(217 days)
The Stryker Spine AVS® Anchor-L Lumbar Cage System is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
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 I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS® Anchor-L Lumbar Cage System is to be implanted via an open, anterior approach.
The AVS® Anchor-L Lumbar Cage System may be used as an intervertebral device with integrated fixation or in conjunction with supplemental fixation. When used as an intervertebral device with integrated fixation, the AVS® Anchor-L Lumbar Cage must be used with the three internal screws and plate fixation provided by AVS® Anchor-L Fixation Screws and Clip Plate. If AVS® Anchor-L is used with less than three or none of the provided screws, additional supplemental fixation that has been cleared by the FDA for use in the lumbosacral spine must be used to augment stability. The accompanying Clip Plate must be used anytime the device is used with any number of screws.
The AVS® Anchor-L Lumbar Cage System is a hollow, rectangular-shaped PEEK Optima® cage with three tantalum markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima® cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. When without additional supplemental fixation, the Anchor-L Lumbar Cage designed to be used exclusively with the internal supplemental fixation provided (AVS® ANCHOR-L Fixation Screws and Clip Plate).
The provided text is a 510(k) summary for a medical device called the AVS® Anchor-L Lumbar Cage System, which is an intervertebral fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices through design features and mechanical testing.
It does not contain information related to a study that involves an AI/ML device, nor does it include details like acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance. This type of information is typically found in submissions for AI/ML-driven diagnostic or assistive devices, not for a traditional orthopedic implant like this lumbar cage.
Therefore, I cannot provide a response filling in the requested table and details because the provided document does not contain the relevant information.
Based on the provided document, here's what can be extracted, acknowledging that much of the requested information is not present for this type of device:
The document describes a mechanical device, specifically an intervertebral fusion cage. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biomechanical performance data, not clinical performance or diagnostic accuracy.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical/Biomechanical) | Reported Device Performance |
|---|---|
| Static Compression (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Compression (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Static Compression Shear (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Compression Shear (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Static Torsion (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Torsion (per ASTM F2077) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Expulsion (per ASTM F04-25-02-02 Draft) | Performed, demonstrated substantially equivalent performance to predicate devices. |
| Subsidence (per ASTM F2267) | Performed, demonstrated substantially equivalent performance to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not provided in the summary for the mechanical tests. Sample sizes for mechanical testing are typically relatively small and governed by the specific ASTM standards.
- Data provenance (country of origin, retrospective/prospective) is not applicable to mechanical testing of an engineering device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for mechanical tests is the physical measurement of performance against established engineering standards (ASTM). No human experts are used to establish ground truth in this context; rather, engineers and technicians conduct the tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable for mechanical testing. Test results are objective measurements.
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
- No, an MRMC comparative effectiveness study was not done. This device is a physical intervertebral cage, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is defined by adherence to specific ASTM (American Society for Testing and Materials) standards for mechanical and biomechanical properties of intervertebral body fusion devices. These standards specify how the device should perform under various forces (compression, shear, torsion, expulsion, subsidence).
8. The sample size for the training set
- This is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable. There is no training set for a mechanical device.
§ 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.