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This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

Note: 8 inch Sleeved IC 3 Pocket consists of a subset of the original population:

8 inch Sleeved IC 3 Pocket
This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

Sleeved IC 3 (not finalized) catheters are E-beam sterilized hydrophilic-coated, single-use catheters. The subject device has two drainage eyelets that are used to manage urinary incontinence.

The device is inserted into the urethra to drain urine from the bladder.

The device is available in 16 inch and 8-inch lengths. The device is available in various Fr sizes ranging from Fr 08 through Fr 16. The catheter is made from Thermo-plastic Elastomer (TPE), (not made with phthalates, not made with PVC). The catheter sleeve is manufactured from Low Density Polyethylene (LDPE). The catheter sleeve allows for the user to grip the catheter anywhere along the length during insertion.

The device is packaged in a foil which was designed to be easy to open and to facilitate access to the catheter. The device is contained in a primary package that consists of both the catheter assembly and the hydration fluid. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid. The device is available with and without the integrated urine collection bag. The device is available in straight and pocket packaging configurations.

The subject device covers several configurations:
• Sleeved IC 3 straight (SWT) is an intermediate catheter in a straight configuration
• Sleeved IC 3 Plus is the same catheter with an attached urine bag
• Sleeved IC 3 Pocket has the catheter coiled up for a smaller footprint
• Sleeved IC 3 Plus Pocket is the same coiled catheter with an attached urine bag

The devices are surface devices with mucosal membrane contact with prolonged contact duration (> 24 hours to 30 days) due to cumulative use. The devices are intended to be used in both professional healthcare facilities and the home environment.

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LoFric Origo is indicated for short- and long-term bladder management with intermittent urinary catheterization.

The subject device: LoFric® Origo™ is a range of sterile, single-use, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheters, designed to accommodate the individual anatomy of male users, are available in various lengths and French sizes, and come in three tip designs: Nelaton (straight tip), Flexible (straight ball-shaped tip), and Tiemann (Coudé tip). Each catheter is individually packaged together with an adjustable insertion grip, or an extendable protective sleeve attached to the catheter along with a sterile water sachet (packet). The adjustable insertion grip or the extendable protective sleeve are provided to minimize touching the catheter shaft directly during insertion and retraction. The water sachet is provided for wetting of the hydrophilic surface and is to be broken immediately before use in order to soak the tubing.

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The Cure Twist® is a pre-lubricated intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Twist® Female Catheter is a ready-to-use intermittent catheter pre-lubricated with a water based gel and includes polished eyelets for smooth insertion and easy drainage. The catheters are manufactured in CH8 to CH16 sizes. They are single use devices made from polyvinyl chloride (PVC) and sterilized by ethylene oxide.

The Cure Medical Catheter Insertion Kits components are used to aid catheter insertion. The Cure Twist® Female Catheter plus insertion kit include the Cure Twist® Female Catheter, ambidextrous gloves (PVC or nitrile), a benzalkonium chloride (BZK) wipe, an under pad and a urine collection bag with a universal connector.

The Cure Twist catheters are expected to be used in professional healthcare facilities, homes, work, public bathrooms, as well as out and about.

The provided document is an FDA 510(k) clearance letter for the Cure Twist Female Catheter. It outlines the device, its indications for use, and a comparison to a predicate device, along with a summary of performance data. However, it does not contain the specifics of a study or acceptance criteria in the format requested, particularly for AI/machine learning device evaluation.

The document indicates that the device is a urological catheter, not an AI/ML device. Therefore, a study proving an AI device meets acceptance criteria, including specifics like sample sizes for test and training sets, expert consensus, MRMC studies, or ground truth establishment, would not be found in this type of clearance letter. The performance data points listed (sterilization, biocompatibility, packaging integrity, etc.) are standard for a physical medical device, not an AI algorithm.

Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the physical and mechanical properties of a catheter, validated through standard engineering and biological testing, not AI model performance.

Explanation of why the requested information cannot be provided from this document:

• Device Type: The Cure Twist Female Catheter is a physical medical device (urological catheter), not an artificial intelligence/machine learning (AI/ML) device.
• Performance Data Scope: The "Performance Data" section lists tests relevant to physical medical devices (e.g., sterilization, biocompatibility, packaging integrity, flow rate, tensile strength). These are not metrics or studies typically associated with evaluating AI/ML algorithms.
• Absence of AI/ML Specifics: There is no mention of deep learning models, algorithms, human readers, ground truth consensus for image or data interpretation, or any other elements that would be present in a study proving an AI device's performance.

If this were an AI device, the 510(k) summary would typically include details about:

• Clinical Performance Study: Often a standalone study or a multi-reader, multi-case (MRMC) study.
• Performance Metrics: Sensitivity, specificity, AUC, F1-score, accuracy, etc.
• Test Set Description: Number of cases, demographics, data provenance, and how ground truth was established.
• Training Set Description: Size and how ground truth was established.
• Human Reader Performance: If AI assistance improves human reader performance (MRMC).

Since the provided document pertains to a traditional physical medical device, those types of studies and acceptance criteria are not applicable or detailed within this clearance letter.

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Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is for male patients only (adults and pediatric above the age of 1 years).

The Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.

The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.

The Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

The provided FDA 510(k) clearance letter and supporting Traditional 510(k) summary pertain to a urological catheter (Luja Coudé) and its substantial equivalence to a predicate device. This document focuses on the mechanical and material properties of the catheter, not on an AI/software as a medical device (SaMD) or diagnostic imaging device.

Therefore, many of the requested details, such as MRMC comparative effectiveness studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, and complex adjudication methods, are not applicable to this type of medical device submission. These elements are typically required for AI/ML-based diagnostic devices where performance is measured in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) and reader improvement.

The provided information focuses on bench testing (non-clinical performance) to demonstrate the device's physical and biological properties meet established standards and are equivalent to the predicate.

Here's an analysis of the provided text in relation to your questions, highlighting what is available and what is not:

Analysis of Acceptance Criteria and Study Proof for Luja Coudé Catheter

Based on the provided FDA 510(k) clearance letter and Traditional 510(k) summary, the Luja Coudé catheter demonstrates its performance through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies or AI/ML performance evaluations involving human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Biocompatibility and bench performance testing were conducted to verify the proposed subject devices with modified hydrophilic coating met the pre-determined acceptance criteria per specified requirements." It also states, "The subject devices met the pre-determined acceptance criteria after simulated shipping distribution and aging cycle per specified performance requirements."

However, the specific numerical acceptance criteria or the exact reported performance values are not detailed in this public summary. Instead, the summary lists the tests conducted and confirms that the device met the criteria.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical test (e.g., number of catheters tested for friction, kink, etc.). It only states that "Testing was performed on final, finished, and sterilized devices." This is typical for bench testing where the number of units tested is governed by standard protocols (e.g., ISO, ASTM, internal methods) to achieve statistical confidence for manufacturing and design verification, but individual numbers are not usually disclosed in 510(k) summaries unless a specific, novel statistical method for performance testing is employed.
• Data Provenance: The studies are "non-clinical" (bench testing). Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in the context of human subject data. The device is manufactured by Coloplast A/S in Humlebæk, Denmark, and the tests would have been performed in a controlled laboratory environment.

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

• Not Applicable. For this type of device (a physical urological catheter), "ground truth" is established through physical measurements, chemical analysis, and standardized biological assessments in a lab setting, not by human experts interpreting clinical data (like radiologists interpreting images). The "experts" involved would be engineers, material scientists, and microbiologists conducting the tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among human readers/experts in diagnostic studies, typically for AI/ML device validation. This is not relevant for the bench testing of a physical catheter.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study is relevant for AI/ML-driven diagnostic devices where the AI assists human readers. This device is a physical medical instrument, not an AI diagnostic tool.

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

• No. This question applies to AI algorithms. The Luja Coudé is a physical catheter designed for direct patient use via insertion, not an algorithm.

7. The Type of Ground Truth Used

• For this device, the "ground truth" is based on:
  • Standardized Bench Test Measurements: Objective physical properties (e.g., friction coefficients, kink resistance, dimensions, pH, osmolality) measured against international and proprietary Coloplast standards (ISO 20696, Coloplast TMs).
  • Biocompatibility Testing: Laboratory assays and in-vivo animal models (for systemic toxicity, irritation, sensitization) that demonstrate the material's safety in a biological environment, conforming to ISO 10993 standards.
  • Sterility Assurance Level (SAL): Defined by microbial inactivation standards (SAL 10⁻⁶).

8. The Sample Size for the Training Set

• Not Applicable. The concept of a "training set" is for AI/ML models. This device does not use an AI/ML model. The design and manufacturing process for the catheter would involve extensive development and testing, but not in the sense of an "AI training set."

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

• Not Applicable. As there is no AI training set, there is no ground truth to establish for it. The development of the catheter relies on established engineering principles, material science, and manufacturing quality control.

Summary: The provided document is a 510(k) summary for a physical medical device (catheter) that relies on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence and safety/effectiveness. It does not involve AI/ML technology or human reader studies. Therefore, many of the questions related to AI/ML device validation are not applicable.

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Luja Set is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is indicated for male patients only (adults and pediatric above the age of 1 years).

The medical device is an intermittent, ready-to-use, sterile, hydrophilic-coated catheter with integrated urine bag. It contains a catheter with a flexible tip that facilitates passage through the sphincter in the urethra. The catheter is shielded by a sleeve, which serves as protection from the user's hands during insertion. Several small holes (micro-holes) by the straight tip, create a draining zone, which allow the urine to flow from the bladder out through the catheter to a urine bag. The drainage end of the catheter is attached to a urine bag with a tear off section to open the bag for emptying. The catheter is sterilized by radiation. The Luja Set is available in sizes: CH10, CH12, CH14, and CH16.

The provided FDA 510(k) Clearance Letter for the Luja Set indicates that it is a Special 510(k) Notification. This type of submission is used when a modification is made to a manufacturer's own legally marketed device (the predicate device) where the modification does not require a new intended use and the methods for evaluating the changes are well-established.

Crucially, the provided document describes the device itself (a urological catheter), its intended use, and its similarities/differences to a predicate device (Luja Coudé) and a reference device (SpeediCath Flex Set). It details the non-clinical performance testing performed (flow rate and kink stability), but it DOES NOT contain the actual acceptance criteria or the specific results proving those criteria were met.

The document states: "Bench performance testing was conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions." However, the "applicable submission sessions" are not included in this document.

Therefore,Based on the provided document, I cannot fulfill most of the detailed requests regarding acceptance criteria and study particulars because the document does not contain the acceptance criteria or the specific performance data.

Here's what I can extract and state based only on the provided text, along with what cannot be determined:

Acceptance Criteria and Device Performance

• Acceptance Criteria: Not explicitly stated in the provided document. The document only mentions that "the proposed subject devices met the pre-determined acceptance criteria per specified requirements."
• Reported Device Performance: Not explicitly stated in the provided document. The document mentions that "Risk assessment was conducted, and two performance risks were identified: flow rate and kink stability. To support the flow rate and kink stability testing, the SpeediCath Flex Set (K222059) was used as a reference device." However, the actual performance data (e.g., specific flow rates achieved, quantitative kink stability metrics) are not provided.

Study Details (Based on available information and inferences from a 510(k) for a physical medical device)

The information provided is for a physical medical device (urological catheter), not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions regarding AI/ML clinical validation studies (like multi-reader multi-case studies, expert adjudication, ground truth establishment for AI models, training set details) are not applicable to this type of device and submission.

Here's a breakdown based on the context of the device:

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

   • Acceptance Criteria: Not listed in the provided document.
   • Reported Device Performance: Not listed in the provided document. The document only states that testing was performed for "flow rate and kink stability."

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

   • Sample Size: Not specified.
   • Data Provenance: Not applicable in the context of a physical device's non-clinical bench testing. This typically refers to clinical data. The testing mentioned (flow rate, kink stability) is bench testing on the device itself.

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

   • Not Applicable. This question is relevant for AI/ML or imaging-based devices where human expert readings establish ground truth. For a physical device like a catheter, "ground truth" is established through standardized physical measurements and engineering specifications, not expert consensus interpreting data.

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

   • Not Applicable. 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

   • No. This is a physical medical device, not an AI/SaMD. MRMC studies are not relevant here.

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

   • Not Applicable. This is a physical medical device.

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

   • For this device, "ground truth" for non-clinical testing is based on engineering specifications, physical measurements, and adherence to international standards (e.g., ISO 20696:2018 for urethral catheters, ASTM F623-19 for Foley Catheters, as cited). It's not a diagnostic ground truth from patient data like pathology or expert consensus.

8. The sample size for the training set

   • Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

   • Not Applicable. This device does not involve a "training set" in the context of machine learning.

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The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.

SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The document (K242049) is a Traditional 510(k) Summary for the Coloplast SureCath Set, a sterile, single-use hydrophilic coated intermittent catheter with an integrated urine bag. It demonstrates substantial equivalence to predicate devices. The information provided primarily focuses on non-clinical performance testing rather than human clinical studies involving AI assistance.

Based on the provided text, the device SureCath Set is a medical device, not an AI/ML powered device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI, or standalone algorithm performance are not applicable.

Here's a breakdown of the requested information based on the provided document:

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

The document broadly states that "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." It also mentions various ISO and ASTM standards to which the device was tested. However, it does not explicitly list specific quantitative acceptance criteria or detailed reported performance values for each test. It only states that the device "met the pre-determined acceptance criteria."

Implicit Acceptance Criteria (based on standards and test descriptions):

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical test. It states "Testing was performed on final, finished, and sterilized devices." The provenance of the data is from Coloplast A/S, Denmark. The tests are non-clinical, bench performance tests, so the concepts of "retrospective or prospective" human data don't directly apply here.

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 to this type of non-clinical device testing. There are no "experts" establishing a "ground truth" for a test set in the way it would be for an AI/ML clinical study (e.g., radiologists interpreting images). The "ground truth" for non-clinical tests is based on objective measurements against established engineering and biological standards.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. Non-clinical bench tests rely on objective measurements against defined standards.

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 conducted. The device is a physical medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, there is no "AI assistance" for human readers to improve upon.

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

No, a standalone algorithm-only performance study was not done. The device is not an algorithm or software requiring human-in-the-loop performance.

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

The "ground truth" for the non-clinical tests is based on:

• Compliance with recognized international standards (ISO, ASTM, EN/IEC).
• Pre-determined acceptance criteria defined by Coloplast for specific performance aspects (e.g., strength, friction, volume, activation).
• Objective measurements of physical and chemical properties.

8. The sample size for the training set

This information is not applicable. "Training set" is a concept for AI/ML models. This document describes testing for a physical medical device.

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

This information is not applicable, as there is no training set for a physical medical device.

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Luja Coudé is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The product is indicated for male patients only (adults and pediatric above the age of 1 years).

Luja Coude is a single-use, sterile, hydrophilic coated catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation.

The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products.

Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, and 18 Fr.

The provided text is a 510(k) summary for a medical device (Luja Coude catheter) and outlines its substantial equivalence to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria based on AI/ML performance metrics. The document focuses on non-clinical performance testing (bench testing, biocompatibility, packaging, aging) and usability testing relevant to catheter functionality and safety.

Therefore, I cannot extract the information required for your request, as the document does not describe:

• AI/ML performance metrics (e.g., accuracy, sensitivity, specificity).
• A test set or training set for an AI/ML model.
• Ground truth experts or adjudication methods for AI/ML performance.
• MRMC studies comparing human readers with and without AI assistance.
• Standalone algorithm performance.

The document states: "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions." This refers to standard medical device performance and safety testing, not AI/ML model validation.

In summary, the provided text does not contain the type of study and data required to answer your prompt about an AI/ML device's acceptance criteria and performance.

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Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), & Sleeved IC 2 Plus Pocket (16" and 8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
Sleeved IC 2 Pocket (8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

The Sleeved IC 2 (not finalized) catheters are:

• E-beam sterilized.
• Hydrophilic-coated, single use catheter.
• Have two drainage eyelets that is used to manage urinary incontinence.
• The Sleeved IC is inserted into the urethra to drain urine from the bladder.
• Available in 16 inch and 8 inch lengths.
• Available in various Fr sizes ranging from Fr 08 through Fr 16.
• Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC.
• Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter.
• Lubricated by direct contact with the hydration fluid.
• Available with and without integrated urine collection bag.
• Available in pocket and straight packaging configurations.
• Environment of use: hospital, home setting, public places.

The provided document describes the FDA clearance for the "Sleeved IC 2 Family" of intermittent catheters (K233524). It details the device's characteristics, indications for use, and a comparison to a predicate device ("Sleeved IC" K220667). It also summarizes the non-clinical testing conducted to support the substantial equivalence claim.

However, the document does not contain the specific information required to complete a table of acceptance criteria with reported device performance from a clinical study, nor does it detail a study that demonstrates the device meets specific acceptance criteria in the way described in the prompt.

Here's an explanation of why the requested information cannot be fully provided based on the input:

• Type of Submission: This is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device. For many moderate-risk devices (Class II), clinical studies are not always required if non-clinical performance testing can demonstrate substantial equivalence.
• Focus of the Document: The document focuses primarily on the technical characteristics and non-clinical testing (e.g., physical performance, biocompatibility, sterilization, packaging) to show that the new device performs as safely and effectively as the predicate device. It explicitly states, "Brief Description of Non-Clinical Testing".

Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes for test sets (as no clinical test set is described), number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for a clinical study because this information is not present in the provided text.

The document does include details on the non-clinical testing performed, which serves as the "study" demonstrating the device meets the requirements for clearance.

Below is a partial response based on the information available, noting where specific requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing against recognized standards rather than specific acceptance criteria from a clinical study. The "reported device performance" is that the device "met all applicable requirements" of these standards.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for any of the non-clinical tests. Non-clinical bench testing often uses small, representative samples.
• Data Provenance: Not specified, but generally, such testing is conducted in controlled laboratory environments by the manufacturer or contract labs. It is non-clinical (i.e., not from human subjects).

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

• Not applicable. The testing described is non-clinical and does not involve expert review or "ground truth" establishment in the context of clinical expert consensus. Performance is measured against engineering and biological standards.

4. Adjudication method for the test set

• Not applicable. This is not a clinical study involving human interpretation or adjudication.

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 device is a urological catheter, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

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

• Not applicable. This device does not incorporate an algorithm.

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

• For non-clinical performance, the "ground truth" is established by the specifications and measurable parameters defined in the referenced international and national standards (e.g., ISO 20696 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not applicable. (See #8)

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Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.

GentleCath Air for Women is a sterile, single use, disposable, hydrophilic, intermittent urethral catheter. A urethral catheter is a tubular device intended for being introduced into the urinary bladder through the urethra in order to provide drainage of the bladder. The catheter tube is made using Thermoplastic Elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. GentleCath Air for Women is designed for portability, ease of use and discreet disposal. Catheters are individually packed and are wetted ready for use upon removal from the case. Catheters are available in the following product sizes: CH10, 12, and 14.

This document describes the GentleCath Air for Women intermittent urinary catheters (CH10, CH12, CH14). The information provided is from a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the details about specific acceptance criteria and the study proving it are largely in reference to a comparison with established standards and the predicate device.

Here's the breakdown of the requested information based on the provided text:

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

The document does not provide a direct table of specific acceptance criteria with corresponding performance metrics like a typical medical device performance study would. Instead, it refers to performance testing conducted per applicable sections of voluntary and FDA consensus standards. The "Performance Data" section lists the types of testing performed and the standards used, indicating that the device met the requirements of these standards.

Here's a summary of the performance testing categories and the standards referenced, which imply the acceptance criteria are adherence to these standards:

2. Sample size used for the test set and the data provenance

The document does not provide specific sample sizes for any of the performance tests. It lists the types of tests performed and the standards followed, implying that the sample sizes were appropriate for those standards.

The provenance of the data is not explicitly stated as "country of origin" or "retrospective/prospective." However, the submission is from "ConvaTec, Ltd., First Avenue, Deeside Industrial Park, Deeside, Flintshire CH5 2NU, United Kingdom," suggesting the testing was likely conducted in or overseen by this entity.

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

This type of information (expert review for truth establishment) is not present in the provided document, as it pertains to device performance testing against engineering and biological standards, not diagnostic interpretation.

4. Adjudication method for the test set

Not applicable, as this is related to expert review of diagnostic cases, which is not the focus of this 510(k) submission.

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 device is an intermittent urinary catheter and does not involve AI or human "readers" or diagnostic interpretation in the context of an MRMC study.

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

Not applicable, as this device does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by adherence to the referenced international and FDA consensus standards. For example, for biocompatibility, the ground truth is defined by the criteria within ISO-10993-1. For flow rate, the "ground truth" is meeting the specified flow rate limits of ISO 20696.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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