Search Results

Endo Wrist Stapler 45 and Stapler 45 Reloads: The Intuitive Surgical Endo Wrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection, transection and/or creation of anastomoses in General. Thoracic. Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

EndoWrist Stapler 30 and Stapler 30 Reloads: The Intuitive Surgical Endo Wrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and or creation of anastomoses in General. Thoracic. Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

EndoWrist Stapler 45 and Stapler 45 Reloads: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).

EndoWrist Stapler 30 and Stapler 30 Reloads: The Intuitive Surgical EndoWrist Stapler 30 and Stapler 30 Reloads are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).

This document is a 510(k) summary for the Intuitive Surgical EndoWrist Stapler 45 and 30, and their respective reloads. It primarily discusses updates to the Indications for Use statements due to changes in compatible da Vinci Surgical Systems.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table. Instead, it makes a general statement about substantial equivalence.

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: "Design verification and design validation testing were not required since design inputs were not changed." This indicates that no new testing (and therefore no new test set or data provenance) was performed to support this 510(k) submission, as the changes were limited to labeling/indications for use and not the fundamental design or performance of the device.

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)

Since no new verification or validation testing was conducted, there are no experts mentioned for establishing ground truth for a test set.

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

Since no new verification or validation testing was conducted, there is no adjudication method mentioned.

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

No MRMC comparative effectiveness study was mentioned or performed. This device is a surgical stapler, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

Not applicable. This device is a surgical stapler, not an algorithm, so standalone performance in that context is not relevant. The device operates with a human surgeon in the loop.

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

As no new performance testing was conducted, no specific ground truth type is mentioned or implied for this submission. The basis of the submission is the substantial equivalence to predicate devices whose performance was previously established.

8. The sample size for the training set

The document does not mention a training set because the submission is about updating indications for use for an existing physical device, not a machine learning algorithm.

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

Not applicable, as no training set for a machine learning algorithm is discussed.

Ask a specific question about this device