(133 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 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.
aprevo anterior and lateral lumbar interbody fusion devices (ALIF and LLIF):
The aprevo® anterior and lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplementation 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 implanted via a variety of open or minimally invasive approaches.
aprevo® transforaminal lumbar interbody fusion devices (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 (DD), 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 implanted via a variety of open or minimally invasive approaches.
The aprevo® Intervertebral Body Fusion Devices include ALIF-X, ALIF, LLIF, TLIF-O, and TLIF-C interbodies. The aprevo® 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.
The provided text describes a 510(k) premarket notification for a medical device called "aprevo® anterior and lateral lumbar interbody fusion device". It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly regarding changes in a manufacturing process (addition of a new heat treatment).
Based on the document, this is not a study of a device that uses Artificial Intelligence (AI) or machine learning (ML), nor does it involve a multi-reader multi-case (MRMC) comparative effectiveness study, human readers, or ground truth establishment in the context of diagnostic or prognostic AI/ML applications. The device in question is an implantable interbody fusion device, and the "performance" described relates to mechanical properties and material characteristics, not diagnostic accuracy or expert interpretation.
Therefore, many of the requested elements for describing acceptance criteria and study that proves a device meets them (especially those related to AI/ML, human readers, sample sizes for test/training sets, ground truth establishment for interpretative tasks, and effect sizes of AI assistance) are not applicable or extractable from this document.
The document primarily focuses on non-clinical testing/performance data to demonstrate substantial equivalence following a manufacturing change.
Here's a breakdown of the relevant and non-relevant information based on your request:
Acceptance Criteria and Study for aprevo® Interbody Fusion Device
Study Type: Non-clinical (mechanical and material performance) to demonstrate substantial equivalence for a manufacturing process change. This is not a clinical study or a study involving AI/ML performance.
Applicable Sections from Request:
- 1. A table of acceptance criteria and the reported device performance: This can be partially derived from the Discussion of Non-Clinical Testing/Performance Data section, as it outlines the tests performed to show equivalence.
- 2. Sample size used for the test set and the data provenance: For mechanical testing, this refers to the number of devices tested. Data provenance is not explicitly stated but is implied to be from internal testing by the manufacturer.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable in the context of an implantable device's performance, but if interpreted as device-only performance (without human input during its function), then yes, the mechanical tests are "standalone" in that sense.
- 7. The type of ground truth used: For mechanical properties, the "ground truth" would be established engineering standards (ASTM F2077-18, ASTM F3001-14) that define acceptable performance.
Non-Applicable Sections from Request (as per the provided document's content):
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable for mechanical tests of an implantable device.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable. This is not an AI/ML diagnostic or image interpretation device.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Detailed Response:
1. Table of Acceptance Criteria and Reported Device Performance
The document details that the "subject device underwent mechanical performance testing to validate that the performance of the worst-case subject devices is substantially equivalent to the previously cleared predicate devices." The acceptance criteria implicitly involve meeting the performance requirements of the cited ASTM standards, and the reported performance is that substantial equivalence was demonstrated.
| Acceptance Criteria Category | Specific Test Standard / Goal | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Performance | ASTM F2077-18: Methods for intervertebral body fusion devices | Demonstrated substantial equivalence to predicate devices. |
| - Static/Dynamic Compression | The results "did not identify any new or increased risks". | |
| - Static/Dynamic Compression Shear | ||
| Material Performance | ASTM F3001-14: Standard specification for additively manufactured titanium-6 aluminum-4 vanadium alloys | Demonstrated substantial equivalence to predicate devices. |
| - Tensile Testing | The results "did not identify any new or increased risks". | |
| - Microstructure Assessment per ASTM F3001 | ||
| - Chemical Composition Assessment per ASTM F3001 | ||
| Overall Comparison | Substantial Equivalence to Predicate Devices (K222009, K222082, K231140) in Function and Performance | Concluded to be substantially equivalent in design, function, and performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the number of devices (samples) used for each mechanical test. Standard practice for such tests under ASTM typically involves a minimum number of samples (e.g., n=5 or n=6 per condition) to achieve statistical significance. However, the exact sample sizes are not provided in this summary.
- Data Provenance: The data provenance is implied to be from internal testing conducted by Carlsmed, Inc., as part of their premarket notification submission to the FDA. The country of origin for the data is not specified, but the company is based in Carlsbad, California, USA. The testing is prospective in the sense that it was conducted specifically to demonstrate equivalence for this submission, although the data itself is on device performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This is a mechanical/material performance study of an implantable medical device, not a study involving human interpretation of medical images or data. "Ground truth" for these tests refers to the objective physical measurements against established engineering standards.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication process is involved as it's not an interpretive or diagnostic study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No. This type of study is typically performed for diagnostic or AI-assisted diagnostic devices. This device is an implantable interbody fusion device, and its performance is assessed via mechanical and material properties, not human reader accuracy with or without AI assistance.
6. If a Standalone Performance Study was done:
- Yes (in principle for mechanical device testing). The "Discussion of Non-Clinical Testing/Performance Data" describes tests performed on the device itself (e.g., static/dynamic compression, tensile testing) to evaluate its mechanical and material properties against established standards. These tests are performed on the device samples in a laboratory setting, independent of human clinical application for their evaluation of device performance in terms of strength, integrity, etc.
7. The Type of Ground Truth Used:
- The "ground truth" for this study is established by validated engineering standards and specifications (ASTM F2077-18 for mechanical properties and ASTM F3001-14 for material properties). The performance of the devices is measured against the requirements outlined in these standards and compared to the performance of predicate devices.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for an AI/ML model, this question does not apply.
§ 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.