Search Results

The SpineKure Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit).

The Balloon Catheter's main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning.

The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge.

The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R).

This document is a 510(k) Premarket Notification for the SpineKure Kyphoplasty System. It is focused on demonstrating substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this document.

Here's a breakdown of the available information and what's missing, based on your request:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document in the format of acceptance criteria and reported device performance. The document lists "Verification activities including mechanical and functional testing as required by the risk analysis were performed to evaluate the performance and the safety of the subject devices and the test results met the preset criteria". However, the "preset criteria" themselves and the exact reported performance against those criteria are not detailed in a table.

The non-clinical tests performed include:

• Biocompatibility tests (cytotoxicity, irritation, skin sensitization, systemic toxicity, pyrogen test)
• Mechanical and functional testing (Balloon deflation time, Burst pressure (constrained, unconstrained), Fatigue strength, Balloon dimension before and after inflation, Insertion and withdrawal force, Tensile bond strength)
• Shelf life test
• Sterilization validation
• Packaging integrity testing

The document states that "the test results met the preset criteria and it does not raise any new issues of safety or effectiveness," indicating the device performed acceptably in these tests, but the specific numerical acceptance criteria and results are not listed.

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 for the non-clinical tests. The document only lists the types of tests performed. Clinical tests were explicitly stated as "N/A - No clinical tests were conducted for this submission."

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/provided as no clinical study involving expert ground truth assessment was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided as no clinical study involving expert adjudication was conducted.

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/provided as this is a medical device (kyphoplasty system), not an AI/imaging device, and no clinical human reader study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided as this is a medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable/provided as no clinical study requiring a ground truth was conducted. The "ground truth" for the non-clinical tests would be the established performance standards for such mechanical and biological tests, but these are not explicitly detailed.

8. The sample size for the training set

This information is not applicable/provided as no clinical study or algorithm requiring a training set was conducted/developed. The manufacturing and testing processes for this physical device do not involve "training sets" in the context of AI/machine learning.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reasons as point 8.

Ask a specific question about this device