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The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.

The Lotus No Balloon Catheter is a sterile, single patient use drainage catheter made of silicone elastomer. The catheter is used to pass fluids to and from the urinary tract, suprapubically or through the nephrostomy tract. The catheter is supplied in French sizes ranging from 8Fr to 26Fr.

The acceptance criteria and study proving the device meets them are described for the LotusCatheter (Lotus No Balloon Catheter) as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details the types of tests conducted but does not present a formal table with specific numerical acceptance criteria and corresponding reported performance values. However, it states that the Lotus No Balloon Catheter passed the modifications of the tests.

The study that proves the device meets the acceptance criteria is described as follows:

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

The document does not specify the exact sample size for each test conducted on the Lotus No Balloon Catheter. However, it indicates that testing was conducted "in accordance with modified performance requirements of its predicate device, the Hakki Urinary Catheter (K101900)." The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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

This information is not applicable as the described study involves physical and biological performance testing of a medical device (catheter) against established standards, not interpretation of data by human experts for establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for physical and biological performance testing of a medical device. The tests are designed to objectively measure performance against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable as the LotusCatheter is a physical medical device (urological catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be relevant.

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

This information is not applicable as the LotusCatheter is a physical medical device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance testing cited is based on established industry standards and predicate device performance requirements. Specifically:

• ASTM F623-99:2013 (though modified)
• Performance requirements of the predicate device, Hakki Urinary Catheter (K101900)
• ISO 10993 series for biocompatibility (specific parts listed: 10993-5:2009, 10993-10:2010, 10993-11:2010, 10993-11:2017, ISO 10993-6:2016)

8. The Sample Size for the Training Set:

This information is not applicable for physical device performance testing. There is no concept of a "training set" in this context.

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

This information is not applicable for physical device performance testing.

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The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. It must be connected to a standard urinary collector.

The Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra and is an improved version of the straight urinary catheter. The Hakki catheter has built-in expandable/retractable Malecot type wings permitting holding capabilities less than that of a Foley catheter, but allows greater holding power than a straight catheter. By design the Hakki catheter has the ability to maximize drainage of a bladder, due to the location of its drainage opening at the natural drainage point within the bladder. The Hakki catheter is activated by expanding and contracting the catheter through the built-in patented bellows, which open and close the wing tip. The newly designed Hakki urinary catheter functions in the same manner as a straight or Foley catheter and is inserted through the urethra into the bladder.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for each performance test (flow rate, expanded leaflet integrity, response to pullout), nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Testing was performed in accordance to Food and Drug Administration guidance's and recognized international standard ASTM F 623-99 (Reapproved 2006)."

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

This information is not provided in the document. The testing was described as "Non-clinical device performance testing," which implies laboratory-based tests rather than expert-driven clinical evaluations for ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document. As the tests were non-clinical performance tests, an adjudication method for human interpretation would not typically be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was mentioned. The device is a urinary catheter, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical medical device (urinary catheter), not an algorithm or AI system. The performance tests described (flow rate, leaflet integrity, pullout response) are standalone physical tests of the device's mechanical properties.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance tests (flow rate, expanded leaflet integrity, response to pullout) was based on the specifications and requirements outlined in the recognized international standard ASTM F 623-99 (Reapproved 2006).

8. The Sample Size for the Training Set

This information is not applicable. The Hakki Urinary Catheter is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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