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The Imagyn Expandable Laparoscopic Introducer is indicated for use in providing access to the peritoneal cavity for diagnostic and operative instruments during laparoscopic procedures.

The Imagyn Expandable Laparoscopic Introducer is a single use, sterile device made from both metal and plastic components. For second-site use during laparoscopic procedures, the device incorporates a valve system that maintains adequate insufflation pressures while diagnostic or operative instruments are in use.

This document is a 510(k) summary for a medical device (Imagyn Expandable Laparoscopic Introducer). It describes the device, its intended use, and comparisons to predicate devices. However, this summary does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving the device meets those criteria, particularly regarding AI-related metrics like standalone performance, MRMC studies, or ground truth establishment for training/test sets.

The summary describes non-clinical tests for this physical medical device, not a software or AI-driven diagnostic device. Therefore, many of your questions are not applicable to the provided text.

Here's a breakdown of what can be answered based on the input:

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

   • Acceptance Criteria (Implied):
     • Device performs according to its description.
     • Device performs according to its intended use.
     • Adequate performance for intended use.
     • Maintains adequate insufflation pressures.
     • Achieves laparoscope and/or laparoscopic instrument insertion without loss of pneumoperitoneum.
   • Reported Device Performance:
     • "Non-clinical tests were performed to demonstrate that the device performed according to its description and intended use."
     • "These included visual, dimensional, leak, puncture, instrument passage, and mechanical testing and demonstrated adequate performance for the intended use."
     • "The device has equivalent technological characteristics to the predicate devices to achieve laparoscope and/or laparoscopic instrument insertion without loss of pneumoperitoneum." (This is a comparison statement, implying the device also achieves this.)

2. 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 summary refers to "non-clinical tests" (likely laboratory or bench testing on physical units of the device), not a study involving patient data. Therefore, concepts like test sets, data provenance, retrospective/prospective studies are not relevant to the information given.

3. 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 / Not provided: No experts were mentioned for establishing ground truth, as this is a physical device being tested for its mechanical and functional properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable / Not provided: No adjudication method is described because no "test set" in the context of diagnostic performance or human interpretation is mentioned. The "tests" were physical.

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

   • Not applicable: This is a physical medical device, not an AI software. No MRMC study was conducted or is relevant.

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

   • Not applicable: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Implicit Ground Truth: The ground truth for this device's performance would be engineering specifications, established medical device safety and efficacy standards, and the demonstrated functional behavior (e.g., passing instruments, holding insufflation, not leaking, resisting puncture). This isn't "expert consensus" or "pathology" in the typical sense, but rather compliance with design requirements and regulatory expectations for a device of its type.

8. The sample size for the training set

   • Not applicable / Not provided: No training set is mentioned as this is a physical device undergoing non-clinical testing, not an AI model being developed.

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

   • Not applicable / Not provided: No training set was used.

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