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

The Sleeved IC 2 (not finalized) catheters are:

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

• Not applicable. (See #8)

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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 Sleeved IC (final name to be determined) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Sleeved IC is inserted into the urethra to drain urine from the bladder. The catheter is available in 16in length. The catheter is available in 12 and 14 Fr sizes. The catheter is provided in a sterile manner, utilization method. The device is made from Thermo-plastic Elastomer (TPE) and is phthalate free and PVC free. This directly hydrated catheter is packaged in a foil 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. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid.

The provided text describes a 510(k) premarket notification for a medical device called "Sleeved IC," which is an intermittent catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the "VaPro2 Intermittent Catheter" by Hollister Incorporated (K180824).

The document details the device's characteristics and compares them to the predicate device, along with the non-clinical testing performed. However, it does not provide explicit acceptance criteria in the form of numerical performance thresholds or a specific study that measures device performance against these criteria as typically seen for AI/ML devices.

Instead, the document focuses on demonstrating substantial equivalence through a series of engineering, biocompatibility, and sterilization tests. The "acceptance criteria" are implied to be the successful completion of these standard tests and conformity to relevant ISO and industry standards for medical devices of this type. The "study" proving acceptance criteria is the sum of these non-clinical tests.

Let's break down the information based on your requested points, highlighting what is present and what is absent in the document regarding performance criteria specific to an AI/ML device.

Missing Information/Not Applicable for this Device Type:

This device is a physical medical device (intermittent catheter), not an AI/ML device. Therefore, many of your specific questions related to AI/ML performance, such as sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, training set details, and adjudication methods for ground truth in an AI context, are not applicable to this 510(k) submission.

Information Extracted from the Document:

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

   The document does not present a table of acceptance criteria and device performance in the format typically used for AI/ML devices (e.g., sensitivity, specificity, F1-score). Instead, the "acceptance criteria" are implied by successful completion of various non-clinical tests and conformity to standards. The "reported device performance" is that it met all applicable requirements.

   Acceptance Criteria (Implied)	Reported Device Performance
   Conformity to BS EN ISO 20696:2018 (Sterile urethral catheters for single use)	Met all applicable requirements.
   Equivalence of lubricity to predicate device	Substantial equivalency of catheter lubricity demonstrated via testing.
   Catheter strength and security of drainage funnel fit	Testing conducted showed it met requirements.
   Flow rate through catheter	Testing conducted showed it met requirements.
   Catheter kink stability and peak tensile force	Testing conducted showed it met requirements.
   Biocompatibility (ISO 10993 series)	All requirements met for biological endpoints (cytotoxicity, irritation, sensitization, systemic toxicity).
   Sterilization (ISO 11137 series, ANSI/AAMI/ISO 11737 series)	Met all requirements of the listed FDA recognized standards. The required Sterility Assurance Level (SAL) has been validated.
   Packaging integrity (maintenance of sterile barrier)	Verified through shelf life.
   Transportation testing (no impact on safety/efficacy)	Verified no impact from transportation hazards.

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

   This information is not provided for the non-clinical tests. Medical device performance testing often uses a statistically relevant number of samples for each specific test (e.g., a batch of catheters for tensile strength, a certain number of test animals for biocompatibility), but these specific sample sizes and data provenance (e.g., country of origin, retrospective/prospective) are not detailed in this 510(k) summary.

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

   This is not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert interpretation as ground truth.

4. Adjudication method for the test set

   This is not applicable for the same reasons as above.

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

   This is not applicable as this is a physical medical device, not an AI-assisted diagnostic system.

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

   This is not applicable as this is a physical medical device.

7. The type of ground truth used

   The "ground truth" for this device's non-clinical testing refers to established scientific principles, physical measurements (e.g., force, flow rate), chemical analysis, and biological responses as defined by the referenced ISO standards and industry best practices. It's not "expert consensus" or "pathology" in the context of diagnostic performance.

8. The sample size for the training set

   This is not applicable as this is a physical medical device and does not involve AI/ML training.

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

   This is not applicable for the same reasons as above.

In summary, the provided document describes a traditional medical device 510(k) submission, not an AI/ML device. Therefore, the questions tailored to AI/ML device performance validation are not addressed, as they are not relevant to this type of product. The "acceptance criteria" are implied by regulatory compliance and successful completion of standard non-clinical tests demonstrating substantial equivalence to a predicate device.

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

The Female IC (not finalized) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Female IC is inserted into the urethra to drain urine from the bladder. This directly hydrated catheter is packaged in a polypropylene/polyethylene case which was designed to be easy to open, close and dispose of, with a discrete consumer design. A "first use label" on the case indicates to the end user if the product was previously opened.

The provided document is a 510(k) summary for a medical device (Female IC intermittent catheter) and primarily discusses its substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It does not include information about AI/ML algorithm performance, clinical studies involving human readers, or specific performance metrics like sensitivity, specificity, and AUC that would be expected for an AI/ML medical device.

Therefore, I cannot fulfill the request for information related to acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional medical device (catheter) and its regulatory clearance process based on substantial equivalence, not AI/ML performance.

If you have a document describing an AI/ML medical device, please provide that, and I will be happy to extract the requested information.

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

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

• Hydrophilic-coated PVC catheter (phthalate free)
• Two smooth catheter eyelets
• Color-coded funnel
  The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The primary packaging is designed to be easy to open, close and dispose of, with a discrete consumer design. The outer packaging also contains a 'first use label' that indicates to the end user if the product was previously opened.

This document is a 510(k) premarket notification for a medical device, specifically an intermittent catheter called "Infyna Chic." It's not a study proving the device meets acceptance criteria for an AI/ML product, but rather a regulatory submission demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance testing.

Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device is not present in this document. The document details the device's physical and material properties, sterilization methods, and packaging integrity tests, along with a comparison to a predicate device.

To directly answer your prompt, based only on the provided text, the answer is that this document does not contain the information you requested about AI/ML device performance and testing. It's for a traditional medical device (catheter).

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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.

The VaPro 2 Plus and VaPro 2 Plus Pocket 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 Plus and VaPro 2 Plus Pocket 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
• Available with a Firmer Style Catheter (Standard packaging only with packaging differentiated as F-Style)
• Urine Collection bag
  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.
  The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.

The provided text describes the regulatory clearance of a medical device, the VaPro 2 Plus and VaPro 2 Plus Pocket intermittent catheters, based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is a 510(k) summary for a urological catheter, which is a physical medical device. The "brief description of non-clinical testing" mentions standards for physical performance (e.g., EN 1618, ISO 8669-2), biocompatibility (ISO 10993 series), and sterilization (ISO 11137 series). These are standard tests for physical medical devices to ensure safety and function, but they are not related to artificial intelligence performance, diagnostic accuracy, or human-algorithm interaction.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for training set.
9. How ground truth for the training set was established.

This document is focused on the regulatory clearance process for a physical medical device and asserts substantial equivalence, not the performance evaluation of an AI-powered diagnostic or assistive tool.

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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.

The VaPro 2 Intermittent Catheter 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 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
• Available with a Firmer Style Catheter (Standard packaging only with packaging differentiated as F-Style)
  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, (Standard and Pocket), was designed to facilitate access for those with limited dexterity. The Pocket version was designed to be discreet and easy to store.

This document is a 510(k) premarket notification for a medical device called the "Vapro 2 Intermittent Catheter." It is a request to the FDA to determine if the new device is substantially equivalent to legally marketed predicate devices.

The information provided here concerns the performance of a physical medical device (a catheter), not a software or AI-driven device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., accuracy, sensitivity, specificity, human reader improvement) is not applicable here.

The document discusses non-clinical testing to demonstrate performance and safety, which is standard for physical medical devices but doesn't align with the detailed AI/software performance metrics requested in the prompt.

Therefore, I cannot provide the requested information regarding AI/software performance metrics from this document because it is about a physical medical device and not an AI/software device.

However, I can extract information about the non-clinical testing performed for this physical device:

• Acceptance Criteria & Reported Performance (Non-Clinical Physical Properties):

  • Physical Performance Properties: VaPro 2 "met all applicable requirements of EN 1618, EN 1616 and EN 13868." (Specific thresholds not detailed in this summary).
  • Biocompatibility Testing: VaPro 2 "met the requirements of ISO 10993-1, 10993-11 and 10993-12." (Specific thresholds not detailed in this summary).
  • Sterilization: VaPro 2 "met all requirements of ISO 11137-1, ISO 11137-2, AAMI/ANSI/ISO 11737-1 and AAMI/ANSI/ISO 11737-2." (Specific thresholds not detailed in this summary).

• Sample Size Used for Test Set and Data Provenance: Not applicable in the AI/software context. For physical device testing, sample sizes would be determined by the specific ISO/EN standards cited, but these details are not provided in this summary.

• Number of Experts, Qualifications, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Sample Size, Training Set Ground Truth: These questions are specifically tailored to AI/software performance evaluation and are not relevant or described in this document about a physical medical device. The "ground truth" for a physical catheter's performance is typically established by laboratory testing against engineering specifications and international standards.

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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 Onli intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:
Σ Ready to use, single use intermittent catheter
Σ Hydrophilic-coated, phthalate free catheter
Σ Two smooth catheter eyelets
Σ Color coded funnel
Σ Not made with natural rubber latex
Σ Gripper on the16-in. catheter to aid with insertion

The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be easy to open and facilitate access to the catheter.

The provided document is a 510(k) summary for the Onli Intermittent Catheter. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, most of the requested information (acceptance criteria for an algorithm, study design for AI/ML performance, ground truth, sample sizes for AI/ML training/test sets, expert qualifications, adjudication, MRMC studies, standalone performance) is not applicable to this document. This document describes a medical device, a urological catheter, and its performance characteristics, which are mainly mechanical and biological, not algorithmic.

Here's what can be extracted from the provided text:

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

The document does not specify "acceptance criteria" in the sense of predefined thresholds for an AI/ML algorithm's performance (e.g., sensitivity, specificity). Instead, it describes performance testing conducted to demonstrate safety and effectiveness for a physical medical device. The "reported device performance" is a statement of compliance or satisfactory results rather than specific numerical metrics.

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

This information is not present in the document. The tests performed are for a physical medical device (catheter), not an AI/ML algorithm.

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 present in the document. Ground truth, in the context of AI/ML, refers to labels for training or testing data, which is not relevant for a physical catheter.

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

This information is not applicable and not present in the document.

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 present in the document. An MRMC study is relevant for diagnostic imaging devices often involving AI, not for a urological catheter.

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

This information is not applicable and not present in the document. This is a physical device, not an algorithm.

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

This information is not applicable and not present in the document.

8. The sample size for the training set

This information is not applicable and not present in the document. There is no AI/ML algorithm with a training set for this device.

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

This information is not applicable and not present in the document.

In summary: The provided document describes the regulatory submission for a physical medical device, the Onli Intermittent Catheter, demonstrating its substantial equivalence to a predicate device based on various physical and biological performance tests. It does not contain any information related to the development, testing, or performance of an AI/ML algorithm.

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VaPro Plus Pocket 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 VaPro Plus Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:

• 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
  The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.

The provided text describes the 510(k) summary for the VaPro Plus Pocket Intermittent Catheter, an amendment to an existing device (VaPro Plus intermittent catheter, K141642). The submission primarily addresses changes to the device's packaging, not the device itself. Therefore, the "study" described focuses on testing relevant to these packaging changes rather than a clinical performance study of the catheter's efficacy for urinary drainage.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since the changes were primarily packaging-related, the acceptance criteria are not clinical performance metrics but rather safety and material integrity aspects.

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

• Test Set Sample Size: Not explicitly stated for any of the tests. The document only mentions "Biocompatibility was performed on the new packaging," "Sterility testing was performed," "Packaging integrity testing was performed," and "Transportation testing was performed." The specific number of samples or units tested is not provided.
• Data Provenance: Not explicitly stated, as the tests were performed by the manufacturer (Hollister Incorporated). It is an industrial setting rather than a retrospective or prospective clinical study on human subjects from a specific country.

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

• Not applicable. The tests performed (biocompatibility, sterility, packaging integrity, transportation) are laboratory or engineering tests with objective pass/fail criteria, not subjective assessments requiring expert consensus on a "ground truth" derived from patient data.

4. Adjudication method for the test set:

• Not applicable. As described above, the tests are objective laboratory or engineering evaluations, not studies requiring adjudication of human-read 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, which is a physical medical device for urinary drainage. It is not an AI-powered diagnostic or imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not applicable. This is not an algorithm or AI device.

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

• For Biocompatibility: Ground truth is established by meeting the requirements of ISO 10993 standards, which involve cytotoxicity, sensitization, irritation, and other systemic effects based on material properties and extracts.
• For Sterility: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) usually of 10^-6, meaning a one-in-a-million chance of a non-sterile unit, as per ISO 11137.
• For Packaging Integrity: Ground truth is established by proving the packaging can maintain a sterile barrier over its shelf life through physical and microbial challenge tests (e.g., burst strength, seal integrity, microbial ingress).
• For Transportation Testing: Ground truth is that the device (catheter) functions as intended and is undamaged after simulated shipping conditions.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not applicable, as there is no training set for this type of device.

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