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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 1S3000) for resection and/or creation of anastomoses in General, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) 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).

The Intuitive Surgical EndoWrist® Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The devices can be used with staple line or tissue buttressing material.

The Endowrist Stapler Instrument, when used with the compatible Stapler 45 Reloads, delivers multiple rows of staples and transects the tissue along the middle of the staple line. The Endowrist Stapler Instrument is a reusable device while the Stapler 45 reloads (available in various sizes) are single-use/disposable devices.

The EndoWrist Stapler 45 Instrument is intended for resection, transection, and/or creation of anastomoses in 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).

IS4000 EndoWrist Stapler 30 Instrument is intended for resection, transection, and/or creation of anastomoses in 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). The Stapler 30 Instrument is a reusable, fully wristed articulating device offered in two configurations, a straight tip and a curved-tip.

EndoWrist Stapler Reusable Accessories consist of a Stapler Cable, Stapler Release Kit, Stapler Cannula, Blunt Obturator, Stapler Cannula Reducer, and Stapler Motor Pack (SMP).

EndoWrist Stapler 45 Accessories mainly consist of: Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical site; Obturators, which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point; "Other" Accessories, include the SRK (Stapler Release Kit).

This FDA 510(k) summary (K170879) describes the reprocessing instructions for existing Intuitive Surgical EndoWrist Stapler instruments and accessories. It does not include detailed acceptance criteria or a study demonstrating device performance against specific acceptance criteria for the functionality of the staplers. Instead, the 510(k) focuses on validating the reprocessing instructions for these already cleared devices, ensuring they can be safely reprocessed for multiple uses without compromising their safety or effectiveness.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document as the document is not about the initial performance of a new device in terms of its clinical efficacy, but rather about the validation of its reprocessing procedures.

However, I can provide information relevant to the reprocessing validation that is present in the document.

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

Note: The document states "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements" for these tests. Specific quantitative acceptance limits or failure rates for the reprocessing validation are not provided in this summary.

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 in this 510(k) summary for the reprocessing validation tests.
• Data Provenance: Not specified in this 510(k) summary. The context implies it would be internal testing by Intuitive Surgical, Inc.

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. The "ground truth" here relates to the effectiveness of reprocessing, established through laboratory testing and human factors studies, not clinical interpretation by medical experts.

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

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple reviewers. This document describes validation testing of reprocessing instructions.

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 document is not about AI assistance or clinical efficacy; it pertains to the validation of reprocessing instructions.

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

Not applicable. This document is not about an algorithm or AI.

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

For the reprocessing validation, the "ground truth" would be established by:

• Cleaning Validation: Objective measurements of residual soil/bioburden after reprocessing.
• Thermal Disinfection Validation: Objective measurements demonstrating inactivation or removal of microorganisms.
• Human Factors Validation: Observation and assessment of users' ability to correctly follow the reprocessing instructions.

8. The sample size for the training set

Not applicable. This document describes validation testing, not a machine learning model's training.

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

Not applicable. This document describes validation testing, not a machine learning model's training.

Study Information (from document):

The document states: "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of Cleaning Validations, Thermal Disinfection Validation and Human Factors Validation studies. Design validation and biocompatibility testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate devices."

This indicates that multiple studies were conducted to specifically validate the reprocessing instructions. The detailed methodology and results of these studies (e.g., specific protocols, microbial challenges, residual limits, human factors study design) are not provided in this summary but would have been submitted as part of the full 510(k) application. The conclusion is that these studies demonstrated substantial equivalence to the predicate device in terms of reprocessing effectiveness and safety.

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