(108 days)
When used as an intervertebral body fusion device, the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion 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 at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.
Degenerative disc disease (DDD) is defined as back pain of discogenic origin 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.
When used as a vertebral body replacement (VBR) the Vu ePOD and Vu LPOD VBR System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (ie. fracture).
The Vu ePOD and Vu LPOD VBR System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autograft or allograft only.
The Vu ePOD and LPOD VBR System is intended for use with supplemental internal spinal fixation such as the BodyForm Thoracolumbar Fixation System or the Coral Spinal System.
The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices are comprised of PEEK OPTIMA-LT cages with fenestrations and radii on all sides and toothed ridges. The toothed ridges of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu ePOD is a straight shaped cage while the Vu LPOD has a curved shape. The Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices may be used individually or in a pair depending on the surgical need.
The provided document is a 510(k) Summary for the Vu ePOD and Vu LPOD Intervertebral Body Fusion Devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering and mechanical testing, rather than extensive clinical studies on human subjects.
Therefore, many of the typical acceptance criteria and study design elements found in a clinical study for a medical image analysis AI device (like human reader performance, expert consensus on ground truth for AI training/testing, MRMC studies, etc.) are not applicable to this submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Tests/Standards | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Static Axial Compression (ASTM F-2077, ASTM F-2267) | Performed as designed and met or exceeded all product specifications. |
| Static Compression Shear (ASTM F-2077, ASTM F-2267) | Performed as designed and met or exceeded all product specifications. | |
| Dynamic Axial Compression (ASTM F-2077, ASTM F-2267) | Performed as designed and met or exceeded all product specifications. | |
| Dynamic Compression Shear (ASTM F-2077, ASTM F-2267) | Performed as designed and met or exceeded all product specifications. | |
| Subsidence (ASTM F-2077, ASTM F-2267) | Performed as designed and met or exceeded all product specifications. | |
| Expulsion (ASTM F-2077, ASTM F-2267) | Performed as designed and met or exceeded all product specifications. | |
| Substantial Equivalence | Similar indications for use to predicate device | Yes, similar to Vu aPOD and predicate REVEAL VBR. |
| Similar basic design | Yes, similar to Vu ePOD and Vu LPOD. | |
| Similar operating principle, materials, manufacturing, sterilization, packaging | Yes. | |
| Used with supplemental fixation | Yes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a number of devices. The "Summary of Test Data" indicates that "Mechanical testing of the subject device consisted of static axial compression, static compression shear, dynamic axial compression, dynamic compression shear, subsidence and expulsion." This implies that a sufficient number of device samples were manufactured and tested according to the specified ASTM standards.
- Data Provenance: The device manufacturer is Theken Spine, LLC, located in Akron, Ohio, USA. The testing was conducted in accordance with ASTM (American Society for Testing and Materials) standards. The data is from prospective mechanical testing conducted on manufactured devices, not from human subjects or retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The ground truth for this device's performance is established through objective mechanical engineering tests against defined performance specifications and ASTM standards, not through expert human assessment of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Mechanical test results are quantitative and objective. There is no need for human adjudication of the test results themselves, only for the interpretation and comparison against pre-defined engineering specifications.
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
This is not applicable. This is a device for intervertebral body fusion and vertebral body replacement, not an AI device or a diagnostic imaging tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. There is no algorithm or AI component in this medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is the pre-defined engineering specifications derived from relevant ASTM standards (ASTM F-2077, ASTM F-2267) and the device's design requirements. The mechanical tests verify that the device meets these objective, quantifiable standards for strength, stability, and durability.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI/algorithm for this device. The development of the device's design and manufacturing processes is informed by engineering principles and materials science, not machine learning training data.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set for an AI/algorithm, there is no ground truth established in this context. The design and performance requirements (analogous to "ground truth" for traditional medical devices) are based on biomechanical principles, clinical needs, and regulatory standards.
§ 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.