(70 days)
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:
| Response Type | Test Specification | Reported Device Performance (Result) |
|---|---|---|
| Qualitative | Material Verification | PASS (Materials were found to meet pre-established specifications.) |
| Qualitative | Visual Inspection for Defects and Cleanliness | PASS (All devices passed the inspections for defects and cleanliness.) |
| Quantitative | Dimensional Inspection | PASS (Dimensions were found to meet pre-established specifications.) |
| Qualitative and Quantitative | Mechanical Inspection | PASS (Function of the device was verified against pre-established specifications.) |
| Qualitative and Quantitative | Suture Retention | PASS (Function of the device was verified against pre-established specifications.) |
| Qualitative and Quantitative | Destructive Testing of Failure Modes | PASS (The device exceeded the maximum working load of the pre-established specifications.) |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.