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The Tranquil-L Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.

The Tranquil-L Interbody System is intended for use at either one level or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The patients may have had a previous non-fusion spinal surgery at the involved level(s). The Tranquil-L device is intended to be used supplemental fixation systems.

The Tranquil-L Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.

The purpose of this traditional 510(k) is to gain clearance for additional implant footprints for the ALIF surgical approach.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Tranquil-L Interbody System." It outlines the device's indications for use, its classification, and a comparison to predicate devices, along with performance data.

However, the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML medical device.

Instead, this document pertains to a physical orthopedic implant device (intervertebral body fusion device) designed for spinal surgery. The "performance data" mentioned refers to mechanical engineering principles and mechanical testing (e.g., compression, compression shear, subsidence, and expulsion testing) of the physical implant, not the performance of a software algorithm or AI.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size for test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study and effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes the regulatory clearance process for a traditional physical medical device based on substantial equivalence to existing predicate devices, focusing on its mechanical properties and intended surgical use. It is not about an AI/ML-driven diagnostic or therapeutic device.

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