(91 days)
The aprevo® posterior/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® posterior/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, cortical, and/or corticocancellous bone. The device may be implanted via an open or minimally invasive approach.
The aprevo® posterior/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 months of non-operative treatment. The aprevo® transforaminal lumbar interbody fusion device is to be filled with autograft bone and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone. The device is 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). The device may be implanted via an open or minimally invasive approach.
The aprevo® posterior/transforaminal intervertebral body fusion device is designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo® device incorporates patient specific features and includes 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® posterior/transforaminal lumbar interbody fusion device is additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 and provided sterile. The associated instruments, which facilitate the placement, adjustment, and removal, if necessary, of the interbody device, are manufactured from stainless steel per ASTM A564 and provided sterile packaged for single use.
This FDA 510(k) clearance letter pertains to a physical medical device, specifically an intervertebral body fusion device, not a software-based AI device. Therefore, much of the information typically sought for AI/ML device acceptance criteria (e.g., ground truth establishment, training set details, multi-reader multi-case studies) is not applicable or present in this document.
However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
Acceptance Criteria and Device Performance Study for aprevo® posterior/transforaminal lumbar interbody fusion device
This device is a physical implant designed for spinal fusion, and its acceptance criteria primarily revolve around mechanical performance and substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance (from "Non-Clinical Testing" section) |
|---|---|---|
| Mechanical Performance | Static Axial Compression (per ASTM F2077) | Demonstrated substantially equivalent mechanical performance |
| Dynamic Axial Compression (per ASTM F2077) | Demonstrated substantially equivalent mechanical performance | |
| Compression-Shear (per ASTM F2077) | Demonstrated substantially equivalent mechanical performance | |
| Subsidence Resistance (per ASTM F2267) | Engineering analysis showed performance as intended | |
| Biocompatibility | Biocompatible with the human body (implicitly required for all implants, compared to predicate) | Equivalence to cited predicate devices |
| Sterility | Provided sterile (standard for implantable devices) | Provided sterile |
| Materials | Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 | Additively manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 |
| Indications for Use | Consistent with predicate devices | Substantially equivalent to cited predicate devices, as determined by FDA |
| Design/Components | Similar to predicate devices (patient-specific features, aperture for bone graft) | Substantially equivalent to cited predicate devices |
| Manufacturing | Standard processes, equivalent to predicate | Substantially equivalent to cited predicate devices |
| Packaging & Labeling | Appropriate for sterile implantable device | Substantially equivalent to cited predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific "test set" sample sizes in the context of clinical or evaluation studies as would be seen for AI/ML. For a physical device, testing is primarily non-clinical.
- Sample Sized for "Test Set": Not explicitly stated in terms of a population size. Non-clinical testing typically involves a sufficient number of device samples or test configurations to demonstrate mechanical performance according to the specified ASTM standards.
- Data Provenance: The mechanical testing references ASTM standards (e.g., ASTM F2077, ASTM F2267), indicating laboratory setting for mechanical performance evaluation. A "cadaveric validation" was also performed. Details on the number of cadavers are not provided. The data is thus derived from non-clinical (laboratory/engineering) studies and a cadaveric study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the clearance is for a physical medical device, not a diagnostic or prognostic AI/ML device requiring expert ground truth for interpretation. Mechanical testing and cadaveric validation do not typically involve human experts establishing a "ground truth" in the same way an AI model's output would be compared to a consensus reading.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or prognostic devices to assess the impact of AI on human reader performance. This device is a physical implant.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. This device is a physical implant and does not involve an "algorithm only" performance. Its performance is assessed through its mechanical properties and successful fusion in conjunction with human surgical intervention and bone graft.
7. The Type of Ground Truth Used
For the mechanical performance, the "ground truth" is established by adherence to engineering standards (ASTM F2077, ASTM F2267) and the performance characteristics of predicate devices against which the new device is compared for substantial equivalence. For the cadaveric validation, the "ground truth" would be the observed physical behavior and performance within the cadaveric model. There is no clinical ground truth (like pathology or outcomes data from human patients) presented in this 510(k) summary, as "Clinical Testing" is explicitly stated as "Not applicable."
8. The Sample Size for the Training Set
This information is not applicable. This refers to a training set for an AI/ML model, which is not relevant to this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.