(155 days)
The Avenue T TLIF Cage System 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) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous or allogenic bone graft for fusion.
After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral locking pin.
The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and ASTM F2063 wrought nickel-titanium shape memory alloy anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.
The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.
This looks like a 510(k) submission for a medical device, specifically an intervertebral body fusion device (Avenue T TLIF Cage). The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, much of the information you've requested regarding AI algorithm performance, ground truth, expert consensus, and reader studies is not applicable to this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily refers to general performance criteria through mandated ASTM standards and other non-clinical tests. It doesn't present precise numerical acceptance criteria with corresponding performance values in a direct table format as might be seen for an AI algorithm. Instead, it states that the device "is sufficient for its intended use" and "conformance to endotoxin limits."
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Dynamic compressive shear testing per ASTM F2077-11 | Sufficient for intended use |
| Stability/Fixation | Static anchoring plate expulsion testing | Sufficient for intended use |
| Durability | Wear testing & debris analysis | Not explicitly detailed, but implied as sufficient |
| Biocompatibility | Corrosion testing | Not explicitly detailed, but implied as sufficient |
| Sterility/Endotoxin | Limulus Ameebocyte Lysate (LAL) endotoxin testing | Conformance to endotoxin limits |
| Design Integrity | Finite Element Analysis | Not explicitly detailed, but implied as sufficient |
2. Sample Size Used for the Test Set and Data Provenance:
This question is not applicable as there is no "test set" in the context of an AI algorithm or clinical study with human patients used for demonstrating performance in this 510(k) submission. The non-clinical tests would have their own sample sizes (e.g., number of devices tested for mechanical properties), but these are not specified in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This question is not applicable. There is no "ground truth" establishment in the context of medical image interpretation or diagnosis by experts as this submission is for a physical implant device, not a diagnostic AI tool.
4. Adjudication Method for the Test Set:
This question is not applicable for the same reasons as (3).
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:
This question is not applicable. This submission is for a physical medical device (spinal cage), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used:
This question is not applicable. For an intervertebral body fusion device, "ground truth" would relate to successful fusion or clinical outcomes, which are not assessed in this non-clinical submission. The "truth" for the bench tests is adherence to engineering specifications and performance standards.
8. The Sample Size for the Training Set:
This question is not applicable. This is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable. This is not an AI algorithm.
Summary of Relevant Information from the Document:
- Device Type: Avenue® T TLIF Cage (Intervertebral body fusion device with integrated fixation, lumbar).
- Purpose of Submission: To demonstrate substantial equivalence to a predicate device via non-clinical performance data.
- Performance Data Provided: Non-clinical bench testing, including:
- Finite Element Analysis
- Dynamic compressive shear testing per ASTM F2077-11
- Static anchoring plate expulsion testing
- Wear testing & debris analysis
- Corrosion testing
- Limulus Ameebocyte Lysate (LAL) endotoxin testing
- Conclusion: The non-clinical testing demonstrated that the Avenue T TLIF Cage is sufficient for its intended use, conforms to endotoxin limits, and is substantially equivalent to legally marketed predicate devices.
- Clinical Data: "Clinical testing was not required to demonstrate substantial equivalence." (Page 5)
This document is a typical 510(k) clearance letter and summary for a Class II medical device, relying heavily on engineering and material performance tests rather than clinical trials or AI performance evaluations.
§ 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.