(98 days)
The Cortina™ [MAX] Lumbar Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Cortina™ [MAX] Lumbar Cage System should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Cortina™ [MAX] Lumbar Cage System is an intervertebral fusion device made from medical grade PEEK with tantalum markers manufactured from EVONIK PEEK as described in MAF-1922 with the submissions of the predicate Cortina [MAX] (K171914 and K180431) or medical grade titanium per ASTM F136 with a TECOTEX® surface coating. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies. This submission is intended to add the titanium implants and expand the size offering to include larger footprints.
1. Acceptance criteria and reported device performance
The document does not explicitly state numerical acceptance criteria for device performance. Instead, it argues that the new device, the Cortina™ [MAX] Lumbar Cage System made from titanium, requires no additional testing because it is identical in form, shape, and function to previously cleared PEEK devices (K171914/K180431). The rationale given is that titanium material produces implants with a higher yield load and stiffness when the shape is identical.
Similarly, for the PEEK devices, the document states that the addition of longer PLIF implants (36-42 mm) does not create a new mechanical worst-case compared to the previously tested 20x9x7mm PLIF (K171914/K180431), thus no additional testing is required for the additional length in the line extension.
The DLIF implants also do not need to be tested as a new worst-case because their design and footprint do not represent a new worst-case for either static or dynamic mechanical testing, and the smallest DLIF is significantly larger than what was previously tested.
Therefore, the reported "device performance" in this context is that the new iterations of the device (titanium material and expanded PEEK sizes) are expected to perform equivalently or better than the previously cleared predicate devices for which performance was established, without the need for new mechanical testing to demonstrate this equivalence.
2. Sample size used for the test set and data provenance
No new test set was used for this submission. The device's substantial equivalence is based on comparisons to previously cleared predicate devices. Therefore, there is no new data provenance to report beyond what would have been established for the predicate devices.
3. Number of experts used to establish the ground truth for the test set and their qualifications
Not applicable. As no new test set was directly used for this submission, no new ground truth was established by experts for this specific 510(k). The equivalence is based on technical characteristics and previous clearances.
4. Adjudication method for the test set
Not applicable. No new test set requiring adjudication was performed for this 510(k) submission.
5. Multi-reader multi-case (MRMC) comparative effectiveness study
No MRMC comparative effectiveness study was done. This submission focuses on substantial equivalence based on material and size modifications to an existing device, rather than a comparative effectiveness study involving human readers and AI.
6. Standalone (algorithm only without human-in-the-loop performance) study
Not applicable. This device is an intervertebral body fusion device (physical implant), not a software algorithm or AI device.
7. Type of ground truth used
For the purpose of this 510(k) submission, the "ground truth" relies on the established performance and safety of the predicate devices (Cortina™ [MAX] Lumbar Cage System - PEEK version, K171914/K180431, and other referenced devices). This would have been established through a combination of mechanical testing, material characterization, and potentially clinical data (if required for the predicates) to demonstrate their safety and effectiveness.
8. Sample size for the training set
Not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth to establish for it in this context.
§ 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.