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The Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line and tissue buttressing material (natural or synthetic).

The Intuitive Surgical EndoWrist® Stapler 45, Stapler 45 Reloads and Accessories is a reusable surgical stapler system designed for use exclusively with the Intuitive da Vinci Surgical System (Model IS3000). It is intended for resection, transection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery by placing multiple rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).

The provided document is a 510(k) summary for the Intuitive Surgical EndoWrist Stapler 45 System and Stapler 45 Reloads (K171388). This document describes the device's substantial equivalence to a predicate device and includes information on verification and validation testing, but it does not contain the level of detail typically found in a study report for an AI/ML device. Therefore, I cannot fully answer all aspects of your request as it pertains to AI/ML device study criteria.

However, I can extract information related to acceptance criteria, testing performed, and ground truth as described in the summary for this medical device.

Manufacturer: Intuitive Surgical, Inc.
Device Name: EndoWrist Stapler 45 System and Stapler 45 Reloads
Predicate Device: EndoWrist Stapler 45 System and Stapler 45 Reloads (K113706)

Here's the breakdown of available information:

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

The document does not explicitly state numerical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, which are common for AI/ML devices. Instead, it describes general acceptance based on meeting design verification and validation specifications, and achieving substantial equivalence to a predicate device.

• Subject devices were cleaned and sterilized and then tested for clamp, fire, electrical connectivity of reload and Stapler Motor Pack.
• Reported Performance: "Subject device and subject device sub-assemblies met design verification specifications." |
  | Design Verification (Sub-Assembly Specific) | - Evaluated "environmental assisted cracking susceptibility and requirements that have been affected by the design change."
• Reported Performance: "Subject device sub-assemblies met design verification specifications." |
  | Reliability/Life Testing | - Subject devices were fired, clamped, and reprocessed for the estimated life of the product.
• Reported Performance: "Subject device met reliability/life specifications." |
  | Design Validation (Clinical Setting / User Needs) | - Evaluated "general, functional, and interaction (compatibility) requirements for the subject device."
• Animal model testing evaluated "performance based on comparative tissue approximation, hemostasis, and staple formation in accordance with its intended use."
• Reported Performance: "Design Validation results confirm the design modifications to the Stapler 45 Instrument do not raise any new questions of safety and effectiveness." |
  | Overall Substantial Equivalence Determination (FDA's) | - Reported Performance: Declared substantially equivalent to the predicate device (K113706), meaning it has the "same intended use, indications for use, technological characteristics, performance data, and utilize the same disposable accessories and instrument accessories," and the "results of the design verification and validation tests do not raise new issues of safety and effectiveness." |

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

• Sample Size: The document does not specify the numerical sample sizes for any of the tests (e.g., number of devices, number of sub-assemblies, number of animal models). It uses general terms like "Subject device sub-assemblies," "Subject devices," and "Tests with an animal model."
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of device testing, it would generally be prospective testing conducted in a laboratory or controlled setting.

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 information is not provided in the document. The testing described (mechanical, functional, animal model) does not rely on expert interpretation of data in the way an AI/ML diagnostic device might.

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

This information is not provided in the document. Adjudication methods are typically relevant for expert agreement in ground truth establishment for AI/ML models, which is not described here.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or implied. This type of study is specific to AI/ML devices where human readers (e.g., radiologists) use the AI for assistance. The EndoWrist Stapler 45 System is a surgical instrument, not an AI diagnostic tool.

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

This concept is not applicable to the device described. The EndoWrist Stapler 45 System is a surgical instrument used by a human surgeon with the da Vinci Si Surgical System. It is not an algorithm operating independently.

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

The document describes several forms of "ground truth" or reference points for testing the device:

• Design Specifications: For verification testing, the ground truth is the predefined design specifications (e.g., maximum calculated load, expected clamp/fire/electrical connectivity).
• Predicate Device Performance: For validation, the critical "ground truth" is the performance of the legally marketed predicate device (K113706), against which the subject device is compared to demonstrate substantial equivalence.
• Physiological/Biological Response: In the animal model, the ground truth relates to expected outcomes like "comparative tissue approximation, hemostasis, and staple formation." This implicitly relies on established surgical and physiological standards for successful stapling.
• Absence of New Safety/Effectiveness Concerns: The ultimate "ground truth" for FDA clearance in this context is the determination that the device is as safe and effective as the predicate and raises no new concerns.

8. The sample size for the training set

This information is not applicable/not provided. The EndoWrist Stapler 45 System is a mechanical surgical instrument, not an AI/ML system that requires a "training set."

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

This information is not applicable/not provided. As above, there is no "training set" for this type of device.

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