(45 days)
The NDO Surgical, Inc. Overtube is indicated for endoscopic use when repeated endoscopic intubation is anticipated.
The NDO Surgical, Inc. Overtube is an extruded, flexible, polyvinyl chloride tube, reinforced with stainless steel wire braiding. The stainless steel reinforcing is fully encapsulated in the PVC tube. The proximal end of the Overtube has a polyurethane flange that is bonded to the tube.
The NDO Surgical, Inc. Overtube is inserted through the patient's mouth into the esophagus following standard medical procedures. Once in place, the NDO Surgical, Inc. Overtube is used as a channel for passage of an endoscope and/or endoscopic instruments into the esophagus. It is designed and intended for circumstances in which repeated endoscopic intubation may be necessary.
The provided document is a 510(k) premarket notification letter from the FDA regarding the NDO Surgical Overtube. This type of document is for a medical device that claims substantial equivalence to a legally marketed predicate device, rather than a novel AI/ML device requiring clinical studies with acceptance criteria, ground truth, and reader studies.
Therefore, the specific information requested about acceptance criteria, study details (sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment is not found within this document. This document focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and material composition.
Here's what can be extracted, although it does not directly answer the detailed questions about acceptance criteria and clinical study specifics:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or reported device performance in the context of clinical study outcomes or AI/ML performance metrics. The FDA's substantial equivalence determination for this device is based on its comparison to a predicate device, as opposed to meeting specific performance thresholds from a de novo clinical trial.
However, the document states: "The NDO Surgical, Inc. Overtube is substantially equivalent to the predicate of the Bard Endoscopic Overtube in intended use, technological characteristics of the material compostion and processes used in its application." This statement implies that the "acceptance criteria" for clearance was the demonstration of sufficient similarity to the predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a clinical study with a test set of data. The submission is based on comparison to a predicate device.
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):
Not applicable. There is no mention of ground truth establishment by experts for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of a test set or adjudication method.
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 document pertains to a physical medical device (an overtube), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The concept of ground truth in the context of AI/ML or clinical study outcomes is not relevant here. Substantial equivalence is established through comparison to a predicate device.
8. The sample size for the training set:
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set or ground truth establishment in this context.
§ 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.