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

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

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

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

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

Acceptance Criteria and Device Performance

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

Study Details (Non-AI/Software Device)

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

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

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

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

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

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

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

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

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

7. The sample size for the training set:

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

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

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

Summary of the Device and Study from the Document:

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

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The Silicone Urethral Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine, or for routine post-operative drainage and bladder irrigation. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old).

The Silicone Urethral Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of shaft, drainage funnel, inflation funnel, irrigation funnel (if present), balloon and valve. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid.

The device is made of silicone and available in different types (e.g., male, female, Tiemann, 2-way, 3-way etc.) and sizes for adult and pediatric use.

The device is for single use and provided with sterile. The indwelling time is no more than 30 days.

This document is a 510(k) clearance letter for a Silicone Urethral Catheter, a physical medical device. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in submissions for AI/ML-enabled medical devices.

Therefore, the provided document does not contain the information requested for an AI/ML-enabled medical device. It thoroughly details the non-clinical performance testing for a traditional, physical medical device, but there is no mention of an algorithm, AI, machine learning, or any form of data-driven performance metrics, ground truth establishment, or human-in-the-loop studies.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a Silicone Urethral Catheter, which is a physical product for urine drainage. The 510(k) summary focuses on its material, dimensions, performance (e.g., flow rate, balloon integrity), biocompatibility, sterilization, and shelf-life. There's no indication of any software, algorithm, or AI component.
• Non-Clinical Testing Only: The "Summary of Non-Clinical Performance Testing" explicitly states the types of bench tests conducted (e.g., Balloon Size and Shaft Size, Flow Rate, Balloon Integrity, etc.) and biocompatibility tests.
• No Clinical/Animal Testing: Section 9, "Clinical Testing and animal testing," explicitly states: "Clinical and animal testing were not performed for Silicone Urethral Catheter as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Silicone Urethral Catheter, did not require clinical and animal studies to support substantial equivalence." This further confirms the absence of any studies involving human data or interpretations by experts for diagnostic purposes that would be relevant to AI/ML.

To answer your specific questions based on the absence of this information in the provided document:

1. Table of acceptance criteria and the reported device performance: Applicable to physical performance characteristics (e.g., flow rate, balloon volume), but not "AI performance" criteria like sensitivity, specificity, AUC.

   • Acceptance Criteria Examples (from document):
     • Meets all requirements of biocompatibility (tested per ISO 10993-1)
     • Meets pre-determined testing and acceptance criteria for bench tests (ASTM F623-19, ISO 20696:2018, FDA guidance 'Conventional Foley Catheters')
     • Sterilized in accordance with ISO 11135:2014
     • Maintains product and package integrity and device sterility throughout shelf-life.
   • Reported Device Performance: The document states that the testing "demonstrated that the Silicone Urethral Catheter meets all the pre-determined testing and acceptance criteria" and that "All evaluation acceptance criteria were met" for biocompatibility. Specific quantitative results are not provided in this summary but would be in the full submission.

2. Sample size used for the test set and the data provenance: Not applicable to an AI test set. This would refer to the number of units tested for physical properties (e.g., how many catheters were tested for flow rate). The document doesn't specify these sample sizes, nor does it mention data provenance as it's not a data-driven device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" as understood in AI/ML (e.g., expert labels for images) was established, as there's no diagnostic or analytical function.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No AI component, no human readers involved in a diagnostic workflow related to the device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to diagnostic ground truth. The "ground truth" for this device would be its physical specifications and performance against established standards (e.g., a catheter's flow rate must meet X ml/min, balloon must hold Y volume without rupture).

8. The sample size for the training set: Not applicable. No AI model to train.

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

In conclusion, the provided FDA 510(k) clearance letter for the Silicone Urethral Catheter pertains to a conventional medical device and does not contain any information related to AI/ML device performance, acceptance criteria, or study methodologies.

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The Cure Catheter Insertion Kit is an intermittent urinary catheter kit indicated for the purpose of bladder drainage for males and females. The urinary catheter kit comes in a variety of configurations and sizes packaged sterile for single-use.

The Cure Catheter Insertion Kits (K1, K2, K2-90, K3), Cure Hydrophilic Catheter Kit (HMxxUK), Cure Pocket Catheter Kit (MxxUK), Cure Catheter Closed System Kit (CSxx)) contain sterile products used during intermittent urinary catheterization. Two types of kit are provided, one where a urinary catheter is included and one without a catheter. The components allow users to select one or more of the products to help prevent contamination of the environment and the user and to maintain a no-touch technique during the insertion of the catheter. Catheters are inserted through the urethra and indicated for the purpose of bladder drainage.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Cure Catheter Insertion Kit" and related products. It outlines the regulatory classification, intended use, and a comparison to a predicate device.

However, it does not contain information about specific acceptance criteria or a study that objectively proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or screening device.

The "Performance Data" section lists various validation tests for general device characteristics, such as:

• Sterilization validation: Conforms to AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008/AMD:2019.
• Biocompatibility testing: Conforms to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1".
• Sterile packaging: Conforms to ISO 11607-1:2019 and ISO 11607-2:2019.
• Real-time aged shelf-life testing: Conforms to ISO 11607-1:2006 with justification to version 2019.
• Packaging integrity testing: Conforms to ASTM F2096-11 (2019).
• Urinary catheter testing: Conforms to ISO 20696:2018.

These are standard engineering and safety tests for medical devices, ensuring they are safe, sterile, and perform their basic mechanical function. They are not clinical performance studies to assess diagnostic accuracy or the direct clinical efficacy of a software-driven device.

Therefore, the specific information requested in the prompt, such as acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity), study design details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), is not available in this 510(k) clearance letter.

This document is for a urological catheter and accessories, which are physical medical devices, not an AI or software-based diagnostic tool. The performance data listed refers to the manufacturing, material, and sterility aspects, which are crucial for this type of device, but do not involve the types of criteria and studies you've asked about for AI/diagnostic devices.

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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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Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.

Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments.

The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized.

The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier.

The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations:

• Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
• Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr)
• Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) .

The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr).

This document is a 510(k) Summary for a medical device (Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not to present a comparative effectiveness study or a detailed algorithm performance study for an AI/ML enabled device.

Therefore, the provided text does not contain the information required to populate most of the fields in your request, such as a formal acceptance criteria table with reported performance specific to an AI device, sample sizes for test/training sets of AI models, details about expert ground truth establishment, or MRMC study results. The non-clinical performance testing described focuses on standard medical device validation (e.g., sterilization, biocompatibility, physical properties) rather than AI model performance.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Device Performance Study (Non-AI Device)

This document is a 510(k) submission for a non-AI medical device (Hydrophilic Intermittent Catheter). The "acceptance criteria" here refer to testing to ensure the device meets established standards and performs comparably to predicate devices, rather than a statistical performance threshold for an AI algorithm. The "study" refers to non-clinical bench testing, packaging tests, aging tests, and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical medical device (catheter) and not an AI device, "acceptance criteria" and "reported device performance" are described in terms of compliance with relevant international standards and successful bench testing, rather than metrics like sensitivity, specificity, or AUC for an AI model. Therefore, a table structured for AI performance metrics is not directly applicable. However, we can reframe the "acceptance criteria" as the types of tests performed and the "reported device performance" as compliance with those tests and standards.

2. Sample Size for Test Set and Data Provenance

This document describes a medical device (catheter) validation, not an AI/ML model study. Therefore, the concept of a "test set" in the AI/ML sense (a dataset used to evaluate a trained model) does not apply. The validation involves various physical, chemical, and biological tests on samples of the manufactured device. The document does not specify the exact number of units or samples used for each bench test, but it indicates the tests were performed to demonstrate compliance with relevant standards.

• Date Provenance: The manufacturing entity is Well Lead Medical Co., Ltd. in Guangzhou, China. The testing would have been conducted on devices manufactured within their facility or by contracted laboratories. The origin of the data (i.e., test results) is from these non-clinical, controlled tests. It is not "retrospective" or "prospective" in the clinical study sense for data collection.

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

Not applicable. For a physical medical device like a catheter, "ground truth" is established by adherence to engineering specifications, material properties, sterility, and biocompatibility. This is determined through objective testing against widely accepted standards (e.g., ISO, ASTM), rather than by expert consensus on clinical data similar to an AI diagnostic device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies or AI algorithm validation where expert disagreement on ground truth labels needs to be resolved. For standard device testing, compliance to a defined physical, chemical, or biological specification is measured objectively.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study assesses the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). This device is a physical catheter, not an AI-enabled diagnostic tool.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)

Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's validation is based on:

• Compliance with international standards (e.g., ISO, ASTM for sterility, biocompatibility, physical properties).
• Objective measurements from bench testing (e.g., pH, osmolarity, strength, seal integrity).
• Established material science and biological compatibility criteria.

8. Sample Size for the Training Set

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

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

Not applicable. This is not an AI/ML algorithm.

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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):

• Strength of connection between catheter and urine bag.
• Aseptic insertion (non-touch approach) of catheter through urine bag.
• Water amount of 20 ml in ampoule must activate coating on catheter.
• Friction of the coated catheter after 30 seconds activation time.
• Tearing and emptying of the urine bag.
• Volume of the urine bag.
• Strength of the urine bag. |
  | Usability | Met acceptance criteria per EN/IEC 62366-1. |
  | Packaging Integrity | Met acceptance criteria per ISO 11607-1, DS EN ISO 20696, ASTM D4169-22 for maintenance of sterile barrier and impact of transportation. |
  | Shelf Life/Aging Stability | Met acceptance criteria after accelerated aging per ASTM F1980-21, demonstrating stability for the defined shelf life (24 months at time of submission, planned 36 months). |

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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The InnoCare Specialty Foley Catheter is intended for urethral catheterization for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.

The InnoCare Specialty Foley Catheter is a 16 French, two-way silicone Foley catheter for urethral catheterization to drain urine from the bladder. The catheter is retained in the bladder by use of a retention balloon attached to the distal end of the catheter. The device is offered in a straight tip configuration and a Coude tip configuration. The inflation lumen of the catheter contains a secondary balloon deflation mechanism. This mechanism is designed to provide a fluid escape pathway to allow for balloon deflation in the event of a forced withdrawal or catheter pullout. The device is provided sterile and for single use.

The provided text describes a 510(k) premarket notification for a medical device, the InnoCare Specialty Foley Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing. It does not contain information about a clinical study involving human patients, nor does it detail acceptance criteria and a study proving device performance in a clinical setting as you've requested.

Specifically, the document states:

• "Performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness."
• "Bench testing of the subject device included dimensional verification, functional and performance testing per ASTM F623:2019 requirements, simulated use testing of the secondary balloon deflation mechanism and Magnetic Resonance Compatibility testing per FDA Guidance (2023)..."
• "All pre-determined acceptance criteria were met."

Therefore, I cannot provide the detailed information requested regarding a clinical study and its various components (sample size, ground truth, expert qualifications, MRMC study, etc.) because the provided document does not contain this information. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing, not a human-in-the-loop clinical trial or an AI algorithm study.

However, I can extract information about the non-clinical acceptance criteria implied by the tests performed.

Here's what can be inferred from the provided text regarding the non-clinical acceptance criteria and "study":

1. Table of Acceptance Criteria and Reported Device Performance:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Subacute Systemic Toxicity
• Genotoxicity
• Implantation | All tests demonstrated the subject device is biocompatible for its intended use. |
  | Dimensional Verification | Met pre-determined acceptance criteria. |
  | Functional and Performance (per ASTM F623:2019) | Met pre-determined acceptance criteria. |
  | Simulated Use Testing of Secondary Balloon Deflation Mechanism | Met pre-determined acceptance criteria. |
  | Magnetic Resonance (MR) Compatibility (per FDA Guidance 2023) | Met pre-determined acceptance criteria. |
  | Sterilization Validation (per ISO 11135:2014) | Validated to be sterilized using ethylene oxide. |
  | Shelf Life (including performance testing, package integrity after environmental conditioning, simulated distribution, and accelerated aging) | Data supports the claimed shelf life. |

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

• Sample Size: Not specified for any of the non-clinical tests. Medical device bench testing typically uses a small, statistically justified sample size, but the exact number isn't provided here.
• Data Provenance: The tests are laboratory-based ("bench testing," "biocompatibility testing," "sterilization validation"), implying they were conducted by the manufacturer or a contract research organization. There is no mention of country of origin of data in terms of patient data, as this is not a clinical study. The tests are prospective in nature as they are conducted specifically for this submission.

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

• Not Applicable. For non-clinical bench testing, "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM, FDA guidance) and validated test methods, not by human expert consensus or adjudication in the way it would be for a clinical AI study.

4. Adjudication method for the test set:

• Not Applicable. No adjudication method is mentioned as this pertains to human interpretation/reading, which is not part of this type of non-clinical device testing.

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 non-clinical evaluation of a physical medical device (Foley catheter), not an AI-assisted diagnostic device, so an MRMC study is not relevant or performed.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• Established Industry Standards and Specifications. For each test, the "ground truth" is defined by the requirements of the specified standards (e.g., ISO 10993-1:2018 for biocompatibility, ASTM F623:2019 for functional performance, ISO 11135:2014 for sterilization) and the device's own design specifications.

8. The sample size for the training set:

• Not Applicable. This is not a machine learning model, so there is no training set.

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

• Not Applicable. This is not a machine learning model.

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