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The MILI System is intended for posterior, non-cervical pedicle fixation of the spine. It is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of one or more of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolithesis (Grade I/II) with objective evidence of neurological impairment, fracture, dislocation, scoliosis (one level), kyphosis, spinal tumor, failed previous fusion (pseudarthrosis),

The MILI System, when used as a pedicle screw fixation system, is indicated for use in patients: a) who are receiving fusion using autogenous graft only; b) who are having the device fixed or attached to the thoracolumbar or sacral spine; and c) who are having the device removed after the development of a solid fusion mass.

The MILI System is indicated only for one-level or adjacent two-level procedures.

The Aesculap Implant Systems (AIS) MILI System is a minimally invasive posterior plating system for the thoracolumbar spine. This system is intended for posterior, non-cervical pedicle fixation. The AIS MILI System consists of plates and cannulated screws. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS MILI System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MILI (Minimally Invasive Lumbar Implant) System:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document explicitly mentions "cadaver testing," which indicates a biological, non-human live subject sample. However, the exact number of cadavers used is not specified.
• Data Provenance: The document does not specify the country of origin for the biomechanical or cadaver testing. It also doesn't indicate if the data was retrospective or prospective, though cadaver testing would inherently be prospective for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• The document does not provide information on the number or qualifications of experts used to establish a "ground truth" for the test set in the context of expert consensus or clinical outcomes. The cadaver testing focuses on surgical implantation feasibility, which would likely be assessed by surgeons or anatomists, but their specific roles and numbers are not detailed.

4. Adjudication Method (Test Set)

• The document does not specify an adjudication method. For cadaver testing, methods like 2+1 or 3+1 are typically for clinical outcome or image interpretation, which isn't the focus here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The evaluations are focused on the device's physical and mechanical properties and surgical feasibility, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The MILI System is a physical implant, not an AI algorithm. Therefore, there is no standalone (algorithm-only) performance study described.

7. Type of Ground Truth Used

• The ground truth in this context is primarily established through mechanical/physical testing results demonstrating equivalence to predicate devices and observational assessment (cadaver testing) of the device's ability to be implanted successfully according to its intended technique. It is not based on expert consensus for clinical diagnosis, pathology, or long-term outcomes data in live patients for these performance tests.

8. Sample Size for the Training Set

• Not applicable. As the MILI System is a physical medical device (implant) and not an AI/machine learning algorithm, there is no "training set" in the context of data-driven model development. The design and manufacturing process for the device would have involved engineering design, material testing, and rapid prototyping, but these are not considered a "training set" in the same way as for AI.

9. How Ground Truth for the Training Set Was Established

• Not applicable. Refer to point 8. There is no training set in the AI sense for this device. The "ground truth" for its design and performance would be established through engineering principles, material science, biomechanical standards, and iterative design and testing.

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