(105 days)
The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.
The provided document is a 510(k) summary for the Reliance Lumbar IBF System, which is an intervertebral body fusion device. This type of regulatory submission usually does not include detailed studies on software performance or AI algorithms, as it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, intended use, and mechanical/performance testing for the physical device itself.
Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria, particularly pertaining to AI or software performance, is not present in this document. The document describes non-clinical testing for the physical implant components, specifically Finite Element Analysis to assess the effect of new sizes on structural properties, and sterilization validation.
Here's a breakdown of why the requested information cannot be provided from this document:
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A table of acceptance criteria and the reported device performance: This document only states that "Finite Element Analysis has been carried out to access the effect of new sizes on the structural properties of the implant. Test results show the new components are not the new worst case when compared to the approved Reliance Lumbar IBF PEEK, 1-04-XXX, per K113540." It does not provide specific acceptance criteria or quantitative performance data from this analysis.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned, as the testing described is primarily mechanical/structural analysis, not software validation on clinical 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): Not applicable, as this is not a study involving expert-derived ground truth for software or AI.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of testing described.
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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: Not applicable. This document is for a physical medical implant, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component described.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for the type of testing described (mechanical testing).
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The sample size for the training set: Not applicable. No AI training is described.
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How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission relates to a physical intervertebral body fusion device and not a software or AI-powered medical device. Therefore, the detailed information about AI-related acceptance criteria, studies, and data provenance is not relevant to this document and is not present.
§ 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.