(338 days)
The neoWave LS Porous Titanium Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). neoWave LS Porous Titanium Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The neoWave LS Porous Titanium Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The neoWave C Porous Titanium Cage is intended for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.
When used as a Cervical Interbody Fusion device, Ti3D Cervical is indicated for use in skeletally mature patients with cervical degenerative disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received six (6) weeks of prior non-operative treatment prior to treatment with the devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion.
Xenix Medical neoWave LS Lumbar Straight Cages are intervertebral body fusion devices intended for use in the lumbar spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 6-17mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.
Xenix Medical neoWave C Cervical Cage is intervertebral body fusion device intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.
Xenix Medical Ti3D Cervical Cages are intervertebral body fusion devices intended for use in the cervical spine and made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in 4-12mm heights and various footprints to accommodate patient anatomy. The implants are provided sterile. Devices incorporate Xenix Medical's proprietary NANOACTIV micro and nano-roughened surface designed to improve fixation to adjacent bone. The Xenix Medical implant surfaces have been engineered with surface features at a nanometer (100) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by mineralization in human mesenchymal stem cells in vitro. The implant surface demonstrates elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance document.
This document describes the premarket notification (510(k)) for new Wave LS Lumbar Straight, newWave C Cervical, and Ti3D Cervical intervertebral body fusion devices. This submission aims to add a nanotechnology claim and a change in the additive manufacturing (AM) supplier.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility/Surface Characteristics | In vitro evaluations and imaging studies (for nanotechnology claim) | Demonstrate production of micro and nano surface roughness (1-100 nanometers) and exhibit specific osteogenic differentiation. | "The in vitro study results demonstrated the modified NANOACTIV nanosurface as supporting differentiation of mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix as compared to non-treated surfaces." |
| Mechanical Performance | ASTM F2077 | Maintain mechanical integrity and performance comparable to predicate devices. | "confirmatory mechanical testing per ASTM F2077 was performed to support the change in AM supplier. ASTM F2077 testing was performed on the cervical (dynamic axial compression, dynamic torsion) and lumbar (dynamic axial compression, dynamic compression shear) versions of the devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "test set" in terms of patient data. The performance testing described focuses on in vitro and mechanical evaluations.
- For in vitro evaluations and imaging studies: The sample size isn't specified, but it refers to "human mesenchymal stem cells in vitro." The provenance is in vitro (laboratory setting).
- For mechanical testing (ASTM F2077): The number of devices tested isn't specified, but it was performed on "cervical (dynamic axial compression, dynamic torsion) and lumbar (dynamic axial compression, dynamic compression shear) versions of the devices." This is laboratory-based testing, not human data.
The data provenance is limited to laboratory studies (in vitro and mechanical testing) and does not involve human subjects or clinical data in the context of this 510(k) submission. Therefore, it is retrospective in the sense that no new clinical patient data was collected for this specific submission for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance testing described (in vitro and mechanical) does not involve expert review or establishment of "ground truth" in the clinical sense with patient data. The "ground truth" for the in vitro study would be the observable cellular and biochemical responses, which are quantitative and not subject to expert consensus in the same way clinical diagnoses would be.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human-read test set or clinical outcome data that would require an adjudication method. The evaluations are objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes laboratory-based in vitro and mechanical testing, not clinical studies involving human readers or patient cases. Therefore, no effect size of human readers improving with or without AI assistance is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to this device. The devices are intervertebral body fusion cages, which are physical implants, not AI algorithms. The "nanotechnology claim" refers to the surface features of the physical implant, not a software algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility/Surface Characteristics (in vitro studies): The ground truth is established by observable cellular and biochemical responses (e.g., mineralization in human mesenchymal stem cells) as measured and quantified in a laboratory setting.
- For Mechanical Performance (ASTM F2077): The ground truth is defined by objective measurements of mechanical properties according to the ASTM F2077 standard.
8. The Sample Size for the Training Set
This information is not applicable. The described device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by prior research and engineering principles, but not a dataset used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI algorithm.
§ 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.