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The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.

The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.

The provided text does not describe acceptance criteria for a device, nor does it detail a study that proves a device meets specific acceptance criteria in the manner requested.

Instead, the document is a 510(k) Substantial Equivalence Determination letter from the FDA to Standard Bariatrics for their device, the "Standard Clamp." This letter affirms that the FDA has reviewed the company's premarket notification and determined the device is substantially equivalent to a legally marketed predicate device (the Doyen Atraumatic Bowel Clamp).

The "Performance Data" section of the document mentions some preclinical evaluations but does not provide the detailed information requested about acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.

Here's what can be extracted and what is missing, based on the provided text:

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

• Not Available. The document does not specify quantitative acceptance criteria. It broadly states: "Testing demonstrates acceptable performance of the Standard Clamp, its ability to clamp the stomach, and non-traumatic tissue effect." This is a qualitative statement, not a set of measurable criteria with reported results against them.

2. Sample sized used for the test set and the data provenance

• Not Available. The document only mentions "in vivo" evaluation and "histological assessment." It does not specify the number of samples (e.g., animals, tissue samples), the country of origin, or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Available. The document states a "histological assessment" was performed, implying a pathologist or similar expert would interpret the results, but it does not specify the number or qualifications of such experts.

4. Adjudication method for the test set

• Not Available. No information is provided regarding adjudication methods.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• Not Available. No MRMC study is described. The comparison made is between the Standard Clamp's tissue effects and "other surgical devices including surgical staplers, soft tissue clamps, and graspers" and specifically the "Doyen clamp" in a histological assessment (tissue damage), not a human reader performance study.

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

• Not Applicable. The device is a manual surgical instrument, not an AI algorithm. Therefore, "standalone" performance in the context of an AI algorithm is not relevant or described.

7. The type of ground truth used

• Histological assessment (Pathology). The document states: "Tissue effects from the Standard Clamp were compared... in a histological assessment." This implies that the ground truth for "tissue effect" was determined by pathological examination of tissue samples.

8. The sample size for the training set

• Not Applicable/Available. As this is a manual surgical instrument and not an AI/ML device, the concept of a "training set" is not relevant. No such data is provided for device development.

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

• Not Applicable/Available. See #8.

In summary, the provided text confirms the FDA's marketing clearance based on substantial equivalence to a predicate device, and it briefly mentions preclinical testing related to tissue effects. However, it lacks the detailed methodology, acceptance criteria, and specific performance results typically found in a clinical study report for advanced medical devices, especially AI-driven ones.

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