(77 days)
The AEON-C™ Stand Alone System is a stand-alone anterior cervical fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment with a cervical intervertebral intervertebral fusion device.
The AEON-C™ Stand Alone System includes PEEK interbodies and titanium interbodies, which utilize a titanium alloy locking mechanism that is either integrated in an anterior fixation plate or within the interbody. Both PEEK interbodies and titanium interbodies, with or without fixation plates, are to be anchored to patient anatomy via two (2) titanium alloy bone screws. The implant design includes multiple footprints, heights and lordosis options and the screw design includes multiple diameters and lengths, to fit a variety of patient anatomies.
The provided text is a 510(k) summary for the Dio Medical AEON-C™ Stand Alone System, which is an intervertebral body fusion device.
1. Table of Acceptance Criteria and Reported Device Performance
This type of medical device (intervertebral body fusion device) does not typically have "acceptance criteria" in the same way software or diagnostic AI devices do, which might involve performance metrics like sensitivity, specificity, or AUC. Instead, for devices like this, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through mechanical testing, biocompatibility, and material characterization.
However, the provided document explicitly states the following under "Performance Data":
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K191477) | The subject and predicate devices are identical. No performance testing required as the submission is only transferring the name of a system already cleared under K191477. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K191477. No testing is required."
Therefore, there was no new test set used for this particular 510(k) submission (K223140). The device is asserted to be identical to a previously cleared predicate device (K191477).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new test set or performance study was conducted for this submission.
4. Adjudication Method for the Test Set
Not applicable, as no new test set or performance study was conducted for this submission.
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 an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no new performance study was conducted. For mechanical devices, "ground truth" typically refers to established engineering standards, biomechanical testing results, and clinical outcomes data from prior studies on equivalent devices, which would have been part of the original predicate device's clearance.
8. The sample size for the training set
Not applicable. The device is a physical implant, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.