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The illifies/20tives/20tiveF, when used with compatible Linear Digital Loading Units®, has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

The annives/iDrivell/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The illifies/40riveF/ infore, when used with compatible Circular Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end- to-side, and side-to-side anastomoses.

The iDrive is a reusable, hand-held medical device that is used to operate various SuraASSIST® Digital Loading Units® (DLUs), all of which were previously cleared to market. The iDrive consists of a handpiece with integrated controls that operate the DLUs.

The provided text is a 510(k) Summary for a medical device called iDrive. It describes the device, its intended use, and its similarities to predicate devices. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to existing devices rather than presenting detailed performance study results against predefined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods based on the provided input. This information is simply not present in the given text.

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The iDriveS/iDrive&/iDriveF, when used with compatible Vascular Digital Loading Units®, have applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, fransection, and/or creation of anastomoses. They can be used with staple line or buttressing material such as bovine pericardium.

The iDrive is a reusable, hand-held medical device that is used to operate various SurgASSIST® Digital Loading Units® (DLUs), all of which were previously cleared to market. The iDrive consists of a handpiece with integrated controls that operate the DLUs.

This PMA pertains to a powered surgical stapler (iDrive) with various attachments (DLUs). The device itself is an incremental modification of a previously cleared device. Therefore, a comprehensive standalone performance study (such as a diagnostic accuracy or clinical trial), specifically for the AI component, is not relevant in this context. The provided text does not include information about acceptance criteria or a study proving that the device meets those criteria, as it's not a diagnostic AI device.

Here's an analysis of why these aspects are absent and what information is available in relation to your questions:

• No AI Component: The device described (iDrive) is a battery-powered surgical stapler handle designed to operate various Digital Loading Units (DLUs). There is no mention of any artificial intelligence, machine learning, or software algorithm for analysis, diagnosis, or prediction in the provided documentation. Therefore, questions related to AI performance, ground truth, experts, and reader studies are not applicable.
• Device Modification, Not Novel Device: The submission is a "Special 510(k) Device Modification." This means the iDrive is a modification of previously cleared predicate devices (i45, i45S, i60, i60S, Power Extenders). The core function and indications for use remain largely the same, with the modification primarily enabling the firing of multiple DLUs from a battery-powered, untethered hand-held device.
• Focus on Substantial Equivalence: For a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device. This typically involves comparing technological characteristics and indications for use, often supported by bench testing and sometimes limited biocompatibility or sterility data, rather than large-scale clinical performance studies as would be required for a novel, high-risk device or a diagnostic AI.

Therefore, many of the specific questions you asked are not applicable to this type of device and submission.

Here's what can be extracted from the provided text based on your request, with an explanation of why certain information is missing:

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

• Not Applicable / Not Provided: This document does not contain acceptance criteria or performance data in the context of diagnostic accuracy or clinical outcomes, as it is a device modification for a surgical stapler handle, not a diagnostic AI device. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the performance is considered equivalent to the already cleared predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: As there is no described performance study for a diagnostic algorithm, there are no test sets, data provenance, or sample sizes related to AI performance. Device modifications for surgical staplers typically undergo bench testing for functional equivalence and safety, but the details of such testing (e.g., number of staples fired, force measurements) are not typically included in the summary provided for a Special 510(k) but would be in the full submission.

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)

• Not Applicable / Not Provided: There is no AI component requiring ground truth establishment by experts.

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

• Not Applicable / Not Provided: No AI test set, therefore no adjudication method.

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 / Not Provided: There is no AI component, so no MRMC study involving human readers and AI assistance.

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

• Not Applicable / Not Provided: No AI algorithm.

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

• Not Applicable / Not Provided: No AI component requiring ground truth. For a mechanical device like this, "ground truth" would relate to engineering specifications and performance metrics verified by testing, not clinical diagnostic accuracy.

8. The sample size for the training set

• Not Applicable / Not Provided: No AI component, therefore no training set.

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

• Not Applicable / Not Provided: No AI component, therefore no training set or ground truth for it.

In summary, the provided FDA 510(k) summary for the iDrive surgical stapler handle is for a device modification and does not involve any artificial intelligence or sophisticated diagnostic algorithms. Therefore, the questions related to AI performance, ground truth, experts, and reader studies are not addressed in this document.

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