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

The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).

GC Air for Men is a sterile, single use, disposable, hydrophilic, intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). 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. Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction.

The provided document describes the Convatec GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a medical device (a urinary catheter), not an AI/ML diagnostic or predictive system. Therefore, the typical acceptance criteria and study designs relevant to AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, ground truth establishment by experts) are not applicable or present in this document.

The "Performance Testing" section on page 5 refers to standard testing for physical medical devices and their materials, sterilization, and packaging, not clinical performance metrics related to AI/ML.

Therefore, an answer formatted as requested cannot be provided from this document.

If you have a document pertaining to an AI/ML medical device, please provide that.

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The 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.

The Intermittent Catheter (final name to be determined) is a hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinent Catheter is inserted into the urethra to drain urine from the bladder. The Intermittent Catheter is available in 7 in. and 16 in. lengths. The 7 in. catheter is available in sizes 8, 10, 12, 14 Fr and the 16 in. catheter is available in sizes 8, 10, 12, 14, 16 Fr. The Intermittent Catheter is provided sterile, using e-beam Irradiation sterilization. The device is made from Thermo-plastic Elastomer (TPE), and is phthalate free, PVC free. This directly hydrated catheter is packaged in a peel-able 4 sided pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid in one compartment. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid There is a gripper on the 16 inch catheter to aid with the insertion process, if desired.

Based on the provided text, the device in question is an Intermittent Catheter, and the submission is a 510(k) Pre-market Notification seeking substantial equivalence to a predicate device. The document does not describe an AI/ML-based medical device. Therefore, many of the requested elements pertaining to AI/ML device testing (e.g., training set, test set, ground truth establishment for AI, MRMC studies, standalone algorithm performance, number of experts for AI ground truth, adjudication methods) are not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing of physical performance, biocompatibility, sterilization, and packaging integrity, comparing the new device to its predicate.

Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present for this type of device submission.

Acceptance Criteria and Device Performance for an Intermittent Catheter

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

The document states: "The physical performance properties of the Intermittent Catheter met all applicable requirements of BS EN ISO 20696:2018, Sterile urethral catheters for single use." and "Biocompatibility testing met the requirements of the following standards..." and "Sterilization met all requirements of the following FDA-recognized standards:".

Since this is a substantial equivalence submission for a traditional medical device (not AI/ML), the "acceptance criteria" are compliance with established performance and safety standards, and the "reported device performance" is that it "met all applicable requirements" or "met all requirements." Specific numerical accept/fail criteria or performance metrics are not explicitly tabulated in the summary provided.

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

• Sample Size: Not explicitly provided. The text mentions "Testing was conducted to support size designation..." but does not give the number of catheters or samples tested for each criteria (e.g., "size designation," "lubricity," "security of fit," "flow rate," "kink stability," "tensile force").
• Data Provenance: Not specified. Standard medical device testing for regulatory clearance is generally conducted under controlled laboratory conditions, not typically involving patient data in the same way as AI/ML or clinical trials. It's safe to assume the testing facilities are in the country of the applicant (USA) or a compliant jurisdiction, but this is not stated. The data would be prospective in the sense that the tests were 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 (e.g. radiologist with 10 years of experience)

• Not Applicable. This is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image/data interpretation. Testing involves physical and biological assays against established standards.

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

• Not Applicable. As above, this is not an AI/ML diagnostic study involving human interpretation and adjudication. Testing involves objective measurements and adherence to specified performance limits within 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

• Not Applicable. This is not an AI/ML device, and no MRMC study was conducted or required. The "effectiveness" is demonstrated by meeting performance standards and equivalence to the predicate device.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable in the AI/ML sense. The "ground truth" for this device's testing is adherence to the specified requirements in the referenced international and FDA-recognized standards (e.g., BS EN ISO 20696:2018 for physical properties, ISO 10993 series for biocompatibility, ISO 11137 series for sterilization). For example, "ground truth" for lubricity would be a quantitative measurement meeting a predefined specification within the standard.

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, not an AI/ML model.

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SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a 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. This device is intended for males only.

The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for males. It is a single use catheter with an integrated urine bag. The catheter is a hollow tube consisting of polyurethane and methylmethacrylate-acrylonitrilebutadiene-styrene polymer [MABS]. It facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in one size FR/CH 12/18. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) containing polyethylene glycol (PEG) inside a tube. The swelling medium resides between the catheter and the tube and lubricates the catheter.

The provided text describes the 510(k) premarket notification for the "SpeediCath Compact Set" Urological Catheter and Accessories, product number K200820, from Coloplast A/S. This document focuses on demonstrating substantial equivalence to a predicate device (SpeediCath Compact Set, K121458), rather than detailing specific acceptance criteria and a study to prove a device meets those criteria from an AI/algorithm perspective.

The document does not describe an AI/algorithm-based device and therefore does not contain information on:

• Acceptance criteria for an AI algorithm's performance.
• A study proving an AI device meets acceptance criteria.
• Sample size used for an AI test set or its data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods for an AI test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone performance of an AI algorithm.
• Type of ground truth used for AI models.
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

Instead, the document focuses on the substantial equivalence of a physical medical device (a urological catheter) based on non-clinical performance testing.

Here's a summary of the non-clinical performance testing for the SpeediCath Compact Set, as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific numerical acceptance criteria (e.g., a specific coefficient of friction value) and reported performance against those. Instead, it indicates that testing was conducted per applicable standards and that "the results were acceptable."

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

• Sample Size: Not specified in the provided text for any of the tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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 and not provided. The tests described are non-clinical, laboratory-based performance tests, not clinical evaluations requiring expert interpretation of ground truth in the context of an AI device.

4. Adjudication method for the test set:

• This information is not applicable and not provided, as the tests are non-clinical.

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, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

7. The type of ground truth used:

• Not applicable, as the tests are non-clinical hardware performance evaluations against established physical/chemical standards, not against "ground truth" as it would be defined for an AI diagnostic or predictive model (e.g., pathology, outcomes data, expert consensus). The "ground truth" here is effectively the established engineering and biological standards.

8. The sample size for the training set:

• Not applicable, as this is not an AI device.

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

• Not applicable, as this is not an AI device.

Conclusion from document: The document concludes that "The performance testing demonstrates the subject device is as safe and as effective as the predicate device." This is the basis for the FDA's substantial equivalence determination for this physical medical device.

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SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a 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. This device is intended for females only.

The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for females. It is a single use catheter with an integrated urine bag. The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a cover and plug make up the primary packaging and the sterile barrier. The subject device is the same as the predicate device, apart from the swelling medium. The swelling medium resides between the catheter and the tube and lubricates the catheter. The swelling medium in the subject device contains polyethylene glycol (PEG), and the predicate contains polyvinylpyrrolidone (PVP).

The provided text is a 510(k) summary for a medical device (SpeediCath Compact Set), and it describes the performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not detail the acceptance criteria and device performance in the context of an AI/ML device or a similar complex medical device that would necessitate the extensive requirements outlined in your prompt (e.g., number of experts, adjudication methods, MRMC studies, training set details).

This document is for a urological catheter, where the primary concern is the material (specifically, the swelling medium) and its physical and biological properties. The "performance testing" here refers to standard engineering and biocompatibility tests, not clinical performance in the sense of diagnostic accuracy or effect on human readers.

Therefore, I cannot directly answer your prompt using the provided text. The information requested (e.g., acceptance criteria for AI, sample sizes for AI test/training sets, expert consensus for ground truth in diagnostic accuracy, MRMC studies) is fundamentally different from the nature of the device and testing described in this 510(k) summary.

In summary, the provided document does not contain the information needed to address your prompt about acceptance criteria and study design for an AI/ML medical device.

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SpeediCath Soft 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 cather is inserted into the bladder allowing urine to drain.

The product is for adult male patients only.

The SpeediCath Soft is a sterile, single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by adult males with missing or reduced bladder control. The catheter has a grip which serves as protection from the user's touch and aids the user during insertion.

The provided text details the 510(k) submission for the Coloplast SpeediCath Soft urological catheter. Based on this document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document lists a comprehensive set of performance tests conducted for the SpeediCath Soft, implying that for each test, pre-determined acceptance criteria were established. The general statement made is that "All tests met the pre-determined acceptance criteria." While specific numerical acceptance criteria and detailed performance results for each test are not explicitly provided in a table within this document, the following table summarizes the types of tests conducted (which serve as the basis for acceptance) and the general performance statement provided.

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

The document does not specify the sample sizes used for each of the non-clinical tests listed. It states that "Performance testing for SpeediCath Soft was conducted according to applicable sections of non-recognized and recognized voluntary consensus standards." These standards typically define appropriate sample sizes for testing.

The data provenance is for a medical device (urological catheter) and the tests conducted are non-clinical, likely in a laboratory setting by the manufacturer, Coloplast. There is no indication of country of origin of the data beyond the manufacturer being based in Humlebaek, Denmark. The studies are described as "Performance testing," implying they were specifically conducted for this submission, making them prospective in nature for regulatory purposes, although the underlying methods might be well-established.

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

This section is not applicable. The tests conducted are non-clinical engineering and performance tests on the catheter itself (e.g., flow rate, tensile strength, biocompatibility), not tests involving human "readings" or interpretations that would require expert consensus for ground truth. Usability testing, which might involve human subjects, is mentioned, but details on "experts establishing ground truth" are not provided.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image analysis or clinical trials where multiple human readers interpret data, and a consensus mechanism is needed for the ground truth. The tests performed are objective, quantitative measurements or qualitative assessments 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any element of AI assistance in this submission. This is a 510(k) for a physical medical device (catheter), not a diagnostic AI system.

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

This is not applicable, as the device is a physical urological catheter, not an algorithm or AI system.

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

For the non-clinical performance tests, the "ground truth" is defined by the acceptance criteria specified in the referenced ASTM and ISO standards. For example, a flow rate test would have a pre-defined minimum or range of acceptable flow rates. Biocompatibility would be assessed against established criteria for cytotoxicity, irritation, etc., as per ISO 10993 standards. These are objective measures against a standard, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

This is not applicable as the device is a physical product and not an AI or machine learning algorithm that requires a "training set."

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

This is not applicable as the device is a physical product and not an AI or machine learning algorithm that requires a "training set" with established ground truth.

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

Jimushi Sterile Urethral Catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. This product is supplied in three slightly different forms: 1) Common model (conventional uncoated type), 2) Hydrophilic coated model, 3) Hydrophilic coated with water pocket model. The catheter body is made of polyvinyl chloride (PVC) with or without hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel shaped connector at the proximal end can be connected to a urine collection container. The catheter body is sterilized by EO, where the water pocket in some models is pre-sterilized by radiation.

The provided text is a 510(k) premarket notification for a medical device (Jimushi Sterile Urethral Catheter for single use). This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

It does not describe a study involving an AI-powered device or an algorithm's performance. Instead, it focuses on the physical and performance characteristics of a traditional medical catheter. Therefore, it does not contain the information requested in your prompt regarding AI model acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone algorithm performance.

The document primarily covers:

• Device Description: Jimushi Sterile Urethral Catheter for single use, its materials (PVC, hydrophilic coating), and its intended use (intermittent urinary catheterization).
• Predicate Device: Teleflex Medical Rusch FloCath Quick Urological Catheter.
• Similarities and Differences: A detailed table comparing the subject device to the predicate device across various parameters like indications for use, contraindications, population, size range, materials, and sterilization methods.
• Non-clinical Performance Data (Bench Testing): A list of physical and performance tests conducted on the subject device (e.g., visual inspection, flow rate, strength, biocompatibility, sterilization validation) and their "Pass" results, indicating the device meets established standards.

In summary, this document is entirely irrelevant to your prompt about an AI-powered device and its acceptance criteria due to the nature and purpose of the 510(k) submission described.

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The LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.

The Lotus No Balloon Catheter is a sterile, single patient use drainage catheter made of silicone elastomer. The catheter is used to pass fluids to and from the urinary tract, suprapubically or through the nephrostomy tract. The catheter is supplied in French sizes ranging from 8Fr to 26Fr.

The acceptance criteria and study proving the device meets them are described for the LotusCatheter (Lotus No Balloon Catheter) as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details the types of tests conducted but does not present a formal table with specific numerical acceptance criteria and corresponding reported performance values. However, it states that the Lotus No Balloon Catheter passed the modifications of the tests.

The study that proves the device meets the acceptance criteria is described as follows:

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

The document does not specify the exact sample size for each test conducted on the Lotus No Balloon Catheter. However, it indicates that testing was conducted "in accordance with modified performance requirements of its predicate device, the Hakki Urinary Catheter (K101900)." The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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

This information is not applicable as the described study involves physical and biological performance testing of a medical device (catheter) against established standards, not interpretation of data by human experts for establishing ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for physical and biological performance testing of a medical device. The tests are designed to objectively measure performance against predefined specifications.

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:

This information is not applicable as the LotusCatheter is a physical medical device (urological catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable as the LotusCatheter is a physical medical device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance testing cited is based on established industry standards and predicate device performance requirements. Specifically:

• ASTM F623-99:2013 (though modified)
• Performance requirements of the predicate device, Hakki Urinary Catheter (K101900)
• ISO 10993 series for biocompatibility (specific parts listed: 10993-5:2009, 10993-10:2010, 10993-11:2010, 10993-11:2017, ISO 10993-6:2016)

8. The Sample Size for the Training Set:

This information is not applicable for physical device performance testing. There is no concept of a "training set" in this context.

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

This information is not applicable for physical device performance testing.

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Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.

The proposed B. Braun Actreen® Hi-Lite Intermittent Urinary Catheter devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. These Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 7.5 inch length with a variety of French gauge sizes ranging from 6-16 with a straight tip. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.

The provided text is a 510(k) Pre-market Notification for a medical device, the Actreen® Hi-Lite Intermittent Urinary Catheters. This document details the process for obtaining FDA clearance for a device by demonstrating its "substantial equivalence" to a predicate device already on the market.

It's important to understand that a 510(k) summary does not contain the detailed clinical study results or statistical analyses that would typically be required to answer your specific questions about acceptance criteria for an AI/ML medical device, especially regarding aspects like MRMC studies, human-in-the-loop performance, or the nuances of ground truth establishment for complex image analysis.

The "studies" described in this document are primarily non-clinical performance tests demonstrating the physical, chemical, and biological safety and functionality of a physical medical device (a catheter) compared to an existing, similar catheter.

Therefore, many of your questions are not applicable to the information provided in this 510(k) summary. I can, however, extract the relevant "acceptance criteria" and "performance data" as presented for this specific type of device.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for an AI/ML context:

Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K180801) through various non-clinical tests. The "performance" is the successful outcome of these tests, confirming that the new device performs similarly and safely to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are for a physical urinary catheter, not an AI/ML device. They relate to material compatibility, physical properties, and sterility, as outlined in the referenced standards. The "performance" is the successful meeting of these standards, which is stated as a conclusion rather than detailed results.

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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.

This submission is to add an additional size (Fr 08) to the currently cleared 16-inch Pocket and Plus Pocket configurations of VaPro 2.

The VaPro 2 Pocket Line Extension is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Pocket Line Extension has the following features:

• Hydrophilic-coated PVC catheter (phthalate free)
• Two smooth catheter eyelets
• Protective sleeve
• Protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion
• Color-coded funnel.
• Urine Collection bag (for the Plus Pocket version)

The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store. In the Plus Pocket configuration, the urinary catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.

The provided text is a 510(k) summary for a medical device (VaPro 2 Pocket Line Extension, a urological catheter). It outlines the device's characteristics, intended use, and a comparison to predicate and reference devices. However, this document does not contain any information about a study proving the device meets acceptance criteria related to standalone or human-in-the-loop AI performance, nor does it discuss ground truth establishment, expert consensus, or sample sizes for AI model training or testing.

The document details the following non-clinical testing for the catheter:

• Physical performance properties: Met requirements of EN 1618, EN 1616, EN 13868. The Plus Pocket version also met ISO 8669-2 and ASTM-D1003-13.
• Biocompatibility testing: Met requirements of ISO 10993-1, 10993-5, 10993-12. The Plus Pocket version also met ISO 10993-11.
• Sterilization: Met requirements of ISO 11137-1, ISO 11137-2, AAMI/ANSI/ISO 11737-1, and AAMI/ANSI/ISO 11737-2.

This information refers to traditional medical device performance and safety testing, not the type of studies typically conducted for AI/ML-based medical devices (e.g., diagnostic algorithms, image analysis software). Therefore, I cannot extract the requested information about AI model acceptance criteria, study methodologies, or performance metrics from this document.

For a K-number submission like this, the device is considered substantially equivalent to a predicate device, meaning it has the same intended use and similar technological characteristics, and any differences do not raise different questions of safety and effectiveness. The "acceptance criteria" here are that the physical and biological characteristics of the new device are comparable to those of the predicate device and meet relevant performance standards, as indicated by the brief description of non-clinical testing.

If you are looking for information regarding AI model validation in FDA submissions, you would typically find it in K-numbers for devices that explicitly leverage artificial intelligence or machine learning for their primary function, such as diagnostic assistance or image interpretation. This document does not describe such a device or study.

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