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The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.

The MONDRIAN ALIF Cage with Supplementary Fixation Plate System is intended for use with either two or four titanium alloy screws which are provided with the system. When used with screws and implants with lordotic angles ≤20°, the MONDRIAN ALIF Cage with Supplementary Fixation Plate System is a stand-alone interbody fusion device. If the physician chooses to use fewer than the number of screws compatible with the plate, then a supplemental spinal fixation system that is cleared for use in the lumbosacral spine must be used. Hyperlordotic cage offerings (>20°) require the use of a supplemental fixation system (e.g. facet screws or posterior fixation).

The MONDRIAN ALIF Cage with Supplemental Fixation Plate System are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals. The system is comprised of spacers, plates, screws and instruments to facilitate the installation of the implants. The spacers are manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136, plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

The document describes the MONDRIAN ALIF Cage with Supplementary Fixation Plate System, an intervertebral body fusion device.

Acceptance Criteria and Reported Device Performance:

The document states that the rationale for substantial equivalence is based on the following general characteristics being similar to predicate devices:

• Axial Dynamic Compression (per ASTM F2077)
• Screw Push-Out Testing
• Plate-Cage Disassembly Testing
  Results indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised. |
  | Clinical Tests | No specific clinical tests are mentioned as being performed for this submission ("o" is listed under clinical tests with no further details). The document relies on substantial equivalence to predicate devices, implying that clinical performance is considered similar based on the similarities in the device's characteristics and the non-clinical test results. |

Study to Prove Device Meets Acceptance Criteria:

The document describes a non-clinical study to demonstrate substantial equivalence to previously cleared predicate devices (K192863 and K160597).

1. A table of acceptance criteria and the reported device performance: This is provided above.

2. Sample size used for the test set and the data provenance:
   The document does not explicitly state the sample sizes for the non-clinical tests (Axial Dynamic Compression, Screw Push-Out, Plate-Cage Disassembly Testing). It also does not mention data provenance as these are laboratory/bench tests, not patient data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were non-clinical, mechanical tests performed according to ASTM standards. Expert consensus would not be used to establish "ground truth" for these types of tests; rather, the results would be compared against predefined criteria from the standard or predicate device performance.

4. Adjudication method for the test set: Not applicable. This was a non-clinical, mechanical testing study, not a study requiring adjudication of expert interpretations.

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 an implantable medical device (ALIF cage), not an AI-assisted diagnostic or imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device. The non-clinical tests assess the mechanical performance of the physical device.

7. The type of ground truth used: For the non-clinical tests, the "ground truth" or reference for acceptance would be the performance criteria (e.g., strength, durability) specified by relevant ASTM standards (e.g., ASTM F2077) and/or comparison to the mechanical performance of the predicate device(s).

8. The sample size for the training set: Not applicable. This is a non-clinical performance study of a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device submission.

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