(14 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. If the device is being used without the CSTS Integrated Plate, supplemental fixation must be used.
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 heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights and orientations to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.
This FDA 510(k) clearance letter for the Cervical Spine Truss System (CSTS) is for a physical medical device (an intervertebral body fusion device), not an AI/software device. Therefore, the information typically required to describe the acceptance criteria and study proving an AI/software device's performance (as outlined in the prompt's requested information points) is not present in this document.
The document discusses the mechanical and safety performance of the physical device and its substantial equivalence to a predicate device, but it does not contain details about:
- Acceptance criteria for an algorithm's performance
- Sample sizes for data used in AI model testing
- Expert involvement in ground truth establishment for AI
- Adjudication methods for AI test sets
- MRMC studies for AI assistance
- Standalone AI performance
- Training set details for AI
The 510(k) summary explains that the purpose of this specific submission (K251117) is to "add additional configurations to the integrated plate product offering and to provide the integrated plate as sterile packaged." It then states that "The modifications made to the CSTS Integrated Plate for this submission did not create a new worst-case condition for any mechanical or MR safety tests. The results of the predicate testing are applicable to the subject devices and no further testing was required."
In summary, based solely on the provided FDA 510(k) clearance letter for the Cervical Spine Truss System (CSTS), it is not possible to answer the detailed questions about acceptance criteria and study design for an AI/software device's performance because the device itself is a physical implant, not an AI or software product.
§ 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.