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The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Dorado ALIFT, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients mav also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

The SpineFrontier Lumbar IBF System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.

The provided text describes a 510(k) premarket notification for a medical device, the SpineFrontier Lumbar IBF System. This is a premarket submission and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics in the way a clinical trial for a new drug or novel medical device would.

Therefore, many of the requested sections about acceptance criteria and study details (like sample sizes, ground truth establishment for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission as the device is not an AI/ML-based diagnostic or prognostic device.

Here's an analysis of the provided information in relation to your questions:

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

Since this is a 510(k) submission for an intervertebral fusion device, the "acceptance criteria" are related to mechanical performance and demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typical of AI/ML systems (e.g., sensitivity, specificity, AUC). The reported "performance" is that the device meets the criteria of established mechanical testing standards.

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. This submission relies on mechanical testing against recognized standards, not a clinical test set of patient data. The "sample size" would refer to the number of devices tested mechanically, but specific numbers are not provided in this summary.

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. Ground truth in the context of diagnostic/prognostic AI is not relevant for this device. Mechanical integrity is assessed against engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically employed when there is human interpretation or classification involved, common in clinical studies or AI evaluations. This is a mechanical device.

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 not an AI system, so MRMC studies involving human readers and AI assistance are irrelevant.

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

Not applicable. This device is a physical intervertebral fusion system, not an algorithm.

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

Not applicable directly in the sense of clinical "ground truth." The "ground truth" for this device's evaluation is adherence to established mechanical performance standards as outlined in the ASTM documents and the FDA's guidance for intervertebral fusion devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this context means demonstrating substantial equivalence for 510(k) clearance) is a mechanical testing evaluation.

• Study Design: The SpineFrontier Lumbar IBF System underwent mechanical testing to assess its performance.
• Methodology: The device was evaluated in accordance with the "FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007." This guidance document defines the relevant performance criteria for such devices.
• Specific Tests Conducted:
  • ASTM F2077-03: Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
  • ASTM F2267-04: Subsidence Under Static Axial Compression
  • ASTM Draft Standard F-04.25.02.02: Static Expulsion
• Results/Conclusion: The device was "found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing)." The submission explicitly states, "Clinical data was not required for this device."

In essence, the "study" was a series of engineering and materials tests designed to show that the proposed device performs mechanically at least as safely and effectively as legally marketed predicate devices, thereby establishing substantial equivalence as required for 510(k) clearance.

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