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The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

The Ryder Urological Balloon Catheter Inflation Device consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a high pressure connecting tube. The Device has a fluid capacity of 20 cc and an operating pressure range of vacuum to 20 atm.

This document is a 510(k) summary for a medical device (Ryder Urological Balloon Catheter Inflation Device) and does not contain detailed information about a clinical study with acceptance criteria, sample sizes, expert involvement, or adjudication methods in the way a diagnostic AI study would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and safety testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Based on the information given, here's what can be inferred and what cannot:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. This document describes a new device submission, not a study involving a "test set" in the context of clinical performance data. The device's safety was assessed through materials testing and comparison to a predicate.
• Data Provenance: Not applicable.

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. No "ground truth" establishment in a diagnostic sense is described.

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

• Not applicable. This device is not an AI-assisted 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, not an algorithm.

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

• For the safety testing, the "ground truth" was adherence to USP guidelines for biocompatibility of materials.

8. The sample size for the training set

• Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned.

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

• Not applicable.

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