(294 days)
The Reliance VBS System is intended for use in the thoracolumbar spine (T1-L5) to replace a portion of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture) in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Reliance VBS is designed to restore biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period of time.
The Reliance VBS System is to be used with a legally cleared anterior or posterior supplemental fixation device. Additionally, the Reliance VBS is intended to be used with bone graft.
The Reliance VBS System is comprised of implant and instrument components. The implant component, the Reliance VBS device, is a spacer, which replaces a portion of the vertebral bodies in the anterior column of the thoracic and lumbar spine. The spacer may be made of PEEK with Tantalum markers, or made of Titanium alloy.
This K063637 510(k) summary is for a spinal intervertebral body fixation orthosis, the Reliance VBS System. This is a traditional medical device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/ML device is not applicable here.
The document details the device's description, intended use, and its substantial equivalence to other legally marketed predicate devices based on material, intended use, levels of attachment, size range, and use with supplemental fixation.
Here's the information that can be extracted from the provided text, re-contextualized to highlight why AI/ML specific criteria are not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Relevant for AI/ML) | Reported Device Performance (Relevant for AI/ML) |
|---|---|
| Not Applicable (AI/ML device) | Not Applicable (Traditional medical device) |
- Explanation: This summary does not define specific "acceptance criteria" in the quantitative performance sense that would be typically found for an AI/ML device (e.g., specific sensitivity, specificity, or accuracy thresholds). Instead, for this traditional spinal implant, acceptance is based on demonstrating substantial equivalence to predicate devices. This means the device performs similarly, has similar materials, intended use, and design principles as devices already approved for market.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. There is no "test set" in the context of an AI/ML performance evaluation.
- Data Provenance: Not applicable. The device relies on demonstrating equivalence to existing, legally marketed predicate devices, not on a data-driven performance study.
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. There is no "ground truth" to be established by experts for a performance study of this traditional implant. The evaluation is based on engineering principles, material science, and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" or need for adjudication for a performance study.
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-assisted diagnostic or treatment planning device, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm to evaluate.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. Ground truth is not a concept applied in this 510(k) for a traditional implant. The "truth" in this context is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. There is no training set for an AI/ML model for this device.
9. How the ground truth for the training set was established
- Not applicable.
Summary specific to K063637:
The K063637 document demonstrates substantial equivalence of the Reliance VBS System to several predicate devices. This involves comparing aspects like:
- Materials: PEEK or Titanium alloy for the implant components.
- Intended Use: Used in the thoracolumbar spine (T1-L5) for vertebral body replacement due to tumor or trauma to restore height and achieve decompression, for a prolonged period, even without fusion.
- Indications for Use: Exactly matches the intended use, including the requirement for use with a legally cleared anterior or posterior supplemental fixation device and bone graft.
- Levels of Attachment: Thoracolumbar spine (T1-L5).
- Size Range: Implied to be comparable to predicate devices.
- Use with Supplemental Fixation: Explicitly stated, mirroring predicate devices.
The "study" to prove this device meets "acceptance criteria" (which in this case is substantial equivalence) is the 510(k) submission itself, which provides the detailed comparison to the predicate devices as found in the full submission. The FDA's review and clearance of the 510(k) (as evidenced by the letter dated SEP 27 2007) signifies that the company successfully demonstrated this substantial equivalence. No specific clinical trials or performance studies, as would be required for novel or high-risk devices, are detailed in this summary because substantial equivalence to existing devices was established for market clearance.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.