(177 days)
The Stryker Spine AVS™ ASL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ ASL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
The Stryker Spine AVSTM ASL PEEK Spacer is a ring shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMA LT1. The AVSTM ASL PEEK Spacer incorporates Tantalum marker pins to aid in radiographic visualization. The upper and lower aspects of the AVSTM ASL PEEK Spacer are open, and the superior and inferior surfaces have serrations that assist in the anchorage and seating of the device. The AVSTM ASL PEEK Spacer is offered in both parallel (0°) and wedge (4° & 8°) shapes. These shapes are available in a variety of footprint sizes to fit the anatomical needs of a wide variety of patients.
Analysis of Stryker Spine AVS™ ASL PEEK Spacers (K051205)
The provided document is a 510(k) Summary of Safety and Effectiveness for the Stryker Spine AVS™ ASL PEEK Spacers. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting extensive clinical studies with specific acceptance criteria in the traditional sense of AI/software devices. Therefore, the information typically requested for AI device evaluations (such as acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is largely not applicable to this premarket notification for a physical medical implant.
Instead, the "acceptance criteria" here are met by demonstrating compliance with FDA's guidance for spinal systems and substantial equivalence to already-marketed predicate devices.
Summary of Acceptance Criteria and Device Performance (as applicable to this type of device):
| Acceptance Criteria Category | Acceptance Criteria / Standard | Reported Device Performance / Evidence of Compliance |
|---|---|---|
| Material Equivalence | Device material (PEEK OPTIMA LT1, Tantalum marker pins) is comparable to predicate devices. | "Documentation is provided which demonstrates the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material..." |
| Design Equivalence | Device design (ring-shaped, hollow frame, lateral fenestrations, serrations, available shapes/sizes) is comparable to predicate devices. | "...design, and indications for use. Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVS™ ASL PEEK Spacer." |
| Indications for Use Equivalence | Device intended use (vertebral body replacement in thoraco-lumbar spine, anterior decompression, height restoration, use with supplemental fixation) is comparable to predicate devices. | "Documentation is provided which demonstrates the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material, design, and indications for use." |
| Biocompatibility | Material must be biocompatible for implantation. (Implied by use of PEEK OPTIMA LT1, a commonly accepted medical-grade material, and substantial equivalence to predicates.) | Not explicitly detailed in this summary, but inherent in the use of medical-grade PEEK OPTIMA LT1 and the FDA's acceptance of the 510(k) submission, suggesting standard biocompatibility testing would have been conducted or referenced. |
| Mechanical Performance / Safety | Device must meet mechanical performance standards for spinal implants (strength, fatigue, stability). Adherence to FDA's Guidance for Spinal System 510(k)'s (May 3, 2004). | "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVS™ ASL PEEK Spacer." This guidance would specify mechanical testing requirements to ensure safety and function. |
| Radiographic Visualization | Device must be radiographically visible for post-implantation assessment. | "The AVS™ ASL PEEK Spacer incorporates Tantalum marker pins to aid in radiographic visualization." |
Study Information (as applicable to this 510(k) document):
2. Sample size used for the test set and the data provenance:
- Not Applicable (N/A): This is a 510(k) premarket notification for a physical implant, not a software or AI device. "Test sets" in the context of AI models (e.g., medical images for diagnostic performance) are not used here. The "testing" referred to is mechanical, material, and design verification against established standards and predicate devices. The data provenance would relate to the source of materials, manufacturing processes, and compliance with standards rather than clinical data from human subjects in a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: Ground truth in the AI/software sense is not established for this device. Compliance is based on engineering specifications, material properties, and comparison to existing devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Not relevant for this type of device submission.
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:
- N/A: This is a physical implant, not an AI or diagnostic imaging device. MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A: Not applicable to a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Predicate Equivalence: The "ground truth" for this device's acceptance is its conformity to industry standards (e.g., mechanical testing per FDA guidance for spinal systems) and demonstrating that its material, design, and intended use are substantially equivalent to previously cleared predicate devices. There is no biological "ground truth" in the sense of a disease state being confirmed.
8. The sample size for the training set:
- N/A: Not applicable to a physical medical implant. There's no training set for an AI model.
9. How the ground truth for the training set was established:
- N/A: Not applicable to a physical medical implant.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.