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The VaPro™ 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™ 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 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. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity.
The VaPro Plus has the addition of a collection bag that is connected to the catheter for use when drainage into a suitable receptacle is not feasible or practical.

This document describes a 510(k) premarket notification for the VaPro™ intermittent catheter and VaPro Plus™ intermittent catheter, submitted by Hollister Incorporated. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

The information provided does not describe the acceptance criteria, reported device performance, or a study that specifically proves the device meets acceptance criteria in the manner typically presented for AI/ML devices outlining metrics like sensitivity, specificity, or AUC, as requested in your prompt. This document pertains to the regulatory clearance of a physical medical device (an intermittent catheter), not a software or AI/ML algorithm.

Therefore, many of the specific questions you asked are not applicable to the content of this regulatory submission. However, I can extract the relevant information regarding performance testing that was submitted to the FDA for this device.

Here's a breakdown based on the provided document:

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

The document does not explicitly present a table of quantitative acceptance criteria and reported device performance in the format of specific metrics (e.g., accuracy, sensitivity, specificity, etc.) typically associated with AI/ML systems. Instead, the performance evaluations are related to the safety and functionality of the physical catheter.

Summary of Performance Testing Conclusions:

• Biocompatibility: Complied with ISO 10993 standards based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1.
• Product Evaluation: Supports device functionality.

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 document. The filing mentions "biocompatibility testing" and "product evaluation" but does not detail the sample sizes, data provenance, or specific methodologies (like retrospective or prospective studies) in the context of human data. The testing mentioned would likely involve laboratory tests on the device materials and components, not a "test set" of patient data for evaluating an algorithm's performance.

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/not provided. Ground truth establishment by experts, especially in the context of image interpretation or clinical outcomes, is relevant for AI/ML studies. For a physical medical device like a catheter, "ground truth" would relate to its physical properties, material safety, and functional performance, which are assessed through laboratory and possibly limited human user studies, not typically by expert consensus on a "test set" in the radiological or pathological sense.

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

This information is not applicable/not provided. Adjudication methods are used to resolve discrepancies in expert interpretations when establishing ground truth for evaluating AI/ML algorithms. This concept does not apply to the biocompatibility and functionality testing of a physical medical device as described.

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/not provided. MRMC studies are used to evaluate diagnostic imaging systems and AI/ML algorithms in a clinical setting by comparing human reader performance with and without AI assistance. This device is an intermittent catheter, not a diagnostic imaging system or an AI/ML diagnostic tool.

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

This information is not applicable/not provided. Standalone performance is relevant for AI/ML algorithms. This document concerns a physical medical device, not an algorithm.

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

For the "Performance Testing Conclusions" mentioned:

• Biocompatibility: The "ground truth" would be established by the ISO 10993 standards and FDA guidance (#G95-1), which define acceptable biological responses and material safety profiles. Compliance with these standards is determined through specific laboratory tests, not expert consensus in the clinical sense, pathology, or outcomes data in the usual context of AI/ML evaluation.
• Product evaluation: The "ground truth" for device functionality would be based on engineering specifications and performance requirements relevant to a medical catheter (e.g., flow rates, material tensile strength, durability, ease of use, lubricity).

8. The sample size for the training set

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

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

This information is not applicable/not provided. As above, "training set" and its ground truth are concepts for AI/ML.

In summary: The provided document is an FDA 510(k) clearance letter for a physical medical catheter. It describes the device, its intended use, and indicates that biocompatibility and product evaluation were performed to establish substantial equivalence to predicate devices. It does not contain the specific performance metrics or study designs typically requested for AI/ML device evaluations.

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The VaPro 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 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. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity.

The provided text is a 510(k) Summary for a medical device (VaPro™ Intermittent Catheter), which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed metrics typically associated with AI/software devices.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and AI performance metrics are not applicable to this type of submission.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

• Not Applicable in the traditional sense of a performance study with specific metrics. The provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than defining and meeting specific quantitative performance acceptance criteria in an AI/Software context.
• The "performance" described is primarily functional and safety-related for a physical catheter, evaluated through biocompatibility and product evaluation to support functionality.

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

• Not Applicable. This is a hardware device (catheter) submission. There is no "test set" of data in the context of an AI/Software algorithm. The testing would involve physical samples of the catheter for biocompatibility and functional evaluation. No details on sample sizes for these physical tests are provided in the summary.

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 hardware device. There is no ground truth established by experts in the context of diagnostic interpretation or AI model training/testing.

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

• Not Applicable. No adjudication method for a test set is mentioned as this is not an AI/Software device requiring such a process.

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 a physical medical device (catheter), not an AI/Software system. Therefore, no MRMC study or AI assistance 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)

• Not Applicable. For this physical device, "ground truth" would relate to confirmed physical properties, material safety (biocompatibility), and functional performance (e.g., flow rates, lubrication effectiveness) validated against established standards, not diagnostic outcomes.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/Software system that requires a "training set."

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

• Not Applicable. Same as above, no training set for a physical device.

Information that can be extracted or inferred regarding device evaluation:

• Device Performance Reported (for a physical device):

  • Biocompatibility: "Biocompatibility testing was performed based on Performance Testing the United States Food and Drug Administration Office of Conclusions: Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Results indicate compliance to the standard."
  • Device Functionality: "Product evaluation also supports device functionality."

• Predicate Device Equivalence (which implies the new device also meets foundational criteria present in predicates):

  • Intended Use: Matches or is highly similar to predicates.
  • Condition of Use: Single Use (matches predicates).
  • Prelubricated: Yes - by water vapor hydration (similar mechanism to predicates).
  • Ready to Use: Yes (similar to Speedicath and Incare, different from Lofric).
  • End Design: Funnel (matches predicates).
  • Sterile: Yes (matches predicates).
  • No-touch design: Yes - contains sleeve (similar to Lofric and Incare, different from Speedicath).
  • Lubricant: PVP Based (similar to Lofric and Speedicath, different from Incare).
  • Protective Tip: Yes (similar to Incare, different from Lofric and Speedicath).

Conclusion:

The provided 510(k) summary is for a physical medical device (intermittent catheter). The evaluation criteria and "proof" of performance are based on standard engineering tests for physical properties, materials, and biocompatibility, as well as demonstrating substantial equivalence to other legally marketed devices. It does not contain information related to acceptance criteria, study sizes, ground truth establishment, or performance metrics typically associated with AI/Software medical devices.

Ask a specific question about this device