(109 days)
The Nephromax™ High Pressure Balloon Dilatation Catheters are recommended for dilatation of the nephrostomy tract.
The NephroMax Balloon Catheter, styled after the Gruntzig technique, is a multiple lumen catheter with a dilatation balloon mounted at the distal tip. Provided with the balloon catheter is a 24F (8 mm) or 30F (10 mm) renal sheath. Dilatation balloon catheters are used to exert radial force to dilate nephrostomy tracts. The balloon features a silicone coating to reduce friction between the balloon surface and renal sheath.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NephroMax Balloon Dilatation Catheter:
Acceptance Criteria and Study Details for NephroMax Balloon Dilatation Catheter
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for each test. Instead, it describes "performance testing" conducted to "demonstrate equivalence" to the predicate device. The reported "performance" is that the results "demonstrate equivalence of the NephroMax Balloon Catheter to the predicate balloon dilatation catheter."
| Test Parameter | Acceptance Criteria (Explicitly Stated) | Reported Device Performance (as stated) |
|---|---|---|
| Effective Working Length | Not explicitly stated | Demonstrates equivalence |
| Catheter Tip Length/RO Marker Location | Not explicitly stated | Demonstrates equivalence |
| Deflation Time | Not explicitly stated | Demonstrates equivalence |
| Balloon Diameter/Length at Rated Burst Pressure | Not explicitly stated | Demonstrates equivalence |
| Balloon Compliance | Not explicitly stated | Demonstrates equivalence |
| Multiple Inflation | Not explicitly stated | Demonstrates equivalence |
| Balloon Burst | Not explicitly stated | Demonstrates equivalence |
| Proximal Balloon Bond Tensile | Not explicitly stated | Demonstrates equivalence |
| Balloon Protector Removal Force | Not explicitly stated | Demonstrates equivalence |
| Guidewire Passability | Not explicitly stated | Demonstrates equivalence |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "samples aged at T=0 and T=7 months accelerated aging" were used. However, it does not specify the number of samples per test or per aging condition.
- Data Provenance: The study was a bench evaluation conducted by Boston Scientific Corporation. The data is thus prospective in the sense that it was generated specifically for this submission, and its origin is internal to the manufacturer. No country of origin for external data is mentioned, as it is a bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable to the type of study performed. The testing described is a bench evaluation (mechanical and physical performance tests) and does not involve human expert assessment for "ground truth" in the way clinical studies or visual diagnostic AI systems would. The "ground truth" is based on objective measurements against engineering specifications and comparison to the predicate device.
4. Adjudication Method for the Test Set
- This information is not applicable as it was a bench evaluation, not a study requiring adjudication of expert opinions or clinical outcomes.
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, an MRMC comparative effectiveness study was not performed, nor is it relevant to this device. This device is a medical instrument (balloon catheter), not an AI diagnostic or assistance tool. The submission is a traditional 510(k) for a medical device redesign/update, focusing on physical and mechanical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done because this is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the performance testing implicitly refers to engineering specifications, design requirements, and the established performance characteristics of the predicate device. The tests aim to demonstrate that the new device meets these specifications and performs equivalently to the predicate.
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is a physical device being evaluated through bench testing, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the reasons stated above (no training set for a physical device).
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