(260 days)
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No
The summary describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies are based on mechanical testing of the device.
Yes
The device is implanted to fuse adjacent bone surfaces in patients with Degenerative Disc Disease for therapeutic relief of back pain.
No
Explanation: The device is an interbody fusion device intended for surgical implantation to promote spinal fusion, not for diagnosing medical conditions.
No
The device description clearly states it is a "hollow device with texture on two opposing convex sides" and is offered in various physical dimensions, indicating it is a physical implant, not software. The performance studies also describe physical tests like compression and wear.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Advanced Vertebral Solutions IBF device is an implantable device used for spinal fusion. It is a physical structure placed within the body to facilitate bone growth.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's condition. Its purpose is structural support and facilitating fusion.
Therefore, this device falls under the category of a medical device (specifically, an implantable orthopedic device), but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Advanced Vertebral Solutions IBF device, when used with autologous bone graft, is indicated for use in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Advanced Vertebral Solutions IBF device is to be implanted via a transforaminal approach. The device is to be used singly in the lumbosacral spine with supplemental posterior fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
Advanced Vertebral Solutions Express IBFD AVS Express is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces. Advanced Vertebral Solutions Express IBFD AVS Express is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Advanced Vertebral Solutions designed the Advanced Vertebral Solutions Express IBFD AVS Express to be placed through a transforaminal approach and to address vertebrae in the lumbosacral region of the spine.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lumbosacral region of the spine, L2 to S1
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to demonstrate that the Advanced Vertebral Solutions EXPRESS IBFD is substantially equivalent to other predicate devices. Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Subsidence Test per ASTM F2267 Wear Debris ASTM F2077 and ASTM F1877 Static Expulsion Test The results of these studies showed that the subject Advanced Vertebral Solutions EXPRESS IBFD met the acceptance criteria.
No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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