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

The subject device is intended used for drainage of the urinary system, sterile and for single use. Duration of use ≤ 24 hours. The subject device is supplied in four forms: Uncoated type, Normal type, Water sachet type, Ready-to-use type. The Disposable Intermittent Catheter is made from the TPU, and the hydrophilic coating (optional). The surface hydrophilic coating is made from polyvinyl pyrrolidone. The free contact sleeve is optional.

The provided FDA 510(k) clearance letter and summary describe a Disposable Intermittent Catheter (TPU Catheter). This document focuses on the substantial equivalence of the new device to a predicate device based on non-clinical performance testing.

It is crucial to understand that this document does not describe a study involving algorithms, human readers, or image analysis. Therefore, many of the requested categories related to AI performance, expert review, and ground truth for such studies are not applicable. The information provided pertains to the physical and material characteristics, sterility, and biocompatibility of a medical device (a catheter).

Here's an analysis of the acceptance criteria and supporting studies as presented in the document, with explanations for the unapplicable sections:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on compliance with various international standards for medical devices, particularly those for urethral catheters, sterilization, packaging, and biocompatibility. The "reported device performance" is the statement that the device met these criteria.

Study Details (Non-AI/Software Device)

Since this is a physical medical device (catheter) and not an AI/software device, most of the requested fields related to AI study design are not applicable.

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

   • Sample Size for Test Set: Not explicitly stated in terms of a "test set" as understood in AI/software evaluation. Each test (e.g., kinking, seal strength, biocompatibility, sterility) would have its own sample size of catheters or materials, but these specific numbers are not provided in the summary.
   • Data Provenance: Not applicable in the context of an AI/software device. The tests are performed on the manufactured catheters themselves.

2. 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. Ground truth, in the context of human expert review for AI, is not relevant here. The "ground truth" for these performance tests is established by adhering to the methodologies and pass/fail criteria defined in the referenced international standards. The evaluation is conducted by qualified laboratory technicians and scientists in accordance with these standards.

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

   • Not Applicable. This concept is for resolving discrepancies in expert opinion for ground truth establishment in studies involving diagnostic/interpretive tasks. This device undergoes standardized physical and biological testing, not interpretive adjudication.

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 device is an intermittent urinary catheter, not an AI-assisted diagnostic tool. No MRMC study was performed.

5. 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.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Standardized Test Results / Compliance with ISO/ASTM Standards. For example, "ground truth" for sterility is the absence of microbial growth as determined by ISO 11737-2 methods. For biocompatibility, it's the lack of adverse biological responses per ISO 10993 series. These are objective measurements against defined criteria, not expert consensus on an interpretation.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/software device with a "training set."

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

   • Not Applicable. This is not an AI/software device with a "training set."

Summary of the Device and Study from the Document:

The Disposable Intermittent Catheter (TPU Catheter) underwent non-clinical performance testing to demonstrate its safety and effectiveness and substantial equivalence to a legally marketed predicate device (K200134). The studies involved a series of tests to ensure the device complies with relevant international standards for physical characteristics (e.g., kinking resistance, friction), sterilization (radiation processing, sterility assurance, bioburden), packaging integrity, shelf life, and biocompatibility. All tests met their predetermined acceptance criteria, leading to the conclusion that the device is as safe and effective as the predicate. The changes in material (TPU instead of PVC) and sterilization method (radiation instead of ethylene oxide, though both achieve SAL 10-6) were supported by specific testing, especially biocompatibility.

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The PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

The PVC Hydrophilic Urethral Catheter is a single use urinary catheter designed for clean intermittent catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer with/without water sachet (pure water). The catheters are coated with a coating containing polyvinyl pyrrolidone (PVP) - a kind of hydrophilic polymer, which binds the water molecules to the catheter to reduce the risk of friction while inserting the catheter into the urethra. Coating is activated by the water by squeezing the water sachet or purified water. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PVC Hydrophilic Urethral Catheter is supplied in French size ranging from 8 to 18. It is available for male and female.

This document describes a 510(k) premarket notification for a PVC Hydrophilic Urethral Catheter (K212567). However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical urological catheter, not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of medical device described in the provided text.

The document primarily focuses on demonstrating "substantial equivalence" of the new PVC Hydrophilic Urethral Catheter to a legally marketed predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) based on non-clinical performance testing and biocompatibility testing.

Here's a breakdown of the information that is present, but tailored to a physical medical device, not an AI/ML one:

Acceptance Criteria and Device Performance (for a physical catheter)

The document states that the "PVC Hydrophilic Urethral Catheter meets all the pre-determined testing and acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria. It mentions the types of tests conducted:

Explanation of the Study and its intent:

The study conducted was a non-clinical performance testing and biocompatibility testing program. The purpose of these tests was to demonstrate that the new PVC Hydrophilic Urethral Catheter is substantially equivalent to a predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) in terms of safety and effectiveness, as required for a 510(k) submission.

Regarding the specific questions asked for AI/ML devices, here's why they are not applicable and thus not available in the provided text:

1. Sample sized used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML model. Testing was likely performed on
   physical catheter samples in a laboratory setting.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI/ML sense is established by human experts for a physical catheter's performance. Performance is measured against engineering specifications and biocompatibility standards.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus for AI/ML model output, not physical device testing.
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 for AI-assisted image interpretation or similar.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "truth" for this device's performance is derived from physical measurements (e.g., flow rate, strength, friction) and standardized biological responses from biocompatibility tests.
7. The sample size for the training set: Not applicable. No AI/ML model, so no training set.
8. How the ground truth for the training set was established: Not applicable. No AI/ML model, so no training set or ground truth establishment in that context.

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