(56 days)
The Calibrate CCX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Calibrate CCX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.
The subject Calibrate CCX Interbody System is an expandable lumbar intervertebral body fusion system designed to be inserted through a posterior or transforaminal surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F136. The Calibrate CCX Interbody System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create parallel expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces.
The provided document does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.
The document is an FDA 510(k) clearance letter for the Calibrate CCX Interbody System, which is a spinal fusion device, not an AI/ML-based device. The 510(k) process for this type of device relies on demonstrating substantial equivalence to a predicate device through non-clinical testing (e.g., mechanical performance, biocompatibility).
The "Performance Data" section explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical study, particularly not one involving AI/ML performance metrics, was conducted or required for this clearance.
Therefore, I cannot provide the requested information based on the given document.
§ 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.