(141 days)
The Innovasis C-Box PEEK Cervical IBF device is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.
The single use devices are rectangular in shape with rounded corners and are offered in a variety of different heights to accommodate patient anatomy. The design features include: · Proportional sizing for the cervical spine · 6º lordosis · Manufactured with Invibio PEEK OPTIMA® polyetheretherketone · Large central window for bone autograft material • Radiolucent · Tantalum markers to facilitate and verify device placement · Custom position instruments to facilitate proper implant placement · Proud tooth design on superior and inferior surfaces to resist migration
The provided documentation describes a 510(k) premarket notification for the C-Box® PEEK Cervical IBF System, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance statistics from a clinical study for the new device.
Therefore, many of the requested elements regarding acceptance criteria, device performance, sample sizes, and expert validation are not applicable or explicitly stated in this type of regulatory document. Instead, the focus is on demonstrating that the new device is as safe and effective as a previously cleared device.
Here's an analysis based on the provided text:
Acceptance Criteria and Study Details for C-Box® PEEK Cervical IBF System
This submission is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study of the new device itself.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical performance (e.g., sensitivity, specificity) for the new device. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data and material equivalency.
| Acceptance Criteria (Demonstrated Equivalency to Predicate Devices) | Reported Device Performance (Non-Clinical) |
|---|---|
| Design configurations are substantially equivalent. | The C-Box® PEEK Cervical IBF has a rectangular shape with rounded corners, proportional sizing for the cervical spine, 6º lordosis, large central window for bone autograft, radiolucent body with tantalum markers, and custom position instruments. These features are implicitly presented as substantially equivalent to the predicate devices. |
| Applied mechanical loads are substantially equivalent. | Performance testing per ASTM F2077-11 (Test Methods for Intervertebral Body Fusion Devices) and ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression) was performed. These tests cover: Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, Subsidence, and Expulsion. The results "indicate that the C-Box PEEK Cervical IBF is substantially equivalent to the predicate device." |
| Product sizes and shapes are substantially equivalent. | The device is offered in a variety of different heights and features 6º lordosis, described as "proportional sizing for the cervical spine". This is presented as substantially equivalent to predicate devices. |
| Materials used are equivalent. | Implants are machined from medical grade polyetheretherketone (Invibio PEEK Optima®) per ASTM F-2026. Radiographic markers meet ASTM F-560 for unalloyed Tantalum. These materials are explicitly stated as equivalent to those used in predicate devices. |
| Biocompatibility requirements have been demonstrated. | Implicitly demonstrated through the use of Invibio PEEK Optima® (per ASTM F-2026) and Tantalum (per ASTM F-560), which are well-established biocompatible materials for surgical implants, and likely by direct comparison to the predicate devices which use similar materials. The document states "Biocompatibility requirements have been demonstrated." |
| Manufacturing and processing methods are substantially equivalent. | Not explicitly detailed, but stated as a conclusion: "Manufacturing and processing methods are substantially equivalent." |
| Shelf life is equivalent. | Not explicitly detailed, but stated as a conclusion: "Shelf life is equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "testing" referred to is non-clinical performance testing on the device itself (e.g., mechanical tests), not a clinical trial on a patient population. The sample size for these non-clinical tests (e.g., number of devices tested for mechanical properties) is not specified.
- Data Provenance: The mechanical performance data is generated in a laboratory setting per ASTM standards. This is not clinical data, so country of origin of patient data or retrospective/prospective status is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As this is a 510(k) for an intervertebral fusion device, the "ground truth" for demonstrating substantial equivalence is based on engineering analyses, material science, and comparison to predicate devices, not on expert adjudication of clinical outcomes or images in a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not relevant for a mechanical implant device 510(k) submission, which focuses on physical and material equivalency rather than software or imaging diagnostic performance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a mechanical implant, not an algorithm or an AI-powered diagnostic tool.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on adherence to recognized ASTM standards for material properties and mechanical performance, and documented similarities in design, materials, and intended use with already-cleared predicate devices. The clinical ground truth for the predicate devices' safety and effectiveness was established when they received clearance or approval.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 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.