(84 days)
The Deflecting Ureteral Access Sheath is indicated for use in endoscopic urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidney.
The Deflecting Ureteral Access Sheath consists of a tapered dilator and a sheath, which are both coated with a hydrophilic coating, which is activated when wet. The tip of the sheath is designed such that it may be deflected in order to position the tip of the sheath to a desired site within the kidney to allow better access to surgical site. The deflecting feature also aids in positioning/maneuvering instruments such as endoscopes positioned inside the sheath.
The Deflecting Ureteral Access Sheath consists of two components, the sheath and the dilator, The sheath consists of an elongated body attached to a lever and handle assembly. Activation of the handle/lever mechanism results in desired deflection of the sheath. The dilator is assembled into the sheath during placement. The tapered tip of the dilator is designed for easy placement. The Deflecting Ureteral Access Sheath can be placed over a guidewire or by itself, The female luer fitting on the dilator is securely attached to the sheath handle during placement. Devices such as syringes and suction and irrigation equipment with luer port connectors may be attached to the dilator when irrigation and/or aspiration of the surgical site is desired. The dilator may also be used by itself in similar procedures.
The Deflecting Ureteral Access Sheaths will be made available as disposable, single use, sterile devices in two sizes (35cm and 60 cm).
The provided text describes a 510(k) summary for the "Deflecting Ureteral Access Sheath." This is a medical device, and the information presented focuses on regulatory approval rather than a detailed study comparing its performance against specific acceptance criteria in a quantitative sense as might be seen for an AI/CADe device.
Therefore, many of the requested categories for AI/CADe studies (like sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission.
However, I can extract the acceptance criteria and the "reported device performance" in terms of what the performance data summary claims to demonstrate.
Here's a breakdown derived from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Tests Performed) | Reported Device Performance |
|---|---|
| Surface Friction and Hydrophilic Coating Adhesion Test | Performance and functional testing demonstrates substantial equivalence to predicate devices. |
| Kink Free Test | Performance and functional testing demonstrates substantial equivalence to predicate devices. |
| Tip Deflection Test | Performance and functional testing demonstrates substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device, and the "performance data" refers to engineering and functional tests, not clinical data sets in the AI/CADe sense. The text does not specify sample sizes for these functional tests, nor their provenance.
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. Ground truth as typically understood for AI/CADe studies (e.g., expert consensus on medical images or pathology) is not relevant here. The "ground truth" for the functional tests would be established by engineering specifications and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human expert evaluation, which is not described for this device's performance data.
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 not an AI/CADe device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The device's performance is inherently standalone in that its physical properties are tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's assessment would be engineering specifications and physical testing standards. The text asserts that the device meets these standards and is "substantially equivalent" to predicate devices, which implies it performs comparably in these physical tests according to established benchmarks.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See above.
§ 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.