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Both the Auto Suture* Cannula** and the Auto Suture* Modified Versaport* Trocar (K954108) are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry

The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter. While the Auto Suture* Modified Versaport* Trocar (K954108) is a totally disposable trocar with cannula.

The provided text is a 510(k) summary for a surgical instrument (Trocar Cannula) from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than conducting extensive clinical studies with acceptance criteria for performance metrics like accuracy, sensitivity, or specificity that are common for diagnostic AI devices.

Therefore, the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not applicable to this 510(k) summary for a manual surgical instrument.

Here's why each point isn't applicable:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) process for this type of device relies on comparing design, materials, and intended use to a legally marketed predicate, not on quantitative performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this device.
4. Adjudication method 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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
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. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

The 510(k) summary provided details about:

• Submitter and Contact Person: United States Surgical Corporation, Janet G. Johnson.
• Date Prepared: August 9, 1996.
• Classification Name: Manual Surgical Instrument for general use.
• Common Name: Trocar Cannula.
• Proprietary Name: Trademark name not yet determined.
• Predicate Device: Auto Suture* Modified Versaport* Trocar (K954108).
• Device Description: A two-piece device consisting of a reusable sleeve and a disposable plastic housing with seal adapter. Compared to the predicate which is totally disposable.
• Intended Use: For use in various endoscopic procedures (gynecologic, general, thoracic, urologic) to create and maintain a port of entry.
• Materials: Component materials are in accordance with ISO Standard #10993-1, indicating biocompatibility assessment.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic AI or imaging device, and therefore the requested information regarding performance studies and acceptance criteria is not found within this context.

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