Search Results

The Spine Innovation Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Spine Innovation Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Spine Innovation Interbody System.

The Spine Innovation Interbody System is an interbody fusion device and corresponding instruments intended to stabilize the spinal segment to promote fusion. The Spine Innovation Interbody consists of PEEK walls, an autogenous material aperture, two titanium linkages that connect the PEEK walls, angular anti-migration teeth, and tantalum x-ray markers.

The Spine Innovation Interbody is available in various sizes to accommodate varying patient anatomy. The Spine Innovation Interbody is available in undeployed widths ranging from 8-12mm, heights ranging from 8-16mm, lengths of 26 or 30mm, and lordotic angles of 0° (parallel), 5°, 10° or 15°.

The Spine Innovation Interbody System implants are intended to be inserted posteriorly via an open or minimally invasive approach.

The Spine Innovation Interbody System is non-sterile and is to be sterilized by the end user.

This document is a 510(k) Premarket Notification from the FDA regarding the Spine Innovation Interbody System, a medical device for spinal fusion. As such, it describes the acceptance criteria for substantial equivalence to a predicate device, focusing on non-clinical performance testing and technological characteristics, rather than performance of an AI/ML device or a device with a human-in-the-loop component.

Therefore, many of the requested items (e.g., number of experts, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable to this type of medical device submission.

Here's a breakdown of what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices through mechanical performance testing. The "reported device performance" is that the Spine Innovation Interbody System met these criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: This document doesn't specify the exact number of devices (sample size) for each mechanical test. The ASTM standards typically outline the minimum number of samples required for such tests.
• Data Provenance: The tests are benchtop mechanical tests and cadaveric testing. The document does not specify the country of origin of the data or whether it's retrospective or prospective, as these terms are generally more relevant to clinical studies involving human subjects or AI/ML model development.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth, in the context of expert consensus, radiologists, etc., is not relevant to the mechanical bench testing of an interbody fusion device. The "ground truth" for these tests are the established ASTM standards and the performance of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are not relevant to mechanical bench testing.

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 a physical medical device, not an AI/ML product or a product that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for these tests are the established mechanical performance standards (ASTM) and the demonstrated performance of legally marketed predicate devices. The device is considered to meet acceptance criteria if its mechanical performance is substantially equivalent to these benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set. The device manufacturing processes are subject to Good Manufacturing Practice (GMP) requirements.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Ask a specific question about this device