(81 days)
The ATEC Cervical Spacer System is intended for spinal fusion procedures at one or two levels from C2 – T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC Cervical Spacer System is intended for use with supplemental fixation systems and or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
The ATEC Cervical Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbodies feature an internal graft aperture for placement of graft material to promote fusion through the cage.
This document is a 510(k) premarket notification for a medical device called the "ATEC Cervical Spacer System." It is not a study demonstrating the device meets acceptance criteria related to an AI/ML algorithm's performance. Instead, it's a submission to the FDA to demonstrate "substantial equivalence" to legally marketed predicate devices, which allows the device to be marketed without requiring a full Pre-Market Approval (PMA) application.
Therefore, the requested information about acceptance criteria, study design for AI/ML performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document.
The document states:
- "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data. No clinical studies were conducted."
The "performance data" section refers to nonclinical testing to demonstrate the physical and mechanical properties of the intervertebral fusion device itself, not the performance of an AI/ML algorithm.
Here's what the document does describe regarding the device itself (not an AI algorithm):
1. Acceptance Criteria and Reported Device Performance (Nonclinical Testing):
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Static and dynamic axial compression | Supports substantial equivalence to predicate devices |
| Static and dynamic torsion | Supports substantial equivalence to predicate devices |
| Subsidence | Supports substantial equivalence to predicate devices |
| Expulsion | Supports substantial equivalence to predicate devices |
| Particulate and gravimetric analysis | Supports substantial equivalence to predicate devices |
| Bacterial endotoxin testing (BET) | Supports substantial equivalence to predicate devices |
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to nonclinical, bench-top mechanical testing, not a clinical test set for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
7. The type of ground truth used: Not applicable. For nonclinical tests, the "ground truth" is defined by the physical or mechanical properties measured against the established standards (e.g., ASTM standards).
8. The sample size for the training set: Not applicable. There is no AI algorithm.
9. How the ground truth for the training set was established: Not applicable. There is no AI algorithm.
§ 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.