(63 days)
Introduces sutures and facilitates knot tying of surgical sutures in endoscopic (videoscopic) procedures.
ETHICON ENDOSUTURE System is comprised of two (2) parts, the ENDOSUTURE System ENDO-HOLDER Cannula Knot Pusher and the ENDOSUTURE System suture. Each is available separately for assembly at the surgical site. The ENDOSUTURE System ENDO-HOLDER is a one-piece stainless steel device designed to accept the ENDOSUTURE System suture. The ENDOSUTURE System ENDO-HOLDER is provided non-sterile for sterilization before initial use and is reusable. ENDOSUTURE System sutures are conventional sutures, the same suture materials available by ETHICON, Inc. allowed to be marketed by FDA. The ENDOSUTURE System suture is configured in either a loop or pre-tied with needle or a suture strand with needle. Pre-threaded to each ENDOSUTURE System suture is a plastic passer and slide component that is designed for loading the suture in the ENDOSUTURE System ENDO-HOLDER.
The provided text describes a medical device, the ETHICON ENDOSUTURE System, and its substantial equivalence to a predicate device. However, the information provided does not contain the level of detail required to answer all aspects of your request, particularly regarding specific acceptance criteria for performance metrics, detailed study results, or the involvement of experts in ground truth establishment.
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document focuses on "substantial equivalence" and does not explicitly list acceptance criteria with pass/fail thresholds for specific performance metrics. Instead, it states that "Differences do not raise new questions of safety and effectiveness." and that "Benchtop evaluations were conducted on the sutures used in the ENDOSUTURE System to assess USP characteristics (diameter, knot tensile strength and needle pull-off). Comparative benchtop functionality testing was conducted to assess knot security following knot placement. Nonclinical laboratory testing was conducted to determine breaking strength retention."
While these are the types of tests performed, the specific numerical results or the acceptance criteria for those results (e.g., "knot tensile strength must be > X Newtons") are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. It mentions "benchtop evaluations" and "nonclinical laboratory testing" but does not specify the number of samples tested or the origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The tests described are laboratory-based (benchtop, nonclinical) and do not appear to involve human interpretation needing expert ground truth establishment in the way an AI diagnostic tool would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. Given the nature of the described tests, adjudication by experts for a test set is not applicable.
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
An MRMC comparative effectiveness study was not done. This device is a surgical instrument (suture system), not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the described device. The device is a physical surgical tool and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the benchtop and nonclinical laboratory tests, the "ground truth" would be established by scientific and engineering standards and measurements. This includes USP characteristics (diameter, knot tensile strength, needle pull-off), and objective measurements of knot security and breaking strength retention. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific performance evaluations.
8. The sample size for the training set
This concept is not applicable to the described device. The device is a physical surgical tool and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This concept is not applicable to the described 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.