(28 days)
The KIMBAT™ mini Spinal Implant is intended for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the lumbar spine and is intended for use with supplemental internal fixation. The KIMBAT™ mini is intended to be implanted singularly. The supplemental internal fixation systems that may be used with the KIMBAT™ mini spinal implant include, but are not limited to, SIGNUS Conklusion rod system, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss, TiMX, and Profile).
The KIMBAT™ mini is a hollow, curved frame spinal implant. The upper and lower aspects of the implant are open and the upper and lower surfaces of the implant provide a surface feature which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. The KIMBAT™ mini implant is available in a variety of heights. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition of the patient.
The provided text describes a 510(k) summary for the KIMBAT™ mini spinal implant, which is a vertebral body replacement device. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies or AI algorithm validation.
Therefore, many of the requested sections about acceptance criteria, study details, ground truth, and AI performance cannot be directly answered from the provided text. The document is a regulatory filing for a medical device that relies on established functional and safety testing as per industry standards, rather than a study validating a diagnostic or AI-driven system.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional and Performance Requirements | Met through testing in accordance with applicable industry standards or FDA guidance documents. |
| Substantial Equivalence | Found to be substantially equivalent to predicate devices (KIMBAT™ Spinal Implant K052533) based on similarities in principles of operation, technology, materials, and indications for use. |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an AI algorithm or diagnostic study. The testing referenced is likely mechanical and functional testing of the physical implant, not a data-based evaluation. Therefore, sample size and data provenance are not applicable in the way specified for AI/diagnostic studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical implant, not a diagnostic or AI system requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no described test set or adjudication process for a diagnostic or AI system.
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
Not applicable. This document pertains to a physical medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the functional and safety testing, the "ground truth" would be the engineering specifications and performance standards established by applicable industry standards or FDA guidance documents for a spinal implant. For the substantial equivalence claim, the "ground truth" is the characteristics and performance of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states that to verify the device design met its functional and performance requirements, "representative samples of the device underwent testing in accordance with applicable industry standards or FDA guidance documents." This functional and safety testing served as the primary study to ensure the device performs as intended and is safe. The specific details of these tests (e.g., types of tests, number of samples, results) are not provided in this summary, but are typically contained in the full 510(k) submission.
Furthermore, the core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (KIMBAT™ Spinal Implant K052533). The conclusion is based on "similarities in principles of operation, technology, materials and indications for use" between the KIMBAT™ mini and the predicate. This comparison of characteristics and intended use constitutes the "study" for establishing regulatory acceptance 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.