(292 days)
The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine.
This device is intended to be used in patients who have had six weeks of non-operative treatment.
The Vusion® CS Plus system is designed for cervical intervertebral body fusion. The implant is a non-sterile PEEK Optima LT1 (ASTM F2026) implant body and two tantalum (ASTM F560) marker pins and is provided in multiple footprints, lordotic angles, and heights to match patient's anatomy. The implant includes machined fixation teeth on the superior and inferior surfaces, a graft window passing between the superior and inferior surfaces, and an insertion hole for implant placement.
The provided document is a 510(k) summary for a medical device called "Vusion® CS Plus," an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical performance data, rather than clinical study data showcasing diagnostic or predictive accuracy. Therefore, information typically found in studies for AI/algorithm-based devices (like acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance) is not applicable here.
This submission relies on engineering and material testing to prove its safety and effectiveness.
Here's an analysis based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Measure) | Description | Reported Device Performance |
|---|---|---|
| Material Equivalence | Vusion® CS Plus uses the same basic design, material (PEEK Optima LT1 and Tantalum marker pins), and sizes (widths, lengths, heights within the range offered by predicate systems) as previously cleared predicate devices. | The Vusion® CS Plus system uses PEEK Optima LT1 (ASTM F2026) for the implant body and two tantalum (ASTM F560) marker pins. Its dimensions are described as "multiple footprints, lordotic angles, and heights to match patient's anatomy" and are within the range offered by predicate systems. This establishes technological similarity. |
| Intended Use Equivalence | The intended use of Vusion® CS Plus is the same as the predicate devices. | The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease of the cervical spine, to be implanted via an open, anterior approach with autogenous bone and used with a supplemental internal fixation system after six weeks of non-operative treatment. |
| Mechanical Performance | The device's mechanical performance, specifically static and dynamic compression, static shear, static and dynamic torsion, and subsidence, should be comparable or superior to predicate devices when tested under worst-case configurations according to specified ASTM standards. | Results: The mechanical test results demonstrated that Vusion® CS Plus devices perform as well as or better than the predicate devices. (Specific quantitative values are not provided in this summary, but the conclusion states equivalence or superiority.) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on mechanical testing of the device itself, not a clinical test set of patient data. The "worst case configurations" of the device were tested. The exact number of units or configurations tested is not specified in this summary.
- Data Provenance: Not applicable. The data comes from laboratory mechanical testing of the device's physical properties, not from patient data (e.g., country of origin, retrospective/prospective are irrelevant here).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "ground truth" derived from expert consensus on patient data in this submission type. The "ground truth" for mechanical testing is established by the ASTM F2077 and ASTM F2267 standards against which the device performance is measured, and comparison to predicate device performance.
4. Adjudication Method for the Test Set
- Not applicable. As there is no "test set" of patient data or corresponding expert ground truth, adjudication methods (like 2+1, 3+1, none) are not relevant here. The evaluation is based on engineering and material standards compliance.
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 an intervertebral body fusion device (physical implant), not an AI or imaging system requiring human interpretation or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this regulatory submission is based on established engineering and material standards (ASTM F2077, ASTM F2267) and the performance characteristics of legally marketed predicate devices. The goal is to demonstrate "substantial equivalence" to these predicates in terms of safety and effectiveness, primarily through mechanical performance.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing process would involve internal development and validation, but not a "training set" as understood for AI/machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's design and manufacturing is based on engineering principles, material science, and compliance with relevant industry 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.