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The BASX™ Bladeless Trocar has applications in abdominal and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.

The BASX™ Bladeless Trocar is a sterile single patient use instrument consisting of a radiolucent sleeve in sizes 5mm, 11mm, and 12 mm diameters. The trocar sleeve for the 11 and 12mm devices contains two seals, an outer integrated self-adjusting seal that accommodates instruments ranging from 5mm to 12mm in diameter where indicated and an internal seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5mm trocar sleeve accommodates only 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.

The provided FDA 510(k) summary for the BASX™ Bladeless Trocar Device indicates that the device's performance was evaluated through bench testing. It explicitly states, "Performance Data Bench testing evaluation was performed to demonstrate that the new device performs as intended." This suggests that physical, mechanical, and/or functional tests were conducted on the device itself, rather than a study involving human or animal subjects or analysis of patient data.

However, the provided document does not detail specific acceptance criteria or report quantitative device performance data from these bench tests. It also lacks information on the other aspects requested in your prompt (sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance).

Therefore, based only on the provided text:

Acceptance Criteria and Study Details for BASX™ Bladeless Trocar Device

1. Table of Acceptance Criteria and Reported Device Performance

Notes: The 510(k) summary states that "Bench testing evaluation was performed to demonstrate that the new device performs as intended." However, it does not explicitly list the acceptance criteria or quantitative results for these tests. The determination of "performs as intended" implies that the device met internal design specifications, but these specifications are not detailed in the provided document.

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not specified. The document only mentions "Bench testing evaluation was performed."
• Data Provenance: The nature of bench testing means the data provenance would be from laboratory-controlled experiments on the device itself, rather than human patient data. There is no mention of country of origin for such data or whether it was retrospective or prospective, as these terms typically apply to clinical studies.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: Not applicable. Bench testing typically relies on engineers and quality control personnel following pre-defined protocols and objective measurements, rather than expert interpretation for ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. Bench testing involves objective measurements rather than subjective assessments requiring adjudication.

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

• MRMC Study: No. The document describes bench testing, which is a laboratory-based evaluation of the device's physical and functional characteristics, not a clinical study involving human readers or cases.

6. Standalone Performance Study

• Standalone Study: Yes, in the context that "Bench testing evaluation was performed to demonstrate that the new device performs as intended." This testing would be on the algorithm/device itself (although "algorithm" is not relevant here as it's a physical medical device) without human intervention in the performance measurement. However, no specific performance metrics are provided.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications and objective measurements. For a physical device like a trocar, ground truth would be established by predefined design specifications and performance requirements (e.g., insertion force, seal integrity, gas leakage rate, material strength).

8. Sample Size for Training Set

• Sample Size: Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms. Design and development were "predicated on use of technology currently used in Ethicon Endo-Surgery trocar devices," implying past experience and data from similar devices informed the design, but not in a formal "training set" sense.

9. How Ground Truth for Training Set Was Established

• Ground Truth Establishment: Not applicable. As above, "training set" is not relevant for this type of device. The design was informed by existing technology, which implies that the performance and safety profiles of those predicate devices served as a baseline of "known good" design principles.

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