Search Results

The Aesculap Biospine VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Aesculap Biospine VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Biospine VBR System may be used with bone graft.

The Aesculap BioSpine VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The device can be adjusted to the exact length required by the patients anatomy affer implantation. Once it is adjusted to the desired length the column is mechanically locked in place by means of locking screws. Spikes on the end plates of the device improve the anchoring of the implant to the vertebral body. It is available in a variety of configurations to accommodate the anatomical requirements of different patients. Components are manufactured from titanium allov (Ti6Al4V) per ASTM F-136, and cobalt chrome (CoCr) per ASTM F1537.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of devices tested for static torsion). It only generally states that "non-clinical testing was performed." The data provenance is prospective as the tests were conducted specifically for this 510(k) submission. No information on country of origin of the data is provided, but it's implied to be from a testing facility rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study is a non-clinical device performance study, not a medical imaging or diagnostic study that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a non-clinical device performance study, not a study involving human interpretation or consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This document describes non-clinical mechanical testing of a medical implant, not a study evaluating human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This document describes mechanical testing of a medical implant, not the performance of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device performance study is the established performance requirements and methodologies defined by the referenced ASTM standards (ASTM F2077, ASTM F2267, ASTM F1877, and ASTM Draft Standard F-04.25.02.02) and the performance of legally marketed predicate devices. The goal was to demonstrate that the Aesculap BioSpine VBR System met or exceeded these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a non-clinical mechanical performance study of a physical device, not an algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as above.

Ask a specific question about this device