(336 days)
The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.
The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6Al-4V ELI alloy that conforms to ASTM F136.
The VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.
The device is supplied in an appropriately labeled sterile packaging.
The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.
The provided text is a 510(k) Summary for Wenzel Spine's VariLift-C, an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a study for device performance against specific acceptance criteria.
Based on the provided information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a table of acceptance criteria for a new device performance study. Instead, it compares the characteristics of the VariLift Cervical Interbody Fusion System to its predicate devices (VariLift Cervical Interbody Fusion System K111123 and BAK®/C-Vista Interbody Fusion System P980048 S003) to establish substantial equivalence.
The "Performance Data" section explicitly states: "Whereas the only change submitted for this Premarket Notification is a change in the Indications for Use, no new performance data is being submitted."
The comparison table provided in the document focuses on features for substantial equivalence, not performance criteria:
| Items | VariLift Cervical Interbody Fusion System | VariLift Cervical Interbody Fusion System (Predicate) | BAK®/C-Vista Interbody Fusion System (Predicate) |
|---|---|---|---|
| Sponsor | Wenzel Spine | Wenzel Spine | Zimmer |
| 510(K) Number | N/A (current submission) | K111123 | P980048 S003 |
| Indications for Use | Per FDA Guidance | Per FDA Guidance | Per FDA Guidance |
| Material | Ti-6Al-4V alloy per ASTM F136 | Ti-6Al-4V alloy per ASTM F136 | PEEK Optima LT1 |
| Implant Levels | One Level | One Level | One Level |
| # Implants per level | Single or Pairs | Single or Pairs | Single or Pairs |
| Supplemental Fixation | With or Without Supplemental Fixation | With Supplemental Fixation | With or Without Supplemental Fixation |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document is a 510(k) summary for substantial equivalence, not a report on a new device performance study with a test set. It does not contain information about a test set, sample size, or data provenance from a new study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no new performance study was conducted, there is no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new performance study or test set 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 document pertains to an interbody fusion device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document concerns a physical medical device (interbody fusion device), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. Since no new performance study was conducted to evaluate the device against specific criteria, there is no mention of ground truth being established for such a study. The "ground truth" for the submission is the regulatory acceptance of the predicate devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; hence, there is no training set involved.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
In summary: The provided 510(k) summary focuses on demonstrating that the Wenzel Spine VariLift® Cervical Interbody Fusion System is "substantially equivalent" to existing, legally marketed devices. It explicitly states that "no new performance data is being submitted." Therefore, the document does not contain the detailed information about acceptance criteria, study sample sizes, expert qualifications, or ground truth establishment that would be present in a report for a new device performance study. The "study" here is the comparison to predicate devices to satisfy regulatory requirements for substantial equivalence.
§ 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.