(207 days)
The Vista@-S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista S Device is implanted via an anterior approach.
The purpose of this submission is a line extension to the Vista®-S Device adding additional height and footprint options. The Vista -S Device is a box-shaped device for interbody fusion fabricated from polyetheretherketone (PEEK). The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of 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 510(k) summary for the Vista®-S Device describes a line extension to an intervertebral body fusion device and relies on showing substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" and "device performance" are established by demonstrating that the new line extension does not negatively impact the safety and efficacy compared to the predicate devices, and that it satisfies relevant ASTM standards and FDA guidance. This is primarily done through performance testing in the form of Finite Element Analysis (FEA).
Here’s a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Requirements) | Reported Device Performance |
|---|---|
| Mechanical Performance (per ASTM F2077-03 and FDA Class II Special Controls Guidance for Intervertebral Fusion Devices): | |
| Axial Compression Strength | FEA simulation performed and results accepted as not representing a new worst case. |
| Torsion Strength | FEA simulation performed and results accepted as not representing a new worst case. |
| Compression Shear Strength | FEA simulation performed and results accepted as not representing a new worst case. |
| Material Equivalence | Identical material (PEEK) as previously cleared predicate devices. |
| Intended Use/Indications for Use Equivalence | Same as predicate devices. |
| Design Features/Overall Geometry Equivalence | Similar to cleared predicate devices. |
| Safety and Efficacy (Overall) | An engineering rationale along with the FEA testing determined that the proposed line extension does not represent a new worst case for testing and are therefore considered substantially equivalent to the predicates. "No significant differences... that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety or efficacy." |
Study Proving Device Meets Acceptance Criteria:
The study conducted to prove the device meets the acceptance criteria was a Finite Element Analysis (FEA) testing study.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable in the traditional sense of patient data. FEA is a computational simulation. The "samples" would be the specific FEA models created for the various device configurations. The document implies that multiple FEA simulations were conducted for axial compression, torsion, and compression shear, but does not specify the exact number of models or iterations.
- Data Provenance: Not applicable as it's an engineering simulation, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This is not applicable for an FEA study. Ground truth, in this context, would be the established engineering principles, material properties, and the ASTM F2077-03 standard itself, which are developed by experts in the field through consensus. The "experts" reviewing the FEA results would be the internal engineering and regulatory teams at Zimmer and the FDA reviewers.
4. Adjudication Method for the Test Set:
Not applicable in the context of clinical adjudication. The FEA results were likely reviewed and accepted by internal engineering and regulatory teams at Zimmer and subsequently by the FDA for the 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This device is an intervertebral body fusion device, and the submission is for a line extension based on mechanical equivalence, not on image interpretation or diagnostic accuracy where MRMC studies are typically employed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the Finite Element Analysis (FEA) testing can be considered a standalone performance assessment of the device's mechanical properties, without human interaction during the test itself. The FEA simulates the device's behavior under specific loads.
7. The Type of Ground Truth Used:
The ground truth used for the FEA study is based on:
- Established engineering principles and biomechanical models.
- Material properties of PEEK.
- The specifications outlined in the ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices.
- Recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device.
8. The Sample Size for the Training Set:
Not applicable. FEA is a simulation technology and does not involve "training sets" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for FEA.
§ 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.