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The Single-Site™ Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

The Single-Site™ Flexible Bladeless Obturator is a sterile, single-use 5mm diameter X 304 mm length dilating obturator that is used in conjunction with a 5mm Curved Cannula. The Obturator has a cap at the proximal end that locks onto the Curved Cannula rim. The Curved Cannula is designed by Intuitive Surgical, Inc. (ISI) for use with their DaVinci SI robot model.

This 510(k) summary (K101671) describes a medical device, the Single-Site™ Flexible Bladeless Obturator, but it does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic or AI-driven aid would.

This document is a premarket notification for a Class II surgical instrument, a device with a known mechanism of action that relies on mechanical performance rather than diagnostic accuracy. The "performance data" section is very brief and focuses on basic functional compatibility rather than a complex performance study with a test set, ground truth, or expert review.

Therefore, the requested information elements related to diagnostic performance (e.g., sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable and not present in the provided text.

Here's a breakdown of what is available and why other sections are not applicable:

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

Explanation: The document does not provide specific numerical acceptance criteria (e.g., >90% success rate, <5% breakage rate). The "performance data" section focuses on verification testing to show functional compatibility and lack of material degradation, which serves as the acceptance of its mechanical integrity for its intended use.

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

• Sample Size: Not specified. The document states "Verification testing was performed" but does not give details on the number of units tested or the number of insertions/removals.
• Data Provenance: Not specified, but generally, such verification testing for mechanical devices is conducted in-house by the manufacturer (Teleflex Medical, Inc.). It is retrospective in the sense that it's performed on manufactured devices before regulatory submission.

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

• Not applicable. This device is a mechanical surgical instrument. Its "ground truth" is its physical functionality (e.g., does it fit, does it degrade). This doesn't involve expert medical interpretation or diagnosis to establish a "ground truth" in the way a diagnostic algorithm would.

4. Adjudication method for the test set

• Not applicable. See point 3. Testing involves objective measurements of mechanical integrity rather than subjective expert adjudication.

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. This is a mechanical surgical device, not an AI-driven diagnostic or assistance tool. MRMC studies are not relevant.

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

• Not applicable. See point 5.

7. The type of ground truth used

• Mechanical Functionality/Integrity: The "ground truth" for this device type would be its ability to correctly insert and remove from the cannula without material degradation. This is assessed via direct observation and potentially measurement during verification testing, not based on expert consensus, pathology, or outcomes data in the traditional sense for diagnostic tools.

8. The sample size for the training set

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

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

• Not applicable. See point 8.

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