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The stand-alone intersomatic IMPIX ALIF S/A implants are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine 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.

Patients should have a satisfactory course of conservative treatment (usually at least six (6) months of non-operative treatment) prior to treatment with an IMPIX-ALIF-S/A stand-alone cage.

The IMPIX ALIF S/A devices should be used with the three (3) bone screws (Small Footprint) or four (4) bone screws (Medium. Large Footprints) accompanying the device. Otherwise, an additional fixation system (e.g., pedicle screw system) should be implanted.

The MEDICREA® IMPIX ALIF S/A is an intervertebral fusion device with integrated fixation use as an adjunct to fusion. The implant is composed of:

• one PEEK cage with tantalum markers
• either 3 or 4 IMPIX ALIF S/A screws , depending on the footprint of cage considered.

The IMPIX ALIF S/A screw is manufactured from titanium alloy (Ti-6Al-4V) meeting ASTM F136 and ISO 5832-3 standards, and the PEEK cage is manufactured from PEEK OPTIMA® LT1 meeting the ASTM F 2026.The tantalum markers are manufactured from tantalum meeting the ASTMF560 and ISO 13782 standards.

Materials: Titanium alloy (Ti-6Al-4V) and PEEK OPTIMA® LT1 and tantalum

The provided document is a 510(k) premarket notification for a medical device (IMPIX ALIF S/A), primarily focusing on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML powered device, or a clinical trial showing efficacy.

The "performance data" section in the document refers to biocompatibility and mechanical testing, which are standard for implantable medical devices, not for assessing the performance of an AI model against specific acceptance criteria.

Therefore, for the requested information regarding acceptance criteria and a study proving the device meets those criteria, most of the fields cannot be filled from the provided text as they are not applicable to the type of regulatory submission presented.

Here's a breakdown of what can be extracted and why other parts cannot be:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The "performance data" refers to engineering and laboratory tests of the physical device, not performance on a dataset of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This information is irrelevant for the mechanical and biocompatibility testing of a physical implant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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. The device is an intervertebral fusion device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility: Adherence to established ISO and ASTM standards for materials and biological reaction.
For mechanical testing: Adherence to established ASTM standards for mechanical properties.
No clinical ground truth (like pathology or outcomes data) was used or provided as no clinical studies were performed.

8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI/ML algorithm that would have a "training set."

9. How the ground truth for the training set was established
Not applicable.

Summary of what the document confirms regarding performance:

• No clinical studies were performed.
• No animal studies were performed.
• The device's performance was assessed through biocompatibility testing and mechanical testing against relevant ISO and ASTM standards, demonstrating compliance and substantial equivalence to predicate devices.
• The biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogen testing.
• The mechanical testing included FEA, static and dynamic axial compression, static and dynamic compression shear, subsidence, expulsion, and screw clip-out evaluation, all performed in compliance with FDA guidance and ASTM standards for intervertebral body fusion devices.

This document specifically highlights that the "performance data" provided was sufficient to establish "substantial equivalence" for regulatory approval without human or animal clinical studies, or any data-driven AI/ML performance evaluation.

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