(260 days)
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.
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.
The provided 510(k) summary describes a medical device, the Advanced Vertebral Solutions EXPRESS IBFD, which is an intervertebral fusion device, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. As such, the information provided is not for an AI/ML powered device, and therefore several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, how ground truth for training set was established) are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for each test are implied to be "meeting the standards of the predicate devices" or "within acceptable limits as defined by the ASTM standards for intervertebral body fusion devices." The document states that the new device met these criteria.
| Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static and Dynamic Compression Test (per ASTM F2077) | Performance comparable to predicate devices and within limits defined by ASTM F2077 for intervertebral body fusion devices. | Met the acceptance criteria. |
| Static and Dynamic Compression Shear Test (per ASTM F2077) | Performance comparable to predicate devices and within limits defined by ASTM F2077 for intervertebral body fusion devices. | Met the acceptance criteria. |
| Subsidence Test (per ASTM F2267) | Performance comparable to predicate devices and within limits defined by ASTM F2267. | Met the acceptance criteria. |
| Wear Debris Test (per ASTM F2077 and ASTM F1877) | Performance comparable to predicate devices and within limits defined by ASTM F2077 and F1877. | Met the acceptance criteria. |
| Static Expulsion Test | Performance comparable to predicate devices and demonstrating adequate resistance to expulsion. | Met the acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document describes non-clinical (mechanical) testing of a medical implant, not performance testing of an algorithm on a data set. The sample sizes would refer to the number of devices tested in each mechanical test, which is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical or image data. The "data" here refers to the physical and mechanical properties of the device, likely generated in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in this context refers to the physical properties measured in mechanical tests, not expert interpretation of clinical data. The "experts" would be the engineers and technicians performing the ASTM standard tests.
4. Adjudication method for the test set
- Not applicable. Since there's no expert interpretation or uncertainty addressed, no adjudication method would be used. The results are quantitative measurements against established standards.
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. This is not an AI/ML powered device. No clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for this device's performance is based on established engineering standards and quantitative measurements from non-clinical mechanical tests (e.g., meeting specific load-bearing requirements, wear rates, and expulsion resistance detailed in ASTM standards F2077, F2267, and F1877). It's about validating physical integrity and performance, not diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML powered 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.