(110 days)
The Arena-C® Cervical Intervertebral Body Fusion System 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 System 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 with an intervertebral cage.
This 510(k) Submission is seeking add new sizes to the previously cleared Arena-C device. 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.
This document is a 510(k) summary for the SpineFrontier Arena-C® Cervical Intervertebral Fusion System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, AUC). This document is for a physical medical device, an intervertebral body fusion system, not a software or AI/ML device.
Therefore, many of the requested fields cannot be answered from the provided text as they pertain to the evaluation of AI/ML software.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify quantitative acceptance criteria for device performance (e.g., success rates, complication rates) that would typically be seen in a clinical study for a physical implant, nor does it present a clinical study with detailed performance results against such criteria. The "performance testing summary" refers to "engineering rationale and finite element analysis" to show that modifications don't create new worst-case scenarios compared to a predicate device, which is a different type of "performance" than what's implied by the request.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This document describes a submission for an add-on to an existing cleared device ("seeking add new sizes to the previously cleared Arena-C device"). It references "engineering rationale and finite element analysis" rather than a clinical study with human subjects for the new sizes. There is no mention of a "test set" in the context of clinical data.
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)
- Cannot be provided. No clinical "test set" and corresponding ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical "test set" and adjudication method is described.
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
- Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical study or ground truth establishment is described. The "ground truth" for this type of device (spinal implant) would typically be successful fusion or long-term patient outcomes, evaluated through clinical trials, which are not detailed here for the size additions.
8. The sample size for the training set
- Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.
9. How the ground truth for the training set was established
- Cannot be provided. This section pertains to AI/ML software evaluation. This document is for a physical implantable device.
Summary of available information from the document:
The document focuses on demonstrating substantial equivalence to predicate devices for a physical implant rather than proving performance against specific acceptance criteria through a clinical study for the new sizes. The core of the submission for the new sizes relies on:
- Identical Indications for Use.
- Identical Materials of manufacture (Peek Optima®).
- Identical Structural support mechanism.
- "Engineering rationale and finite element analysis were used to demonstrate that the modifications to the Arena-C Cervical Intervertebral Fusion Device do not generate new worst case compared to the predicate device."
Essentially, the "study" demonstrating that the device meets criteria is primarily a biomechanical and materials equivalence assessment, not a clinical study with patient outcomes or expert reads, as would be expected for AI/ML performance evaluation.
§ 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.