(78 days)
The Luna 3D 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 symptomative 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 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 Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.
The Benvenue Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D Interbody Fusion System are identical to predicate interbody lumbar cages. The Luna 3D Implant is provided pre-loaded and sterile within a single-use Insertion Tool.
The Luna 3D Implant is available in heights ranging from 8mm to 15mm in 1mm increments. 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 with a bone graft pocket. Teeth engage the implant into the adjacent endplates.
The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic algorithm or AI product would be evaluated (e.g., sensitivity, specificity, or reader studies). This document is a 510(k) premarket notification for a medical device called the "Luna 3D Interbody Fusion System," which is an implant for spinal fusion procedures.
The "Performance Testing" section describes bench testing conducted to evaluate the impact of design changes on product performance. This is typical for mechanical devices and focuses on physical and mechanical properties, not diagnostic accuracy or human-AI comparative effectiveness.
Here's an analysis of the information that is available in relation to your request, and where the requested information is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document describes a medical implant, not an AI or diagnostic device that would have performance criteria like sensitivity or specificity. The "performance testing" referred to are mechanical bench tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. The "performance testing" involved mechanical bench tests (static/dynamic compression, shear-compression, torsion, and subsidence testing). These do not involve "test sets" in the context of patient data or AI evaluation.
3. 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)
- Missing. This concept is not applicable to the type of device and testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. This concept is not applicable to the type of device and testing described.
5. 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
- Missing. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Missing. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing. For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical testing standards (e.g., ASTM F2077, ASTM F2267). The document states the results "confirmed that this design is substantially equivalent to legally marketed predicate devices," implying successful adherence to these standards and equivalence criteria.
8. The sample size for the training set
- Missing. This concept is not applicable to the type of device and testing described.
9. How the ground truth for the training set was established
- Missing. This concept is not applicable to the type of device and testing described.
Summary of available information related to performance:
The document describes performance testing for the Luna 3D Interbody Fusion System, which is a physical implant. This testing was primarily bench testing (mechanical tests) to confirm the new design's equivalence to predicate devices and ensure its structural integrity and performance under various loads.
- Tests Conducted:
- Static/dynamic compression
- Static/dynamic shear-compression
- Static/dynamic torsion tests (per ASTM F2077)
- Subsidence testing (per ASTM F2267)
- Purpose: To evaluate the impact of minor design changes (e.g., addition of an 8-degree lordotic version, expansion of implant height, use of alternative PEEK material, alternative trial instrument) on product performance.
- Conclusion of Testing: The results "confirmed that this design is substantially equivalent to legally marketed predicate devices."
In essence, for this medical implant, the "acceptance criteria" were implied to be meeting the mechanical performance characteristics demonstrated by predicate devices, as assessed through standardized bench tests. This is a very different type of evaluation compared to the performance assessment of AI/diagnostic software.
§ 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.