(50 days)
Solar-S™ (Standalone, With Integrated Fixation) and Solar-A™ (Non-Standalone, With Integrated Fixation) The Solar-STM (Standalone) and Solar-A™ (Non-Standalone) are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Solar-A™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
· Solar-STM Used With Screws:
When used with three (3) screws, interbody devices with a lordotic angle 20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.
· Solar-ATM:
These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Solar-M™ ALIF Spacers (Without Integrated Fixation) Solar-M™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DD), disc herniation (with myelopathy and/or radiculopathy), spondylolilsthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have has at least six (6) months of non-operative treatment. Solar-MIM ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
The Solar™ Lumbar Interbody Fusion System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Solar™ system includes various widths, depths, and heights. The Solar™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature a porous surface to mitigate subsidence and expulsion. The standalone (Solar-S™), anterolateral (Solar-A™), and monolithic (Solar-M™) configurations feature an anterior face with threaded holes and slots to rigidly connect to an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. The DeGen Medical Solar™ spacers are additively manufactured from Puri-Ti™ unalloyed titanium. The Solar-S™ and Solar-A™ incorporate integrated fixation in the form of screws manufactured from Titanium-6AL-4V ELI Alloy per ASTM F136. The Solar-S™ Lumbar Interbody Spacer must be used with three (3) integrated screws and the spacer must have ≤20° of lordosis to be considered for standalone use.
The provided text describes the DeGen Medical Solar™ Lumbar Interbody Fusion System. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance metrics. Therefore, the document does not describe acceptance criteria, a study proving the device meets those criteria, or clinical performance metrics like effect size with human readers.
However, it does describe non-clinical performance testing. Here's what can be extracted and inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a specific performance table in the way a clinical study would for metrics like sensitivity, specificity, or AUC. Instead, for a 510(k), the "acceptance criteria" are implied by demonstrating that the device performs equivalently to legally marketed predicate devices through specific non-clinical tests. The "reported device performance" refers to the successful completion of these tests, confirming substantial equivalence.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Static and dynamic compression testing per ASTM F2077 | Successfully performed, showing equivalency to predicate device. |
| Static and dynamic compression shear testing per ASTM F2077 | Successfully performed, showing equivalency to predicate device. |
| Subsidence testing via ASTM F2267 | Successfully performed, showing equivalency to predicate device. |
| Expulsion testing | Successfully performed, showing equivalency to predicate device. |
| Wear debris characterization per ASTM F1877 | Successfully performed, showing equivalency to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes non-clinical, mechanical and material testing, not a clinical study involving human patients or data sets.
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)
This information is not applicable as the document describes non-clinical, mechanical and material testing. Ground truth in the context of expert review is reserved for clinical studies or AI performance assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical, mechanical and material testing. Adjudication methods are relevant for expert-based assessments in clinical studies.
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
There is no MRMC comparative effectiveness study described in this document. This submission is for a physical medical device (interbody fusion system), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" used would be the established standards and methodologies defined by the specific ASTM (American Society for Testing and Materials) standards mentioned (e.g., ASTM F2077, ASTM F2267, ASTM F1877). These standards specify precise test conditions, measurement techniques, and acceptable ranges for material and mechanical properties, serving as the benchmark against which the device performance is evaluated.
8. The sample size for the training set
This information is not applicable as the document describes non-clinical, mechanical and material testing for a physical device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as above.
§ 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.