(17 days)
The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The VENTURE™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile. The locking plate is manufactured from shape memory metal (Nitinol). The purpose of the application is to add modified fixed and variable angle screws to the system.
This document is a 510(k) summary for the Venture™ Anterior Cervical Plate System, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo safety and effectiveness studies with detailed acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, specific study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from the given text alone. The document does not describe the types of performance studies typically associated with such detailed acceptance criteria.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in a quantitative manner, nor does it present specific performance data against such criteria. The primary "performance" reported is its substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (likely implied to be similar performance and safety profile to the predicate device) | Demonstrated substantial equivalence to the predicate VENTURE™ Anterior Cervical Plate screw and plate components cleared in K042922. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable or not specified. This document discusses a comparison to a predicate device, not a new clinical or performance study with a "test set" in the traditional sense of a clinical trial for a new device.
- Data provenance: Not applicable or not specified. The comparison is made to a previously cleared device (K042922), implying the existing data/performance of that predicate device is being leveraged.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document does not describe a study involving expert-established ground truth for a test set of this new iteration of the device.
4. Adjudication method for the test set:
Not applicable. No "test set" requiring adjudication is described.
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 spinal implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
Not applicable in the context of a new performance study. The "ground truth" for the device's indications and safety is implicitly tied to the established safety and effectiveness of the predicate device (K042922).
8. The sample size for the training set:
Not applicable. The document describes an implant system, not a software or AI device that would require a "training set."
9. How the ground truth for the training set was established:
Not applicable. As above, no training set for an AI/software device is involved.
Summary of what the document does communicate:
The primary "study" or demonstration presented in this 510(k) summary is the assertion of substantial equivalence to a previously cleared device (K042922). This means that the FDA determined that the new components (modified fixed and variable angle screws) of the VENTURE™ Anterior Cervical Plate System are as safe and effective as the predicate device. This determination is made based on comparing indications for use, technological characteristics, and performance data if necessary (though not detailed here) to the predicate device. For such a device, in vitro biomechanical testing or material characterization is common to support equivalence, rather than large-scale clinical trials with specific acceptance criteria and ground truth as might be seen for a diagnostic or AI device.
§ 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.