(83 days)
Tranquil-CTM Interbody System
The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Tranquil-LTM Interbody System
The Tranquil-L™ Interbody System is intended for use 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 radios. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone.
The Tranquil™ Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for both cervical and lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The purpose of this traditional 510(k) is to expand the indications for use to include use with either autograft and/or allograft bone for the Tranquil™ Interbody System, as well as update the fusion level for the Tranquil-C™ Interbody System to include use at multiple levels (e.g., up to 4 levels) from C2 – T1, and add additional footprints.
The provided document is a 510(k) clearance letter from the FDA for the Tranquil™ Interbody System. It details the device's intended use and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any of the detailed aspects of a clinical study or performance evaluation that would typically involve human readers, ground truth, or sample sizes for testing and training sets.
The only "performance data" mentioned is:
- "Mechanical performance testing data was provided as part of the previous submission to establish substantial equivalence for its use."
- "As was demonstrated in this submission through engineering rationale, the additional footprints do not present a new worst case for the testing that was previously performed. Therefore, no new mechanical testing was performed for this 510(k) submission."
This indicates that the submission relies on bench testing and engineering rationale to demonstrate that the expanded indications and additional footprints do not alter the substantial equivalence established by previous mechanical testing. There is no mention of a study involving human subjects or AI performance.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study that proves the device meets them because that information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to predicate devices, primarily through engineering and material comparisons, not clinical performance studies.
§ 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.