(205 days)
IVA-C (ACIF):
The IVA-C Cage System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
AEON-C (ACIF):
The AEON-C Cage System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C Cage System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.
IVA-L (ALIF, PLIF, DLIF, TLIF) & AEON-L (ALIF):
The IVA-L Cage System and AEON-L Cage System are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels 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 AEON-L Cage System is designed for use with or without the bone screws, depending on the surgeon's discretion. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The IVA & AEON Cervical and Lumbar Cage System are cervical and lumbar intervertebral fusion cages that are implanted in the disc space between the intervertebral bodies to obtain fusion and mechanical stability. The cages are manufactured via Selective Laser Melting (SLM) 3D printing technology using a medical grade metal powder and/or by machining (CNC method). The cages are manufactured from titanium alloy powder per ASTM F3001 or titanium alloy per ASTM F136 or PEEK per ASTM F2026. The screws are manufactured from titanium alloy per ASTM F136. They are provided non-sterile to the end user. The patient contacting portion of all instruments is made from Stainless Steel per ASTM F899 and all instruments are provided non-sterile and intended to be sterilized by the end user prior to use.
This FDA 510(k) Clearance Letter is for the IVA & AEON Cervical and Lumbar Cage System, which are intervertebral body fusion devices. It is a Class II device.
Crucially, this document focuses on the substantial equivalence of a physical medical device (intervertebral cages) based on engineering performance tests, materials, and design features, not on the performance of an AI/ML software.
Therefore, most of the requested information regarding AI/ML device performance (acceptance criteria table, study details, human reader improvement, ground truth, training set, etc.) is not applicable to this specific submission.
The document states:
- "Summary of Performance Data (Nonclinical and/or Clinical):" and then lists "Non-Clinical Tests" such as Static/Dynamic Compression Bending, Static/Dynamic Compression Shear Bending, Static/Dynamic Torsion, and Subsidence, all referencing ASTM standards.
- "Clinical Tests: - N/A"
This means that the device was cleared based on non-clinical (laboratory/mechanical) testing, not on clinical performance studies involving patient data or AI/ML algorithm evaluation.
To answer your specific questions in the context of this document:
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A table of acceptance criteria and the reported device performance:
- Not Applicable (N/A) for AI/ML performance.
- For the physical device, the acceptance criteria would be defined by the referenced ASTM standards (e.g., ASTM F2077, ASTM F2267) for specific mechanical properties (e.g., strength, durability, resistance to subsidence). The document states that the "Results of the non-clinical tests indicate that the device will perform within the intended uses," implying these criteria were met, but specific numerical performance data is not provided in this public summary.
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Sample sizes used for the test set and the data provenance:
- N/A for AI/ML performance.
- For the mechanical tests, the "sample size" would refer to the number of physical devices tested to ASTM standards. This information is not provided in this summary. Data provenance is also N/A as it's 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:
- N/A. Ground truth establishment by experts is relevant for diagnostic or AI/ML interpretation performance, not for the mechanical testing of a physical implant.
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Adjudication method:
- N/A. Adjudication is relevant for expert consensus in AI/ML or clinical studies.
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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:
- N/A. This is a physical implant, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is 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 the device, the "ground truth" would be established mechanical properties as defined by the ASTM standards (e.g., material properties, structural integrity under load).
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The sample size for the training set:
- N/A. There is no training set as no AI/ML algorithm is involved.
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How the ground truth for the training set was established:
- N/A. There is no training set.
In summary, the provided FDA 510(k) clearance letter pertains to a surgical implant, not an AI/ML software. Therefore, the questions related to AI/ML device performance and associated studies are not applicable to this document. The clearance is based on the substantial equivalence to predicate devices and adherence to mechanical performance standards, as indicated by the non-clinical tests section.
§ 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.