(90 days)
The Nu Vasive® TLX Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion.
The TLX Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (0) months of non-operative treatment prior to being treated with the TLX Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.
The TLX Interbody intervertebral fusion device is designed to address lumbar pathologies utilizing interbody placement through a standard posterolateral approach. The NuVasive® TLX Interbody System is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and ISO 5832-3, and nickel-cobalt-chromium-molybdenum (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The provided text is a 510(k) summary for the NuVasive® TLX Interbody System, which is a medical device for spinal fusion. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices based on technological characteristics and performance data.
However, the document does not contain information about:
- Acceptance criteria for device performance. It only states that nonclinical testing was performed and "The results demonstrate that the subject TLX Interbody System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate." This implies the acceptance criteria were based on equivalence to the predicate devices' performance, but specific numerical criteria are not given.
- A study that proves the device meets specific acceptance criteria with reported device performance. The document mentions nonclinical testing (static and dynamic axial compression and compression shear testing per ASTM F2077, static push-out testing per ASTM draft standard F-04.25.02.02, and subsidence assessment), but it does not provide the results of these tests or compare them to any explicit acceptance criteria in a table. Instead, it concludes equivalence to predicate devices based on these tests.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is typically for AI-assisted diagnostic devices, which this medical implant is not.
- Standalone (algorithm only) performance. The device is a physical implant, not an algorithm.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot provide the requested information in the format requested based on the provided text. The document is focused on establishing substantial equivalence for regulatory clearance, rather than detailing the specifics of a performance study against predefined acceptance criteria for a novel AI or diagnostic 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.