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The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.

The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.

The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.

The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.

The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.

The provided text describes a 510(k) summary for several endoscopic hand instruments (SILS™ Clincher, Dissector, Grasper, L-Hook, and Shears). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance criteria in a clinical setting. Therefore, many of the requested details, particularly those related to AI algorithm performance studies, will not be present in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criteria for a 510(k) submission like this revolve around demonstrating substantial equivalence to legally marketed predicate devices in terms of indications for use, technological characteristics, and safety and effectiveness.

The "performance data" mentioned refers to in-vitro and in-vivo testing to support the intended use and biological evaluation in accordance with ISO 10993-1:2003 for patient contact materials. However, specific quantitative results or how these results meet pre-defined acceptance criteria are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) context):

Study Details (Based on available information in the document)

Since this is a 510(k) summary for conventional surgical instruments, there is no mention of an AI-powered device or associated studies. Therefore, many of the questions related to AI performance, ground truth, and expert evaluation are not applicable.

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

   • Not Applicable / Not provided. The document refers to "in-vitro and in-vivo testing" but does not specify sample sizes, provenance, or whether the data was retrospective or prospective. This kind of detail is typically found in the full test reports, not a 510(k) summary.

2. 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. As this is not an AI device, there's no concept of establishing "ground truth" by experts in this context for diagnostic performance.

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

   • Not Applicable. This is relevant for diagnostic studies with human readers or AI.

4. 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. This document does not mention an MRMC study or AI assistance.

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

   • No. This is not an AI algorithm.

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

   • Not Applicable. For mechanical surgical instruments, "ground truth" would relate to successful mechanical operation, tissue manipulation, and safety, assessed through engineering tests, pre-clinical models (in-vitro/in-vivo), and potentially clinical observations, not derived from expert consensus on images or pathology.

7. The sample size for the training set:

   • Not Applicable. There is no AI model mentioned, thus no training set.

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

   • Not Applicable. There is no AI model mentioned, thus no training set ground truth.

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