(372 days)
The ACRON™ TLIF System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level 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 at the involved level. The ACRON™ TLIF System is to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The ACRON™ TLIF System is an implant system for a unilateral posterior transforaminal approach (TLIF). It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and autogenous bone graft, provide improved stability, height restoration and lordosis to optimize fusion. The system is comprised of implantable cages and stainless steel surgical instruments, both general and system specific.
The ACRON™ TLIF System cages are manufactured from radiolucent polymer PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, to allow for clear assessment of bone fusion. Two radiopaque markers constructed from Tantalum conforming to ASTM standard F560 allow for radiographic visualization of the implant orientation and placement.
The implants have a convex shape and are offered in 4 sizes, in 2mm increments, ranging in height from 7mm to 13mm with lordotic angle of 8°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Teeth on the superior and inferior surfaces help the implant to resist expulsion and migration. The geometry includes openings to allow for the packing of autogenous bone graft into the axial canal.
Apologies, but the provided text from the FDA 510(k) K171151 letter for the ACRON™ TLIF System does not contain information about the acceptance criteria and study that proves a device meets acceptance criteria for an AI/ML-based medical device.
The document describes a traditional intervertebral body fusion device (implants and instruments) and focuses on demonstrating substantial equivalence to predicate devices through nonclinical testing (static/dynamic compression, subsidence testing). It explicitly states: "No clinical studies were conducted."
Therefore, I cannot provide the requested information, as it pertains to a different type of device (AI/ML) and study methodology than what is described in the provided text.
If you have a document describing the acceptance criteria and study for an AI/ML medical device, please provide that text, and I will do my best to extract the relevant information.
§ 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.