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The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use with the 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 does not contain detailed acceptance criteria for a specific device. Instead, it is a 510(k) summary for the TauTona Pneumoperitoneum Assist Device (TPAD), which focuses on demonstrating substantial equivalence to a predicate device.

The document highlights the clinical study performed to support this substantial equivalence. Below is an interpretation of the study and what can be inferred about "acceptance criteria" through the lens of equivalence:

Interpretation of Acceptance Criteria and Study Performance

The acceptance criteria, while not explicitly stated as numerical targets for performance metrics like sensitivity, specificity, or specific time thresholds, are implicitly based on demonstrating that the subject device is as safe and effective as the predicate device and does not introduce new questions of safety or effectiveness. This is a common approach for 510(k) submissions.

Implicit Acceptance Criteria:

• Non-inferiority in surgeon satisfaction: The average surgeon questionnaire scoring for TPAD should not be significantly worse than for Standard of Care (SOC).
• Non-inferiority in patient satisfaction: The average patient questionnaire scoring for TPAD should not be significantly worse than for SOC.
• Non-inferiority in procedural timing: The average time from incision to Veress needle insertion and from incision to insufflation for TPAD should not be significantly different from SOC.
• Safety: No Severe or Moderate Adverse Events related to TPAD.

Reported Device Performance (against implicit criteria):

• Surgeon Satisfaction: "The primary endpoint of the average surgeon questionnaire scoring was not significantly different for SOC and TPAD across all responses."
• Patient Satisfaction: "The average patient questionnaire scoring was not significantly different for SOC and TPAD across all responses."
• Procedural Timing: "The average timing measurements from the incision to Veress Needle Insertion, as well as time from incision to insufflation, were not significantly different between SOC and TPAD for both timing durations."
• Safety: "No Severe or Moderate Adverse Events related to the TPAD were observed."

Study Details:

Given the nature of the device (a physical assist device, not an AI/software device or diagnostic imaging tool), many of the specific questions related to AI performance metrics (like MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable or detailed in this 510(k) summary.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set (Clinical Study) Sample Size: The clinical study was done in two phases, totaling 30 patients.
  • Phase 1: 20 patients
  • Phase 2: 10 patients
• Data Provenance: The document does not explicitly state the country of origin. It is a clinical study (prospective), comparing the subject device (TPAD) to Standard of Care (SOC).

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable in the traditional sense for this type of device. The study assessed "surgeon satisfaction" and "patient satisfaction" via questionnaires and "timing measurements." These are direct measures from the users and procedures, not "ground truth" established by experts in the sense of image interpretation or diagnosis. The "experts" involved would be the surgeons using the device.

4. Adjudication Method for the Test Set:

• Not applicable. This study is not about subjective interpretation or diagnosis that would require adjudication. It's about direct measurements (time) and subjective feedback via questionnaires (satisfaction).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study is typically for evaluating diagnostic imaging devices where multiple readers interpret cases with and without AI assistance. This device is a physical assist device for a surgical procedure, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable. The TPAD is a physical assist device, not an algorithm or software that operates in a standalone manner. The "performance" is inherently tied to its use by a human.

7. Type of Ground Truth Used:

• The "ground truth" for this study was primarily:
  • Direct procedural time measurements: Objective data like "time from incision to Veress Needle Insertion."
  • User (Surgeon) Reported Experience: Subjective feedback from surgeon questionnaires.
  • Patient Reported Experience: Subjective feedback from patient questionnaires.
  • Observed clinical outcomes: Lack of severe/moderate adverse events.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set for this device.

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