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The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use in the upper left quadrant of the abdominal wall (i.e., Palmer's Point) with a Veress needle for the establishment of a pneumoperitoneum during laparoscopic procedures.

The TauTona Pneumoperitoneum Assist Device (TPAD) is a single use device used during laparoscopic surgical procedures. The device consists of a pad which contains an array of suction cups on one side; a port that attaches to a standard hospital vacuum line; a button to control vacuum to the suction cups; and a handle to allow user to manipulate the device. Suction is applied to the device to allow the user to manipulate (hold and pull on) the tissue around the Veress needle insertion site. The device is crescent in shape to allow removal of the device after use while the Veress needle remains in the patient.

The provided text is a 510(k) summary for the TauTona Pneumoperitoneum Assist Device (TPAD). It outlines the device's purpose, comparison to a predicate device, and the non-clinical and clinical performance testing performed.

However, the 510(k) summary does not include a formal table of acceptance criteria for the device performance or detailed information about the specific "study that proves the device meets the acceptance criteria" in the format requested. It describes a clinical study to evaluate safety, effectiveness, and ease of use, but doesn't explicitly link specific metrics to predefined acceptance thresholds.

Given the information available, I will extract and infer as much as possible to address your request, acknowledging where information is not explicitly stated.

Here's an attempt to answer your questions based on the provided text:

The provided 510(k) summary describes a clinical study to demonstrate the safety, effectiveness, and ease of use of the TauTona Pneumoperitoneum Assist Device (TPAD). While formal, quantitative "acceptance criteria" for metrics are not explicitly presented in a table format with corresponding reported performance, the summary describes the outcomes of the study.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical thresholds are not provided in the document, this table is constructed based on the described study outcomes and implied "acceptance" as demonstrated by the findings.

Note: The "Acceptance Criteria" provided above are inferred from the study's discussion of "primary endpoint," "secondary endpoints," and "statistical significance" compared to standard of care or theoretical medians, rather than explicit pre-defined numerical thresholds in an acceptance criteria table.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Study): 20 individuals total, split into two arms:
  • TPAD arm: 10 patients
  • Standard of Care (SOC) arm: 10 patients
• Data Provenance:
  • Country of Origin: United States (U.S.). The study was performed at an academic center in the U.S.
  • Retrospective or Prospective: Prospective (described as a "randomized clinical study").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the "number of experts used to establish the ground truth" in the sense of independent expert review of cases for accuracy. Instead, the "ground truth" or device performance was assessed by:

• Surgeons: who performed the procedures and completed questionnaires on device feasibility/ease of use. Their specific qualifications (e.g., years of experience, specialty) are not detailed beyond "surgeon."
• Patients: who completed surveys to assess patient satisfaction.
• Study Staff: who likely monitored adverse events, collected time metrics, and captured photographs.

Therefore, the "experts" are the performing surgeons and the patients themselves providing direct feedback on their experience.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set in the context of expert review (e.g., 2+1, 3+1). The primary endpoint (surgeon questionnaire) was completed by the performing surgeon, not an independent panel, and secondary outcomes were objective measurements (time, adverse events) or patient self-reported.

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 comparative effectiveness study was not performed. This device is not an AI-based diagnostic or assistive software for image interpretation, but rather a physical surgical assist device. Therefore, the concept of "human readers improving with AI assistance" is not applicable here. The clinical study compared the use of the TPAD device (a physical assist device) against the Standard of Care.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical surgical assist device and does not involve AI algorithms or standalone performance. It is used with a human surgeon.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was established through:

• Direct observation and measurement: Time metrics (time to obtain laparoscopic access, time to complete insufflation).
• Surgeon feedback: Questionnaires on feasibility/ease of use, reflecting the practical aspects of the device during actual use.
• Patient outcomes: Adverse event monitoring (bruising resolution) and patient reported satisfaction via surveys and photographs.

This can be categorized as a combination of objective clinical measurements, direct user (surgeon) assessment, and patient-reported outcomes. It is not based on expert consensus of reviewed cases, pathology, or large-scale outcomes data in the traditional sense of diagnostic accuracy studies.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device and contains no software/AI that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical medical device and contains no software/AI that would require a "training set."

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