(79 days)
The Arena-C™ 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™ 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 SpineFrontier Cervical Interbody Fusion Device System (Arena-C™ Cervical Intervertebral) 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®, 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 provided text describes a 510(k) premarket notification for a medical device called the Arena-C™ Cervical Intervertebral Body Fusion System. The submission states that clinical data was not required for this device, and therefore, a study evaluating device performance against acceptance criteria in a clinical setting, as one might find for an AI/ML device, was not performed or submitted.
Instead, the basis for substantial equivalence was established through mechanical testing and comparison of indications for use, function, operating principles, and materials to predicate devices.
Given this, I cannot provide the information requested in points 1-9 as they pertain to clinical or AI/ML-based device performance studies, which were explicitly stated as "not required" for this submission.
Here's what I can extract regarding the device's evaluation:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test Method) | Reported Device Performance Statement |
|---|---|
| ASTM F2077-03 (Static & Dynamic Axial Compression) | "The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device... has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of... performance (mechanical testing)." |
| ASTM F2077-03 (Static & Dynamic Torsion) | "The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device... has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of... performance (mechanical testing)." |
| ASTM F2077-03 (Static & Dynamic Shear Compression) | "The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device... has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of... performance (mechanical testing)." |
| ASTM F2267-04 (Subsidence Under Static Axial Compression) | "The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device... has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of... performance (mechanical testing)." |
| ASTM Draft Standard F-04.25.02.02 (Static Expulsion) | "The SpineFrontier Arena-C™ Cervical Intervertebral Body Fusion Device... has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of... performance (mechanical testing)." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This was a mechanical testing study, not a clinical study with a test set of patient data. The materials used for mechanical testing are not described in terms of "provenance."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert review was established for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method was used as there was no test set requiring ground truth establishment by experts.
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 not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The evaluation was based on mechanical test standards, not clinical ground truth.
8. The sample size for the training set:
Not applicable. There was no training set, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. There was no training set or ground truth establishment for a training set.
§ 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.