(87 days)
The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc.
The SpineFrontier® Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. The system is comprised of devices made of PEEK OPTIMA® HA, with various heights to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist the device movement following implantation.
The implants are provided in two configurations: straight and lordotic (6°) implant sizes for both configurations are offered in three footprints (12x14mm, 11x17mm) and heights from 5mm - 12mm, in 1mm increments.
The SpineFrontier Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the cervical spine (example: Anterior Cervical Plate Fixation).
Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device components are supplied non-sterile, are single use, and are fabricated from PEEK-OPTIMA® HA and contain tantalum markers for radiographic visualization.
This document is an FDA 510(k) premarket notification for a medical device called the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own clinical performance against acceptance criteria in the way an AI/ML device would. Therefore, most of the questions about acceptance criteria, sample sizes, ground truth, and expert adjudication are not applicable (N/A) in this context.
Here's an analysis based on the provided text, addressing the questions where information is available or applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as such for clinical performance, but implied through substantial equivalence to predicate devices for mechanical properties) | Reported Device Performance (from "PERFORMANCE DATA") |
|---|---|
| Mechanical integrity for intended use (e.g., sufficient strength to withstand spinal loads) | The device underwent mechanical testing according to ASTM standards (F2077, F2267, Draft Standard F-04.25.02.02) for static axial compression, torsion, compressive shear, subsidence, expulsion, and dynamic axial compression and torsion. The device also underwent material characterization, including biocompatibility (ISO 10993) and retention of HA and mechanical performance after artificial aging. |
| Biocompatibility | Biocompatibility of PEEK-OPTIMA® HA Enhanced per ISO 10993, including an in-bone study using a large animal model and fusion assessment. |
| Conclusion: "The results of this non-clinical testing show that the strength of the Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: The document describes non-clinical performance testing (mechanical and material characterization). It does not specify sample sizes for these tests, which are typically determined by engineering standards rather than statistical clinical trial sample size calculations.
- Data provenance: N/A. The data is from laboratory performance testing, not human patient data.
- Retrospective or prospective: N/A. This refers to a study design on human subjects, which is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. This device is an implant, and its performance is evaluated through mechanical testing and material characterization, not by human experts establishing ground truth for diagnostic imaging or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No human adjudication is involved in the performance testing of this device type.
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
- N/A. This is not an AI/ML medical device, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For mechanical testing, the "ground truth" is defined by the physical properties and performance metrics established by industry standards (e.g., ASTM F2077, F2267).
- For material characterization and biocompatibility, the "ground truth" is established by relevant ISO standards (e.g., ISO 10993) and scientific principles, potentially including animal studies for in-bone assessment.
8. The sample size for the training set
- N/A. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- N/A. This is not an AI/ML 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.