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The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.

The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.

The provided text describes the 510(k) premarket notification for the Peralta Stone Removal Catheter. It details the device's indications for use, its comparison to predicate devices, and a summary of non-clinical testing. However, it explicitly states "No clinical data were provided in order to demonstrate substantial equivalence."

Therefore, based on the provided document, a study proving the device meets acceptance criteria related to clinical performance or human reader studies does not exist in this submission. The acceptance criteria and "study that proves the device meets the acceptance criteria" would primarily refer to the non-clinical testing performed.

Here's an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission primarily relying on non-clinical testing and substantial equivalence, the "acceptance criteria" are derived from the performance standards and tests outlined. The document does not provide specific numerical acceptance criteria for each test, but rather states that the device "conforms to the performance specifications."

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

• Biocompatibility: Not specified, but standard ISO testing involves specific sample sizes for tests like cytotoxicity and sensitization.
• Dimensional, Functional, Usability, Mechanical Testing: Not specified, but generally a representative sample of manufactured devices would be tested.
• Ex Vivo Testing: "Ex vivo testing in porcine ureters was performed." Sample size (number of ureters or experimental runs) is not specified.
• Animal Testing (In Vivo): "In vivo testing on four ureters in a porcine model." This implies a sample size of four ureters.
• Data Provenance: The studies were sponsored by Calcula Technologies, Inc., and performed as part of their 510(k) submission. The location of the studies is not explicitly stated in the document, but it is implied to be part of their regulatory compliance process for the US market. The studies are prospective in nature, as they were conducted specifically for this submission.

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

• Not Applicable in the traditional sense for this submission. For a medical device 510(k) that relies on non-clinical testing for substantial equivalence, "ground truth" isn't established by expert consensus on clinical outcomes or images in the same way it would be for an AI/CADe device. The ground truth for the non-clinical tests is established by direct measurement, physical performance, and biological responses according to established protocols.
• The "experts" involved would be the engineers, scientists, and technicians conducting the performance, mechanical, and biocompatibility tests, following validated methods. Their qualifications are not specified but are implied to meet industry standards for such testing.

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

• None in the context of expert adjudication of clinical outcomes or images. The "adjudication" for non-clinical tests would involve review and approval of the test protocols and results by internal quality and regulatory personnel.

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 study was NOT done. This type of study is relevant for AI-powered diagnostic or CADe devices where human readers' performance is augmented by AI. The Peralta Stone Removal Catheter is a physical medical device, not an AI/software device designed to assist human interpretation.

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

• No. This question is not applicable. The device is a physical catheter, not an algorithm.

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

• For the non-clinical tests, the "ground truth" is based on:
  • Direct measurements (for dimensional verification).
  • Defined physical parameters and failure points (for functional and mechanical testing).
  • Biological responses (for biocompatibility, e.g., cell viability, irritation response).
  • Observation of performance in simulated environments (ex vivo and in vivo animal models demonstrating the ability to grasp, manipulate, and remove stones, and dilate ureters).
• In the animal study, the ground truth was the pre-placed urinary stones (3mm and 4.3mm) and the observed ability of the device to remove them.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for an AI model, there is no ground truth established for one.

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