(111 days)
The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.
The Vista -S Device is a box-shaped vertebral body replacement fabricated from polyetheretherketone (PEEK) that is designed to accommodate the partial replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.
The provided text is a 510(k) summary for the Vista®-S Device, a vertebral body replacement device. This type of regulatory submission in the medical device industry does not typically involve the kind of "acceptance criteria" and "device performance study" as would be found in an AI/software device submission.
Instead, a 510(k) demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. The studies conducted for such devices are typically focused on bench testing (e.g., mechanical strength, fatigue), biocompatibility, and sometimes limited animal studies, rather than clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of medical device and the information provided in the 510(k) summary.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense for this device type.
- For a spinal implant like the Vista®-S Device, "acceptance criteria" would typically relate to mechanical properties (e.g., compressive strength, fatigue life, subsidence resistance), biocompatibility, and sterilization effectiveness. The 510(k) summary does not detail specific acceptance criteria or quantitative performance data from such tests.
- Instead, the submission focuses on substantial equivalence to predicate devices in terms of materials, technological characteristics, and basic principles of operation. The "performance" is implicitly deemed acceptable if it meets the safety and effectiveness standards of the predicate.
2. Sample size used for the test set and the data provenance
- Not Applicable.
- No clinical "test set" in the context of diagnostic accuracy or AI performance is mentioned. The studies conducted would be non-clinical (mechanical, biological). The document does not specify sample sizes for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable.
- There is no "ground truth" to establish for a test set in this context. The evaluation is on the device's physical properties and comparison to existing technology, not on interpretations by experts.
4. Adjudication method for the test set
- Not Applicable.
- No clinical test set requiring adjudication is mentioned.
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 device is a physical implant, not an AI or diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable.
- This is not an algorithm or AI device.
7. The type of ground truth used
- Not Applicable in the traditional sense.
- For this type of device, "ground truth" would be established by validated engineering standards, material specifications, and regulatory guidelines for mechanical testing and biocompatibility. The summary does not elaborate on these details.
8. The sample size for the training set
- Not Applicable.
- There is no "training set" for this physical device.
9. How the ground truth for the training set was established
- Not Applicable.
- No training set is involved.
Summary of what is known from the provided text:
- Device Name: Vista®-S Device
- Device Type: Vertebral Body Replacement Device (spinal implant)
- Intended Use: Partial replacement of a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5) due to tumor or trauma (e.g., fracture). Intended for use with supplemental internal spinal fixation systems and may be used with bone graft.
- Regulatory Pathway: 510(k) Premarket Notification, demonstrating "substantial equivalence" to predicate devices.
- Basis for Acceptance: The FDA determined the device is substantially equivalent to legally marketed predicate devices with respect to intended use/indications for use, materials, technological characteristics, and basic principles of operation. This means the device is deemed as safe and effective as existing devices without requiring new clinical performance studies of the type typical for AI or diagnostic devices.
- Classification: Class II, product code MQP (Spinal intervertebral body fixation orthosis).
The provided text focuses on the regulatory submission process and the classification of the device rather than detailed performance studies or AI validation.
§ 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.