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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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The SILS™ Stitch 10 mm single use suturing device has application in endoscopic surgery for the placement of interrupted or running stitches in soft tissues

SILSTM Stitch is an endoscopic suturing device that contains two jaws at its distal end, with opposing handles and a toggle lever at its proximal end. The device holds and passes a needled suture between the two jaws. The suture needle is passed from one jaw to another by squeezing the opposing handles and secured in each jaw by activating the toggle lever.

The provided text states that "No additional in-vitro or in-vivo testing has been performed in support of the intended use of this device." This means there is no performance data or study described. Therefore, the requested sections cannot be filled.

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For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

The provided text is a 510(k) summary for the SILS™ Port, a surgical trocar. It includes information about the device's intended use and performance data, but it does not contain the specific details required to answer your questions about acceptance criteria, study design, and ground truth establishment.

The document states: "In-vitro and in-vivo testing has been performed in support of the intended use of this device." However, it does not elaborate on the specific acceptance criteria, the results of these tests, sample sizes, expert qualifications, or how ground truth was established.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone study was done: While "in-vitro and in-vivo testing" is mentioned, the specific nature of these studies (e.g., standalone vs. human-in-the-loop) and their results are not detailed.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and the general statement of performance testing, rather than a detailed breakdown of a specific clinical or performance study with acceptance criteria and ground truth methodology.

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