(84 days)
The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The TranS1 Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autograft and/or allograft comprised of cancellous and/or coricocancellous bone graft, and a supplemental spinal fixation system that is cleared for use in the lumbar spine.
The TranS1 Interbody Fusion System is used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. The devices are designed to be used in conjunction with supplemental spinal fixation instrumentation. The subject devices are multiple component systems comprised of single-use implants designed to treat the lumbar spine.
The TranS1 Interbody Fusion System lumbar implants are fabricated from PEEK (ASTM F2026) with Tantalum (ASTM F560) x-ray markers. The TranS1 Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
I am sorry, but the provided text only discusses the FDA's 510(k) clearance for the TranS1 Interbody Fusion System, which is a medical device used for spinal fusion procedures. It specifies the intended use, material composition, and references performance testing conducted according to ASTM standards for static and dynamic mechanical properties, as well as subsidence and expulsion.
However, the text does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML performance metrics (e.g., accuracy, sensitivity, specificity), or any study details proving an AI/ML device meets such criteria.
Therefore, I cannot fulfill your request for information about:
- A table of acceptance criteria and reported device performance for an AI/ML device.
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- MRMC study for an AI/ML device.
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§ 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.