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510(k) Data Aggregation
(115 days)
Rampart O and Rampart P are 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 I 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 nonoperative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
Rampart O and Rampart P are 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.
The Spineology Rampart O and P Devices are designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights. The device and associated instruments are provided non-sterile.
This document is a 510(k) summary for the Spineology Rampart O and P Devices, which are intervertebral body fusion devices. The purpose of this 510(k) is to add devices as small as 20 mm in length and to add products that include features allowing for rotation of the devices after insertion on implants with tantalum markers.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets the criteria:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (materials, configuration, performance characteristics). | Demonstrated similar performance characteristics to the identified predicate devices in preclinical testing. |
| Compliance with FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". | Tested in compliance with this guidance document. |
| Mechanical performance (static compression and static compression shear) comparable to predicate devices. | Preclinical testing included static compression and static compression shear according to ASTM F2077. This testing demonstrated similar performance characteristics. |
| Suitability for new sizes (as small as 20mm in length). | The 510(k) specifically adds devices as small as 20mm in length. Preclinical testing would have supported this. |
| Functionality of new features (rotation after insertion with tantalum markers). | The 510(k) adds products with features allowing for rotation of devices after insertion on implants with tantalum markers. Preclinical testing would have supported this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify a "test set" in the context of human data. The testing mentioned is preclinical. For preclinical mechanical testing, sample sizes would typically be several units per test condition to ensure statistical robustness, but the exact numbers are not provided in this summary.
- Data Provenance: The data is preclinical testing. The country of origin and whether it's retrospective or prospective are not applicable to the type of testing described (mechanical testing).
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)
This section is not applicable as the provided text describes preclinical mechanical testing of an intervertebral body fusion device, not an AI/software device that requires expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3.
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
This section is not applicable. The device is an intervertebral body fusion device, which is a physical implant, not a software or AI tool requiring MRMC studies for human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the preclinical testing, the "ground truth" would be established by engineering standards and physical measurements based on ASTM F2077. For instance, load cells and displacement sensors would provide objective data on static compression and shear forces, which are then compared against performance characteristics of predicate devices.
8. The sample size for the training set
This section is not applicable as the device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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