(60 days)
The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.
The Ureteral Access Sheath Set is a single use sterile device, indicated for use in endoscopic urology procedures, to facilitate the passage of endoscopes and other instruments through the urinary tract. It is comprised of two components: a dilator with a tapered tip and a tapered sheath. Both the sheath and the dilator are made from polyurethane. The sheath length varies from 20 cm (shortest) to 60 cm (longest) by model. A luer fitting made attached to the proximal end of the dilator may be used to introduce contrast during a retrograde pyelogram procedure. The dilators range in length from 25 cm (shortest) to 70 cm (longest). The thru-lumen of the dilator tip is 0.040 - 0.045 inches and it can be used over a guidewire of up to .038 inches diameter. The sheath and the dilator are coated with a hydrophilic coating, which is activated by wetting the device in saline or sterile water. The hydrophilic feature allows for easier insertion and removal of the ureteral sheath. The luer fitting on the dilator cannot be pushed through the lumen of the cone shaped handle because of its larger size and therefore acts as a safety feature by preventing the dilator from being over inserted into the sheath. A latch mechanism is added to the ureteral access sheath set, which locks the dilator in place inside the sheath during insertion of the dilator and sheath in the urological tract. Two suture loops are attached at the cone of the sheath, which may be used to secure the sheath to the drapes of the patient to retain the sheath in position during surgery.
The provided text describes a 510(k) summary for a medical device, the Ureteral Access Sheath Set, not an AI/ML-powered device. Therefore, the requested information regarding AI/ML-specific study design elements (such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone performance, and expert qualifications/adjudication methods) is not applicable and not present in the given document.
The document discusses performance data related to the physical characteristics and functionality of the device, which are traditional engineering and material science tests, not clinical performance studies involving a test set, ground truth, or human-in-the-loop performance.
Here's a breakdown of the available information regarding acceptance criteria and the study, adapted to the context of this traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Performance Data Summary" section, which lists the types of tests performed to demonstrate the device's functionality and equivalence to predicate devices. The reported device performance is that these tests were successfully completed, indicating substantial equivalence.
| Acceptance Criterion (Test) | Reported Device Performance |
|---|---|
| Surface Friction | Verified |
| Hydrophilic Coating Adhesion | Verified |
| Fluid Flow | Verified |
| Handle Pull Strength | Verified |
| Luer Fitting Pull Strength | Verified |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. This type of device performance testing typically involves a specific number of units from manufacturing lots, but the document does not detail this.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The data comes from internal laboratory testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes. For this device, "ground truth" is adherence to engineering specifications and functional requirements. The "experts" would be the engineers and quality control personnel performing or overseeing the tests.
4. Adjudication method for the test set
Not applicable. There is no ambiguous clinical data requiring adjudication. Tests have objective pass/fail criteria based on specifications.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used
For this device, the "ground truth" is the engineering specifications and quality control standards against which the device's physical and functional properties are measured. For example, a "Fluid Flow" test would have an expected flow rate range that constitutes a "pass."
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and therefore has no training set in that context.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
Summary of the Study:
The study referenced in the document is a series of performance and functional tests conducted on the Ureteral Access Sheath Set. These tests were designed to verify the device's physical and functional properties, specifically:
- Surface Friction
- Hydrophilic Coating Adhesion
- Fluid Flow
- Handle Pull Strength
- Luer Fitting Pull Strength
The stated purpose of these tests was to demonstrate that the device is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues. The document explicitly states that "The performance and functional testing demonstrates that the Ureteral Access Sheath Set is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This implicitly means the device met the pre-defined acceptance criteria for each of these tests.
§ 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.