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The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.

The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter intended to be used by adult and pediatric males and females for the purpose of bladder drainage. The catheter is manufactured with conventional medical grade PVC. The surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP) and, when activated with water it becomes slippery and ready to use. The straight and Coudè tip configurations have been designed to eliminate trauma to the urethra and are offered in a variety of sizes. Each catheter is provided in sterile, single-use packages.

The provided text is a 510(k) summary for the Cure Catheter® Hydrophilic Coated. It predominantly focuses on demonstrating substantial equivalence to predicate devices based on device features, materials, and intended use, rather than on detailed performance criteria suitable for AI/ML devices. Therefore, much of the requested information (acceptance criteria for performance metrics, details of studies with test sets, ground truth establishment, sample sizes for training/test sets, expert qualifications, MRMC studies, and standalone performance) is not applicable or not provided in the document.

The document states that performance testing was conducted through "design verification and design validation activities," and these support the device's functionality and safety/effectiveness. However, specific acceptance criteria and detailed quantitative results from these tests are not provided in this summary.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. The document does not detail specific "test sets" in the context of typical AI/ML performance studies. It refers to "design verification and design validation activities," which are general engineering and quality assurance processes, but doesn't quantify samples or data provenance in this submission.

3. 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 / Not provided. The device is a physical medical device (urinary catheter), not an AI/ML diagnostic tool requiring expert-established ground truth on a test set of data.

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

• Not applicable / Not provided. See point 3.

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 / Not done. This is a physical device, not an AI system designed to aid human readers.

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

• Not applicable / Not done. This is a physical device.

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

• Not applicable. For a physical device like a catheter, "ground truth" typically refers to engineering specifications, material properties, and clinical performance in terms of safety and efficacy (e.g., ability to drain bladder without complications). The document states biocompatibility and functional performance were verified, implying such engineering and potentially in-vitro/in-vivo testing was done, but specific "ground truth" establishment methods as one would define them for an AI/ML device are not relevant or detailed.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML device.

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

• Not applicable / Not provided. This is not an AI/ML device.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document broadly states that:

• "Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use."
• "Product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness."

These statements imply a series of standard medical device testing, likely including:

• Biocompatibility testing: To ensure the materials (PVC, hydrophilic coating) are safe for contact with the human body, following standards like ISO 10993.
• Physical and Mechanical Testing: To verify properties like tensile strength, catheter tip integrity, coating durability, flow rates, and lubricity.
• Sterilization Validation: To ensure the sterilization process is effective.
• Packaging Validation: To ensure sterility is maintained until use.
• Potentially, simulated use or in-vitro performance testing: To confirm the hydrophilic coating's activation and low friction properties under simulated physiological conditions.

However, the 510(k) summary does not provide specific details on the methodologies, sample sizes, or quantitative results of these "studies," as its primary purpose is to demonstrate substantial equivalence to existing predicate devices, rather than a detailed report of novel performance data. The FDA's clearance (K132500) confirms that based on the provided information, the device was deemed substantially equivalent to already legally marketed devices.

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An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

The Cure Pediatric Catheter device is an intermittent urinary catheter intended to be used by pediatric males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to open, sterile, single-use packages.

The provided text describes a 510(k) premarket notification for a medical device called the "Cure Pediatric Catheter." This document is a regulatory submission, not a study report. Therefore, it does not contain the detailed information necessary to fully address all parts of your request which are typical for studies proving device performance against acceptance criteria.

However, I can extract the available information and highlight what is not present in this type of document.

Understanding the Document's Nature:

This is a 510(k) Summary, which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device), rather than directly proving performance against pre-defined acceptance criteria in the sense of a clinical or analytical study with statistical endpoints. Substantial equivalence is established primarily through comparisons of technological characteristics, materials, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not provided in a 510(k) Summary for a device like a urinary catheter. Acceptance criteria typically involve specific quantitative benchmarks (e.g., flow rate, force to insert, material strength, biocompatibility limits) that would be evaluated in a detailed test protocol.

Instead, the document states:

• "The Cure Pediatric Catheter is substantially equivalent to the predicate devices."
• "The catheter design is identical to both predicates K072539 and K080881 (except in length) and materials are identical to the predicate K080881."
• "Standard biocompatibility tests were performed on the Cure Catheter to establish device safety. All tests were performed in accordance with ISO10993-1... The studies indicated that the Cure Pediatric Catheter is biocompatible and safe for its intended use."

These statements serve as the "reported device performance" in the context of a 510(k) as they indicate compliance with established standards and similarity to devices already on the market, which inherently implies acceptable performance. Specific numerical "acceptance criteria" and "reported performance" values are not listed here.

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

• Sample Size: Not explicitly stated. Biocompatibility testing for medical devices involves a variety of tests on material samples, not a "test set" of patients or images as might be seen for AI/diagnostic devices. The number of samples for ISO 10993 testing is determined by the specific methods employed (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity).
• Data Provenance: Not explicitly stated. Biocompatibility tests are typically performed in a laboratory setting, either internally by the manufacturer or by a contract research organization. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of biocompatibility testing, it is always prospective for the device being evaluated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable to this type of device and submission. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic devices that interpret data (like images). For a simple Class II urinary catheter, performance and safety are assessed through engineering specifications, material testing, and biocompatibility studies, not by expert interpretation of clinical cases to establish a "ground truth."

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert opinions when establishing ground truth for diagnostic studies. This is not pertinent to the evaluation of a urinary catheter's physical and biological properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC study was not done. This type of study is primarily for diagnostic imaging devices or algorithms where human readers interpret cases, and the AI's impact on their performance is evaluated. A urinary catheter is a therapeutic/drainage device, not an interpretive diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone performance study in the context of an algorithm was not done. There is no AI algorithm in this device. The device itself is a physical medical instrument. Its "standalone performance" refers to its physical and material properties (e.g., sterility, biocompatibility, dimensions, material integrity) as confirmed by standard engineering and biological tests, not an algorithm's output.

7. The Type of Ground Truth Used

This question is not applicable in the conventional sense of expert consensus, pathology, or outcomes data for diagnosing a condition. For this device, the "ground truth" for demonstrating safety and effectiveness relies on:

• Compliance with recognized standards: Such as ISO 10993-1 for biocompatibility.
• Material specifications: Ensuring materials meet medical-grade requirements and match predicate devices.
• Design specifications: Confirming physical dimensions and features are appropriate and identical to predicates (except length).
• Performance specifications: While not detailed in the summary, underlying testing would verify catheter integrity, burst pressure, surface friction, etc., against defined engineering standards.

So, the "ground truth" is essentially adherence to established engineering, material science, and biological safety standards, as well as a demonstration of substantial equivalence to already approved devices.

8. The Sample Size for the Training Set

This question is not applicable as there is no AI algorithm or "training set" for a urinary catheter.

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

This question is not applicable as there is no AI algorithm or "training set" for a urinary catheter.

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The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.

The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag and intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in sterile, single-use packages. The Cure Catheter™ Closed System is also offered as part of a complete kit.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cure Catheter™ Closed System:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria and Performance:

• The document primarily focuses on biocompatibility and substantial equivalence to a predicate device as the key acceptance criteria.
• The "Reported Device Performance" column largely reiterates that the device met the stated criteria or aligns with the design specifications, indicating compliance.
• The document doesn't provide specific numerical thresholds or detailed pass/fail rates for these criteria beyond stating that they were "met."

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

• Sample Size for Test Set: The document does not specify a sample size for the test set used in the nonclinical testing for biocompatibility. It only states that "Standard biocompatibility tests were performed."
• Data Provenance: The biocompatibility tests were performed by North America Science Associates, Inc. (NAmSA). The country of origin of the data is not explicitly stated but can be inferred to be within North America given the name of the testing organization. The tests were nonclinical, meaning they were not performed on human subjects but rather in a laboratory setting (e.g., in-vitro or in-vivo animal studies as per ISO 10993). Therefore, the data is retrospective in the sense that it's a report on tests already completed.

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

• This information is not provided in the document. For nonclinical biocompatibility testing, ground truth is established by adherence to recognized standards (like ISO 10993-1) and the successful outcome of the tests as interpreted by relevant scientific personnel, but not typically by "experts" in the sense of clinical reviewers establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

• This is not applicable and not provided as the evaluation involved nonclinical biocompatibility testing and substantial equivalence, not a diagnostic or clinical performance study requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or data, often comparing AI assistance to unassisted human performance. The Cure Catheter™ is a urological catheter, and its evaluation focuses on material safety, functional design, and substantial equivalence, not diagnostic accuracy.

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

• This is not applicable. The Cure Catheter™ is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is inherent in its physical properties and design.

7. The Type of Ground Truth Used

• The "ground truth" for the biocompatibility testing was established by adherence to internationally recognized standards (US FDA General Program Memorandum #G95-1 and ISO 10993-1) and the measured outcomes of the performed tests (e.g., absence of cytotoxicity, irritation, sensitization).
• For the substantial equivalence claim, the ground truth was the characteristics of the predicate device (Rusch MMG/O'Neil Catheter) and the comparison of the Cure Catheter's features, function, and intended use against those characteristics.

8. The Sample Size for the Training Set

• This is not applicable as the Cure Catheter™ is a physical medical device and does not involve machine learning algorithms that require a "training set."

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

• This is not applicable as the device does not involve a training set.

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The Cure Catheter™ is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The unders catheter comes in a variety of sizes packaged sterile for single-use.

The Cure Catheter™ device is an intermittent urinary catheter intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to-open, sterile, single-use packages.

The provided text describes a 510(k) premarket notification for the "Cure Catheter™", an intermittent urinary catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable or not present in the provided document.

However, I can extract information related to the device's safety and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical performance data for human users. The non-clinical testing for biocompatibility was performed by NAmSA, but the sample sizes (e.g., number of units tested, number of animal subjects) for these tests are not provided. The data provenance is North America Science Associates, Inc. (NAmSA), and the nature of these tests (e.g., in vitro, in vivo animal studies) would classify them as non-clinical rather than retrospective or prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The document describes non-clinical biocompatibility testing and a comparison to a predicate device, not clinical performance with ground truth established by experts.

4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.

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 is a medical device (catheter), not an AI/imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used
For biocompatibility, the "ground truth" would be established by the results of standardized tests according to ISO 10993-1 and FDA G95-1 guidelines, demonstrating the absence of harmful biological responses. For substantial equivalence, the "ground truth" is the characteristics and performance of the predicate device (Rusch Easy Cath).

8. The sample size for the training set
Not applicable; there is no mention of a training set for an algorithm or a clinical study.

9. How the ground truth for the training set was established
Not applicable.

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