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The ECI Sabre BT™ Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and permit maintenance of insufflation.

The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non-threaded), plastic cannula which is available with an inner diameter of 5, 10 or 12mm. The blunttipped trocar is a multi-piece assembly consisting of a plastic handle, and a smooth, rounded plastic tip. This device is intended for use in laparoscopic procedures where the initial incision has been made surgically. The trocar's blunt, atraumatic tip gently moves aside the internal viscera when the device is inserted through the incision site.

Because the OD of the cannula is non-threaded, the device is supplied with an adjustable plug or "olive" which is secured to the patient's skin using sutures placed through the device's "tie posts." The olive has a silicone inner lock ring which firmly grasps the cannula OD when the device is manually tightened.

The provided text describes a 510(k) premarket notification for a medical device, the ECI Sabre BT™ Blunt-Tip Surgical Trocar. It does not contain information about acceptance criteria, device performance, or a study report in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices, product description, indications for use, and biocompatibility testing.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The only performance-related information provided is:

Biocompatibility:

• Cytotoxicity Test
• USP Intracutaneous Toxicity Test
• Guinea Pig Maximization (Kligman) Sensitization Test

Conclusion:
"Based on the indications for use, technological characteristics and performance testing, the ECI Sabre BT™ Blunt-Tip Surgical Trocar has been shown to be safe and effective for its intended use."

This conclusion is very general and does not provide specific acceptance criteria or quantitative performance metrics typically found in a study report for a diagnostic AI device.

It's important to note that this document is for a surgical trocar, which is a physical medical device, not an AI or software device. Therefore, the questions related to AI-specific metrics like "standalone algorithm performance," "MRMC comparative effectiveness study," "ground truth," "training set," and "test set" are not applicable to the information provided. The "performance testing" mentioned in the conclusion likely refers to mechanical, functional, and sterility testing typical for physical medical devices, which are not detailed in this summary.

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