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The Stable-L Lumbar Interbody System is indicated for spinal fusion procedures in skeletally mature patients. Stable-L is designed for use with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. Stable-L is intended for use in interbody fusions in the lumbar spine from L2 to S1 at one or two adjacent levels in the treatment of symptomatic degenerative disc disease (DDD). The DDD patients may also have up to Grade 1 spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

When used with the provided blades, supplemental fixation is required.

When used with the provided screws, each interbody fusion device having a lordotic angle 20° or less is intended to be used with the bone screws provided and requires no additional fixation. However, for hyperlordotic devices (> 20° lordosis), due to the increased risk of anterior migration with hyperlordotic implants, the devices should be used with the bone screws provided and supplemental fixation such as posterior fixation.

The existing Stable-L Interbody System is a lumbar interbody system including an interbody cage additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and associated bone screws manufactured from titanium alloy per ASTM F136. The device is offered in a variety of sizes to accommodate patient anatomy. Stable-L Interbody devices are provided either non-sterile to be sterilized by the end-user or sterile via gamma irradiation.

The subject submission seeks to add interbody cages with integrated blade fixation as well as expand the size offerings available. Additionally, this submissions seeks to gain clearance for a minor modification to the Stable L Cover Plate as well as extend the shelf life of devices provided sterile.

The provided FDA 510(k) clearance letter and summary for the "Stable-L Lumbar Interbody System" describe a spinal implant, not an AI/software medical device.

Therefore, the requested information regarding AI/software device acceptance criteria, performance studies (e.g., MRMC studies, ground truth establishment, training/test set details), and expert qualifications is not applicable to this document.

The document focuses on the physical characteristics and mechanical performance of the intervertebral body fusion device. The "Performance Testing" section mentions:

• Expulsion
• Blade compression/collapse
• Confirmatory Dynamic compression and dynamic shear per ASTM F2077
• Confirmatory insertion and screw pull out testing

These tests are standard for implantable mechanical devices and aim to demonstrate that the device performs equivalently to previously cleared predicate devices and does not raise new questions of safety or effectiveness. The criteria for these tests would typically involve specific force, displacement, or fatigue cycle thresholds, and the reported performance would be the successful completion of these predefined values.

In summary, this document does not contain the information needed to answer your request about AI/software device acceptance criteria and performance studies.

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The Tranquil-L™ Interbody System is intended 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 non-operative 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 at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.

The Tranquil-L Interbody System is a lumbar interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. Implants are provided sterile via gamma irradiation. Instruments are provided clean and non-sterilization at the user's facility.

The purpose of this special 510(k) is to gain clearance for modifications to existing lumbar implants and add implant footprints for the DLIF surgical approach.

This FDA 510(k) Premarket Notification is for the Tranquil-L Interbody System, a lumbar interbody fusion system. The document states that engineering analysis and confirmatory testing were conducted to demonstrate substantial equivalence to previously cleared devices. However, the provided text does not contain specific acceptance criteria or reported device performance metrics in a table format. It also lacks details regarding the sample size, data provenance, expert involvement for ground truth, adjudication methods, or specific standalone or MRMC study results.

Therefore, based solely on the provided text, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, as this information is not present.

The document primarily focuses on establishing "substantial equivalence" of the modified Tranquil-L Interbody System to its predicate devices by indicating that:

• Materials are identical to the primary predicate (Titanium Alloy (Ti-6Al-4V ELI) per ASTM F3001).
• Geometry differences are slight, and analysis and testing have shown equivalent performance.
• Engineering analysis and confirmatory testing were conducted, including dynamic compression and dynamic compression shear per ASTM F2077.

Without specific performance metrics from these tests and the acceptance thresholds, a table of acceptance criteria and reported performance cannot be generated. Similarly, information regarding ground truth establishment, expert qualifications, and study design details (sample size for test/training, provenance, MRMC, standalone) are not available in this document.

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