(101 days)
The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device must be used with supplement fixation.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy.
This document, a 510(k) Premarket Notification from the FDA, pertains to a medical device (Cervical Spinal Truss System) and does not describe acceptance criteria, performance data, or study designs for an AI/ML-based medical device. Therefore, I cannot provide the requested information.
The document discusses:
- Device Name: Cervical Spinal Truss System (CSTS) Interbody Fusion Device
- Regulation Number and Name: 21 CFR 888.3080, Intervertebral Body Fusion Device
- Regulatory Class: Class II
- Product Code: ODP
- Indications for Use: For skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one or two contiguous disc levels, used as an adjunct to fusion with autograft and/or allogenic bone graft.
- Device Description: Open architecture truss design made from Ti6Al4V alloy, manufactured via an additive process.
- Predicate Devices: Primarily 4WEB CSTS (K121741), with additional predicates K142112, K171496, and K11119.
- Performance Standards: References ASTM standards for mechanical and MR compatibility testing (e.g., ASTM F2077, F2267, F2119, F2052, F2213, F2182).
- Conclusion: The manufacturer concludes the device is substantially equivalent to the predicate devices based on comparisons of indications for use, materials, function, sizes, and mechanical test results.
There is no mention of any AI/ML components, acceptance criteria for an AI/ML model, or studies related to AI/ML performance. The document focuses on the substantial equivalence of a physical implantable device based on its design, materials, and mechanical properties compared to already cleared devices.
§ 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.