(82 days)
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
The ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-XL™ 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology consists of additive manufactured titanium cages of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The articulating device assembly allows for placement of implant while remaining attached to inserter. The open geometry of the implants allows them to be packed with autograft bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone (e.g., minimally manipulated allograft such as Grafton™ DBM DBF, etc.) Demineralized bone must be used with bone marrow aspirate. The device is not intended to be used as a stand-alone implant.
Stainless steel and titanium implants are not compatible. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
The provided text is a 510(k) summary for the Medtronic Sofamor Danek ARTiC-L™ 3D Ti and ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology. This document is a premarket notification for a medical device to demonstrate substantial equivalence to a legally marketed predicate device.
The information you are asking for, specifically acceptance criteria and details of a study proving a device meets those criteria, is typically associated with the performance evaluation of an AI/ML-enabled medical device. The document provided does not pertain to an AI/ML device. Instead, it concerns an intervertebral body fusion device, which is a physical implant used in spinal surgery.
Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as defined by AI/ML performance metrics (e.g., sensitivity, specificity, data provenance, expert labeling, MRMC studies) are not applicable to this document.
The "Performance Data" section in the document discusses:
- MRI Safety Evaluation: This involved standard ASTM tests (F2052, F2213, F2119, F2182) to ensure the implant is safe in an MRI environment. The results of these tests and the specific acceptance criteria (e.g., "magnetic field interactions for a medical device should be below the 10-cm distance limit for patient safety") are not detailed in this summary but are standard for such devices.
- Design Validation: A minor change to surgical technique (inclusion of demineralized allograft bone mixed with bone marrow aspirate) was noted, with the claim that it does not impact implant or instrument design. No specific "acceptance criteria" for this design validation are provided here, as it's a statement of non-impact.
- Clinical Outcomes: "Clinical outcomes on the usage of demineralized allograft bone combined with bone marrow aspirate were provided to support this application." This refers to evidence for the adjunctive material rather than the primary device, and again, specific metrics or acceptance criteria for these outcomes are not delineated in this summary.
In summary, the provided document does not contain the information required to answer your prompt about AI/ML device acceptance criteria and performance studies because the device in question is a physical surgical implant, not an AI/ML-enabled device.
§ 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.