(18 days)
The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior lumbar interbody fusion device with interfixation is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone and/or cortico-cancellous bone. These implants may be implanted via a variety of open or minimally invasive approaches. ALIF-X implants are intended for standalone use at one or two levels of the spine when used with the screws that accompany the implant and with implants less than or equal to 20 degrees of lordosis. At more than two levels or with implants greater than 20 degrees of lordosis, ALIF-X is intended to be used with the screws that accompany each implant and with supplemental fixation. When used at more than one level in patients with degenerative scoliosis and/or sagittal deformity, the aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
The aprevo® anterior lumbar interbody fusion device with interfixation is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features to allow the surgeon to tailor the procedure to the individual needs of the patient and includes an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001, while the screws are machined from material per ASTM F136. The devices are accompanied by an inserter instrument which facilitates the placement of the interbodies. Both the interbody devices and instrument are provided as single use, sterile-packed product to the end user. The purpose of this 510(k) is to modify the indications for use of the subject device to include standalone indications.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device called "aprevo® anterior lumbar interbody fusion device with interfixation."
This type of document primarily focuses on establishing substantial equivalence to previously cleared devices, rather than detailing specific performance acceptance criteria and studies demonstrating adherence to those criteria for software or AI/ML components. The text describes the device, its intended use, comparison to predicate devices, and regulatory classification. It does not mention any AI/ML components, software, or studies evaluating algorithm performance, human reader improvement with AI assistance, or related aspects.
Therefore, I cannot fulfill your request for information about acceptance criteria and a study that proves the device meets them based on the provided text.
§ 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.