(230 days)
The Luna XD Ti Interbody Fusion System consists of the Luna XD Ti 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 XD Ti Interbody Fusion is to be used with autogenous bone graft and/or allogence bone graft composed of cancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.
The Benvenue Luna XD Ti Interbody Fusion System consists of the Luna XD Ti 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 XD Ti Interbody Fusion System are identical to the primary predicate device. The Luna XD Ti Implant is provided pre-loaded and sterile within a single-use Insertion Tool.
The Luna XD Ti Implant is an assembly of three (3) PEEK components referred to as the Top, Middle and Bottom, similar to the Luna 3D Gen2. Additionally, a Nitinol Spine is inserted into the middle component to retain its normally closed shape configuration. And finally, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder. The final components have radiopaque tantalum markers for fluoroscopic visibility.
The outer surfaces of the Top and Bottom components have teeth in addition to the already rough surface created by the Ti coating, which are designed to enhance the implant's resistance to expulsion. Upon insertion of the outer components, the middle component is inserted to expanded into its ultimate height. The central cavity of the implant accommodates placement of autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft through a graft window.
The Luna XD Ti Implant is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580).
The Luna XD Ti 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 with a bone graft pocket. Teeth engage the implant into the adjacent endplates. In addition, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder conforming to ASTM F1580 with a specified grain size and morphology. This additional titanium coating offers initial stability due to increased surface roughness and possibly also long-term stability due to bony ingrowth created from osteoconductive microenvironment on the device surface.
The Luna XD Ti Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580). This 510(k) is submitted in support of the additional surface coating to an existing Device cleared under K183560.
The extract provided describes the Luna XD Ti Interbody Fusion System, which is an intervertebral body fusion device. The document is an FDA 510(k) premarket notification summary.
Based on the provided text, the device is not an AI/ML powered device. The information focuses on mechanical testing, material properties, and sterilization, comparing the device to a predicate device. Therefore, several of the requested categories related to AI/ML device performance, such as 'number of experts used to establish ground truth', 'adjudication method', 'MRMC study' and 'standalone algorithm performance' are not applicable to this submission.
Here is the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate device comparison) | Reported Device Performance (Luna XD Ti Interbody Fusion System) |
|---|---|
| Mechanical performance (Axial Compression, Torsion, Compression-Shear) at same load as predicate device | Comparable to predicate device; coating process does not impact mechanical performance. Runout testing successfully completed. |
| Coating thickness, porosity, and surface roughness characterized per ASTM F1854 standards | Characterized and deemed substantially equivalent to predicate based on the overall submission. |
| Shear Strength (ASTM F1160) | Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence. |
| Static Shear Strength (ASTM F-1044) | Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence. |
| Tensile Strength (ASTM F-1147) | Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence. |
| Abrasion Resistance (ASTM 1978-99) | Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence. |
| Debris Analysis (ASTM F1877) | Conducted on the Luna XD Ti PEEK implant coated with commercially pure Titanium following testing per ASTM F2077 and after implantation. Results "demonstrate that the devices are substantially equivalent to the predicate devices." |
| Sterility Assurance Level | 10^-6 sterility assurance level (Gamma radiation for sterilization of components) |
| Indications for Use, Intended Use, Design | Identical to primary predicate device. |
| Overall safety and effectiveness | Device is "as safe, as effective, and performs as well as or better than the primary predicate device." |
2. Sample size used for the test set and the data provenance:
- The document primarily describes mechanical and material testing based on ASTM standards. It does not mention human subject studies or a "test set" in the context of clinical data for AI/ML performance. The "testing" refers to bench testing of the device and its materials.
- No information on "data provenance" (country of origin, retrospective/prospective) is provided as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (interbody fusion system) of the mechanical type, not an AI/ML diagnostic or prognostic tool. Therefore, "ground truth" as related to expert interpretation of data is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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:
- No. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical and material performance, the "ground truth" is established by adherence to recognized ASTM and other relevant standards for material properties, mechanical integrity, and biocompatibility, as well as comparison to the performance of a legally marketed predicate device. The ultimate "ground truth" for substantial equivalence lies in demonstrating that the modified device performs similarly or better than the predicate device in relevant bench tests.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.