(19 days)
The GENICON Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The Genicon Specimen Retrieval Bag System is comprised of a flexible plastic bag and deployment mechanism. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
I am sorry, but the provided text from the FDA 510(k) document for the GENICON Specimen Retrieval Bag (GeniStrong) does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the format requested.
The document is a general FDA clearance letter and a 510(k) Summary. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a performance study with quantitative acceptance criteria and results.
Specifically, the document states:
- "There were no clinical trials performed on the GENICON Specimen Retrieval Bag (GeniStrong)." This immediately tells us there's no clinical performance data to report in the context of human reader studies, ground truth establishment, or multi-reader multi-case studies.
- The "Nonclinical Tests" section describes bench testing for various mechanical properties (introduction forces, seam strengths, puncture forces, fluid permeability, transparency, open and closure forces, re-deployment tests). However, it does not provide specific acceptance criteria values (e.g., "seam strength must be >X Newtons") or the precise numerical results obtained for each test. It generally states that "The tests show that after multiple deployments there are no concerns of safety or effectiveness of the device after multiple uses" and that "The critical performance features of the device passed all minimum acceptance currently applied to the product." This is a qualitative summary, not quantitative data.
Therefore, I cannot populate the table or answer the specific questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data, as this information is simply not present in the provided text.
The document indicates "Bench Testing and Clinical Evaluation performed" for the predicate device, but for the GENICON Specimen Retrieval Bag (GeniStrong), it explicitly states "There were no clinical trials performed." The focus is on demonstrating equivalence through material composition, design, and non-clinical bench testing.
§ 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.