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Rampart™ O, Rampart™ T, and Rampart™ A 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™ O, Rampart™ T, and Rampart™ A implants are designed for use with autograft and/or allograft 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 O, Rampart T, and Rampart A 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. These devices are made of PEEK-OPTIMA LT1 with titanium or tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft and/or allograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

The provided document is a 510(k) premarket notification for intervertebral body fusion devices, seeking clearance to expand the indications for use. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about the performance of a device that relies on AI or algorithms, nor does it present acceptance criteria or a study proving that a device meets such criteria in the context of an AI/algorithmic medical device.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered based on the available text:

1. A table of acceptance criteria and the reported device performance:
   Not applicable. This document is a 510(k) submission for an intervertebral body fusion device, not an AI/algorithmic device. No performance metrics or acceptance criteria for an AI system are present.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not applicable. No test set for an AI/algorithmic device is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not applicable. No ground truth establishment for an AI/algorithmic device is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. No test set adjudication for an AI/algorithmic device is mentioned.

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. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. No standalone algorithm performance is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. No ground truth for an AI/algorithmic device is mentioned. The document references "published clinical data for lumbar intervertebral body fusion devices" and a "clinical literature review," but this is for predicate device comparison and safety profile, not for establishing ground truth for an AI algorithm.

8. The sample size for the training set:
   Not applicable. No training set for an AI/algorithmic device is mentioned.

9. How the ground truth for the training set was established:
   Not applicable. No training set or ground truth for an AI/algorithmic device is mentioned.

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Rampart A is an intervertebral body fusion device 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 six months of non-operative treatment.

Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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

The provided text is a 510(k) summary for the Rampart A Lumbar Interbody Fusion Device. This document is a regulatory submission to the FDA for a medical device and does not describe a study involving an AI or an algorithm.

Therefore, I cannot provide information on acceptance criteria or studies proving device performance related to AI/algorithm performance. The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical implant (an intervertebral body fusion device).

Here's an analysis based on the information available in the provided text, specifically highlighting why the requested AI/algorithm-related information cannot be extracted:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (for the physical device): The document doesn't explicitly list numerical acceptance criteria in a table format for this specific submission beyond demonstrating substantial equivalence. The "performance" assessment is based on comparison to predicate devices, focusing on intended use, technological characteristics, materials, sterilization, packaging, and operating principle.
• Reported Device Performance (for the physical device): The document states "No performance testing was required for this change. An engineering rationale, including a finite element analysis (FEA) to compare the Rampart A to the existing predicate testing (conducted in accordance with ASTM F2077) supported the substantial equivalence of the Rampart A device." This indicates that the performance was demonstrated through an engineering rationale and FEA comparing it to performance data of previously cleared, substantially equivalent predicate devices, rather than new, explicit performance metrics for Rampart A itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as this is not an AI/algorithm study. The "test set" here refers to the engineering analysis and comparison to predicate device data, not a clinical data set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is not an AI/algorithm study. Ground truth in the context of an interbody fusion device would be related to clinical outcomes, which are not detailed in this 510(k) summary as no de novo clinical study was performed. The "ground truth" for the engineering rationale would be established engineering principles and ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as this is not an AI/algorithm study.

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/algorithm study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable as this is not an AI/algorithm study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the engineering rationale, the "ground truth" would be established engineering principles and the performance data of the predicate devices as per ASTM F2077. For the device's clinical efficacy, it's based on the established safety and effectiveness of substantially equivalent predicate devices for the specified indications for use (L2 to S1 in patients with degenerative disc disease with up to Grade 1 spondylolisthesis).

8. The sample size for the training set

• Not applicable as this is not an AI/algorithm study.

9. How the ground truth for the training set was established

• Not applicable as this is not an AI/algorithm study.

In summary, the provided document is a regulatory submission for a physical medical device. It does not contain information about acceptance criteria or studies related to AI or algorithms.

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