specific question about this device