(133 days)
The NaviAid ™ BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization).
The NaviAid™ BGE affords deep access into the small intestine, while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, working channel including biopsy and treatment. The NaviAid™ Balloon Guided Endoscopy (BGE) system comprises an accessory kit containing the disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the Balloon Guided Endoscopy (BGE) disposable accessory kit is to facilitate advancement of a standard endoscope deeper into the small intestine. The NaviAid™ BGE system "upgrades" standard endoscopes to a double balloon endoscopy system. The NaviAid™ BGE accessory kit includes two balloons - the Guiding Balloon for Small Intestine ("GBS") and the Stabilizing Balloon ("SB"). Both balloons are inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the two balloons through two foot-pedals. Each balloon is connected to a dedicated tube that runs along the endoscope, and is connected at its proximal (user) end to the ASU. The balloon tubes are attached to the endoscope with clips and silicon bands. The NaviAid™ BGE accessory kit is mounted (deflated) on the tip of the endoscope, and is inserted with the endoscope into the gastrointestinal tract of the patient. The SB is the proximal balloon that is used to anchor the endoscope (near its tip) to the intestinal wall. The GBS is the distal balloon that can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the GBS inflation tube at its proximal side, outside the patient body. When the GBS balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip (now with a deflated balloon) is advanced, and the GBS inflation tube serves as a "guidewire" that leads the endoscope as it is pushed towards the GBS anchoring location. The sequence of inflation and deflation of the balloons enables "pleating the small intestine on to the endoscope" or forming a rail on which the endoscope can be guided and advanced towards the GBS anchoring location. The balloons and tubes do not compromise the endoscope's flexibility, although its field of view may be reduced by up to 8%. Additionally, the balloons do not significantly compromise the maneuverability of the endoscope's tip and do not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. The NaviAid BGE accessory kit is disposable and intended for single use, while the ASU is re-usable.
The provided document describes the NaviAid™ BGE device and its non-clinical performance tests to demonstrate substantial equivalence to a predicate device, the Fujinon Double Balloon Endoscopy System. There is no information regarding a study defining acceptance criteria, and then proving the device meets that criteria. The document states "Clinical Performance Data: Not Applicable".
Here's an analysis of the provided information as it relates to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it lists several non-clinical performance tests conducted without specifying quantitative acceptance criteria or detailed results for each. The conclusion drawn is that "The non-clinical tests demonstrated that the NaviAid™ BGE device meets its design and performance specifications."
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. The document focuses on non-clinical tests rather than clinical studies with test sets of patient 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 applicable as no clinical study with a "test set" and "ground truth" established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical study with a "test set" requiring adjudication is described.
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
No such study was done. The device is an accessory to an endoscope, not an AI-powered diagnostic tool, and the document explicitly states "Clinical Performance Data: Not Applicable".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The NaviAid™ BGE device is a physical accessory used with a human-operated endoscope, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as no clinical study generating "ground truth" is described. The "ground truth" for the non-clinical tests would have been the engineering specifications and test protocols designed to ensure the device functions as intended.
8. The sample size for the training set
This is not applicable as there is no mention of a "training set" for an algorithm. The device is a physical medical accessory, not an AI model.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set."
Summary of available information related to acceptance criteria and performance:
The document lists the following non-clinical performance tests conducted on the NaviAid™ BGE device:
- Electrical & Mechanical Safety Testing (IEC 60601-1)
- Electromagnetic Compatibility Testing (IEC 60601-1-2)
- Software Validation (IEC 60601-1-4 & FDA Guidelines)
- Biocompatibility Testing (ISO 10993)
- ASU Test
- Bond Strength Test
- Air Leakage Test
- Balloon Burst Pressure Test
- GBS Inflation Tube & Bending Radius Test
- Endoscope Flexibility & Insertion Test
- Components Degradation Test
- Endoscope Diameter Test
- GBS Inflation/Deflation Cycle Test
- ASU Connections
- Disposables Mounting Testing
- In-Vitro Validation Test
- Packaging Validation
The document concludes that "The non-clinical tests demonstrated that the NaviAid™ BGE device meets its design and performance specifications." It also states, "Furthermore, the tests showed that the NaviAid™ BGE device is easy to use and user friendly and does not cause damage to the intestine."
Essentially, the "acceptance criteria" here are implied to be the successful completion and passing of these various non-clinical engineering and safety standards/tests. The "study that proves the device meets the acceptance criteria" is the execution of these listed non-clinical tests, with the reported device performance being that it "meets its design and performance specifications."
§ 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.