Search Results

The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

The Universal Cannula Seal (5-12 mm) is a sterile, single-use (disposable) seal used with da Vinci cannula, obturators, and reducers. The Universal Cannula Seal has an opening that is sized to allow specific diameter ranges of instruments and surgical accessories to pass through to the surgical site while maintaining an air-tight system and an insufflated body cavity. Identical to the predicate seals, the subject seal has an insufflation port with a universal luer fitting and an insufflation lever.

The document describes the Universal Cannula Seal (5-12 mm) and its performance data, but it does not provide specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense with metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on design verification and validation testing to demonstrate performance and establish substantial equivalence to predicate devices. The "acceptance criteria" are implied by the successful completion of these tests, meaning the device met the predefined design input requirements for each test.

Here's a breakdown of the information based on your request, with gaps highlighted where the provided text does not contain the information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "a series of bench tests," "tests with an animal model and a cadaver," and "testing was performed." Specific numbers of devices, animals, or cadavers used for these tests are not provided.
• Data Provenance: Not explicitly stated. The document describes bench testing, animal model testing, and cadaver testing. The location or specific context (e.g., country) of where these tests were conducted is not mentioned. It is implied to be prospective testing for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The testing described (bench, animal, cadaver) relies on objective measurements and functional assessments rather than expert consensus for "ground truth" in the way it might be for a diagnostic AI device.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for establishing ground truth in diagnostic studies. The described tests for the Universal Cannula Seal are functional and performance-based, not involving such adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Universal Cannula Seal is a surgical accessory, and its evaluation focuses on its physical and functional performance, not diagnostic accuracy.

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 accessory (a cannula seal), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance tests was established through objective measurements and predefined engineering and performance specifications. For example:

• Physical dimensions and compatibility with instruments (e.g., "Diameter/instrument compatibility markings," "Obturator compatibility").
• Mechanical properties (e.g., "Stopcock axial load," "Seal latch strength," "Torque limits," "Force limits").
• Functional performance (e.g., "Insufflation valve open and close," "Leak test seal").
• Biological and material compatibility standards (e.g., "No Natural rubber latex," "Biocompatibility testing per ISO 10993-1").
• Successful functioning in a simulated surgical environment (animal model and cadaver studies).

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI algorithm requiring a training set.

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

This question is not applicable as the device is not an AI algorithm.

Ask a specific question about this device