(92 days)
The EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener and Accessories is indicated for use in transoral tissue approximation, full thickness plication in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia
The EndoGastric Solutions, EsophyX2 device with SerosaFuse Fasteners consist of an all mechanical, flexible fastener delivery device with user controls outside the patient's body and sterile polypropylene fasters delivered transorally through a flexible shaft into the Oldy and sterile delivery mechanism comprised of three elements a flexible shaft into the OI tra delivery mechanism comprised of three elements: a style, a pusher rod, and a delivery tube. All three fastener delivery elements run the letinents. I sylet, a pusher rod, and a delivery tube. All three the luments run the delivery tube and the purpos nod ide. The Stylet runs the lumen of the delivery tube and the pusher rod rides over the length of the stylet. The stylet is designed to pierce and hold the pusher fou nace over the length of the stylet is designed to pierce and hold the desired tissue plication in place and guide the fastener into. There are two separate tubes or channels in the device, referred to as the posterior and anterior channels. A fastener is loaded automatically onto the stylet via a replaceable fastener cartridge containing ten fasteners for each channel. To load, the fastener cartridge lever is depressed, which snaps a fastener onto the stylet. The fastener is then pushed down the proximal handle assembly to the distal tissue port via the pusher rod where it is then ready to be deployed into the tissue. When the desired tissue approximation/ plication is achieved, the pusher rod is used to push the fastener into the tissue, guided by the stylet which precedes it into the tissue. The leading leg of the fastener slides along the stylet into the tissue. Slight additional pressure advances the pusher causing leg of the fastener to disengage from the stylet and the fastener then seats across the desired tissue, plication. A new fastener is loaded proximally in the device at the loading port, after retracting the pusher rod. The loading and fastening procedure can be repeated. The unit is provided sterile and is a single use device.
The provided text describes a Special 510(k) submission for a device modification, the EndoGastric Solutions EsophyX2 System. This type of submission is for modifications to a legally marketed device and typically doesn't involve new clinical studies for effectiveness, but rather verification testing to confirm the modified device performs as intended and is as safe and effective as the predicate device.
Therefore, the input does not contain the kind of detailed information about acceptance criteria, efficacy studies (like MRMC, standalone), ground truth establishment, or sample sizes for clinical trials that would be present in an original 510(k) or PMA. The focus is on demonstrating substantial equivalence through design, performance, and biocompatibility testing against the predicate device.
Given these limitations, here is the information extracted and, where data is not available, a clear indication that it's not provided in the document:
1. A table of acceptance criteria and the reported device performance
The document states: "Verification testing provided proof the modifications met the design specifications". However, it does not detail specific acceptance criteria values or the quantitative results of these performance tests. It broadly asserts that the modifications were validated.
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. The submission focuses on device modifications and internal verification testing, not a clinical trial with a defined test set of patients.
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 applicable and not provided. As this is a 510(k) for a device modification, there is no mention of a "test set" requiring ground truth established by experts in the context of clinical efficacy. The substantial equivalence is based on engineering and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable. The device is a surgical tool (endoscopic clip applier), not an AI-powered diagnostic system, so an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical tool that requires human operation; it does not operate in a "standalone" algorithmic fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device modification, the "ground truth" for showing equivalence would have been validated engineering specifications and biocompatibility standards. The document states "biocompatibility testing provided evidence there were no changes to that safety aspect of the device." It does not refer to clinical outcomes, pathology, or expert consensus as ground truth for this modification.
8. The sample size for the training set
This information is not applicable and not provided. The development of this mechanical device 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 information is not applicable and not provided.
§ 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.