(119 days)
The Cook 810 Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.
The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange.
The Ureteral Introducer Sets is a bundle of two Ureteral Introducer Sets, composed of the Cook® 810 Set and Desilets-Hoffman Introducer Set. The Cook 810 Set is composed of a dilator and a delivery sheath, which is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. To use this device, antegrade (i.e., through a percutaneous tract) or retrograde (i.e., transurethral) access is achieved using a wire guide up to 0.038 inches in outer diameter, using standard access techniques. Next, the dilator is inserted over the wire guide and used to dilate the ureter/ureteral orifice. The physician would then place the delivery sheath over the dilator to dilate the anatomy to 10 French before placing the tip of the sheath into the desired anatomical location. The dilator is withdrawn while maintaining the position of the introducer sheath. Wires may then be placed/exchanged through the sheath, and the delivery sheath is subsequently removed from the patient. The dilator is an outer diameter of 8 French and 88 centimeters (cm) in length. Both ends of the dilator have smooth round tips and both tips are tapered at 5 millimeters (mm) as well. The sheath is an outer diameter of 8.5 French and 30 or 50 cm in length, depending on the selected set.
The Desilets-Hoffman Introducer Set is used for retrograde or antegrade ureteral access and to facilitate wire guide exchange. The Desilets-Hoffman Introducer Set includes a delivery sheath and dilator. The delivery sheath is 10 French and 30 cm in length. The dilator is 8 French and available in 70 or 88 cm in length. One of the sets ("RB" version) has a radiopaque band on the delivery sheath to aid in fluoroscopic visualization during placement.
This document is a 510(k) premarket notification for a medical device and thus does not contain the detailed information necessary to fully answer all aspects of your request regarding a stand-alone study with acceptance criteria and device performance. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive standalone validation study report with detailed performance metrics against pre-defined acceptance criteria.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "All predetermined acceptance criteria were met." However, it does not provide a table with specific numerical acceptance criteria or the corresponding numerical device performance results. Instead, it lists the types of tests performed.
| Acceptance Criteria Category (Implied) | Reported Device Performance Summary |
|---|---|
| Dimensional Accuracy | All predetermined acceptance criteria were met. |
| Tensile Strength | All predetermined acceptance criteria were met. |
| Assembly After Kinking | All predetermined acceptance criteria were met. |
| Dilator Tip Rollback | All predetermined acceptance criteria were met. |
| Radiopacity | All predetermined acceptance criteria were met. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-mediated Pyrogenicity) | All evaluation criteria were met; conforms to biocompatibility requirements based on intended use. |
| Sterilization | All predetermined acceptance criteria were met. |
| Package Integrity and Stability | All predetermined acceptance criteria were met. |
| Shelf-life | All predetermined acceptance criteria were met. |
Missing Information: Specific numerical acceptance thresholds (e.g., "tensile strength > X N") and specific numerical results for each test (e.g., "tensile strength = Y N").
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample sizes for each of the performance tests conducted. It also does not discuss data provenance in terms of country of origin or whether the data was retrospective or prospective, as these tests are typically bench and lab-based rather than clinical human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Since the performed tests are primarily bench, mechanical, material, and biological (biocompatibility) tests, the concept of "experts establishing ground truth" in the context of clinical interpretation (like radiologists for image analysis) does not apply. The "ground truth" for these types of tests would be established by validated test methods and reference standards.
4. Adjudication Method for the Test Set:
Not applicable, as this refers to adjudication of expert opinions or clinical outcomes, which are not detailed in the context of these engineering and biocompatibility tests.
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 device is a ureteral introducer set, a physical medical device, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance tests listed are standalone tests of the device itself (e.g., tensile strength, biocompatibility), which can be considered "algorithm only" in the sense that they evaluate the device's inherent properties without active human intervention in its function during the test. There is no "human-in-the-loop" aspect to these specific performance validations as they are not AI/diagnostic tools.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance tests described, the "ground truth" would be based on:
* Validated test methods and industry standards: For dimensional testing, tensile strength, kinking, rollback, radiopacity, sterilization, package integrity, and shelf-life, results are compared against predefined engineering specifications and relevant ISO or ASTM standards.
* Established biological safety standards: For biocompatibility, the tests (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity) results are compared against criteria outlined in ISO 10993 standards.
8. The sample size for the training set:
Not applicable. This device is a physical medical device, not an AI algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no "training set" for this type of device.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).