(119 days)
The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is indicated 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 and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DDD patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is made from a titanium alloy (Ti-6Al-4V ELI per ASTM F3001 and TI-6Al-4V ELI per ASTM F136) and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: PLIF (Lordotic; 3°, 6°, and 15°, Convex) and TLIF (Straight, Curved Lordotic and Curved Parallel)
This document describes the regulatory clearance for a medical device and, as such, does not contain information about acceptance criteria or a study proving a device meets them in the way described in your request.
The provided text is a 510(k) summary for the TirboLOX-L™ Lumbar IBFD, an intervertebral body fusion device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish performance against acceptance criteria in the context of an AI/software as a medical device (SaMD) evaluation.
Therefore, I cannot extract the following information as it is not present in the provided document:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
What the document does describe in terms of "performance data" is the results of non-clinical, mechanical testing to ensure the structural integrity and biocompatibility of the physical implant.
Here's the relevant section from the document concerning "Performance Data":
Performance Data:
The TirboLOX-L™ Lumbar IBFD has been tested in the following test modes:
- ASTM F2177-14 Static Axial Compression
- Static Shear
- Dynamic Axial Compression
- Dynamic Shear
- ASTM 3267-04 Static Subsidence
- AAMI ST72 Bacterial Endotoxin Testing
Additionally, expulsion testing was performed. The results of this non-clinical testing show that the strength of the TirboLOX-L™ Lumbar IBFD is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
This information relates to the physical characteristics and safety of the implant itself, not to the performance of a diagnostic or therapeutic algorithm.
§ 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.