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The device is intended for the retrieval and removal of excised gallbladders, or other similar tissue specimens, during the course of laparoscopic surgery.

The device consists of a polyurethane specimen container used in conjunction with a stainless steel cone retractor. The excised gallbladder, or other similar tissue specimen, is placed within the specimen bag. The bag is then brought within the confines of the cone retractor. The cone retractor is then used to shield the specimen during trans-abdominal extraction. The device can operate through a variety of trocar port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.

The provided text describes a 510(k) submission for the DeGall II Laparoscopic Gallbladder Extractor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.

The document states: "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to withdraw and contain specimens under conditions in excess of those encountered during normal clinical use." This is a general statement about testing without detailing specific acceptance criteria, method, or results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 as the necessary information is not present in the provided text.

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The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.

The device consists of an introducer and a polyurethane specimen container into which the excised gallbladder is placed. The device, with the specimen held within, is then withdrawn through the abdominal access wound (previously created by the trocar). The device can operate through a variety of access port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.

The provided text describes the 510(k) summary for the Surgicon, Inc. DeGall Laparoscopic Gallbladder Extractor. However, it does not provide specific details about acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study methodologies that would be typically found in a study report. The text focuses on the regulatory submission process and the intended use of the device.

Therefore, for most of your requested information, I must report that the data is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not available. The document states "in-vitro and in-vivo testing" but does not specify sample sizes for these tests.
• Data Provenance: Not available (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not applicable/Not available. This device is a surgical tool, not an AI or diagnostic device requiring expert interpretation for ground truth. The testing mentioned would likely involve engineering and clinical performance evaluations, not expert consensus on medical images or diagnoses.
• Qualifications of Experts: Not applicable/Not available.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not available.

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

• MRMC Study: No. This device is a physical surgical instrument, not an AI or imaging device that would typically be evaluated in an MRMC study related to human reader performance.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable. This is a manually powered and controlled physical device, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not applicable in the context of typical AI/diagnostic device evaluation. For a surgical device, "ground truth" would refer to its functional performance (e.g., successful specimen containment, integrity of the device, ease of use, safety in animal/cadaver models, etc.), measured through physical tests and observations. The document vaguely mentions "in-vitro and in-vivo testing," implying such functional evaluations.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that uses a training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

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