(284 days)
The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in 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 I 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. Additionally, the DIVERGENCE-L™ Interbody device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCE-L™ Interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches include anterior and oblique.
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 vasular 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.
The DIVERGENCE-LIM 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. 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-L™ 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 the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System, an intervertebral body fusion device. However, this is a 510(k) summary for a medical device and not a study proving the device meets acceptance criteria regarding algorithm performance.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Explanation:
The document is a regulatory submission to the FDA for a medical device (an implantable spinal fusion system), not for a device that uses an algorithm or AI. The "acceptance criteria" discussed in the document refer to the criteria for regulatory clearance (substantial equivalence to predicate devices), material specifications (e.g., PEEK, titanium alloy), and general device safety and performance tests (e.g., non-pyrogenicity endotoxin testing).
The mentions of "clinical data" refer to published retrospective clinical data for similar lumbar interbody fusion devices, used to support the claim that adding allogenic bone graft and expanding the indication to include deformity conditions poses no new risks. This is a review of existing literature to support the safety and effectiveness of the device's indications and material options, not a performance study of an AI or algorithm-based device.
Thus, all the specific points about acceptance criteria and studies related to algorithm performance (test sets, training sets, ground truth, experts, MRMC studies) are not applicable to this document.
§ 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.