(122 days)
The Optio-C™ Anterior Cervical Intervertebral Body Fusion Device (IBFD) is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C™ IBFD is comprised of one Optio-C™ PEEK IBF Spacer, one Optio-C™ Anterior Cervical Plate and three Optio-C™ bone screws.
The Optio-C™ IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.
The Optio-C™ Anterior Cervical System is comprised of an anterior cervical plate, PEEK IBF spacer and three bone screws and is intended for stand-alone cervical interbody fusion procedures at one level from C2 to T1. The subject device is used to provide structural stability in skeletally mature individuals following discectomy and is offered in multiple contours, lordotic angles, footprints and heights in order to accommodate variations in cervical anatomy.
The plate and PEEK spacer are assembled prior to implantation and placed in the disc space, flush with the adjacent vertebral bodies via an anterior surgical approach. The PEEK spacer is filled with autograft to facilitate fusion. The bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration.
The plate, with integrated anti-backout locking cap mechanism, is offered in a standard width (16mm)as a one-level configuration in multiple heights (6-12mm). The Diamond Tip bone screws are offered in self-drilling and self-tapping tip design, with a variableangle and have a cortical/cancellous thread design.
The subject device can be implanted in two orientations: Standard orientation- two screws cephalic and one screw caudal or Inverted orientation- one screw cephalic and two screws caudal.
The plate and screws are also made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The PEEK spacer is manufactured from radiolucent Polyetheretherketone (PEEK) per ASTM F2026 and contains radiographic markers comprised of Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136.
The plate and PEEK spacer are supplied sterile; the bone screws and instrumentation are supplied non-sterile and are to be sterilized by the end user.
The Optio-C™ Anterior Cervical System is supplied with the instrumentation necessary for use of the system, e.a. trials, rasps, and inserters that facilitate assembly, insertion and removal of the implants.
The provided text describes a medical device, the Optio-C™ Anterior Cervical System, and its clearance by the FDA. However, it does not include information about acceptance criteria for device performance, nor does it detail a study proving the device meets specific acceptance criteria in the way clinical studies for diagnostic or AI-powered devices usually do.
The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing efficacy or accuracy through new clinical trials with defined acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment is not present in the provided document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document in the context of specific performance metrics with acceptance limits. The document describes bench testing conducted to ensure the device's mechanical properties, material biocompatibility, and sterility, with the general statement that "performance is acceptable for its intended use" and that the device is "substantially equivalent" to predicate devices. There are no quantitative acceptance criteria or reported specific performance results in terms of sensitivity, specificity, or similar metrics for diagnostic devices.
The bench tests performed are:
- For the Intervertebral Body Fusion Device (IBFD):
- ASTM F2077 Static and Dynamic Axial Compression
- ASTM F2077 Static and Dynamic Compression Shear
- ASTM F2077 Static and Dynamic Torsion
- ASTM F2267 Subsidence testing
- For the cervical plate:
- ASTM 1717 Static Torsion
- ASTM 1717 Static and Dynamic Compression Bending
- Other tests:
- Wear Testing for particulate evaluation (ASTM 1877)
- Gamma Sterilization (ISO 11137 and ISO 11737)
- Packaging Sterility Testing (ISO 11607)
- Sterilization for end user facility (ISO 17665 and AAMI TIR12)
- Biocompatibility Assessment (ISO 10993-1)
The document states that "The test results conclude the Optio-C™ Anterior Cervical System to be substantially equivalent to the predicate devices listed above." This implies that the device performed comparably to, or within acceptable limits defined by, the predicate devices for these engineering and material tests.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and therefore not provided in the document as it describes a medical implant (hardware), not an AI/diagnostic device that would typically have test sets of data (e.g., images, patient records). The "testing" referred to is bench testing on the physical device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided. The ground truth for mechanical and material properties of an implant is established through validated engineering standards (ASTM, ISO) and laboratory measurements, not through expert consensus on a test set of data.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for human expert ground truth establishment in studies involving interpretation of data, which is not the nature of this device's testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This information is not applicable and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI-assisted interpretation, especially concerning human reader performance. The Optio-C™ Anterior Cervical System is a physical implant, not a diagnostic tool requiring interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. This concept is for AI algorithms, not for physical medical implants.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" is defined by established engineering standards and material specifications (e.g., ASTM F2077, ASTM F2267, ASTM 1717, ASTM 1877, ISO 11137, ISO 11737, ISO 11607, ISO 17665, AAMI TIR12, ISO 10993-1). The device's performance is compared against these standards or against the performance of predicate devices as measured against these standards.
The document also mentions "Design Validation / Cadaver Testing will be conducted to ensure the Optio-C™ Anterior Cervical System performance is acceptable for its intended use and to ensure substantial equivalence to the predicate(s)." This type of testing would assess the device's mechanical stability and surgical handling in a more realistic setting, with the "ground truth" being the device's ability to maintain structural integrity and facilitate fusion as intended, likely compared to established clinical benchmarks or predicate performance. However, no results from this cadaver testing are included in this summary.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. "Training set" refers to data used to train AI models, not relevant for this physical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a cervical spine implant to previously cleared predicate devices through engineering bench testing and material compatibility assessments, rather than presenting clinical study data with specific performance acceptance criteria found in submissions for diagnostic or AI-powered devices. Much of the requested information is not relevant to this type of device and submission.
§ 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.