(34 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 lo S 1 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 confim1ed 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 titanium markers. The subject device is offered in a variety of styles and sizes to accommodate various patient anatomies.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Mode | Acceptance Criteria (from ASTM standards) | Reported Device Performance (as stated in document) |
|---|---|---|
| Static axial compression (per ASTM F2077-11) | Not specified in the document; implied to meet the standard's requirements for devices of this type. | "the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use" |
| Dynamic axial compression (per ASTM F2077-11) | Not specified in the document; implied to meet the standard's requirements for devices of this type. | "the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use" |
| Static subsidence (per ASTM F2267-04) | Not specified in the document; implied to meet the standard's requirements for devices of this type. | "the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use" |
| Static expulsion (per ASTM DRAFT F-04.25.02.02) | Not specified in the document; implied to meet the standard's requirements for devices of this type. | "the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use" |
Note: The document only provides a general statement that the device's strength is sufficient and substantially equivalent to predicate devices, rather than specific numerical performance metrics against pre-defined acceptance criteria. The acceptance criteria are referenced implicitly by stating adherence to ASTM standards.
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance testing of mechanical properties. It does not refer to a "test set" in the context of patient data or clinical studies. Therefore, information regarding sample size for a test set, country of origin, or retrospective/prospective nature is not applicable to this submission, as it focuses on device characteristics, not clinical performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or clinical ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical mechanical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical medical implant (lumbar cage system), not an algorithm or an AI-powered system.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this document is established through physical testing against recognized mechanical engineering standards (ASTM standards). The document states that the testing validates the "strength" of the device.
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device and its mechanical testing, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
Summary of the Study:
The provided document (K180431) describes a 510(k) premarket notification for the Cortina™ [MAX] Lumbar Cage System. The submission is primarily for a name change from the Cortina™ (K171914) to Cortina™ [MAX], with no changes to the device itself.
The "study" referenced in the document is a series of non-clinical performance tests designed to assess the mechanical strength and stability of the lumbar cage system. These tests were conducted according to established ASTM standards:
- Static axial compression per ASTM F2077-11
- Dynamic axial compression per ASTM F2077-11
- Static subsidence per ASTM F2267-04
- Static expulsion per ASTM DRAFT F-04.25.02.02
The acceptance criteria for these tests are implicitly the requirements of the respective ASTM standards for intervertebral body fusion devices. The reported device performance is a qualitative statement that "the strength of the Cortina™ (MAX) Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
This document does not describe a clinical study, an AI/algorithm-based device, or a study involving human readers or patient data for performance evaluation. It is solely focused on demonstrating the physical and mechanical equivalence of the device to its predicate through engineering testing.
§ 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.