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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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Self-Cath Closed System is intended for use in male adult patients requiring bladder drainage as determined by their physician. The device is 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.

The Self-Cath Closed System is a disposable single-use, catheter designed for intermittent catheterization integrated with a urine collection bag. The device is sterilized with ethylene oxide (EO) sterilization. The catheter is made with PVC with DEHT as a plasticizer. The Self-Cath catheter used in the system is identical to the catheter recently cleared in K221401.The catheter is provided with a gel lubricant that is placed inside a urine bag, which is closed off with a protection cap (introducer tip cap). During use, the protection cap is removed, and the catheter is pushed out of the urine bag through the introducer tube and tip. The drainage end of the catheter is inside the bag allowing urine to be drained directly into the bag. The urine bag has a tear off section to open the urine bag for emptying. The Self-Cath Closed System includes gloves, swab sticks, a wipe, and a drape in addition to the components above.

The provided text is a 510(k) premarket notification for a medical device called the "Self-Cath Closed System." It primarily focuses on demonstrating substantial equivalence to a predicate device. This type of document is generally for medical device clearances and does not typically involve AI/ML technology or human performance studies in the way you've outlined.

Therefore, many of the specific questions you've asked regarding AI device performance, sample sizes for training sets, expert qualifications for ground truth, MRMC studies, and standalone AI performance are not applicable to this document.

However, I can extract information related to the acceptance criteria and performance testing conducted for this non-AI medical device.

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

The document states: "All tests met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria and detailed reported performance values are not explicitly listed in the provided text. The document refers to meeting performance per applicable sections of voluntary consensus standards and internal methods.

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

The document does not specify the sample sizes used for the various performance tests (e.g., how many catheters were tested for effective length or surface finish). It also does not mention the data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically laboratory-based engineering and material performance tests.

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

Not applicable. This is a physical medical device, not an AI/ML diagnostic tool requiring clinical expert ground truth for interpretation. The "ground truth" for these tests comes from adherence to established international standards and laboratory testing protocols.

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

Not applicable. As this is not an AI/ML diagnostic or measurement device, there is no need for expert adjudication methods in this context. Performance is determined by standardized test results.

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 catheter, not an AI system. No MRMC study was conducted or is relevant.

6. 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.

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

The "ground truth" for the device's performance is established by compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 20696 for catheter performance, EN ISO 8669-2 for urine bags, ISO 11607-1 for sterile barrier, ASTM F1980-16 for shelf-life). These standards define the test methods and the expected performance criteria.

8. The sample size for the training set

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

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

Not applicable. This is a physical medical device.

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The AMSelf TM Closed Catheterization System is intended for use in the drainage of urine from the bladder.

The AMSelf TM Closed Catheterization System is a single-use patient device, compromising a PVC urological catheter and a drainage bag assembled in a closed-system configuration.

This 510(k) submission (K082831) for the AMSelf™ Closed Catheterization System is a premarket notification for a Class II medical device. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, the AMSure™ Urethral Catheterization Tray (K030712), rather than presenting a study to prove performance against specific acceptance criteria for a novel device.

The provided information indicates that "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." However, it does not explicitly detail the acceptance criteria, the specific results of these tests, or how these results "prove" the device meets the criteria. The submission is a standard FDA 510(k) filing, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate device). Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance endpoints is not present in this document.

Given the nature of the document, most of the requested information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth data for training sets is not applicable or explicitly stated.

Here's an attempt to address your prompts based on the available information:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. The "performance" assessment is covered by the statement: "Performance and biocompatibility testing has demonstrated that the AMSelf™ Closed Catheterization System is safe and effective for its intended use." This implies that the device successfully met internal or regulatory performance standards for a catheterization system. The implicit acceptance criterion is that the device performs equivalently to the predicate device, K030712, in terms of safety and effectiveness for urine drainage.

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

The document does not provide details on the sample size used for performance or biocompatibility testing, nor does it specify the provenance of any data (e.g., country of origin, retrospective or prospective). Such details are typically found in the full 510(k) submission, which this summary does not include.

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

This information is not applicable and not provided. The submission is for a physical medical device, not an interpretative AI/image analysis product where "ground truth" is established by experts. Performance and biocompatibility testing for such devices are typically conducted in laboratories following established standards and protocols.

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

This information is not applicable and not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed for this physical device.

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

This information is not applicable and not provided. MRMC studies are generally performed for diagnostic imaging devices or AI-assisted diagnostic tools, not for a physical device like a catheterization system. There is no AI component mentioned in this device.

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

This information is not applicable and not provided. This device is a physical catheterization system, not an algorithm.

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

This information is not applicable and not provided in the context of "ground truth" as typically discussed for diagnostic or AI-driven systems. For a physical device, testing involves objective measures of criteria like sterility, material strength, flow rates, biocompatibility, and leak integrity. The "ground truth" or reference standards are typically established through recognized laboratory testing standards and methods (e.g., ISO standards, ASTM standards, USP monographs), with results empirically measured against these standards, rather than expert consensus on a diagnosis.

8. The sample size for the training set

This information is not applicable and not provided. Since this is a physical medical device and not an AI or machine learning algorithm, there is no "training set."

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

This information is not applicable and not provided, as there is no "training set" for this physical medical device.

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Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.

The Coloplast Self-Cath® CS Closed System catheter (also referred to as "SCCS") is an extension of the existing Coloplast Self-Cath product line. The device is a modification of the Coloplast (Mentor) Self-Cath Closed System catheter, which was cleared under 510(k) K003873. It is available singly and as part of a kit.

The SCCS is intended to be used to drain urine from the bladder. The SCCS is a catheter and collection bag assembly for inserting a catheter from a closed, sterile bag through an insertion tip into the bladder. It consists of a sterile, pre-lubricated catheter with a pre-lubricated introducer tip on the proximal end, which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter and introducer tip are pre-lubricated with a water-soluble hydrophilic water-based lubricant. The catheter provides a conduit for draining the bladder into the pre-attached urine collection bag.

This document is a 510(k) summary for the Coloplast Self-Cath® CS Closed Urinary Catheterization System, seeking clearance due to substantial equivalence to a previously cleared device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for diagnostic AI/ML products.

This 510(k) is for a physical medical device (a catheter system), not a software or AI-driven diagnostic device. Therefore, the questions about performance metrics (e.g., sensitivity, specificity), ground truth, expert readers, and training/test sets are largely incongruent with the information provided. The "acceptance criteria" for a device of this type would typically revolve around physical and biological compatibility, manufacturing quality, and functional performance relative to its predicate, rather than algorithmic accuracy.

However, I will extract relevant information and address the questions to the best of my ability based on the provided text, highlighting where the information is not applicable or available for this type of device submission.

Acceptance Criteria and Study Information for the Self-Cath® CS Closed Urinary Catheterization System

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

For this type of physical medical device, acceptance criteria are generally established against the functional, material, and safety characteristics of a legally marketed predicate device. The document states a claim of "Substantial Equivalence," which is the primary "acceptance criterion" for a 510(k) submission. Performance is assessed by demonstrating this equivalence through various tests (often mechanical, biological, and material compatibility), which are not detailed in this summary.

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

This information is not provided in the 510(k) summary. For a physical medical device, "test set" would typically refer to the samples used in engineering, biocompatibility, and sterility testing, not clinical data sets in the way AI/ML products require. The document states it is a "modification" of an existing device (K003873), implying that much of the foundational testing and validation was done for the predicate, and this submission focuses on demonstrating that the modifications do not alter the substantial equivalence.

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

This information is not applicable/provided. For a physical catheter system, "ground truth" and expert consensus in the diagnostic sense are not relevant. Clinical performance might be assessed via user feedback or clinical studies (which are not detailed here), but this is different from establishing ground truth for AI/ML evaluation.

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

This information is not applicable/provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not a part of the substantial equivalence process for a physical device like a catheter.

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

This information is not applicable/provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices, often involving AI. This device is a catheter, not a diagnostic imaging or AI device, so such a study would not be performed.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm, so standalone AI performance is not relevant.

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

This information is not applicable/provided. "Ground truth" in the context of diagnostic accuracy is not relevant for this physical device. The "truth" for a catheter would be its ability to correctly drain urine, its sterility, material safety, and physical properties, which are assessed through engineering and biological testing.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" is for AI/ML models. This document describes a physical medical device.

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

This information is not applicable/provided. Similar to point 8, this question is not relevant for the device described in the document.

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The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the GuardianCatheter™-Infant Urinary Collection Kit. This type of document confirms that a device is substantially equivalent to a predicate device already on the market.

It is important to note that 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, and often do not involve extensive new clinical studies with detailed acceptance criteria and performance metrics as might be seen for novel, high-risk devices or those requiring a PMA (Premarket Approval).

Based on the provided text, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. The letter primarily confirms regulatory clearance and substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions about performance metrics and study details from the text provided. The document outlines the device's indications for use and confirms its regulatory classification, but does not present the type of clinical study data you are asking for.

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The AMSure Foley Insertion Tray is intended for use in the drainage of urine from the bladder

Not Found

This is a 510(k) premarket notification for a medical device called the "AMSure™ Foley Insertion Tray", not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are specific to AI/ML device evaluations, are not applicable and cannot be extracted from this document.

The document focuses on the FDA's determination of substantial equivalence for a physical medical device (Foley Insertion Tray) to a legally marketed predicate device. The review process outlined here does not involve performance studies in the way an AI/ML algorithm would be evaluated. It addresses regulatory compliance, manufacturing practices, and the classification of the device and its components (including the drug component Povidone Iodine Swabsticks).

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The AMSure Urethral Catherization Tray is intended for use in the drainage of urine from the bladder.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Amsino International, Inc. regarding their AMSure Urethral Catheterization Tray.

Based on the content, this document is a regulatory approval letter and does not contain the detailed information required to describe acceptance criteria and study results for device performance.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance. This document solely focuses on regulatory approval, not on the technical details of a study.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Details about a standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The letter confirms the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a detailed technical performance evaluation that would typically involve acceptance criteria and study data as outlined in the request. The "Indications for Use Statement" on page 5 simply states the intended use of the device ("drainage of urine from the bladder") but does not provide performance metrics or acceptance criteria.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details based on the provided text.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device