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The Intuitive Surgical 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

The 8mm SureForm 30 Staplers are fully wristed, articulating, surgical staplers which are designed for use exclusively with a compatible da Vinci Surgical System (herein referred to as "system"). The staplers are controlled by the surgeon using the Surgeon Console of the system. They are intended for resection, transection and/or creation of anastomoses in surgery and achieves its intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).

The 8mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3Al2.5V) staples. The implantable staples are provided in various staple leg lengths (Gray, White, Blue) to accommodate various tissue types.

The provided document is a 510(k) summary for the Intuitive Surgical 8mm SureForm 30 Stapler and Reloads. It outlines the device description, indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria, specific reported device performance values, sample sizes for test sets, data provenance, expert details for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, training set sizes, or how training set ground truth was established for the device.

The document indicates that design verification, compatibility verification, transit verification, biocompatibility, design validation (simulated clinical use), and human factors testing were performed. It states, "The successful completion of testing demonstrated that the subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads design outputs continue to meet design inputs."

Since the detailed information you requested is not present in the provided text, I cannot complete the table or answer points 2-9. The document focuses on demonstrating substantial equivalence rather than providing a detailed technical report of specific performance metrics against acceptance criteria for a new AI/software device.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is missing:

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

Missing Information for Table: The document doesn't provide specific numerical acceptance criteria (e.g., "staple height +/- 0.1mm") or quantitative performance results (e.g., "average staple height was X mm with a standard deviation of Y mm"). It only states that testing was "successful" and criteria were "met."

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

• Sample Size: Not specified for any of the tests (design verification, transit, biocompatibility, design validation, human factors).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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):

• This is not applicable as the document describes a surgical stapling device, not an AI/software device that requires expert-established ground truth on medical images or data. The "ground truth" for this type of device would be physical measurements and performance against engineering specifications. No experts are mentioned in this context.

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

• Not applicable for this type of device submission. Adjudication methods are typically associated with expert review of medical data for AI/software evaluations.

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 a surgical stapling device, not an AI-assisted diagnostic or therapeutic device for human readers.

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

• Not applicable. This is a physical medical device.

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

• For a surgical stapler, the "ground truth" would be established by engineering specifications, physical measurements (e.g., staple formation, cutting efficiency), and functional performance in simulated tissue models. The document refers to "functional design inputs" and "product specifications" rather than medical ground truth sources like pathology.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model.

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

• Not applicable. This is a physical medical device, not a machine learning model.

In summary, the provided document is a 510(k) submission for a surgical stapler, which is a physical medical device. The detailed information requested in points 2-9 typically applies to AI/software as a medical device (SaMD) clearances or approvals, which involve data sets, ground truth establishment by experts, and performance evaluation of algorithms. The submission confirms that the device underwent standard physical device testing (mechanical, biocompatibility, usability) and met its design inputs, demonstrating substantial equivalence to its predicate.

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