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The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.

The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The Standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures. The current Standard Clamp, Disposable has a jaw length of 25 cm. This Special 510(k) is being filed to add a new shorter jaw length (22 cm) to accommodate patients with smaller abdomens.

The Standard Clamp, Disposable is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. The Standard Clamp, Disposable is intended to be inserted into the peritoneal cavity through a 12mm trocar and used in up to six cycles of opening and closure to grasp, clamp and manipulate long, 1.2 to 4.5mm thick, planes of soft tissues such as the stomach. The Standard Clamp, Disposable is not intended for direct contact with the cardiovascular system, lymphatic system or cerebrospinal fluid. The Standard Clamp, Disposable can be used while a surgeon uses devices such as a stapler adjacent to tissue that is clamped with the Standard Clamp, Disposable, e.g., to help guide endoscopic staplers during resection of tissue such as in sleeve gastrectomy.

The provided text is a 510(k) summary for the Standard Clamp, Disposable surgical instrument. The document discusses the addition of a new, shorter jaw length (22 cm) to an existing device (Standard Clamp, Disposable 25 cm), and it asserts substantial equivalence to the predicate device.

However, the document does not contain the detailed type of study information requested in your prompt. Specifically, it does not include:

• A table of acceptance criteria and reported device performance (beyond a general statement that it "meets the same specifications").
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance data.
• Specific ground truth types for testing or training sets.
• Sample size for a training set.
• How ground truth for the training set was established.

Instead, the document states:

"Standard Clamp, Disposable performance bench testing was provided in K170379. Testing for the Standard Clamp, Disposable 22 cm is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Standard Clamp, Disposable 25 cm previously provided in K 170379. The data demonstrates that the Standard Clamp, Disposable 22 cm meets the same specifications for clamping and slip force as the Standard Clamp, Disposable 25 cm."

This indicates that bench testing was performed to compare the new device to the predicate device based on previously established specifications for "clamping and slip force." The specifics of these specifications, the acceptance criteria, and the detailed results are not present in this 510(k) summary but are referenced as being in another section (Section 018) and a previous submission (K170379).

Therefore, I cannot populate the table or answer the specific questions about clinical study details, expert involvement, or AI performance, as this information is not provided in the given text.

The document primarily focuses on demonstrating substantial equivalence based on:

• Identical Indications for Use.
• Similar Technological Characteristics (with the only difference being the jaw length).
• Bench Testing to ensure the new jaw length performs to the "same specifications for clamping and slip force" as the predicate.
• Validation of a packaging change.

This type of 510(k) submission, especially a "Special 510(k)" as mentioned for the jaw length change, often relies heavily on engineering bench tests rather than extensive clinical studies or expert-driven evaluations, particularly when the change is considered minor and does not significantly alter the device's fundamental technology or safety profile. The absence of details about clinical studies, expert reviews, or AI integration further supports the conclusion that this is not the type of device or submission that would typically include such data.

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