(28 days)
The aprevo® anterior and lateral lumbar interbody fusion devices are interbody fusion in skeletally mature patients and are to be used with supplemental fixation 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 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.
The aprevo® transforaminal lumbar interbody fusion device is 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 autogra:f 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 stenoiss, 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 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.
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 provided FDA 510(k) summary (K222082) for the aprevo® anterior and lateral lumbar interbody fusion devices and aprevo® transforaminal lumbar interbody fusion devices does not describe an AI software device or a study proving that the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.
Instead, this document is a regulatory submission for a physical medical device used for spinal fusion. The "Performance Data" section explicitly states: "No new performance data was necessary to evaluate the modifications to the indications for use." This indicates that the regulatory approval is based on substantial equivalence to predicate devices, rather than a new clinical or algorithmic performance study with acceptance criteria.
Therefore, the requested information cannot be extracted from this document as it relates to AI software performance studies, which are not present here.
However, based on the information that is available in the document, here's what can be provided:
Acceptance Criteria and Device Performance (Not Applicable - No AI/Software Performance Study)
This section is not applicable as the provided document is a 510(k) submission for a physical interbody fusion device, not an AI/software device that requires specific performance metrics like accuracy or sensitivity. The submission relies on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria in a study as would be done for an AI device.
Sample Size and Ground Truth (Not Applicable - No AI/Software Performance Study)
2. Sample size used for the test set and the data provenance: Not applicable. No test set for AI performance is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
7. The type of ground truth used: Not applicable.
Comparative Effectiveness and Standalone Performance (Not Applicable - No AI/Software Performance Study)
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
Training Set (Not Applicable - No AI/Software Performance Study)
8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.
Summary of Device and Regulatory Pathway:
- Device Name: aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
- Regulatory Pathway: 510(k) Premarket Notification (K222082)
- Classification: Class II per 21 CFR §888.3080
- Product Code: MAX
- Nature of Device: Physical spinal interbody fusion devices, personalized with patient-specific features, manufactured from titanium alloy (Ti-6Al-4V).
- Indications for Use: Interbody fusion in skeletally mature patients for various lumbar spine conditions (e.g., severe symptomatic adult spinal deformity, degenerative disc disease, spondylolisthesis), to be used with supplemental fixation and bone graft.
- Key Regulatory Finding: Substantial Equivalence to legally marketed predicate devices (K202034, K210542 - aprevo™ Intervertebral Body Fusion Device; K191391 - HEDRON™ Lumbar Spacers). The submission explicitly states "No new performance data was necessary to evaluate the modifications to the indications for use," indicating the approval hinges on equivalence of design, materials, and intended use, not on a new performance study as one would see for an AI 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.