(121 days)
The Cortina™ 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™ 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™ 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.
The provided text is a 510(k) summary for the Cortina™ Lumbar Cage System, a medical device. This type of document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in the context of diagnostic or predictive AI/ML performance.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies for an AI/ML device is not present in this document.
The document discusses mechanical performance data to demonstrate that the device's strength is sufficient for its intended use and is substantially equivalent to predicate devices.
Here's what can be extracted from the document in relation to performance data, although it doesn't align with the AI/ML focus of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics as would be expected for an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, it lists the types of mechanical tests performed and a general conclusion.
| Acceptance Criteria (Not explicitly stated as numerical targets; implied by equivalence to predicates) | Reported Device Performance (General Conclusion) |
|---|---|
| Sufficient strength for intended use (implied by comparison to predicate devices) | "The results of this non-clinical testing show that the strength of the Cortina™ Lumbar Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
Note: This is a qualitative statement of equivalence for mechanical properties, not a quantitative metric for diagnostic accuracy or similar AI/ML performance.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes mechanical testing of physical devices, not a test set of data for an AI/ML algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for mechanical testing is typically established by engineering standards and measurements, not expert consensus on medical images or clinical data.
4. Adjudication Method
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical intervertebral cage system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
For the mechanical tests, the "ground truth" implicitly refers to the physical properties and performance characteristics defined and measured by the ASTM standards mentioned (F2077-11, F2267-04, DRAFT F-04.25.02.02).
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML training set for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
In summary: The provided document is for a physical medical device (intervertebral cage), not an AI/ML-driven device. Therefore, the information requested in the prompt, which is tailored to AI/ML device evaluation, cannot be found in this text. The "Performance Data" section solely addresses mechanical testing to establish substantial equivalence for safety and effectiveness.
§ 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.