(141 days)
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody is indicated for interbody fusion in patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 had six months of non-operative treatment. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion Interbody cage is also required to be used with autogenous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Interbody cages with a lordosis of 18° or greater must be used with at least supplemental, anterior fixation.
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (1-L5) of the vascular structures. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
When used together, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System components can be used only to treat patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages.
The DIVERGENCE-L™ Anterior/Oblique Lumbar interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and must be used with supplemental fixation. The cages are manufactured from medical grade Polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The DIVERGENCE-L™ Anterior/Oblique Lumbar plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-LTM Anterior/Oblique Lumbar plate and bone screws are made from titanium alloy and are provided sterile.
The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.
The subject instruments are reusable and provided non-sterile. The subject instruments must be cleaned and sterilized by the hospital.
The provided text describes a 510(k) premarket notification for a medical device, the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove efficacy or safety from scratch.
Therefore, the information you're asking for, which is typically associated with studies proving device performance against specific acceptance criteria (like human reader studies, ground truth establishment, sample sizes for training/test sets in AI/ML, effect sizes for AI assistance, etc.), is not applicable or present in this document.
This document details:
- Device Description: What the device is (plates, bone screws, interbody cages), its materials, and sterilization.
- Indications for Use: The medical conditions and anatomical locations for which the device is intended.
- Technological Characteristics Comparison: How the new device is similar to its predicate devices.
- Performance Data: This section does not report clinical outcomes or diagnostic accuracy via human or AI evaluation. Instead, it reports engineering and material testing designed to demonstrate the device's physical properties meet established standards for similar devices.
Here's a breakdown of the specific points you requested, in the context of this document:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Adherence to relevant ASTM standards (F1717, F2077, F2267, F-04.25.02.02). Predetermined acceptance criteria set for each test. | "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests." |
| Construct Static Compression | Met predetermined acceptance criteria. | Met criteria. |
| Construct Compression Fatigue | Met predetermined acceptance criteria. | Met criteria. |
| Construct Static Torsion | Met predetermined acceptance criteria. | Met criteria. |
| Static Push-Out | Met predetermined acceptance criteria. | Met criteria. |
| Static Compression | Met predetermined acceptance criteria. | Met criteria. |
| Static Compression Shear | Met predetermined acceptance criteria. | Met criteria. |
| Compression-Shear Fatigue | Met predetermined acceptance criteria. | Met criteria. |
| Subsidence | Met predetermined acceptance criteria. | Met criteria. |
| Expulsion (PERIMETER® Interbody Device and DIVERGENCE-L™ 24° lordosis interbody cage) | Performed as a characterization test; did not include predetermined acceptance criteria. | Performed as a characterization test. |
| Biocompatibility | Conformity with FDA's Draft Guidance for ISO-10993, Part 1. | PEEK, titanium alloy, and tantalum have a "long history of safe and effective use in predicate spinal implants." Silicone and medical grade stainless steel have a "long history of safe and effective use in spinal surgery." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This document does not describe patient or image data test sets. The "test set" here refers to physical samples of the device components (interbody cages, plates, bone screws) used for mechanical and biocompatibility testing. The exact number of samples tested for each mechanical test is not specified in the summary, nor is the country of origin or whether if it was retrospective or prospective.
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. "Ground truth" in the context of clinical or diagnostic performance studies is not relevant to this 510(k) submission, which focuses on engineering performance and material safety. Expert review typically refers to clinical or diagnostic interpretation, which is not the subject of these tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable, as there is no diagnostic or clinical interpretation test set with human readers to adjudicate.
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:
This information is not applicable. This is a submission for a spinal implant, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a submission for a spinal implant, not an AI or diagnostic imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable. The "ground truth" for this device's performance is defined by adherence to established mechanical testing standards (ASTM F1717, F2077, F2267, F-04.25.02.02) and biocompatibility principles. There is no clinical "ground truth" established in this document.
8. The sample size for the training set:
This information is 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:
This information is not applicable. There is no "training set" or corresponding ground truth process as this is not an AI/ML device.
§ 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.