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The subject device is a tubular device that is inserted through the urethra to pass urine from the bladder.

The Teleflex Rusch®FloCath Quick™ 18 French (Fr.) Coudé Hydrophilic Intermittent Catheter is single use, disposable and sterile. The catheter is made of clear polyvinylchloride (PVC) with vertically cut and softly rounded, polished eyes and has a hydrophilic coating. It is composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size is an 18 French gauge and is identified on the packaging. The funnel is color coded red to facilitate size identification. The catheter is 40 cm in overall length. The FloCath Quick is an integrated package that contains the FloCath catheter with a blue protective catheter sleeve and a packet of sterile 0.9% saline. Before opening, the sterile saline pouch is broken to hydrate the catheter. The protective catheter sleeve allows for touchless insertion. The sleeve can also be pushed back and used as an extension to the catheter. The FloCath Quick packaging has a packaging hole to facilitate opening the catheter. Either the packaging hole or the adhesive patch on the catheter pack can be used to hang up the catheter in an appropriate, convenient location while the catheter is hydrated.

The provided text is a 510(k) summary for a medical device (Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance metrics in a clinical context.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of algorithm performance or clinical outcomes are not applicable or cannot be extracted from this document, as it primarily details bench testing and a comparison to a predicate device for regulatory clearance.

However, I can extract the relevant bench testing performance data which serves as the "study" for this type of submission and interpret the "pass" results as meeting implicit acceptance criteria for substantial equivalence.

Here's the information that can be extracted, with explanations for what is not applicable:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" for bench testing are generally that the device performs comparably to the predicate or meets established standards, and in all reported cases, the device "Passed". Specific numerical acceptance thresholds are not explicitly detailed in this summary for each test, but "Pass" indicates they were met.

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

• Sample Size: The document does not specify the sample size for any of the bench tests conducted.
• Data Provenance: The document does not specify the country of origin of the data. The testing described is bench testing, not clinical data, so terms like "retrospective or prospective" do not directly apply.

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)

This section is Not Applicable (N/A). The "ground truth" concept is usually associated with clinical or image-based studies where expert consensus or diagnostic outcomes are used. This submission focuses on engineering bench tests and material biocompatibility, which do not typically involve experts establishing "ground truth" in this manner. The evaluations are based on compliance with international standards and internal protocols.

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

This section is Not Applicable (N/A). Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for objective bench testing of device performance parameters.

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

This section is Not Applicable (N/A). This device is a urological catheter, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

This section is Not Applicable (N/A). As stated above, this is a physical medical device, not an algorithm.

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

This section is Not Applicable (N/A) in the traditional sense. For the bench tests, the "ground truth" or reference for assessment is established by the specified international and industry standards (e.g., EN 1616:1997, ASTM F623:2013, ISO 10993 series, ISO 11135-1:2014). Passing these standards serves as verification that the device meets defined engineering and safety specifications.

8. The sample size for the training set

This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

This section is Not Applicable (N/A). As this is not an AI/ML device, there is no training set or ground truth in that context.

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The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.

The Teleflex Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are single use, disposable and sterile. The catheters are made of clear polyvinylchloride (PVC) with vertically cut and softly rounded polished eyes and are coated with a hydrophilic coating. They are composed of a shaft with a proximal funnel and a tip. The funnel is made of PVC. The shaft size ranges from 6-20 French gauge. The funnel is color coded to facilitate size identification. The Rusch® FloCath™ Quick is an "all-in-one catheter" that allows for convenience and the Rusch® MMG H2O™ is a closed system with integrated collection bag that allows for "no touch" catheterization due to an introducer tip that helps bypass the first 1.5" of the urethra.

This document describes the Teleflex Rusch Hydrophilic Intermittent catheters (comprising Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, and Rusch MMG H2O Singles). This submission is for a 510(k) premarket notification, indicating a claim of substantial equivalence to a predicate device, not necessarily a claim of superiority or novel performance requiring extensive clinical studies typically associated with AI/ML devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of medical device submission.

The submission focuses on establishing substantial equivalence through "bench testing" and biocompatibility studies.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list numerical "acceptance criteria" for each performance characteristic with corresponding reported values in a table format that would be typical for an AI/ML device. Instead, it states that "The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." and "The testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device." It also adds, "Overall, the results are comparable to the predicate and support a determination of substantial equivalence."

Here's a summary of the performance characteristics evaluated and the reported outcome:

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

The document does not specify exact sample sizes for each bench test performed. For physical tests like flow rate and friction, standard engineering practices would involve testing a statistically representative sample from multiple production lots. For biocompatibility, testing is typically performed on material extracts according to ISO standards, which define the sample sizes and controls.

As this is a physical device, not an AI/ML system, concepts like "data provenance" (country of origin of data, retrospective/prospective) are not applicable in the same way. The testing would have been conducted in a laboratory setting.

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

Not applicable. For a physical medical device submission like this, "ground truth" as it relates to expert consensus or labeling of images/data for AI training/testing is not relevant. The performance is assessed against engineering specifications, industry standards (e.g., ASTM F623, ISO 10993), and direct comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable. This concept is typically relevant to AI/ML where human reviewers might adjudicate disagreements in interpretations. For physical device testing, the methods are typically standardized and objective (e.g., measuring flow rate, instrumental assessment of friction).

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. An MRMC study is designed for evaluating diagnostic or interpretive AI systems in a clinical setting by comparing human performance with and without AI assistance. This submission is for a physical urological catheter, not an AI-enabled diagnostic tool.

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

Not applicable. This device is not an algorithm. Performance is assessed on the physical device itself.

7. The Type of Ground Truth Used:

For the physical and biocompatibility testing, the "ground truth" is derived from:

• Engineering Specifications: The design specifications of the device.
• Predicate Device Performance: The known and established performance of the legally marketed predicate device (Rusch® FloCath - K000070). The subject device aims to be "substantially equivalent."
• International Standards: Adherence to standards such as ASTM F623 for physical properties and ISO 10993 series (1, 5, 10) for biocompatibility.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth in that context.

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Aseptic Intermittent Self-Catheterization.

The Rüsch FloNeil (coated, with Water Pack) / Rüsch Flocath IntroGel (uncoated, without Water Pack) - consists of a tubular PVC catheter, a split introducer, a silicone introducer tip. introducer cap, lubrication jelly and a pack of 15ml saline (for FloNeil -coated product) inside a closed urine collection bag.

The provided text is a 510(k) Summary for a medical device (urinary catheters) and the subsequent FDA clearance letter. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway, not a performance study in the sense of accuracy, sensitivity, or specificity.

Therefore, I cannot fulfill your request for the detailed information because the source document does not provide it.

Here's a breakdown of what the document does include:

• Device Name: Rüsch FloNeil (coated, with Water Pack) and Rüsch FloCath IntroGel (uncoated, without Water Pack)
• Intended Use: Aseptic Intermittent Self-Catheterization
• Predicate Device: Rüsch MMG/O'Neil Catheter Set and the MMG O'Neil Urinary Catheter
• Substantial Equivalence: Claimed equivalence in materials, design, and use to the predicate.
• Classification: Class II medical device, 78 KOD, 21CFR 876.5130

To address your query regarding acceptance criteria and a study, these would typically be found in a performance study report, clinical trial summary, or a specific section of a 510(k) submission dedicated to performance testing (if non-clinical or clinical data were required to demonstrate substantial equivalence beyond material and design comparison). This document is a high-level summary.

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