(139 days)
The CASCADIA lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the CASCADIA lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. CASCADIA lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The CASCADIA hyperlordotic lateral lumbar implants (≥22°), are intended for levels L2-L5 and are to be used with CAYMAN United plates in addition to posterior supplemental fixation. The CASCADIA non-hyperlordotic lateral lumbar implants may optionally be used with CAYMAN United plates, in addition to supplemental spinal fixation systems.
The CASCADIA cervical implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The CASCADIA cervical implants are also to be used with supplemental fixation; the hyperlordotic CASCADIA cervical implants (i.e., ≥ 10°) are required to be used with an anterior cervical plate as the form of supplemental fixation.
The CASCADIA implants consist of hollow tube structures additively manufactured from titanium alloy. The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The purpose of the subject submission is to incorporate additional lumbar implant sizes into the system. Also CAYMAN United plates and screws provide additional integrated fixation, once attached to the CASCADIA Interbodies.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar spine.
The provided document is a 510(k) summary for the CASCADIA Interbody System, which is a medical device (intervertebral fusion device). It focuses on demonstrating substantial equivalence to predicate devices, primarily through technological comparison and non-clinical performance evaluation (mechanical testing). This type of submission does not involve a study proving the device meets acceptance criteria related to AI performance, human reader improvement with AI assistance, or standalone algorithm performance, as it is an orthopedic implant, not an AI/software device.
Therefore, the requested information regarding AI-specific criteria, such as acceptance criteria for AI performance, sample sizes for test sets for AI, expert adjudication of AI ground truth, MRMC studies, standalone AI performance, and AI training set details, cannot be extracted from this document, because it pertains to an entirely different type of medical device assessment.
The document discusses:
- Device Description: Hollow tube structures additively manufactured from titanium alloy, available in various sizes.
- Function: Provides support and stabilization of the lumbar spine as an intervertebral body fusion device.
- Indications for Use: For patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar or cervical spine, used with autograft and/or allogenic bone graft as an adjunct to fusion, and with supplemental spinal fixation systems.
- Technological Comparison to Predicates: The design features, materials, and sizes are substantially the same as predicate systems.
- Non-Clinical Performance Evaluation: Tested for static torsion, static compression, dynamic compression (ASTM F2077), subsidence (ASTM F2267), and expulsion. Also, bacterial endotoxin testing (BET) was performed for pyrogenicity.
- Conclusion: No significant differences from currently marketed systems that would adversely affect use; substantially equivalent in design, function, material, and intended use.
In summary, the provided text describes the regulatory filing for a physical medical implant, not a software-driven AI device. As such, the requested details about AI performance and human augmentation are not applicable to this 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.