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The Weck Reusable Obturator is indicated for use with appropriate disposable Weck Vista cannulas in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

The Weck® Reusable Obturator is used to establish penetration into the abdominal cavity during laparoscopic surgical procedures. When used with the appropriate corresponding disposable cannula, the system creates a port of entry into the patient, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The obturator is positioned into the peritoneum as a guide to the corresponding cannula during minimally invasive surgical procedures, and then is removed in order to provide a pathway for the insertion and removal of various sized surgical devices. The Weck® Reusable Obturator is intended to be used by trained physicians.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the traditional sense of a clinical or observational study with human subjects or a defined dataset. Instead, the evaluation was based on bench testing.

• Sample Size: Not explicitly stated as a number of devices or data points, but rather refers to "bench testing" which implies a series of tests conducted on the device.
• Data Provenance: The data originates from internal "bench testing" performed by Teleflex Medical, Inc. The document does not specify country of origin for the data or if it was retrospective or prospective, though bench testing is inherently prospective in its execution for the purpose of verifying performance.

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

This information is not applicable and not provided. The testing performed was bench testing to verify performance characteristics and substantial equivalence, not a clinical study requiring expert assessment for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Bench testing does not typically involve an adjudication method as would be used in clinical trials with multiple expert readers. The evaluation was based on objective measurements and comparisons against predicate devices.

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

No MRMC comparative effectiveness study was mentioned or performed. The study described is a bench test comparison of a reusable device against disposable predicate devices to demonstrate substantial equivalence, not a study involving human readers or comparative effectiveness in a clinical setting.

6. Standalone Performance Study

Yes, a standalone performance evaluation was conducted in the form of "bench testing." This testing was performed on the device itself to verify its performance characteristics and compare them to predicate devices, without human intervention as part of the primary performance measurement.

7. Type of Ground Truth Used

The "ground truth" for this device evaluation was established through objective performance metrics and specifications derived from the predicate devices, as determined through their own clearance processes. The Weck® Reusable Obturator was tested to verify that its performance was "substantially equivalent" and "seamlessly interchangeable" with these established predicate devices.

8. Sample Size for the Training Set

This information is not applicable and not provided. The device being evaluated is a physical medical device (an obturator), not an AI algorithm or software. Therefore, there is no "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for a physical medical device.

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