(162 days)
The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral 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 prior to treatment with a cervical 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 describes the 510(k) summary for the HUVEXEL Co., Ltd's AEON-C™ Stand Alone System. This is a medical device for orthopedic surgery, specifically for intervertebral fusion, and the information presented is related to its mechanical performance and substantial equivalence to existing devices, not an AI/ML algorithm.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and ground truth for training set) are not applicable to this type of device and study.
However, I can provide the acceptance criteria and reported device performance from a mechanical testing perspective, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Testing Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM F2077 (Static & Dynamic) | Demonstrated substantial equivalence to predicate device |
| ASTM F2267 (Static & Dynamic) | Demonstrated substantial equivalence to predicate device |
| Static & Dynamic compression | Performed; demonstrated substantial equivalence |
| Static & Dynamic compression shear | Performed; demonstrated substantial equivalence |
| Static & Dynamic Torsion | Performed; demonstrated substantial equivalence |
| Subsidence | Performed; demonstrated substantial equivalence |
| Expulsion | Performed; demonstrated substantial equivalence |
Description of the Study that Proves the Device Meets Acceptance Criteria:
The study conducted to demonstrate the AEON-C™ Stand Alone System meets acceptance criteria was a non-clinical performance testing study. This study aimed to show that the subject device is substantially equivalent to legally marketed predicate devices.
Specifics of the Study:
- Type of Study: Non-clinical (mechanical) testing.
- Standards Followed: The testing was performed in accordance with ASTM F2077 (Standard Test Methods for Determining Durability of Intervertebral Body Fusion Device Materials and Constructs in a Corpectomy Model) and ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression).
- Tests Performed:
- Static & Dynamic compression
- Static & Dynamic compression shear
- Static & Dynamic Torsion
- Subsidence
- Expulsion
- Objective: To demonstrate that the AEON-C™ Stand Alone System is as safe, as effective, and performs as well as, or better than, the legally marketed predicate devices.
- Conclusion: The non-clinical tests demonstrated that the device is substantially equivalent to the predicate devices.
2. Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This was mechanical testing of the device, not a study involving patient data or a "test set" in the context of AI/ML. The sample size would refer to the number of physical devices tested, but this detail is not provided in a 510(k) summary for mechanical testing as it is assumed to be adequate for the standards.
- Data Provenance: Not applicable, as this refers to mechanical testing results, not clinical data or data from a specific country of origin.
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):
- Not applicable. Ground truth as defined in this request (expert consensus, pathology) is relevant for clinical or diagnostic AI/ML studies. This study is mechanical performance testing against established engineering standards. The "ground truth" here is the performance metrics defined by the ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in studies where human judgment is involved in establishing ground truth for a clinical or diagnostic outcome. This was mechanical testing.
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 applied to AI/ML devices, not a physical intervertebral fusion device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This applies to AI/ML algorithms. The device itself is described as a "Stand Alone System" in the sense that it is a physical implant, but not in the context of an AI algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Performance Standards: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F2077, ASTM F2267) and substantial equivalence to predicates as demonstrated through comparative mechanical testing and material characterization.
8. The sample size for the training set:
- Not applicable. This applies to AI/ML algorithms, not mechanical device testing.
9. How the ground truth for the training set was established:
- Not applicable. This applies to AI/ML algorithms, not mechanical device testing.
§ 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.