(96 days)
aprevo® anterior and lateral lumbar interbody fusion device:
The aprevo® anterior and lateral lumbar interbody fusion devices are interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo® anterior and lateral lumbar interbody fusion devices are 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 graft. These implants may be implanted via a variety of open or minimally invasive approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.
The aprevo® anterior and lateral lumbar interbody fusion devices are indicated for use at one or more levels of the lumbosacral spine as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. aprevo® anterior and lateral lumbar interbody fusion devices 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). These implanted via a variety of open or minimally invasive approaches.
aprevo® anterior lumbar interbody fusion device with interfixation:
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 supplementation 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° of lordosis. At more than two levels or with implants greater than 20° 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.
aprevo® anterior and lateral lumbar interbody fusion device:
The aprevo® anterior and lateral lumbar interbody fusion devices are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient and include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.
The aprevo® anterior and lateral lumbar interbody fusion devices are additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and are provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody devices, are manufactured from stainless steel and provided sterile packaged for single use.
aprevo® anterior lumbar interbody fusion device with interfixation:
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 include an aperture intended for the packing of bone graft. The individualized surgical correction plan and device configurations are developed using patient radiological images.
The aprevo® anterior lumbar interbody fusion device with interfixation is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and is provided sterile. The device includes screws that are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and are offered in a range of lengths. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the device, are manufactured from stainless steel and provided sterile packaged for single use.
The provided document is a 510(k) summary for a medical device called "aprevo® anterior and lateral lumbar interbody fusion device" and "aprevo® anterior lumbar interbody fusion device with interfixation." This document explicitly states that "Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."
Therefore, no clinical study was conducted to prove the device meets acceptance criteria. The FDA's substantial equivalence determination was based on non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since no clinical study was performed, there are no specific clinical acceptance criteria or reported device performance in this context. The non-clinical testing primarily demonstrates that the subject device has similar mechanical properties and performance as the predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as clinical criteria, but implied by non-clinical testing) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device must exhibit similar mechanical properties (e.g., strength, durability) to predicate devices under various loads. | "The subject configuration's manufacturing processes are identical to those of the predicate devices, and mechanical testing confirmed that the subject devices have the same mechanical properties as the predicate devices." |
| Specific tests were performed for: | Passed / Met expectations (implied by conclusion of substantial equivalence) | |
| - Static and dynamic compression | ||
| - Static and dynamic compression shear | ||
| - Tensile testing (per ASTM F3001) | ||
| Material Properties | Device material (titanium alloy Ti-6Al-4V ELI) must conform to ASTM F3001 and F136 standards. | "additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001" and "screws that are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136"; Microstructure and chemical composition assessed. |
| Design/Functionality | Device should perform its intended function of stabilizing the lumbar spinal column and facilitating fusion, consistent with predicate devices. | "The subject devices have identical intended use, indications for use, mechanical properties, raw materials, sterilization, and packaging as the predicate devices." |
2. Sample size used for the test set and the data provenance
Not applicable, as no clinical test set was used for proving acceptance criteria in a comparative clinical study. The non-clinical testing would involve physical samples of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth was utilized.
4. Adjudication method for the test set
Not applicable, as no clinical test set was utilized.
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
Not applicable. The device is an intervertebral body fusion device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical implant, not a software algorithm.
7. The type of ground truth used
For the purpose of non-clinical testing, the "ground truth" would be the established engineering and material standards (e.g., ASTM F3001, ASTM F136) and the performance characteristics of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.