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The IdentiTi™ ALIF Standalone Interbody System is indicated for spinal fusion procedures in skeletally mature patients. The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The IdentiTi ALIF Standalone Interbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.

The IdentiTiTM ALIF Standalone (SA) Interbody System is an integrated intervertebral body fusion device implanted from an anterior or anterolateral approach. The IdentiTi ALIF Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi ALIF Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The interbody spacer includes three screw holes to accept bone screws and bolts that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.

The provided text is a 510(k) summary for a medical device called the "IdentiTi™ ALIF Standalone Interbody System". This document outlines the device's indications for use, its technical specifications, and a comparison to predicate devices, along with performance data from non-clinical testing.

However, the request asks for information about acceptance criteria and a study that proves the device meets those criteria, specifically in the context of an AI/human-in-the-loop study. The provided document explicitly states that no clinical performance data was used for the determination of substantial equivalence ("Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.").

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes for test and training sets, expert consensus, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be found in this document, as it pertains to a different type of medical device submission (an interbody fusion system, not an AI-powered diagnostic/assistive tool) and regulatory pathway (510(k) based on substantial equivalence through non-clinical data).

Here is a summary of what can be extracted from the document in relation to the prompt:

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

• Acceptance Criteria (Implicitly based on substantial equivalence to predicate devices): The device is substantially equivalent in terms of:
  • Intended Use
  • Indications for Use
  • Design
  • Function
  • Technology
  • Performance (based on nonclinical testing)
• Reported Device Performance (from nonclinical testing):
  • ASTM F2077 static & dynamic axial compression, static & dynamic 0 compression-shear
  • ASTM F1877 - particulate analysis
  • ASTM F1714 gravimetric analysis
  • ASTM F2267 subsidence
  • Static push-out
  • Screw push-out
• Conclusion: The results "demonstrate that the proposed IdentiTi™ ALIF Standalone Interbody System is substantially equivalent to the predicate devices for nonclinical testing."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. This document describes non-clinical, mechanical testing of a physical implant device, not a study involving a "test set" of patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth in the context of diagnostic performance or AI algorithms is not discussed. The "ground truth" for this device's performance is derived from standardized mechanical testing protocols.

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:

• No MRMC study was done. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For the physical device's performance, the "ground truth" is adherence to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. This is a form of engineering or mechanical testing standard, not clinical ground truth.

8. The sample size for the training set:

• Not applicable. There is no training set for an AI algorithm mentioned.

9. How the ground truth for the training set was established:

• Not applicable. There is no training set for an AI algorithm mentioned.

In summary, the provided document details the regulatory clearance of a physical medical implant device based on substantial equivalence established through non-clinical bench testing, not on the performance of an AI algorithm or clinical studies requiring human-in-the-loop assessments. Therefore, most of the questions relating to AI performance metrics are outside the scope of this specific document.

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