(154 days)
The Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic 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 I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D GEN2 Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D GEN2 Implant. The Luna 3D GEN2 Interbody Fusion System is to be used with supplemental fixation.
The Benvenue Luna 3D GEN2 Interbody Fusion System consists of the Luna 3D GEN2 Implant and associated accessories set of disposable and re-usable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D GEN2 Interbody Fusion System are identical to the primary predicate device. The Luna 3D GEN2 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.
The Luna 3D GEN2 Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space. Once the implant is in the desired position, the device is expanded into its ultimate height and forming a bone graft pocket. Teeth on the outer surfaces of the top and bottom components engage the implant into the adjacent endplates.
The Luna 3D GEN2Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (VESTAKEEP i4R, conforming to ASTM F2026), nitinol wire (superelastic alloy SE508, conforming to ASTM F2063) and tantalum rod conforming to ASTM F560. This 510(k) was submitted in support of the Generation 2 device.
This FDA 510(k) summary does not describe an AI medical device. It pertains to the Luna 3D GEN2 Interbody Fusion System, which is a physical intervertebral body fusion device used in spinal fusion procedures. The document focuses on mechanical and material testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI algorithm based on data.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI device is not applicable and cannot be extracted from this document.
The "Performance Testing" section (page 5) describes the mechanical testing performed on the device:
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Acceptance Criteria & Reported Performance: Not explicitly stated as acceptance criteria with numerical targets. However, the document states, "The results demonstrate that the Luna 3D GEN2 Interbody Fusion System device is substantially equivalent to the predicate devices." This implies that the performance in these tests met a level comparable to the predicate devices.
- Tests performed:
- Static compression
- Static compression-shear
- Static torsion
- Static modified compression-shear
- Dynamic compression
- Dynamic compression-shear
- Dynamic torsion
- Expulsion
- Subsidence
- Corrosion testing (ASTM F2129)
- Nickel leaching quantitative ICP/MS analysis
- Surgical technique validation in cadaver specimens
- Tests performed:
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Sample size for the test set: Not specified in the provided text. The document mentions "worst-case devices" were subjected to mechanical testing, but the number of devices is not given.
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Data provenance: Not applicable in the context of an AI device. The tests are laboratory-based mechanical and material performance tests.
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Number of experts and qualifications for ground truth: Not applicable. The "ground truth" here is the physical performance of the device under specific mechanical loads and conditions, measured objectively according to ASTM standards.
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Adjudication method: Not applicable.
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MRMC comparative effectiveness study: Not applicable. This is a physical device, not an AI algorithm for diagnostic or prognostic purposes.
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Standalone (algorithm only) performance: Not applicable. This is a physical device.
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Type of ground truth used: Material and mechanical engineering standards (ASTM F2077-14, F2267-04, F2129, F2063, F560) and cadaveric testing for surgical technique validation.
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Sample size for the training set: Not applicable. There is no training set for a physical device.
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How the ground truth for the training set was established: Not applicable.
§ 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.