Search Results

Cellvizio® 100 Series System with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.

Cellvizio® 100 Series System with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

CelioFlex™ UHD 5 Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. The CelioFlex™ UHD 5 confocal Miniprobe is a CystoFlex™ UHD R Confocal Miniprobe with an additional "Grabule" component and with an optical fiber of 3 meters vs. 2 meters. The Grabule is a metallic part glued to the distal tip and the adjacent part of the sheath of the CelioFlex™ UHD 5 Confocal Miniprobe. The Grabule has been designed as a grip for laparoscopic forceps, facilitating user control of the Miniprobe distal tip during laparoscopic procedures. Both the stainless steel 316L metal comprising the Grabule and the epoxy glue (Epotek 301) used to cement the Grabule to the Miniprobe are currently used in the CystoFlex™ UHD R Miniprobe reference device. The Grabule shields the Miniprobe tip from potential wear that repeated handling by forceps might cause.

During standard laparoscopic procedures, CelioFlex™ UHD 5 Confocal Miniprobe is inserted through a pre-installed trocar. When the CelioFlex™ UHD 5 appears on the laparoscope monitor, the surgeon grasps the distal tipped Grabule with the laparoscopic fenestrated forceps to position the Confocal Miniprobe facing the tissue to be imaged.

The provided text is a 510(k) summary for the CelioFlex™ UHD 5 Confocal Miniprobe. It describes the device, its intended use, and its comparison to predicate and reference devices. However, it does not contain a study that demonstrates the device meets specific performance acceptance criteria related to its imaging capabilities or a comparison to a gold standard of truth for diagnostic accuracy.

The "Testing Completed" section lists engineering and manufacturing verification and validation tests, not clinical performance studies with acceptance criteria for diagnostic accuracy. These include:

• Sterilization Efficacy Verification: "All requirements met, Test Passed"
• Reprocessing Sterilization Validation: "All requirements met, Test Passed"
• Biocompatibility (Cytotox) Validation: "All requirements met, Test Passed"

These tests confirm that the device is safe and functions as intended from a manufacturing and material perspective, and that additions like the "Grabule" and increased fiber length do not compromise these aspects. They are not performance metrics for diagnostic accuracy or imaging quality in a clinical context that would typically involve acceptance criteria like sensitivity, specificity, or image resolution compared to a "ground truth".

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of diagnostic performance, as such a study is not present in the provided document.

To directly answer your numbered points based on the provided text's limitations:

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

   • No acceptance criteria for diagnostic accuracy/imaging performance are provided.
   • The reported device performance relates to manufacturing and safety conformity:
     • Sterilization Efficacy Verification: All requirements met, Test Passed
     • Reprocessing Sterilization Validation: All requirements met, Test Passed
     • Biocompatibility (Cytotox) Validation: All requirements met, Test Passed

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as detailed clinical performance studies for diagnostic accuracy are not described in this summary. The "tests" mentioned are likely lab-based engineering/manufacturing verification.

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): Not applicable. "Ground truth" in the diagnostic sense is not established in the described testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is an endoscope component, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable, as this summary does not describe an AI/ML device or its training.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device