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For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.

The Hydrophilic Intermittent Urinary Catheter is made from silicone elastomer with a hydrophilic coating. The device is for urological use only. It is intended for use by patients for bladder management including urine drainage, collection, and measurement. The device consists of an all silicone elastomer single lumen catheter and includes a silicone handle. The catheter has drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has a hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. The handle provides the patient-user an ergonomically designed area for a secure grip and notouch area when inserting the catheter.

The provided text describes a 510(k) premarket notification for a Urological Catheter, focusing on its substantial equivalence to predicate devices. The information primarily covers device description, intended use, technological characteristics, and non-clinical performance data. It does not contain the specific details required to complete your request for acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance, human readers, or detailed test set characteristics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/algorithm-based device, as this documentation pertains to a physical medical device.

The document discusses non-clinical performance data which includes:

• Design Qualification:
  • Included dimensional analysis, appearance, and functional testing according to EN 1616.
  • Lubricity testing according to modified ASTM D1894.
• Long Term Stability/Shelf Life:
  • Included dimensional analysis, appearance, and functional testing according to EN 1616.
• Biocompatibility:
  • ISO 10993-5, Cytotoxicity
  • ISO 10993-10, Sensitization GPMT (Klingman), 2 extracts
  • ISO 10993-10, Vaginal Irritation w/Histopathology, 2 extracts

However, these are performance metrics for a physical device, not an AI or algorithm.

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Hydrophilic-Antibacterial Intermittent Catheter is intended for urological use only. The Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in the management of incontinence, neurogenic bladder dysfunction, and surgical procedures in adult males and females requiring catheterization. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been shown. It is not intended as a treatment for active urinary tract infection.

Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.

The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial coated single lumen catheter with either two or four drainage eyes on the proximal tip. It is constructed from medical grade elastomers.

The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter (Hydrophilic-Antibacterial Intermittent Catheter, Hydrophilic Personal® Catheter K000723, or Antibacterial Personal® Catheter K001143) in a closed system-in-a-bag configuration with an introducer tip and insertion supplies.

Here's an analysis of the provided text to complete the request:

Acceptance Criteria and Study for Rochester Medical Corporation's Urological Catheter and Accessories

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through showing similar technological and performance characteristics, and biocompatibility testing. It doesn't present specific quantitative acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy for a diagnostic device) or provide a study demonstrating a direct comparison against such criteria for the Hydrophilic-Antibacterial Intermittent Catheter or the Intermittent Catheter Closed System Kit.

Instead, the "acceptance criteria" can be inferred from the regulatory pathway: proving substantial equivalence through comparison with existing legally marketed devices and demonstrating that the new device does not raise new questions of safety or effectiveness. The "study" in this context refers to the biocompatibility testing performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility Testing: The document provides details on the methods used for biocompatibility testing but does not specify the sample sizes for each test (e.g., how many cells for cytotoxicity, how many animals for in-vivo tests).
• Data Provenance: The biocompatibility tests are laboratory-based, performed by Rochester Medical Corporation. The document does not indicate country of origin for patients or animals, nor does it classify the data as retrospective or prospective clinical data, as this is pre-market testing.

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

This type of information is not applicable to this 510(k) submission. Biocompatibility testing relies on standardized laboratory protocols (e.g., ISO and USP standards) rather than expert interpretation of clinical ground truth in the way a diagnostic device might require. The "ground truth" for these tests is the outcome of the biological assay itself based on predefined criteria (e.g., cell viability, presence of irritation, mortality).

4. Adjudication Method for the Test Set

This is not applicable. The biocompatibility tests follow standardized, objective laboratory methods. There is no mention of a human adjudication process for interpreting these test outcomes beyond the standard analysis and reporting by the testing personnel.

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

No, an MRMC comparative effectiveness study was not done. This device is a urological catheter, not a diagnostic imaging device typically associated with AI assistance or human reader studies.

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

No, a standalone algorithm performance study was not done. This device is a medical product (catheter), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's safety (biocompatibility) and performance (similarity to predicates) relies on:

• Standardized Laboratory Protocols and Results: For biocompatibility, the truth is established by the factual biological outcomes of in-vitro and in-vivo tests as per ISO and USP standards.
• Engineering and Material Specifications: For technological equivalence, the ground truth is established by comparing the physical, material, and design specifications of the new device against those of legally marketed predicate devices.

8. The Sample Size for the Training Set

There is no mention of a training set in this context. Training sets are relevant for machine learning algorithms or complex diagnostics, not for the submission of a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence and biocompatibility.

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

This question is not applicable as there is no training set mentioned or implied in the provided document.

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Two-Way Catheter: Urethral catheterization for bladder drainage.

Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation.

Radiopaque Catheter:

Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.

INTENDED USE For urological use only.

The catherer consists of a double or triple lumen drainage eye on the proximal tip. The threeway cather has an additional eye for irrigation purposes. The two-way catheter is available with a radiopaque option. The catherer is available in a combination of French sizes, balloon capacties and lengths to accommodate pediative and adult male and female applications. Available catheter lengths range from 10.6 to 15.8, French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.

This document describes the Rochester Medical Corporation All Silicone Foley Catheter. The submission is a 510(k) for substantial equivalence to previously marketed predicate devices.

Acceptance Criteria and Device Performance (Study Information)

The device, a urological catheter, needs to meet the requirements of ASTM F 623-89 Standard Specifications for Foley Catheters and demonstrate biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   ASTM F 623-89 Standard Specifications for Foley Catheters	Meets requirements with the exception of requirements 5.3 and 5.5 regarding catheter tip and shaft diameters. The document states: "These exceptions are due to the proprietary manufacturing process that allows Rochester Medical to manufacture catheters with balloons that are incorporated into the catheter than being applied during a secondary operation, the tip diameter is equivalent to the balloon diameter which complies with therefore is not considered clinically significant."
   Biocompatibility	Biocompatibility testing was completed on catheter samples including tests for: Cytotoxicity, Systemic Toxicity, Intracutaneous Reactivity, Muscle Implantation with Histopathology, Sensitization and Irritation. Results were acceptable for all tests.

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample size for the test sets (ASTM F 623-89 testing and biocompatibility testing). It mentions "catheter samples" for biocompatibility. No information regarding country of origin or whether the data was retrospective or prospective is provided. These are laboratory/bench tests rather than clinical studies on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable (N/A). These are objective bench-top and laboratory tests, not subjective evaluations requiring expert consensus for ground truth.

4. Adjudication method for the test set:
   N/A. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for standard device performance and biocompatibility testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
   No. This is a 510(k) submission for a physical medical device (Foley catheter) and describes bench and biocompatibility testing, not an AI-assisted diagnostic tool or a comparative effectiveness study involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   N/A. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
   For the ASTM F 623-89 Standard Specifications, the ground truth is defined by the objective, measurable requirements stipulated in the standard.
   For Biocompatibility testing, the ground truth is established by the accepted scientific methodologies and criteria for evaluating biological responses to medical devices.

8. The sample size for the training set:
   N/A. This information is typically for AI/Machine Learning models, not for traditional medical device testing. The testing described is verification and validation.

9. How the ground truth for the training set was established:
   N/A. This information is typically for AI/Machine Learning models.

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The Silicone Antibacterial Foley Catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring uring output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant redution in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infection.

The catherer consists of a standard configuration Foley catheter with a drainage lumen that exits through two drainage eyes on the proximal end. A retention balloon is located near the proximal catheter tip. The retention balloon is filled thru a second lumen with a Luer valve that extends from a side arm on the distal end of the catherer to the balloon. The catherer is coated with nitrofurazone impregnated siliconc on the outside surface and inner lumen. It is available in 12, 18 and 20 Fr sizes. All French sizes are provided in a 16 inch length with a 5 or 10 cc size balloon.

Here's a breakdown of the acceptance criteria and study information for the Rochester Medical Corporation Silicone Antibacterial Foley Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

• Statistically significant difference in actuarial survival curves for time until CAUTI between the two groups (p = 0.007, Kaplan-Meier survival, Breslow logrank statistic) for the first 5 days of use. |
  | Material Biocompatibility | Passed Cytotoxicity, USP Systemic Toxicity, Subchronic Toxicity, Intracutaneous Injection, Muscle Implant Study, Sensitization Study, Pyrogenicity, and Hemolysis. |
  | Mutagenicity | Some mutagenic changes indicated (Note: This is a reported finding, not explicitly stated as an "acceptance criterion" that was passed, but part of the testing results). |
  | Antibacterial Activity (In-vitro) | Nitrofurazone-impregnated catheter segments showed antibacterial activity against clinical isolates of uro-pathogens including Coagulase-negative staphylococci, S. aureus, Enterococcus spp., C. Minutissimum, E. Coli, Enterobacter spp., and Klebstella spp. |
  | Conformity to Standards | Meets the requirements of ASTM 623-89 Standard Specification for Foley Catheters. |
  | Elution Profile & Bacteriocidal Levels | Elution profile reproducible, and antibacterial agent released at bacteriocidal levels. |
  | Material Degradation with Aging | No evidence of degradation with aging. |

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

• Sample Size: A total of 344 patients were enrolled in the clinical trial.
• Data Provenance: The study was a "single site randomized, double-blind, controlled clinical trial." This indicates it was a prospective study. The country of origin is not explicitly stated, but given the 510(k) submission to the FDA (USA), it is highly probable the study was conducted in the USA.

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

• The document does not explicitly state the number of experts or their qualifications used to establish the ground truth (diagnosis of CAUTI) for the clinical trial. Clinical trials usually rely on defined diagnostic criteria and sometimes independent clinical adjudication committees, but this specific detail is not provided.

4. Adjudication Method for the Test Set

• The document does not explicitly describe an adjudication method for the diagnosis of CAUTI in the clinical trial. It was a "double-blind" study, meaning neither the patients nor the clinicians administering the treatment knew which type of catheter was being used, which helps reduce bias in assessing outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This study was a clinical trial comparing the device to a conventional catheter in human patients, not a study evaluating human readers' diagnostic performance with or without AI assistance.

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

• Yes, a standalone study was done, in the sense that the device itself (the catheter) was tested for its inherent antibacterial properties in an in-vitro capacity and its clinical effectiveness without direct human interaction. The "algorithm" in this context is the inherent antibacterial mechanism of the device.
  • In-vitro studies specifically showed the antibacterial activity of the nitrofurazone-impregnated catheter segments against various uro-pathogens. This is a standalone performance assessment of the device's mechanism.

7. The Type of Ground Truth Used

• For the clinical trial, the ground truth was clinical outcomes data, specifically the "incidence of catheter associated urinary tract infection (CAUTI)." This would have been determined through clinical diagnosis based on established medical criteria (e.g., urine culture results, clinical symptoms).

8. The Sample Size for the Training Set

• This device is a physical medical device (catheter) with an antibacterial coating, not an AI or software-based device that explicitly requires a "training set" in the machine learning sense. Therefore, the concept of a "training set" is not applicable to this submission. The "training" for the device's performance is embedded in its manufacturing process and design, not in a data-driven training regimen.

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

• As explained above, the concept of a "training set" for an AI algorithm is not applicable to this physical medical device.

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The device is intended for use for urethral or intermittent catheterization. Device sizes are supplied for pediatric and adult male and female applications

The catheter consists of a single lumen catheter with two or four drainage eyes on the proximal tip. The catheter is available in a combination of French sizes and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths range from 6.4 to 15.65 inches and French sizes from 6 to 26 French.

The provided text is a 510(k) summary for a medical device (Rochester Medical Corporation Personal Catheter™). It describes the device, its intended use, and comparisons to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/ML powered device.

The "Testing and Test Results" section refers to:

• Flow rates meeting ASTM 623-89 Standard for Foley Catheters.
• Biocompatibility testing (Cytotoxicity, Sensitization, Reactivity, Genotoxicity, Systemic Toxicity, Muscle Implant, and Bladder Irritation).

These are standard performance and safety tests for a physical medical catheter, not an AI/ML algorithm.

Therefore, I cannot provide the requested information as it is not present in the given input.

To answer your request, the input document would need to describe a study evaluating an AI/ML device, including details such as:

1. Acceptance Criteria: Specific quantitative thresholds for metrics like accuracy, sensitivity, specificity, AUC, F1-score, etc.
2. Reported Device Performance: The actual measured values of these metrics.
3. Sample Size & Data Provenance: Details about the datasets used for testing and training.
4. Ground Truth Establishment: How the true labels (e.g., presence/absence of disease) were determined.
5. Adjudication Method: If human experts were used for ground truth, how disagreements were resolved.
6. MRMC Study: If the AI was evaluated in a human-in-the-loop setting.
7. Standalone Performance: If the AI's performance without human intervention was measured.
8. Training Set Details: Information about the data used to train the AI model.

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