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The ConMed VCARE® Retractor/Elevator is indicated for manipulation of the uterus and injection of fluids or gases during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.

The CONMED VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator is a disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The device consists of a rigid, anatomically curved manipulator tube having at its proximal end an inflatable (intrauterine) balloon for insertion into the uterus to manipulate and maintain the proper attitude of the uterus during procedures snch as hysteroscopy, Laparoscopic Assisted Vaginal Hysterectory (LAVH), and Total Laparoscopic Hysterectomy (TLH). The intrauterine balloon is inflated by passing air from a syringe through a pilot balloon located at the distal end of the device and via a lumen internal to the manipulator (main) tube. Inflation is maintained by a one-way valve positioned in the pilot balloon. The pilot balloon also serves as an indicator of intrauterine balloon inflation. VCARE® incorporates a system of cone-like components of which the forward or cervical cone surrounds and supports the cervix and the rear cone/fiexible tube or vaginal cone is slid along the main tube to adjust the depth of balloon insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear cone/flexible tube component is secured at its proper depth with a locking mechanism situated at the rear of the flexible tube and external to the patient. At the rear of the device is a molded handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme rear of the device is a standard male luer lock connection suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the main tube when diagnostic procedures are prescribed.

The provided text {0} describes the ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator.

Here's an analysis of your questions based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states, "Performance of the ConMed VCARE® (Vaginal-Cervical Ahluwalia's Retractor-Elevator) Retractor/Elevator was tested and passed all functional and biocompatibility criteria." However, it does not specify:

• The sample size used for the test set.
• The data provenance (country of origin, retrospective or prospective nature of the data).

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 provided in the document. The document refers to functional and biocompatibility testing, not an expert-driven evaluation for establishing ground truth or performance against a clinical gold standard.

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

This information is not provided in the document. The testing described appears to be engineering/functional and biocompatibility testing, not a clinical trial requiring adjudication of results based on expert consensus.

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

An MRMC study was not performed as this device is a physical surgical tool, not an AI or imaging diagnostic device. Therefore, there is no AI assistance or human reader improvement effect size to report.

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

This question is not applicable as the device is a physical surgical retractor/elevator, not an algorithm or software.

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

The document indicates "functional and biocompatibility criteria" were used as the basis for evaluation. For functional criteria, this would likely involve engineering specifications and tests (e.g., inflation pressure maintained, locking mechanism integrity, material strength). For biocompatibility, it would involve standard biological safety tests (e.g., cytotoxicity, sensitization) in accordance with relevant standards. These are not typically described as "ground truth" in the same way clinical outcomes or expert consensus would be for diagnostic AI.

8. The sample size for the training set

This question is not applicable as the device is a physical surgical retractor/elevator, not a computational model requiring a training set.

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

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

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