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SpeediCath Compact and SpeediCath Compact Plus is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is indicated for female patients only (adults and children of and above the age of 2 years). Choice of the catheter for the individual patient is made upon recommendation by the local health care professional.

The SpeediCath Compact and SpeediCath Compact Plus are sterile, ready to use intermittent catheters for females. These are single use catheters. The subject catheters have a hollow polyurethane inner tube that facilitates drainage of urine from the bladder through the urethra. SpeediCath Compact is available in size FR/CH 8. FR/CH 12. and FR/CH 12. and FR/CH 14. SpeediCath Compact Plus is 2 cm longer than SpeediCath Compact and is available in FR/CH 10, FR/CH 12, and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside the inner tube, which together with a handle and plug make up the primary packaging and the sterile barrier.

After inserting the catheter through the urethra and into the bladder, urine flows through the polished evelets (holes) at the tip of the catheter, the handle, and the plug. The hydrophilic coating on the catheter, as well as the swelling medium, provide a lubricated surface for minimized friction through the urethra.

The provided text describes a 510(k) premarket notification for a urological catheter (SpeediCath Compact and SpeediCath Compact Plus). The document primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to a new AI/ML device requiring extensive standalone and comparative effectiveness studies.

Therefore, many of the requested details regarding acceptance criteria, study methodologies for AI performance, sample sizes for AI training/test sets, expert adjudication methods, and MRMC studies are not applicable or extractable from this specific document. This document is for a medical device (catheter), not an AI/ML diagnostic tool.

However, I can extract information related to the device's performance testing to meet its acceptance criteria for safety and effectiveness, focusing on what is available in the document.

Acceptance Criteria and Device Performance (as applicable to a physical medical device)

The document details performance testing conducted to ensure the device's safety and effectiveness, particularly in light of a change in its swelling medium compared to the predicate device. The acceptance criteria are implicitly that the device meets the standards of the listed tests.

• Catheter coating - dry out in air
• Catheters, objective friction measurement
• pH of the swelling medium
• Osmolality of the swelling medium |

Study Details (as applicable to a physical medical device's performance testing):

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify the exact sample sizes (e.g., number of catheters) used for each performance test.
   • Data provenance is not explicitly stated in terms of country of origin or retrospective/prospective, but these are in vitro and ex vivo laboratory tests on the device materials and performance, not clinical studies with patient data.

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

   • Not applicable. This device is a physical medical device (catheter), and the "ground truth" for its performance is established by adherence to recognized international standards (ISO, ASTM) and internal test protocols for parameters like friction, biocompatibility, and sterility. There isn't a "ground truth" established by human experts in the context of diagnostic interpretation.

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

   • Not applicable. This concept pertains to human review of diagnostic outputs; here, performance is measured against objective engineering and biological standards.

4. 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 is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device. The "standalone" performance here relates to the physical catheter meeting its specifications.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is derived from established scientific and engineering standards and validated test methodologies. For example, biocompatibility is assessed against ISO 10993, friction against ASTM D1894, and sterility against ISO 11137.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.

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

   • Not applicable.

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