(104 days)
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:
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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. -
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. -
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. -
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. -
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. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No standalone algorithm performance is mentioned. -
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. -
The sample size for the training set:
Not applicable. No training set for an AI/algorithmic device is mentioned. -
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.
§ 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.