(121 days)
The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional.
The Solidity™ Vertebral Body Replacement is a system of corpectomy devices used to provide mechanical support to the thoracolumbar spine. The Solidity™ Vertebral Body Replacement components include a cylindrical center piece and end caps. The center piece provides the capability for device expansion. End caps provide the anatomical footprint for the device. The components are offered in expansions, angle, footprint combinations to accommodate varying patient anatomy.
This document is a 510(k) summary for the Solidity™ Vertebral Body Replacement device, which is a medical device for spinal intervertebral body fixation. This type of device does not typically involve AI/ML components, and therefore the concepts of "acceptance criteria for device performance" in the context of AI models, "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set size," and "ground truth establishment for training set" are not applicable to the information provided in this document.
The document discusses the regulatory compliance and mechanical performance of the device, which are different types of acceptance criteria than those for AI/ML performance.
Here's an analysis of the provided text based on the request, reinterpreting "acceptance criteria" and "device performance" in the context of a non-AI medical device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device must meet established biomechanical standards for spinal implants (e.g., ASTM F2077 for static and dynamic compression, and static and dynamic torsion). | "Mechanical testing of worst case Solidity™ devices included static and dynamic compression, and static and dynamic torsion according to ASTM F2077. In addition, the expulsion properties were evaluated. The mechanical test results demonstrate that Solidity™ performance is substantially equivalent to the predicate devices." |
| Material Composition | Device components must be manufactured from biocompatible and appropriate materials for implantation (e.g., medical-grade titanium alloy). | "Solidity™ components are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136)." This implicitly meets the standard for this material. |
| Substantial Equivalence | Device must demonstrate substantial equivalence in intended use and technological characteristics to legally marketed predicate devices, meaning it is as safe and effective as the predicate. | "The Solidity™ Vertebral Body Replacement possesses the same intended use and technological characteristics as the predicate devices. Therefore Solidity™ is substantially equivalent for its intended use." |
| Intended Use | Device must clearly define its indications for use and demonstrate suitability for those indications. | "The Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional." |
| Basic Design | Device must have a design that is consistent with existing cleared devices for similar purposes (e.g., expanding corpectomy spacer). | The device has the "basic design (expanding corpectomy spacer)" which is the same as one or more predicate devices. |
| Sizes/Dimensions | Device must offer sizes and dimensions comparable to predicate systems to accommodate varying patient anatomy. | "sizes (dimensions are comparable to those offered by the predicate systems)" |
| Fundamental Scientific Technology | Device must use fundamental scientific technology that is the same as previously cleared devices. | "The fundamental scientific technology of the Solidity™ is the same as previously cleared devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is not an AI/ML device study. The provided document details mechanical testing of physical devices. The "test set" here refers to the actual physical devices subjected to mechanical tests. The document does not specify a "sample size" in terms of number of devices tested, other than referring to "worst case Solidity™ devices." Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. For mechanical testing of a medical device, "ground truth" is established by physical measurement against engineering standards (like ASTM F2077), not by expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for subjective data interpretation, which is not the case for mechanical testing of a physical device.
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 information is not applicable. This is a physical medical device, not an AI/ML system. Therefore, no MRMC study involving human readers and AI assistance would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's mechanical performance is based on established engineering standards and material specifications (e.g., ASTM F2077 for mechanical properties, ASTM F136 for material composition). For substantial equivalence, the "ground truth" refers to the characteristics and performance of the legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. There is no "training set" 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.