(94 days)
aprevo® ALIF and LLIF:
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 and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These 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 have had 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 implants may be implanted via a variety of open or minimally invasive approaches.
aprevo® TLIF:
The aprevo® transforaminal lumbar interbody fusion device 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® transforaminal lumbar interbody fusion device 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 device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.
The aprevo® transforaminal lumbar interbody fusion device is 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 have had at least six (6) months of non-operative treatment. aprevo® transforaminal 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 implants may be implanted via a variety of open or minimally invasive approaches.
aprevo® ALIF-X:
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 implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.
The aprevo® anterior lumbar interbody fusion device with interfixation (ALIF-X) is 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 have had at least six (6) months of non-operative treatment. aprevo® 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 implants may be implanted via a variety of open or minimally invasive approaches. The aprevo® anterior lumbar interbody fusion device with interfixation is intended to be used with the screws that accompany each implant and with supplemental fixation.
The aprevo® anterior, lateral and transforaminal 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 CT scans. The aprevo® devices are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F3001 and are provided sterile.
The aprevo® anterior lumbar interbody fusion device with interfixation, (ALIF-X), is 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. 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 and ASTM F136. The aprevo® ALIF-X device has a cavity intended for the packing of bone graft.
This document describes the regulatory clearance for the aprevo® family of devices (ALIF, LLIF, TLIF, ALIF-X). It is a 510(k) submission, which means the manufacturer is demonstrating that their device is "substantially equivalent" to already legally marketed predicate devices.
Therefore, the "acceptance criteria" for a 510(k) submission are typically based on demonstrating that the new device performs as safely and effectively as predicates, often through mechanical testing and equivalence to existing devices. There isn't an "AI-like" performance criteria table in this context because it's a physical medical device clearance, not an AI/ML software clearance.
However, based on the provided text, I can extract the information relevant to the performance testing and conclusions:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary) |
|---|---|
| Device is substantially equivalent to predicate devices regarding indications, design, function, and performance. | Demonstrated substantial equivalence to predicate devices (K222082 and K222009) with respect to indications for use, design, function, and performance. |
| Manufacturing processes are robust and sensitive. | Manufacturing Sensitivity Analyses were conducted. |
| Manufacturing processes are validated. | Manufacturing Validation Activities were conducted. |
| Mechanical performance meets established standards for intervertebral fusion devices. | Mechanical Testing per ASTM F2077 was conducted. (This standard specifies mechanical testing for intervertebral body fusion devices.) The implication is that the device met the requirements of this standard, demonstrating appropriate strength, fatigue resistance, and other mechanical properties for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data or patient-level data. The performance evaluations mentioned are related to mechanical testing and manufacturing processes. For mechanical testing (ASTM F2077), specific sample sizes of the device are tested. For manufacturing sensitivity and validation, these typically involve testing multiple batches or units during the manufacturing process. The document does not provide these specific numbers or the "provenance" of such samples (e.g., country of origin, retrospective/prospective). These details would typically be found in the actual test reports submitted to the FDA, not necessarily summarized in the 510(k) letter or summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable in the context of this 510(k) submission for a physical interbody fusion device. "Ground truth" established by experts is typically relevant for diagnostic or AI/ML-driven devices where human interpretation is being evaluated against an algorithm. Here, the "ground truth" for mechanical testing is established by technical standards (like ASTM F2077) and engineering principles.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in evaluating diagnostic images or clinical scenarios, which is not the type of evaluation described for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done and is not indicated for this type of physical medical device clearance (interbody fusion device). MRMC studies are primarily used for evaluating diagnostic imaging devices or AI tools where human readers are interpreting medical images. There is no mention of AI assistance in relation to human interpretation in this document.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical implant, not an algorithm or software that performs standalone diagnostic functions.
7. Type of Ground Truth Used:
For the mechanical performance testing, the "ground truth" is established by engineering standards and specifications, specifically ASTM F2077. This standard outlines the methodology and acceptance criteria for mechanical testing of intervertebral body fusion devices. For manufacturing processes, the "ground truth" involves validated process parameters and quality control metrics.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML-driven device that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no "training set" for this 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.