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The Loop Tail Ureteral Stent is intended to facilitate drainage from the kidney to the bladder.

The Loop Tail Ureteral Stent is a dual durometer ureteral stent with a renal pigtail and a bladder loop configuration. A "long" and "short" loop version will be available, in sizes 5, 6, 7, and 8 Fr., and lengths ranging from 10cm to 30cm.

The provided FDA 510(k) summary for the Loop Tail Ureteral Stent does not contain specific acceptance criteria with quantitative metrics nor details of a clinical study proving the device meets such criteria in the way a contemporary AI/ML device submission might.

Instead, this submission is for a medical device (a ureteral stent) and relies on demonstrating substantial equivalence to a previously cleared predicate device (Contour Polaris Ureteral Stent K010002) rather than proving performance against specific, quantitative acceptance criteria through a clinical study. The performance data section focuses on "physical comparison and functional testing" to support substantial equivalence.

Based on the provided document, here's an analysis:

1. A table of acceptance criteria and the reported device performance

No specific quantitative acceptance criteria (e.g., success rates, flow rates, durability metrics) are provided in this summary document, as the submission focuses on substantial equivalence based on design and functional testing rather than a clinical outcome study with predefined metrics.

2. Sample size used for the test set and the data provenance

Not applicable in the context of this 510(k) summary. The submission discusses "physical comparison and functional testing," which would typically involve laboratory bench testing of a sample of devices, but it does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of expert review or ground truth establishment in a clinical context for this device. The assessment is based on engineering and material comparisons, and functional testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of adjudication for a clinical test set.

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 medical device (ureteral stent), not an AI/ML-driven diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the sense of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission would be defined by established engineering and material science principles, and the performance of the predicate device.

8. The sample size for the training set

Not applicable. This is a medical device primarily based on engineering design and material science, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. No training set as it's not an ML device.

Summary of the Study Proving the Device Meets Acceptance Criteria (as described in the 510(k) summary):

The device (Loop Tail Ureteral Stent) meets its "acceptance criteria" (which in this context are interpreted as the requirements for substantial equivalence) through a comparison with a legally marketed predicate device (Contour Polaris Ureteral Stent K010002) and a series of non-clinical tests.

The study essentially consists of:

• Technological Characteristics Comparison: The sponsor asserts that the intended use and materials of the proposed device are "identical" to the predicate device. The primary design difference is the bladder loop configuration of the proposed device versus the bladder pigtail of the predicate.
• Functional Testing and Physical Comparison: The submission states that "physical comparison and functional testing support a determination of substantial equivalence." This would involve laboratory bench tests to evaluate properties such as:
  • Material integrity
  • Mechanical properties (e.g., tensile strength, flexibility)
  • Flow characteristics (though not explicitly stated, would be critical for a drainage device)
  • Biocompatibility (based on the materials being identical to the predicate)
  • Durability

The document mentions adherence to "FDA's 'Guidance for the Content of Premarket Notifications for Ureteral Stents'," indicating that the testing performed would align with regulatory expectations for this device type to demonstrate substantial equivalence.

In conclusion, for this specific 510(k) submission from 2003, the "study" proving acceptance criteria adherence is a demonstration of substantial equivalence through material identity, identical intended use, and a battery of non-clinical physical and functional tests, rather than a clinical trial with specific quantitative performance metrics against a predefined ground truth.

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