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The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.

EOI FLXfit Intervertebral Body Fusion Device is made From Titanium (Ti6A14V-ELI per ASTM norm F136). This is an articulated-expanded device with height ranges from 8mm through 14mm. The device also expands in height to provide lordosis angle correction of up to 10°. The FLXfit components are manufactured from titanium alloy (ASTM F136). It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape.

The provided document is a 510(k) summary for the FLXfit Intervertebral Body Fusion Device, which focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. It is not a study that evaluates the performance of a device using clinical or reader studies, especially for AI/ML devices. Therefore, a significant portion of the requested information, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical performance, is not applicable or available in this document.

However, I can extract the acceptance criteria and reported device performance from the provided mechanical testing data.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance data based on mechanical testing standards, rather than clinical efficacy. The acceptance criterion for this type of submission is typically "substantial equivalence" to predicate devices, meaning the device performs at least as well as or better than the predicate devices under the specified tests. The reported performance is that the device met these criteria.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The "test set" here refers to physical devices undergoing mechanical testing, not a dataset of patient cases for an AI/ML device. The document does not specify the number of devices tested for each mechanical test.
• Data Provenance: The data comes from "non-clinical testing" and a "usability cadaveric study." No country of origin is specified, but it can be inferred to be from the manufacturer's testing facilities or contract labs. The nature is experimental, not retrospective or prospective clinical data.

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

Not applicable. For mechanical testing, "ground truth" is established by the specifications of the ASTM standards themselves, and the measurement of physical properties, not by expert consensus on clinical cases. The usability study involved cadavers, likely evaluated by surgical or biomechanical experts, but no details are provided on their number or qualifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among human readers for establishing ground truth from patient data. This document describes mechanical testing.

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 is a medical device (intervertebral body fusion device), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or described.

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

Not applicable. As noted, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• For Mechanical Testing: The ground truth is defined by the requirements of the ASTM standards (e.g., F2077, F2267) which specify acceptable load-bearing capacities, fatigue life, and other mechanical properties for intervertebral body fusion devices. Substantial equivalence to predicate devices also serves as a comparative "ground truth" for performance.
• For Usability Cadaveric Study: The ground truth would be the direct observation and evaluation of the device's clinical application, expansion mechanism, and intra-operative subsidence in a cadaveric model by qualified personnel (likely surgeons or biomechanical engineers).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical testing or regulatory submission for a physical medical device. This term applies to machine learning models.

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

Not applicable. There is no training set mentioned in this document.

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The Cogent Med-LIF is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The Cogent Med-LIF is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular anti-migration teeth, and tantalum x-ray markers. The Cogent Med-LIF is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options, 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 10mm wide and are available in three lengths; 20, 25 and 30mm. The Cogent Med-LIF implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space. The Cogent Med-LIF implants are non-sterile and are to be sterilized by the end user.

The provided document describes the Cogent Med-LIF, an intervertebral body fusion device, and its performance testing for a 510(k) submission. It does not describe a study involving AI, software or an analytical device. Therefore, it is impossible to answer the following sections, as they are not presented in the document:

• Acceptance criteria and reported device performance related to a diagnostic or analytical AI/software device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
• Sample size for the training set.
• How ground truth for the training set was established.

However, I can extract information regarding the physical device's performance testing and its overall conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For the physical device, Cogent Med-LIF, the "acceptance criteria" are implied by compliance with ASTM standards and demonstrating performance comparable to legally marketed predicates. The "reported device performance" is a general statement that the device met these criteria.

Summary of the Study:

The document describes bench testing and a cadaveric implantation study for the Cogent Med-LIF device.

• Bench Tests: These tests focused on the mechanical properties of the device, adhering to established ASTM standards (F2077, F2267, and a draft expulsion standard). The specific acceptance criteria for these tests would be the performance benchmarks defined by these ASTM standards or comparative performance to the predicate devices.
• Cadaveric Implantation Study: This study's purpose was to confirm that autogenous bone graft could be adequately delivered using the Cogent Med-LIF, specifically when compared to a legally marketed predicate device.

Overall Conclusion:
The manufacturer concluded that "mechanical and non-clinical testing of the Cogent Med-LIF device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." This statement serves as the final "reported device performance" and meets the overarching "acceptance criteria" for a 510(k) submission, which is to demonstrate substantial equivalence to a predicate device.

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