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510(k) Data Aggregation
(264 days)
Avenue P is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
The device is implanted via a transforaminal or posterior approach and intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Avenue P is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation cleared for use as an adjunct to fusion in the lumbar spine.
The Avenue® P Cage System consists of various sized, titanium coated, PEEK intervertebral body fusion cages, titanium anchoring plates for integrated fixation, and associated instrumentation. The system is intended to be used to stabilize lumbosacral spinal segments, promote spinal fusion in combination with bone graft and to restrict motion at the implanted vertebral level.
The Avenue® P cages have been designed for use with optional VerteBRIDGE® integrated fixation anchoring plates. Upon insertion, the VerteBRIDGE® anchoring plate provides and maintains additional stability and expulsion resistance by direct purchase into the bony vertebral endplates.
The base material of the Avenue® P Cage System implant is polyetheretherketone (PEEK-OPTIMA LT1) which conforms to ASTM F2026-12. This PEEK base is coated on the superior and inferior surfaces with a plasma sprayed, commercially pure titanium (SPONDYCOAT-T 371A) conforming to ASTM F1580-12.
The provided text describes the Zimmer Biomet Spine, Inc. Avenue® P Cage System (K181096), an intervertebral body fusion device. The submission is a 510(k) premarket notification, which aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, rather than proving its effectiveness through a de novo study with specific clinical performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, and ground truth establishment for AI/algorithm-based devices is not directly applicable in this context.
Here's a breakdown of what is available in the document, and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is typically found in submissions for novel devices or those undergoing a de novo classification, where a specific performance threshold needs to be met to demonstrate safety and effectiveness. For a 510(k) submission like K181096, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through various tests.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Performance Data) |
|---|---|
| Mechanical integrity according to ASTM standards (ASTM F2077) | Intervertebral body fusion device assessed and tested appropriately in accordance with ASTM standards. Functioned as intended and demonstrated substantial equivalence to predicate devices. |
| MR Safety according to ASTM standards (ASTM F2052, F2213, F2119, F2182) | MR Safety testing conducted. In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate devices. |
| Intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles are same as or similar to predicates. | Identified as same as, or similar to, the primary predicate CONCORDE® Bullet (K151773), and additional predicates Lucent Ti-Bond Systems (K150061), Biomet Spine Fusion System (K153695), Avenue T TLIF Cage (K142645), and ROI-C Titanium-Coated Implant System (K151934). |
| No new issues of safety or effectiveness compared to predicate devices. | "The subject Avenue® P components do not raise any new issues of safety or effectiveness when compared to the cited predicates. Performance data presented also demonstrated comparable properties to the previously cleared devices." |
2. Sample size used for the test set and the data provenance: Not applicable. This submission is for a medical device (intervertebral cage) and primarily relies on mechanical and safety testing against established standards and comparisons to predicate devices, not on a test set of data like an AI algorithm would use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is relevant for clinical studies or AI algorithm validation, not for the mechanical and material testing described here.
4. Adjudication method for the test set: Not applicable for the reasons stated above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or treatment planning device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implantable medical device.
7. The type of ground truth used: For this type of device, the "ground truth" aligns with established engineering principles, material science, and biocompatibility standards. The various ASTM standards (F2077 for mechanical testing, F2052, F2213, F2119, F2182 for MR safety) represent the accepted criteria and methodologies for evaluating the performance and safety of such implants.
8. The sample size for the training set: Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for an intervertebral body fusion device. Its focus is on demonstrating "substantial equivalence" to existing, legally marketed predicate devices through engineering and material testing, rather than presenting clinical study data with acceptance criteria for a novel therapeutic or diagnostic outcome. Therefore, many of your specific questions related to AI/algorithm validation or clinical efficacy studies are not addressed in this type of regulatory submission.
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