(132 days)
The ROCCIA® ACIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ROCCIA ACIF is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the ROCCA ACIF device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
The ROCCIA ACIF was developed for primary stabilization of the cervical spine. Treatment is carried out using anterior cervical discectomy and fusion (ACDF) surgery for patients with symptomatic degenerative disc problems. The system as a cage design improves interbody fusion as its generously proportioned design allows for the insertion of either bone or bone substitute materials. At the same time, the cage has a broad supporting surface that largely prevents sinking when implanted correctly.
The ROCCIA ACIF Cage is manufactured from PEEK material. The cage has a large cylindrical hollow in the middle which can be filled with bone material or bone substitute material. The large volume of filling material is in direct contact with the patient's vertebra and supports the fusion of the cage with the bone. The load transmission from the vertebra to the cage is effected via a solid frame construction around the hollow recess. The base and cover plates of the cage have a serrated surface which supports the primary anchorage of the cage.
The cage is available in two different versions: a wedge-shaped version and an anatomic version. The design of the upper and lower surface of the cage corresponds to the respective opposite surface of the intervertebral disc. The upper surface component of the anatomic cage is convex, while the lower side is aligned straight in order to match the natural anatomy of the end plate. The four (4) titanium markers project from the surface of the cage above and below and penetrate into the vertebrae when the cage is inserted. This penetration serves for preliminary fixation of the cage. The markers furthermore support the location and verification of correct positioning of the X-ray images. This positioning is additionally supported by two integrated horizontal titanium marker pins.
The ROCCIA instrumentation is ergonomically appropriate and designed as modular components. The ROCCIA insertion device enables the user to perform various instrumentation steps with just a single instrument. The instruments are designed to be used with the ROCCIA ACIF, and are made of materials common for medical devices used in implantable device instrumentation tools. The instruments are intended to be cleaned, sterilized, and reused for the purposes of the multiple implantation procedure.
The ROCCIA ACIF Cage is manufactured from PEEK conforming to ASTM F2026 and the titanium markers are manufactured from Ti6A4V ELI, conforming to ASTM F136. The ROCCIA instrumentation is manufactured from stainless steels conforming to ISO 16061 and ASTM F898.
This document is a 510(k) summary for the ROCCIA® ACIF intervertebral body fusion device. It does not describe a study that proves the device meets acceptance criteria in the typical sense of a clinical performance study with defined acceptance criteria for efficacy or safety. Instead, it aims to demonstrate substantial equivalence to a predicate device based on non-clinical performance data.
Therefore, many of the requested categories for a clinical effectiveness study will not be applicable or directly available from this document. I will fill in the information that is present and indicate where information is not available.
Acceptance Criteria and Device Performance (based on Non-Clinical Testing for Substantial Equivalence)
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a previously cleared predicate device (K150362, NuVasive CoRoent Small Interbody System). This means the device must perform comparably to the predicate device in non-clinical tests and not raise new questions of safety or effectiveness. The document lists the tests performed and states that the device "passed" or showed "comparable results."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Load Testing | Passed the requirements required by standards ASTM 2077 and ASTM 2267 for static axial compression, static compression, static axial torsional, cyclic compression, and cyclic torsion. |
| Mechanical Load Testing Aged | After placing product for one (1) year and five (5) year aging, passed the requirements for standard ASTM 2077 for cyclic compression. |
| Finite Element Analysis (FEA) | Comparison performed with subject device and predicate device showed acceptable results as compared to the predicate device. |
| Subsidence Behavior Testing | Comparison performed with subject device and predicate device showing comparable results. |
| Static Expulsion Testing | Comparison performed with subject device and predicate device showing comparable results. |
| Biocompatibility | Biological evaluation was performed on known materials supporting that no toxic substances or materials are used; materials used in marketed implant devices. |
| Cleaning and Sterilization Testing | Passed the requirements for sterilization for irradiation to ISO 11137 meeting an SAL of 10⁻⁶ and cleaning validation passed the established requirements. |
| Shelf Life Testing | Packaging and shelf life were validated for 5 years. |
| Storage and Transport Testing | Shipping and transport validation supported there were no adverse effects to the product packaging and remained in a sterile state. |
| Overall Design, Sterilization, Performance | Meets all the requirements for overall design, sterilization, biocompatibility, and performance testing results confirming that the design output meets the design inputs and specifications for the device. |
| Safety and Effectiveness (Clinical) | Not directly assessed by a clinical study for this 510(k). The submission states: "These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device." The non-clinical testing detailed in this submission supports the substantial equivalence of the device. |
Study Details Pertaining to Device Performance (from the document)
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "test set" in this context refers to the ROCCIA® ACIF devices and materials subjected to non-clinical performance testing (mechanical, structural, biological). The document does not specify the number of units or samples used for each non-clinical test.
- Data Provenance: The tests were conducted to specific national and international standards (e.g., ASTM, ISO). The location of the testing laboratories is not specified, but the sponsor is based in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the sense of clinical expert consensus or pathology for diagnostic performance, is not relevant for this type of non-clinical substantial equivalence submission. The "ground truth" for these tests comes from established engineering and biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically associated with clinical studies where expert consensus is needed to establish a definitive diagnosis or outcome. Here, performance is measured against objective engineering and material standards.
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, not a diagnostic imaging AI tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its mechanical and biological properties are tested intrinsically and compared to standards/predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Non-Clinical Ground Truth: Established engineering standards (e.g., ASTM F2077, ASTM F2267) for mechanical properties, ISO 11137 for sterilization, and biocompatibility standards for materials (ASTM F2026, ASTM F136). The predicate device's performance also serves as a comparative "ground truth" for achieving substantial equivalence.
- Clinical Ground Truth: No clinical ground truth (expert consensus, pathology, outcomes data) was used or required for this 510(k) submission, as it relied on substantial equivalence.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this 510(k) submission, as it's not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.