(170 days)
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 radiographic studies. 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-L Interbody System is a lumbar interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the lumbar spine. Implants are provided sterile via gamma irradiation. Instruments are provided clean and non-sterilization at the user's facility.
The purpose of this special 510(k) is to gain clearance for modifications to existing lumbar implants and add implant footprints for the DLIF surgical approach.
This FDA 510(k) Premarket Notification is for the Tranquil-L Interbody System, a lumbar interbody fusion system. The document states that engineering analysis and confirmatory testing were conducted to demonstrate substantial equivalence to previously cleared devices. However, the provided text does not contain specific acceptance criteria or reported device performance metrics in a table format. It also lacks details regarding the sample size, data provenance, expert involvement for ground truth, adjudication methods, or specific standalone or MRMC study results.
Therefore, based solely on the provided text, I cannot provide a detailed answer to your request regarding acceptance criteria and the study that proves the device meets them, as this information is not present.
The document primarily focuses on establishing "substantial equivalence" of the modified Tranquil-L Interbody System to its predicate devices by indicating that:
- Materials are identical to the primary predicate (Titanium Alloy (Ti-6Al-4V ELI) per ASTM F3001).
- Geometry differences are slight, and analysis and testing have shown equivalent performance.
- Engineering analysis and confirmatory testing were conducted, including dynamic compression and dynamic compression shear per ASTM F2077.
Without specific performance metrics from these tests and the acceptance thresholds, a table of acceptance criteria and reported performance cannot be generated. Similarly, information regarding ground truth establishment, expert qualifications, and study design details (sample size for test/training, provenance, MRMC, standalone) are not available in 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.