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The BEVER™ intermittent catheter is indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder -voiding episode. The catheter is inserted into urethra to reach the bladder allowing urine to drain.

BEVERTM Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for men, women and children, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types. The uncoated catheter consists of a tubular polyvinyl chloride catheter shaft with attached a drainage funnel. The catheter is available in sizes 6Fr ~ 22Fr in 2Fr increments for Nelaton-tip and sizes 8Fr ~ 22Fr in 2Fr increments for Tiemann-tip. The coated catheter consists of a tubular polyvinyl chloride catheter shaft, coated with a hydrophilic low-friction coating, with attached a drainage funnel, and a sterile water packet is placed in the package. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water in the attached water packet, it becomes slippery and thus reduces friction against the urethra.

The provided text describes the regulatory submission for the BEVER™ Intermittent Catheter, primarily focusing on demonstrating substantial equivalence to predicate devices rather than an efficacy study with specific acceptance criteria related to clinical performance. The "Device Performance" section refers to compliance with EN standards, and then details a series of biocompatibility tests.

Therefore, many of the requested elements for a study proving device meets acceptance criteria (such as sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not provided in this regulatory submission document.

However, I can extract the information relevant to the acceptance criteria and performance as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are based on compliance with established standards (EN and ISO) and the qualitative outcomes of the conducted tests (e.g., no cytotoxicity, non-irritant, no sensitization, no tearing). There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy mentioned as this is a medical device (catheter) and not an AI/diagnostic device.

2. Sample Size Used for the Test Set and Data Provenance

• Cytotoxicity Test: L-929 mouse fibroblast cells were used. The specific number of replicates or wells is not explicitly stated but implied by the use of "a 96-well microplate." Data provenance is laboratory testing.
• Irritation Test: Test articles were contacted with vaginal tissue (animal model implied). The number of test subjects (animals) is not specified. Data provenance is laboratory testing.
• Sensitization Test: Ten test guinea pigs (per extract) for the test group and five control guinea pigs (per vehicle) for the control group were used. Data provenance is laboratory testing (animal study).
• Packaging Shipment Testing: 2 pieces of packaged-products were submitted for testing. Data provenance is laboratory testing.
• Shelf Life Testing: The sample size for accelerated and real-time aging studies is not specified in the provided text. Data provenance is laboratory testing.

The country of origin for the data (tests) is not explicitly stated, but the submitter is based in Hangzhou, China, suggesting the testing was likely conducted there or overseen by the Chinese manufacturer. All studies appear to be prospective studies conducted for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. The tests performed are laboratory-based assays (e.g., cell viability, tissue examination, animal skin reaction, physical integrity) whose "ground truth" is determined by the experimental results and established biological/physical standards, rather than expert consensus on complex diagnostic images or clinical scenarios. No human expert interpretation to establish a ground truth is mentioned beyond standard laboratory practice.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the tests are laboratory-based with objective measurements (e.g., cell viability assays, macroscopic/microscopic tissue examination, visual inspection for tearing). There is no mention of a subjective "test set" requiring adjudication in the context of clinical or diagnostic performance.

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 medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies or human reader improvement with AI are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Biocompatibility (Cytotoxicity, Irritation, Sensitization): Ground truth was established based on the results of standardized biological assays interpreted against pre-defined criteria in ISO 10993 standards and the control groups. For example, cell viability percentage for cytotoxicity, macroscopic and microscopic evaluation for irritation, and skin reaction scoring for sensitization.
• Physical/Material/Packaging/Sterility/Shelf Life: Ground truth was established by demonstrating compliance with specific EN and ISO standards and by meeting the device specifications after various tests (e.g., physical inspection, sterility indicator, stability testing).

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The manufacturing processes and material selection might be informed by historical data or R&D, but not a formally defined "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set mentioned for this medical device.

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