Search Results
Found 1 results
510(k) Data Aggregation
(87 days)
COLPO CUP CVC-2000
Demarcation of the cervical/vaginal junction during laparoscopy, laparoscopic-assisted vaginal hysterectomy, laparoscopic bladder surgery and other laparoscopic procedures where delineation of the junction is desired.
The Colpo cup is an accessory to the ClearView Uterine Manipulator that is used to demarcate the cervical/vaginal junction during laparoscopy. This product is a sterile, single patient use device.
Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Mechanical Integrity (no parts loose) | Laboratory testing and basic design assure no parts will come loose. |
| Biocompatibility (safe material) | Independent lab testing shows material is safe. |
| Clinical Safety | Clinical evaluation verified safe nature. |
| Effectiveness: | |
| Ease of Use (compared to predicate) | Clinical trials showed it was as effective as the predicate. |
| Device Retention (compared to predicate) | Clinical trials showed it was as effective as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical evaluation" and "clinical trials" but does not explicitly mention the sample size or the country of origin for these clinical studies. It also doesn't specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The document refers to "clinical evaluation" and "clinical trials" but does not detail how the ground truth for these evaluations was established, nor does it mention the number or qualifications of experts involved.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document describes clinical trials comparing the Colpo Cup to a predicate device, focusing on "ease of use" and "device retention," but not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone algorithm-only study was not performed. The Colpo Cup is a mechanical medical device, not an AI or algorithm-based product.
7. The Type of Ground Truth Used
The ground truth for the effectiveness claims ("ease of use" and "device retention") appears to be based on clinical evaluation/observation during "clinical trials," comparing the device's performance directly to the predicate device. For safety, it was based on laboratory testing and clinical evaluation.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Colpo Cup is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1