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The Rubicon Lumbar Interbody Fusion is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

The Rubicon Lumbar Interbody Fusion System consists of cages of various lengths, widths and heights, which can be inserted between two lumbar or lumbrosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The Rubicon Lumbar Interbody Fusion System is to be used with supplemental fixation. The leading edge consists of bullet nose. The cephalad/caudal opening is large to allow for bone through growth. In addition, there are 2 large holes on each side to facilitate bone and to aid in visualizing the fusion mass. The teeth are slanted away from the direction of insertion of the implant to minimize implant migration. The superior and inferior surfaces are convex to better fit the vertebral endplates.

The device is offered in 3 general configurations, specifically shaped for posterior, transforaminal or lateral surgical approaches. The posterior approach configuration is available in 508 possible sizes, with lengths from 22mm, widths from 8mm to11mm, heights from 7mm to 16mm and lordosis angles of 0°, 4° and 8°. The transforaminal approach configuration is available in 720 possible sizes, with lengths from 22mm to 36mm, widths from 9mm to 12mm, heights from 7mm to 18mm and lordosis angles of 0°, 4° and 8°. The lateral approach configuration is available in 330 possible sizes, with lengths from 40mm to 60mm, widths from 18mm to 22mm, heights from 8mm to 18mm and lordosis angles of 0°, 4° and 8°.

The Rubicon Lumbar Interbody Fusion devices are made from PEEK (Polyetheretherketone) per ASTM F2026, with radiographic markers made from tantalum per ASTM F560.

The provided text describes a medical device, the Rubicon Lumbar Interbody Fusion System, and its substantial equivalence to predicate devices, enabling its market clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through the analysis of data, sample sizes, expert involvement, or statistical methods as typically found in an AI/ML device submission.

The document focuses on:

• Regulatory Clearance (510(k) pathway): Demonstrating "substantial equivalence" to legally marketed predicate devices. This pathway does not typically require de novo clinical performance studies or statistical hypothesis testing against acceptance criteria in the same way an AI/ML device would.
• Device Description and Indications for Use: What the device is and what it's used for.
• Technological Characteristics Comparison: Highlighting similarities with existing devices.
• Non-Clinical (Bench) Testing: Listing mechanical tests performed (e.g., Static Compression, Dynamic Compression, Subsidence, Expulsion) as per ASTM standards for intervertebral body fusion devices. These are engineering performance tests, not clinical performance studies involving interpretation of medical images or patient outcomes.

Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/ML device. The document simply doesn't contain that type of data.

To answer your prompt directly based on the provided text:

Based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device's performance.

The document is a 510(k) premarket notification for a physical medical device (Lumbar Interbody Fusion System) and focuses on demonstrating substantial equivalence to predicate devices through design description, indications for use, and mechanical (bench) testing. It does not involve AI or machine learning, nor does it present clinical performance studies with acceptance criteria, sample sizes, expert ground truth, or statistical analyses typically associated with AI/ML device evaluation.

Therefore, the following points cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present, as this is not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML performance testing. The "test set" here refers to mechanical samples for engineering tests, not a dataset for AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on image findings) is not relevant to this device's evaluation.
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, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

The document states that the non-clinical tests performed were:

• Static Compression ASTM F2077-11
• Dynamic Compression ASTM F2077-11
• Static Compression Shear - ASTM F2077-14
• Dynamic Compression Shear ASTM F2077-14
• Subsidence ASTM F2267-04
• Expulsion

These are mechanical engineering tests designed to evaluate the physical integrity and performance of the implant under various forces, as specified by ASTM standards for intervertebral body fusion devices. The conclusion from these non-clinical tests was that "Rubicon believes that the subject Rubicon Interbody Fusion System is substantially equivalent to the predicate systems it was compared to," meaning its mechanical performance is comparable to already marketed devices.

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