(202 days)
The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to phamacological therapy.
The Endoscopic Plication System consists of an instrument, retractor, overtube and implant.
The instrument is passed transorally to create a plication in close proximity to the gastroesophageal junction.
The implant is designed to help pass and secure the suture.
The retractor is designed to secure and retract the tissue during the placement of the implant. It is placed down a working channel of the instrument prior to the procedure.
The overtube is designed to protect the esophagus during the procedure.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the specific study proving the device meets those criteria.
The document is a 510(k) premarket notification letter and a 510(k) summary for the NDO Surgical Endoscopic Plication System. While it mentions "Clinical evaluation" under performance data and states "The clinical comparison shows that the NDO Endoscopic Plication System to be at least as safe and effective as the Bard EndoCinch," it does not provide any specific details about:
- Acceptance criteria: What specific metrics (e.g., success rates, complication rates, improvement in GERD symptoms) were considered, and what thresholds defined acceptance.
- Reported device performance: The actual numerical results from the clinical study.
- Sample size: For either the test set or training set.
- Data provenance: Country of origin, retrospective/prospective.
- Number and qualifications of experts: For ground truth establishment.
- Adjudication method.
- MRMC comparative effectiveness study: No mention of human reader performance or AI assistance.
- Standalone algorithm performance: No mention of an algorithm, only a device.
- Type of ground truth: Not specified beyond "clinical comparison."
- How ground truth was established for training or testing.
The document primarily focuses on establishing substantial equivalence to a predicate device (Bard EndoCinch Suturing System) based on similar intended use, technical characteristics, and the lack of new safety/effectiveness questions from bench and animal testing.
Therefore, I cannot generate the table or answer the specific questions you posed based on the provided text.
§ 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.