(65 days)
The GENICON EZEE Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The GENICON EZEE Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
This document describes the regulatory submission for the "GENICON EZEE Retrieval" device, a specimen retrieval bag for laparoscopic procedures. The provided text outlines the device's technical specifications and a summary of testing conducted to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, many of the requested categories related to AI/ML device evaluation (like sample size, ground truth, experts, MRMC studies, standalone performance, and training set details) are not applicable to this document.
Here's the information that can be extracted or inferred from the provided text regarding the GENICON EZEE Retrieval device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity). Instead, it refers to "performance studies and bench testing" for specific physical attributes. The "reported device performance" is broadly stated as showing substantial equivalence to predicate devices based on these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Deployment Force | Evaluated through bench testing |
| Seam Strength | Evaluated through bench testing |
| Puncture Force | Evaluated through bench testing |
| Biocompatibility | Compliant with FDA Class II requirements for ISO 10993 |
| Sterilization | Ethylene Oxide per ISO 11135-1:2014 |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for the "performance studies and bench testing." Data provenance information (country of origin, retrospective/prospective) is not provided as these are not a clinical study involving patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of an AI/ML device. For the physical performance tests, the evaluation was conducted by the device manufacturer's internal team: "our Chief Technical Officer, Design Engineers, and Chief Medical Officer." Their specific qualifications beyond their titles are not detailed.
4. Adjudication method for the test set
Not applicable as this is not a study requiring adjudication of expert interpretations.
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 MRMC study was done, as this is a medical device (a specimen retrieval bag) and not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used
For the specific performance characteristics (Deployment Force, Seam Strength, Puncture Force), the "ground truth" would be the measured physical properties of the device under test conditions. Biocompatibility and sterilization compliance are based on adherence to ISO standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.