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Rampart T implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Rampart T implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart T implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. The device is made of PEEK-OPTIMA LT1 with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "Rampart™ T Lumbar Interbody Fusion Device."

The document discusses:

• Device Name and Classification: Rampart™ T Lumbar Interbody Fusion Device, classified as an intervertebral body fusion device (Class II).
• Indications for Use: For intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis, to be used with autograft.
• Purpose of Submission: To obtain FDA clearance for expanded indications for use to allow the optional use of allograft (in addition to autograft) as an adjunct to fusion.
• Non-Clinical Testing: Stated that no design changes were made to the device, so non-clinical testing was not required to demonstrate substantial equivalence. Bacterial endotoxin testing (BET) was conducted.
• Clinical Testing: Stated that no clinical testing was required or performed because no design changes were made, and a review of published clinical data for similar devices was provided to support that the use of allograft poses no new risks.
• Conclusion: The technological characteristics are the same as the predicate devices, and the clinical literature review supports the expanded indications for use.

Crucially, this document is about obtaining clearance for a modified indication for use for an existing device, not about proving the performance of a device against specific acceptance criteria through a new study. It relies on the substantial equivalence pathway, meaning it demonstrates that the device is as safe and effective as a legally marketed predicate device, especially for the expanded use of allograft.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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