(89 days)
The CONDUIT™ LLIF Cages with a microscopic roughened surface and micro and nano-scale features is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. CONDUIT™ LLIF Cage is to be used with supplemental fixation. The CONDUIT™ LLIF Cages (>20 degrees) must be used with CONDUIT™ Lateral Switch Plate and supplemental fixation. When used with or without the CONDUIT™ Lateral Switch Plate, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The purpose of this Traditional 510(k) is to seek marketing clearance for 22-degree and 30degree lordosis angled CONDUIT™ Lateral Lumbar Intervertebral Fusion (LLIF) Cages in the CONDUIT™ line of lumbar interbody cages with additional cage height of 14 to 18 mm. The CONDUIT™ line of lumbar interbody cages includes lordosis angles of 0, 8, and 16 degrees.
The CONDUIT™ LLIF Cage is used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using an LLIF (Lateral Lumbar Intervertebral Fusion) approach with cancellous bone graft and/or corticocancellous bone graft materials, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The CONDUIT™ LLIF Cage is intended to be used from L2-S1 in patients with DDD and up to Grade I spondylolisthesis or retrolisthesis at one or two contiguous levels. The device is intended to be used alongside supplemental spinal fixation, either applied anteriorly or posteriorly (e.g., using posterior pedicle screws). The CONDUIT™ Lateral Switch Plate is an optional device that connects to the CONDUIT™ LLIF Cage and adjacent vertebral body(s) to provide additional migration resistance and stability via DePuy Synthes AEGIS Screws. When used with or without the CONDUIT™ Lateral Switch Plate, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.
The CONDUIT™ LLIF Cage is made from Ti-6A1-4V alloy (ISO 5832-3) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.
The provided text describes a 510(k) premarket notification for a medical device, specifically the CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage and CONDUIT™ Instruments. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through clinical trials in the same way a PMA (Premarket Approval) submission would.
Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria (such as detailed performance metrics from a clinical study, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, and MRMC studies for AI devices) is not present in this document.
The document details non-clinical tests performed to demonstrate substantial equivalence, primarily mechanical and material testing, to show that the new variations (additional angles and cage heights) of the CONDUIT™ LLIF Cage are as safe and effective as existing legally marketed predicate devices.
Here's a breakdown of what is available and why the requested information is largely absent:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: For a 510(k), the primary "acceptance criterion" is demonstrating substantial equivalence to predicate devices. This is achieved by showing similar indications for use, technological characteristics, and performance (often through non-clinical testing).
- Reported Device Performance: The document lists the types of non-clinical tests performed, but it does not provide a table of quantitative acceptance criteria or the specific numerical results of these tests (e.g., maximum load for dynamic axial compression). It simply states that these tests were "evaluated to demonstrate substantial equivalence."
Therefore, a table cannot be constructed with the detailed performance metrics you requested from this document.
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Sample sizes used for the test set and the data provenance:
- This document describes non-clinical, mechanical testing of physical devices, not a study involving patient data or AI algorithms. Therefore, there are no "sample sizes" in the context of patient test sets or data provenance (country of origin, retrospective/prospective). The "samples" would be the number of physical cages and instruments subjected to mechanical tests. This specific number is not provided in the summary, only the types of tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/diagnostic device where expert interpretation of images or data would establish ground truth. Substantial equivalence for this intervertebral fusion cage is based on engineering design, material properties, and mechanical performance compared to predicates.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for a mechanical device submission.
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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 is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device lies in its mechanical integrity, biocompatibility, and ability to facilitate fusion as demonstrated by the predicate devices. The non-clinical tests (e.g., ASTM standards) are designed to assess these characteristics, comparing the new device's performance to established engineering standards or the performance of predicate devices. There's no "expert consensus" on imaging or diagnosis in this context.
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The sample size for the training set:
- Not applicable. There is no AI model or training set involved.
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How the ground truth for the training set was established:
- Not applicable. There is no AI model or training set involved.
Summary of Device Performance (from the document):
The submission states:
"The following tests and analyses were performed on the subject device system to demonstrate that the additional angles of the CONDUIT™ LLIF Cage are substantially equivalent to other predicate devices:
- Dynamic Axial Compression (ASTM F2077-18)
- Dynamic Compression Shear (ASTM F2077-18)
- Static Axial Compression analysis (ASTM F2077-18)
- Static Compression Shear (ASTM F2077-18)
Expulsion analysis (ASTMF1839-08) and Subsidence analysis (ASTM F2267-04) were evaluated to demonstrate substantial equivalence.
The additional angled CONDUIT™ LLIF Cages with CONDUIT™ Lateral Switch Plate Construct testing was evaluated and due to the high level of confidence in previous dynamic testing as well as the addition of a Switch Plate resulting in a non-worst-case condition in all Static type tests (ASTM F2077, ASTM F2267 and F1839) was evaluated to demonstrate substantial equivalence.
MRI Safety Testing per ASTM F2052-15, ASTM F2182-17, ASTM F2119-07 and ASTM F2182-19e2 was evaluated to demonstrate substantial equivalence.
The subject device is substantially equivalent to legally marketed predicate devices with respect to indications for use, design, function, material composition, and performance testing standards."
§ 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.