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Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.

Intermittent nelaton catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. The catheter body is made of polyvinyl chloride (PVC) coated with gel lubricating substance. The distal end is either a smooth closed straight or coude tip and has two eyelets for efficient drainage. The funnel shaped color-coded connector at the proximal end can be connected to a urine collection container. There is a contact free device, which is for an easy grip, allowing for touchless insertion. The product is packaged in sealed plastic bags and sterilized with ethylene oxide.

The provided document is a 510(k) summary for a medical device (Intermittent nelaton catheter for single use), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance of an AI-powered device. Therefore, much of the requested information regarding AI study design (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and effect size) is not applicable or present in this document.

However, I can extract the relevant information concerning the non-clinical performance data for the Intermittent nelaton catheter for single use, which serves as the "study" demonstrating the device meets certain performance characteristics.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical performance tests conducted, referencing relevant standards where applicable, and reports a "Pass" result for all of them. This implies that the device met the acceptance criteria defined by these standards or internal benchmarks.

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It states that "bench testing performed verifies that the performance of the subject device is substantially equivalent." The data provenance would be from internal laboratory testing conducted by the manufacturer, Hangzhou Jimushi Meditech Co., Ltd., which is based in P.R. China. These are retrospective tests performed on manufactured devices.

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

Not applicable. These are physical/chemical performance tests on a medical device, not diagnostic interpretations requiring human expert consensus. The "ground truth" is established by adherence to specified international or national standards (e.g., ISO, ASTM, EN, YY).

4. Adjudication method for the test set

Not applicable. Testing against defined physical/chemical standards does not involve expert adjudication in the same way as clinical interpretation. The "adjudication" is inherent in whether the measured performance meets the limits set by the referenced standards.

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 document describes a physical medical device, not an AI-powered diagnostic tool.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For most tests, the ground truth is established by adherence to well-defined international or national standards (e.g., ISO 20696:2018 for product length, flow rate, peak tensile force; ISO 10993 series for biocompatibility; ISO 11135: 2014 for sterilization). For tests where "N/A" is listed for the standard (e.g., Eyelets dimensions, Lubricity of coating, Gel appearance), the ground truth is based on internal specifications and quality control parameters established by the manufacturer.

8. The sample size for the training set

Not applicable. This is not an AI-powered device that requires a training set.

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

Not applicable.

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Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.

Jimushi Sterile Urethral Catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. This product is supplied in three slightly different forms: 1) Common model (conventional uncoated type), 2) Hydrophilic coated model, 3) Hydrophilic coated with water pocket model. The catheter body is made of polyvinyl chloride (PVC) with or without hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel shaped connector at the proximal end can be connected to a urine collection container. The catheter body is sterilized by EO, where the water pocket in some models is pre-sterilized by radiation.

The provided text is a 510(k) premarket notification for a medical device (Jimushi Sterile Urethral Catheter for single use). This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

It does not describe a study involving an AI-powered device or an algorithm's performance. Instead, it focuses on the physical and performance characteristics of a traditional medical catheter. Therefore, it does not contain the information requested in your prompt regarding AI model acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone algorithm performance.

The document primarily covers:

• Device Description: Jimushi Sterile Urethral Catheter for single use, its materials (PVC, hydrophilic coating), and its intended use (intermittent urinary catheterization).
• Predicate Device: Teleflex Medical Rusch FloCath Quick Urological Catheter.
• Similarities and Differences: A detailed table comparing the subject device to the predicate device across various parameters like indications for use, contraindications, population, size range, materials, and sterilization methods.
• Non-clinical Performance Data (Bench Testing): A list of physical and performance tests conducted on the subject device (e.g., visual inspection, flow rate, strength, biocompatibility, sterilization validation) and their "Pass" results, indicating the device meets established standards.

In summary, this document is entirely irrelevant to your prompt about an AI-powered device and its acceptance criteria due to the nature and purpose of the 510(k) submission described.

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