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510(k) Data Aggregation
(237 days)
This device is intended to establish and maintain nephrostomy and internal drainage following pyeloplasty for pediatic patients. This device is intended for patients 6 months and older.
The Salle Intraoperative Pyeloplasty Stent is a single-lumen ureteral stent inserted following pyeloplasty in order to provide internal and external drainage. It is a prolonged indwelling device not to exceed 4 weeks in the body.
The Salle Intraoperative Pyeloplasty Stent Set is comprised of a stent, wire guide, connecting tube, adaptor, and retention disc with pull tie. The Salle Intraoperative Pyeloplasty Stent is a double pigtail stent that advances from the renal pelvis to the bladder with a flexible extended portion that is brought out percutaneously through the kidney. The Salle stent is available in outer diameters of 4.0 or 4.7 French with working lengths of 12 to 18 cm. The stent's proximal pigtail forms in the renal pelvis, while the distal pigtail forms in the bladder. Drainage can occur internally (from the kidney to the bladder) or externally (from renal pelvis to the outside of the patient). The distal (bladder) pigtail coil is available in a multi-length stent configuration with drainage holes. The proximal (kidney) pigtail coil also contains sideports and ink marks to facilitate the visualization of accurate placement. The proximal end of the stent has an internal stylet which acts as a positioning stylet.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Salle Intraoperative Pyeloplasty Stent Set
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing (Performed per ISO 10993-1) | Not explicitly detailed as numerical criteria in the table, but the successful completion of the listed tests is the criterion. | All listed tests successfully completed. |
| - Cytotoxicity | Pass | |
| - Sensitization | Pass | |
| - Intracutaneous | Pass | |
| - Acute Systemic Toxicity | Pass | |
| - Material-Mediated Pyrogenicity | Pass | |
| - Implantation - 2 Week | Pass | |
| - Implantation - 4 Week | Pass | |
| - Subacute/Subchronic Toxicity | Pass | |
| - Genotoxicity | Pass | |
| - Toxicological Risk Assessment of Extractable Chemicals | Pass | |
| Retention Strength and Break Strength Testing (Simulated use – Time Zero and post aging) | Retention Strength: The minimum retention strength shall be greater than or equal to 0.03 N, but less than or equal to 3.9 N (90% coverage, 90% confidence). Break Strength: The minimum break strength shall be greater than 3.9 N (90% coverage, 90% confidence). | All acceptance criteria were met. Pass |
| Retention Strength and Break Strength Testing (Following a 30 Day Artificial urine Soak – Time Zero and post aging) | Retention Strength: The minimum retention strength shall be greater than or equal to 0.03 N, but less than or equal to 3.9 N (90% coverage, 90% confidence). Break Strength: The minimum break strength shall be greater than 3.9 N (90% coverage, 90% confidence). | All acceptance criteria were met. Pass |
| Wire Guide Compatibility, Kink Radius, Flow Rate and Leakage Post Kinking Testing | Wire Guide Compatibility: The appropriate size wire guide shall pass through the inner lumen of each test article. Kink Radius: The kink radius of each test article shall be less than 30 mm based on worst-case analysis. Flow Rate and Leakage Post Kinking: Flow rate performed for characterization purposes only. If leakage detected, test article deemed a failure. | All acceptance criteria were met. Pass |
| Radiopacity Testing (Per ASTM F640-12) | The Salle Stent is visible under fluoroscopy. Visibility of the Salle Stent is equal to or greater than the visibility of the user-defined standard. | All acceptance criteria were met. Pass |
| MR Testing | Magnetically Induced Displacement Force: Deflection Angle <45° (Testing per ASTM F2052-15) Magnetically Induced Torque: $τ_{mag} < τ_{grav}$ (Testing per ASTM F2213-06 (2011)) Electrical Conductivity: <1 S/m MR Image Artifacts: For information only (Testing per ASTM F2119-07 (2013)) | All acceptance criteria were met. Pass |
2. Sample size used for the test set and the data provenance
The document describes "bench testing" and "biocompatibility testing." While it mentions "each test article" for some bench tests, specific numerical sample sizes for these tests are not provided. The data provenance is not specified beyond being "Cook Inc.'s design control system."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a medical device (stent) and the testing described is primarily bench and biocompatibility testing. There is no mention of experts establishing ground truth as would be required for an AI/algorithm-based diagnostic device.
4. Adjudication method for the test set
Not applicable. This is not an study involving human interpretation of data requiring adjudication.
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 a physical medical device, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
For the bench tests, the ground truth is based on defined physical and performance standards (e.g., minimum retention strength in Newtons, maximal kink radius in mm, visibility under fluoroscopy, specific deflection angles/torques for MR compatibility). For biocompatibility, the ground truth is established by the successful completion of tests defined in ISO 10993-1.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an algorithm-based device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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