(30 days)
Rampart™ O 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 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 non-operative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
Rampart™ O 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™ O devices are designed for use with autograft as an adjunct to fusion and are 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.
The provided text describes a 510(k) premarket notification for the Rampart™ O intervertebral body fusion device. This type of submission is for medical devices, not AI/ML-driven diagnostic tools, therefore many of the requested categories are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The device under review is an intervertebral body fusion device, which is a physical implant. The acceptance criteria and "performance" in this context refer to the device's physical properties and its ability to function as intended within the human body, not diagnostic accuracy.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static Compression Strength
- Static Compression Shear Strength | Substantial Equivalence Demonstrated:
- Previous preclinical testing according to ASTM F2077 (static compression and static compression shear) was used to justify substantial equivalence.
- Testing demonstrated similar performance characteristics to the identified predicate devices. |
| Material Biocompatibility: | Assumed to be met as it's an extension of existing cleared devices. |
| Sterility: | Device and associated instruments are provided non-sterile (implies sterilization by user). |
| Design/Configuration: - Range of lengths and heights (for new sizes) | Extended range of sizes for lordotic and non-lordotic implants. Design is similar to predicate devices. |
| Intended Use Safety & Efficacy: | Similar to predicate devices, for lumbar interbody fusion (L2-S1) in patients with DDD and up to Grade I spondylolisthesis, with autograft and supplemental fixation. |
Study Details (Applicability to AI/ML is explained)
This document is for a traditional medical device (implant), not an AI/ML diagnostic. Therefore, many of the questions related to AI/ML performance studies, ground truth, and expert evaluation are not directly applicable.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A (for AI/ML): This is not an AI/ML device. The "test set" in this context refers to the samples used for mechanical testing.
- Mechanical Testing Samples: Not explicitly stated, but typically involves a sufficient number of devices to meet ASTM F2077 statistical requirements for each test type (static compression and static compression shear). The provenance for these physical devices would be their manufacturing origin, not patient data.
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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):
- N/A (for AI/ML): This is not an AI/ML device. "Ground truth" in this context would implicitly refer to established standards for mechanical properties and material science, not clinical expert consensus. Testing is performed by engineers/technicians in a lab setting.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A (for AI/ML): This is not an AI/ML device. Adjudication methods like 2+1 are for clinical judgments or diagnostic accuracy, not mechanical testing.
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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:
- No: This is a physical implant, not an AI-assisted diagnostic tool. MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (for AI/ML): For this physical device, the "ground truth" for proving substantial equivalence relies on established preclinical mechanical testing standards (ASTM F2077) that define acceptable performance parameters for intervertebral body fusion devices. This is a material and mechanical engineering 'ground truth'.
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The sample size for the training set:
- N/A (for AI/ML): This is a physical implant. There is no concept of a "training set" for an AI/ML model.
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How the ground truth for the training set was established:
- N/A (for AI/ML): This is a physical implant. There is no "training set ground truth."
In summary, the provided document is a 510(k) summary for a physical medical implant (Rampart™ O). The study described is a preclinical mechanical testing study demonstrating substantial equivalence to predicate devices, as required for traditional device clearances, not an AI/ML performance study.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.