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

The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. 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 shaft is sized to fit a standard 12 mm trocar. 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 describes a 510(k) premarket notification for a medical device called the "Standard Clamp." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of an AI/ML algorithm.

Therefore, many of the requested details about acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/ML are not available in this document.

However, I can extract the information related to the device's pre-clinical evaluation which serves as a form of performance data for this physical medical device.

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

The document does not provide a formal table of quantifiable acceptance criteria with corresponding performance metrics for the Standard Clamp. Instead, it describes a pre-clinical evaluation and its outcome.

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

• Sample Size: Not explicitly stated as a number of animals or trials. The text mentions "a live anesthetized pig" (singular) and "the porcine stomach laparoscopically." It then refers to "histology samples... for each clamp," implying multiple clamping actions or multiple clamps tested on the same animal. The exact number of clamping instances or samples is not specified.
• Data Provenance: Prospective, in-vivo animal study. The location (country of origin) is not specified, but the submission is to the U.S. FDA.

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

This information is not provided. The histological analysis would typically be performed by a veterinary pathologist, but their number and qualifications are not mentioned.

4. Adjudication method for the test set

Not applicable/not described. This was a direct observation and histological analysis, not a human reader study requiring adjudication.

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

No, an MRMC study was not done. This device is a surgical instrument, not an AI/ML diagnostic tool, so this type of study is not relevant.

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

Not applicable. This is a physical surgical instrument.

7. The type of ground truth used

The ground truth was established through:

• In-vivo observation of tissue effects during and after clamping.
• Histological analysis of resected stomach tissue after clamping.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable.

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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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