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The Cogent Lateral Interbody System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. 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 Lateral Interbody System is an intervertebral body fusion device intended to stabilize the spinal segment to promote fusion. The implants are available in a variety of lengths and heights to accommodate varying patient anatomy. The Cogent Lateral Interbody System implants and instruments are supplied non-sterile. The implants in the The Cogent Lateral Interbody System are manufactured from PEEK, Ti-6Al-4V, and tantalum.

The Cogent Lateral Interbody 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 Lateral Interbody is available in various sizes to accommodate varying patient anatomy. The Cogent Lateral Interbody System is 18 or 22mm wide and includes five available lengths, 40, 45, 50, 55, and 60mm. The Cogent Lateral Interbody System is also available in three lordotic options, 0°, 6°, and 12°. The Cogent Lateral Interbody System is available in heights of 8mm to 16mm.

The Cogent Lateral Interbody System implants may be inserted via an open or minimally invasive approach and may be placed in a lateral or anterolateral orientation.

The Cogent Lateral Interbody System implants are non-sterile and are to be sterilized by the end user.

This document is a 510(k) summary for the Cogent Lateral Interbody System, an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to existing predicate devices. Consequently, it does not contain details about acceptance criteria, the study proving the device meets those criteria, or clinical performance metrics in the way typically required for AI/ML device evaluations.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the Cogent Lateral Interbody System is substantially equivalent to predicate devices (Cogent Med-LIF System and Cogent Med-LIF XL System) based on indications for use, technological characteristics, and performance testing.
• Device Description: Materials (PEEK, Ti-6Al-4V, Tantalum), dimensions, and general design.
• Non-Clinical Testing: A "Cadaveric Usability Study" is mentioned, but no details of acceptance criteria or performance results are provided.
• Clinical Testing: Explicitly states, "No clinical studies were performed."

Therefore, based on the provided text, I cannot answer the specific questions regarding acceptance criteria, study methodologies, and performance metrics as they would apply to an AI/ML device or a device requiring new clinical efficacy data. The information requested (Table of acceptance criteria, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not present in this 510(k) summary because the approval is based on substantial equivalence to existing devices that have already demonstrated safety and effectiveness, rather than novel clinical performance data for this specific device.

The only "study" mentioned is a "Cadaveric Usability Study" under non-clinical tests, and no details about its methodology, acceptance criteria, or results are provided.

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The Cogent Mcd-LIF XL 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 XL includes additional sizes to the Cogent Med-LIF system. The Cogent Med-LIF XL is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF XL consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular antimigration teeth, and tantalum x-ray markers.

The Cogent Med-LIF XL 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 15mm wide and are available in three lengths; 28, 30 and 32mm.

The Cogent Med-LIF XL 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 XL implants are non-sterile and are to be sterilized by the end user.

The document provided is a 510(k) premarket notification from the FDA for a medical device called Cogent Med-LIF XL, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. As such, much of the requested information regarding acceptance criteria, study design, and human reader performance is not available in the provided text.

Based on the available information, here's a breakdown:

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

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide a direct comparison of the Cogent Med-LIF XL's performance against specific numerical benchmarks. Instead, it relies on demonstrating substantial equivalence through bench testing to a legally marketed predicate device.

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

This information is not provided because no clinical studies were performed. The submission relies solely on non-clinical (bench) testing. Therefore, there is no test set in the context of clinical data, and no data provenance from human subjects.

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)

This information is not applicable as no clinical studies were performed, and thus no ground truth based on expert review of patient data was established for a test set. The evaluation was limited to bench testing.

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

This information is not applicable as no clinical studies were performed to generate a test set requiring adjudication.

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

This information is not applicable as this is a mechanical intervertebral body fusion device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study or assessment of AI assistance for human readers was conducted or is relevant.

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

This information is not applicable as this is a mechanical intervertebral body fusion device, not an algorithm or software device.

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

The 'ground truth' for this submission is based on engineering standards and performance established by the predicate device. For the bench tests, the "ground truth" would be the fulfillment of the specified ASTM F2077 mechanical testing requirements, and the "truth" that the device performs comparably to the predicate.

8. The sample size for the training set

This information is not applicable as no machine learning or AI models were used. The device is a physical implant, not a software algorithm requiring a training set.

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

This information is not applicable as no machine learning or AI models were used, and therefore no training set was established.

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

The "study" conducted for the Cogent Med-LIF XL device was exclusively non-clinical bench testing.

• Tests Performed:
  • ASTM F2077 - Static Shear Compression
  • ASTM F2077 - Dynamic Shear Compression
• Purpose: To demonstrate mechanical performance and substantial equivalence to the predicate device (Cogent Med-LIF System, K132738).
• Outcome: The non-clinical testing "indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate."
• Materials Testing: The materials (PEEK, Ti-6Al-4V, Tantalum) were specified to conform to their respective ASTM standards (F2026, F1472, F560), implying their suitability and established performance.
• Absence of Clinical Data: The submission explicitly states, "No clinical studies were performed." The FDA's 510(k) clearance in this case is based on the device having the same indications for use, technological characteristics, and comparable performance through non-clinical testing as a legally marketed predicate device.

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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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