(59 days)
The Amplatz Renal Dilator Set is intended for nephrostomy tract dilation and the placement of a sheath.
The Catheter for Use with Amplatz Renal Dilator Set is intended to be used over a pre-positioned wire guide for percutaneous dilation and access of nephrostomy tract.
The Amplatz Dilator is intended for nephrostomy tract dilation to allow for the placement of a sheath.
The Amplatz Renal Introducer is intended to be used for nephrostomy tract dilation and the placement of a sheath.
The Amplatz Radiopaque TFE Sheath is intended to be used as a working channel to maintain a previously established nephrostomy tract.
The Clear Amplatz Sheath with Radiopaque Stripe is intended to be used as a working channel to maintain a previously established nephrostomy tract.
The Amplatz Renal Dilator Set contains the following components: an 8.0 French Catheter for Use with Amplatz Renal Dilator Set, various fascial dilators, a 10.0 French introducer sheath, various Amplatz Dilators, and various Amplatz Renal Introducers (an assembly of Amplatz Dilator and Amplatz Sheath). The set is intended for nephrostomy tract dilation and the placement of a sheath, which acts as a working channel during percutaneous nephrostomy procedures. It is supplied sterile and intended for one-time use.
The set includes components that may be sold separately with dimensional and material variances compared to the specifications of the original set components. The set components that are available in single sellable unit are as follows:
- Amplatz Renal Dilator Set
- Catheter for Use with Amplatz Renal Dilator Set
- Amplatz Dilator
- Amplatz Renal Introducer
- Amplatz Radiopaque TFE Sheath;
- Clear Amplatz Sheath with Radiopaque Stripe
This document is a 510(k) premarket notification for a medical device. It does not contain the detailed acceptance criteria and study results in the format requested. The document states that "All predetermined acceptance criteria of the testing were met," but it does not provide the specific criteria or the detailed performance data from the studies.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document only mentions that "All predetermined acceptance criteria of the testing were met."
- Reported Device Performance: Not explicitly stated in quantitative terms. The document concludes that "the subject devices perform as intended."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the document.
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 as this is a physical device and not an AI/diagnostic tool requiring expert ground truth for image/data interpretation. The testing focuses on physical and functional properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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. This is a physical medical device (dilators, catheters, sheaths), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the usual sense for diagnostic algorithms. Ground truth would be established through engineering specifications, material properties, and functional performance requirements, as indicated by the types of tests performed (Biocompatibility, Compatibility Verification, Functional Verification, Radiopacity Verification, Shelf Life).
8. The sample size for the training set
- Not applicable. This is for a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Conducted Studies (from the document):
The following tests were conducted to demonstrate that the devices met applicable design and performance requirements:
- Biocompatibility
- Compatibility Verification
- Functional Verification
- Radiopacity Verification
- Shelf Life of Three Years Accelerated Aging
N/A