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The WECK® EFx™ Endo Fascial Closure System has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

Laparoscopic ports are used to establish a port of entry into the abdominal cavity and gain access to the surgical site. Ports are positioned into patients during minimally invasive surgical procedures by trained surgeons in order to provide a pathway for the insertion and removal of surgical devices and removal of specimens. Following the laparoscopic procedure the injury to the abdominal wall defects at the site of the port entry puncture must be repaired and often entails suturing to prevent future complications and particularly herniation. The WECK® EFx™ Endo Fascial Closure System is designed to maintain pneumoperitoneum and facilitate placement and withdrawal of suture loops to perform these repairs.

Here's a breakdown of the acceptance criteria and study information for the WECK® EFx™ Endo Fascial Closure System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily describes bench testing for material and dimensional modifications. It does not provide specific sample sizes for each test listed in the table, nor does it mention a "test set" in the context of clinical or image-based data. Therefore, the data provenance relates to the samples tested in the laboratory.

• Sample Size for Test Set: Not explicitly stated as a number of devices/units, but samples were used for material verification, visual inspection, dimensional inspection, mechanical inspection, suture retention testing, and destructive testing.
• Data Provenance: The tests were performed in a laboratory setting by the manufacturer (Teleflex Medical, Inc.) to verify performance. This is a form of prospective testing (as it was designed to evaluate the modified device) but within a non-clinical, controlled environment. Country of origin of the data is not specified beyond the applicant's address in Research Triangle Park, NC, USA.

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

This information is not applicable to this submission. The tests performed are engineering-based bench tests, not clinical studies requiring expert interpretation of results for ground truth establishment. Specifications for materials, dimensions, and mechanical function serve as the "ground truth" or acceptance criteria for these tests.

4. Adjudication Method for the Test Set:

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical or image-based studies where multiple human readers assess data and discrepancies need resolution. The tests here are objective measurements and evaluations against pre-established engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not conducted. This submission focuses on verification bench testing of product modifications against a predicate device, not on assessing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not conducted. This device is a mechanical surgical instrument, not an AI/software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these bench tests was derived from pre-established specifications and predicate device performance.

• Pre-established specifications: These are internal engineering and quality control standards set by the manufacturer for materials, dimensions, mechanical function, and suture retention.
• Predicate device performance: The overall goal was to demonstrate that the modified device is "substantially equivalent" to the predicate device cleared under K103412. This implies that the predicate device's established performance implicitly serves as a benchmark for the new device's acceptable performance.

8. The Sample Size for the Training Set:

This information is not applicable. This submission details the premarket notification of a medical device (a surgical instrument), not an artificial intelligence or machine learning system. Therefore, there is no "training set" in the context of algorithm development.

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

This information is not applicable for the same reason as point 8. There is no training set for an AI algorithm in this submission.

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