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The SINGLE CHANNEL BALLOON CANNULA is to be used with the VALTCHEV UTERINE MOBILIZER, models VUM-4 or VUM-5, for mobilization of the uterus and injection of dye. It is indicated for use during those procedures requiring manipulation of the uterus such as a minilap, laparoscopic tubal occlusion or diagnostic and operative laparoscopy. It is also an efficient intrauterine injector that effectively seals the internal cervical os against the cervical backflow of fluid during its injection through the device's central lumen and as such can be used in laparoscopic tubal patency studies and, in selected patients, for such procedures as hysterosalpingography.

SINGLE CHANNEL BALLOON CANNULA

I apologize, but the provided text does not contain the information requested about acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) clearance letter from the FDA for a "Single Channel Balloon Cannula," indicating that the device is substantially equivalent to legally marketed predicate devices.

The text focuses on regulatory approval, specifically:

• Device Name: Single Channel Balloon Cannula
• Manufacturer: Conkin Surgical Instruments Ltd.
• FDA Decision: Substantial Equivalence (K974801)
• Indications For Use: Mobilization of the uterus and injection of dye during procedures requiring uterine manipulation (e.g., minilap, laparoscopic tubal occlusion, diagnostic and operative laparoscopy), and as an intrauterine injector for laparoscopic tubal patency studies and hysterosalpingography.

There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information is typically found in a summary of safety and effectiveness data submitted to the FDA, which is not provided here.

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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

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.

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