(32 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 pharmacological therapy.
The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach near the Gastroesophageal Junction that creates a full thickness plication for the treatment of Gastroesophageal Reflux Disease (GERD). The EPS consists of three components: the Endoscopic Plication Instrument, the Retractor and the Implant Cartridge. The Implant Cartridge and retractor are loaded onto the instrument; this is then passed transorally into the stomach to create the plication. The instrument's shaft, which comes into contact with the patient, is made of polyvinyl chloride. The retractor is made of surgical grade stainless steel. with a polycarbonate sheath. The implant is comprised of two titanium tees, 2.0 polypropylene suture and two ePTFE pledgets. The implant is housed in a disposable cartridge. Once the system has been introduced into the stomach, the retractor is engaged into the gastric mucosa and the tissue is retracted into the arms of the instrument. The arms of the instrument are closed and the implant is deployed, creating the full thickness, serosa-to-serosa plication.
This document describes the NDO Surgical Endoscopic Plication System (EPS) for treating GERD. However, it is a 510(k) summary for a substantial equivalence determination and does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.
The document states that the device is "substantially equivalent" to a predicate device (K023234) and that "Bench top, In-Vivo simulated use and ex-vivo performance testing was provided in support of the substantial equivalence determination. The testing demonstrates substantially equivalent performance between the two devices." This implies that the acceptance criteria and performance data were assessed against the predicate device's performance, but the specific details are not provided in this public document.
Therefore, I cannot provide the detailed information requested in the prompt, such as specific acceptance criteria, sample sizes, expert qualifications, or details about MRMC or standalone studies.
Here's what can be extracted from the document, though it's limited in scope for your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in this document. The document refers to "substantially equivalent performance" to the predicate device (NDO Surgical Endoscopic Plication System K023234). This would imply passing various bench-top, in-vivo simulated use, and ex-vivo performance tests to demonstrate comparable safety and effectiveness, but the specific metrics and thresholds are not included.
- Reported Device Performance: "The testing demonstrates substantially equivalent performance between the two devices." No specific quantitative metrics (e.g., accuracy, sensitivity, specificity, clinical outcomes) are provided in this summary.
2. Sample size used for the test set and the data provenance:
- Not specified in this document. The testing mentioned (Bench top, In-Vivo simulated use and ex-vivo) implies test sets were used, but their size and provenance (country, retrospective/prospective) are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a medical device for treatment, not an AI/diagnostic device where ground truth is typically established by experts for image interpretation. The "ground truth" here would relate to the successful and safe deployment and function of the device, likely assessed by engineers, clinicians, and researchers through various performance tests.
4. Adjudication method for the test set:
- Not applicable/ Not specified.
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:
- Not applicable. This is a medical device for a physical procedure, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical endoscopic device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of device, "ground truth" would generally be related to engineering specifications, successful deployment, structural integrity, and functional outcomes in simulated and ex-vivo environments, and ultimately, clinical outcomes in human studies (though not detailed here). The document refers to "Bench top, In-Vivo simulated use and ex-vivo performance testing," which would evaluate these aspects against predefined criteria, likely derived from the predicate device's performance and established engineering standards.
8. The sample size for the training set:
- Not applicable/ Not specified. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary, as this is a 510(k) summary for a medical device (Endoscopic Plication System) seeking substantial equivalence, it focuses on demonstrating that the updated device is as safe and effective as a previously cleared predicate and does not provide the detailed performance metrics, acceptance criteria, or study specifics typically found in a clinical trial report or a submission for a novel AI/diagnostic 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.