(100 days)
The Choice Spine HawkeyeTM Vertebral Body Replacement (VBR) System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System is composed of implant components which have a basic oval/trapezoidal shape with a hollow center for placement of bone graft. The superior and inferior surfaces have ridges, or "teeth" for resisting migration. The replacement implants, "spacers", are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. This system includes implants made of PEEK (ASTM F2026) with Tantalum markers (ASTM F560) or Ti-6Al-4V ELI (ASTM F136 or ASTM F3001).
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System:
This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than strictly defining and meeting performance-based acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily framed as demonstrating equivalence through mechanical testing, especially for worst-case designs. There is no mention of a study involving human-in-the-loop performance, expert ground truth establishment for diagnostic accuracy, or multi-reader multi-case studies as typically seen for AI/diagnostic devices. The acceptance criteria and "study" are focused on the mechanical performance of the implant.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance (Mechanical Testing)
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| The primary acceptance criterion is substantial equivalence to the predicate devices (Choice Spine Vertebral Body Replacement (VBR) System K120570 and K162103, and Choice Spine Lumbar Spacer System K153107) in terms of mechanical performance, especially for the new, taller sizes (51-60mm) and considering the new additive manufacturing method. Specifically, the device must perform comparably to or better than the predicate devices in various mechanical tests to ensure its structural integrity and safety. Expected performance should meet or exceed the benchmarks established by the predicate devices and relevant ASTM standards for spinal implants. The document implies that the device must withstand the forces outlined in the ASTM standards (F2077 for Static/Dynamic Axial & Torsion, F2267 for Subsidence) without unacceptable failure or deformation. The general criterion is that the "performance data is substantially equivalent when compared to the primary predicate" and that the "subject device is substantially equivalent to the predicates listed" based on testing. | The "worst-case size of the additional implants proposed in this submission was subjected to mechanical testing." The results of these tests (Static Axial Compression, Static Torsion, Dynamic Torsion, Dynamic Compression per ASTM F2077, Subsidence per ASTM F2267, and Expulsion testing) "showed that the subject device is substantially equivalent to the predicates listed." Specific numerical results or comparison graphs are not provided in this summary document, only the conclusion of substantial equivalence. |
Important Note: This device is a physical implant, not an AI/diagnostic software. Therefore, the typical acceptance criteria and study methodologies for AI/diagnostic devices (e.g., sensitivity, specificity, MRMC studies, human reader improvement) do not apply to this submission. The "study" here refers to non-clinical mechanical testing.
Study Details (Mechanical Testing)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each mechanical test, but typically, mechanical testing for medical implants involves a small number of samples (e.g., n=3 or n=5) per test condition to demonstrate compliance with standards and equivalence.
- Data Provenance: Not explicitly stated, but implies lab-based mechanical testing of manufactured implant samples. No country of origin for "data" in the sense of patient data, as this is a mechanical test. The testing is non-clinical/pre-clinical. It is not retrospective or prospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is mechanical testing of a physical device against engineering standards, not a diagnostic or AI device requiring expert interpretation of medical images or data. Ground truth is established by the specifications of the device and the mechanical properties derived from experiments.
4. Adjudication method for the test set:
- N/A. Adjudication is not applicable as this is mechanical testing, not a diagnostic interpretation or clinical outcome assessment.
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 device, not an AI or diagnostic software. Therefore, no MRMC study or human reader assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical implant device. The "standalone performance" is its mechanical integrity under various loads without human interaction.
7. The type of ground truth used:
- Engineering specifications and ASTM standards (e.g., ASTM F2077, ASTM F2267). The "ground truth" for this device's performance is its ability to meet the mechanical strength, durability, and subsidence requirements as defined by recognized engineering standards and to demonstrate similar or superior performance to its predicate devices.
8. The sample size for the training set:
- N/A. This is a physical implant, not a software or AI device that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- N/A. Not applicable for this type of device.
§ 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.