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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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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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