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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 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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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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The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The VAPR TRIPOLAR 90 Suction Electrode is a single use, one-piece bipolar RF suction electrode for use in a surgical setting by a surgeon trained in arthroscopic surgery. The VAPR TRIPOLAR 90 Suction Electrode is an RF device which incorporates 3 electrodes in the probe tip: one active electrode and two return electrodes. This configuration optimizes ablation and coagulation in a single device. It has been designed to facilitate access and control the delivery of RF energy to the joint space. The connector plug of the VAPR TRIPOLAR 90 Suction Electrode is designed to interface only with the VAPR VUE Radiofrequency Generator. It has an internal identification code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the VAPR TRIPOLAR 90 Suction Electrode can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be only operated with the VAPR VUE generator at pre-determined default settings specific for this device. The VAPR TRIPOLAR 90 Suction Electrode has three sets of buttons to address surgeon preference when holding the electrode. Each pair of buttons offers the same functionality and are ergonomically positioned for surgeon comfort. In addition the VAPR TRIPOLAR 90 Suction Electrode features vacuum fluid extraction which enhances the efficiency of the electrode and assists in the removal of bubbles and debris created during activation within the operating site. The design includes the ability to vary flow rate to allow the surgeon to make adjustments depending on particular procedural requirements.

This document describes the VAPR® Tripolar 90™ Suction Electrode developed by DePuy Mitek Incorporated. The device is a single-use, one-piece bipolar RF suction electrode intended for resection, ablation, and excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissues in patients requiring arthroscopic surgery.

The acceptance criteria for the VAPR® Tripolar 90™ Suction Electrode and the study that proves the device meets these criteria are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the battery of tests conducted. For all tests, the reported device performance was "Acceptable."

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

The document does not specify the sample sizes used for each individual test. The tests were performed to demonstrate substantial equivalence to predicate devices for regulatory clearance. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, though it can be inferred that the testing was conducted by or on behalf of DePuy Mitek, Inc. (a U.S. company) to meet FDA requirements.

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

This information is not provided in the document. The tests seem to be primarily engineering and bench-top evaluations, rather than clinical studies requiring expert interpretation of results for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (biocompatibility, electrical safety, performance testing), an adjudication method in the context of expert consensus on medical image interpretation or clinical outcomes is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance." Therefore, there is no effect size of human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device does not involve an algorithm or AI. It is a physical medical device. Therefore, a standalone performance study in this context is not applicable. The performance tests evaluate the device's physical and electrical characteristics and its interaction with biological tissues in a controlled environment.

7. The Type of Ground Truth Used

The "ground truth" for the various tests appears to be established by:

• Biocompatibility: Conformance to recognized international standards (ISO-10993).
• Electrical Safety: Conformance to recognized international electrical safety standards (IEC 60601-1, IEC 60601-2-2).
• Performance Data: Acceptable outcomes based on internal engineering specifications and testing protocols, designed to demonstrate the device performs as intended and is substantially equivalent to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The VAPR® Tripolar 90™ Suction Electrode is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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VaPro™ Pocket 40cm 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.

VaPro™ Pocket 20cm 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 VaPro 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)
∑ 2 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.
This product does not utilize a collection bag.

The provided document is a 510(k) premarket notification for a medical device called "VaPro™ Pocket intermittent catheter." It does not contain information about an AI-powered device or a study involving acceptance criteria and device performance as typically understood for AI/ML medical devices.

The document describes a urological catheter and its packaging. The "performance testing" section refers to:

• Biocompatibility testing: Performed on the new packaging (not the device itself, as no change to the device was made).
• Sterility testing: Performed using Gamma Irradiation.
• Package integrity testing: To verify maintenance of the sterile barrier through shelf life.
• Transportation testing: To verify no impact on catheter safety or efficacy.

These are standard engineering and quality control tests for a physical medical device, not performance metrics for an AI algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI-powered device because the provided text describes a physical, non-AI medical device and its packaging.

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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 VAPR® ARCTIC™ Suction Electrode for use with the VAPR VUE® RF System is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the hip.

The VAPR® ARCTIC™ Electrode is a single use, one-piece bipolar suction articulating electrode for use in arthroscopic surgery of the hip. The electrode has a hand-controlled articulating tip to improve access and suction capabilities. This will enhance the efficiency of the electrode and extend the utility of the system by assisting in the removal of bubbles and debris created during activation within the operating site.

The ARCTIC Electrode has been designed to facilitate access and control the delivery of RF energy to the joint space. The plug of the ARCTIC Electrode is designed to fit the VAPR VUE® generator socket only. It has an internal identification capacitor code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be run only off the VAPR VUE electrosurgical generator at pre-determined default settings specific for the device.

The provided text describes a 510(k) premarket notification for the VAPR® ARCTIC™ Suction Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, detailed study design, and AI performance is not explicitly available in the provided text.

However, I can extract information about the types of tests performed to ensure safety and performance, which can be seen as meeting product specifications and user needs.

Here's a breakdown of the available information:

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

The document does not provide a specific table of quantitative acceptance criteria and their corresponding reported performance values. Instead, it lists various verification and validation tests performed to ensure the device meets its specifications and user needs. The conclusion states that the "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use."

Here's a summary of the types of tests conducted:

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

The document does not specify the sample size for individual tests, nor does it provide details about data provenance (e.g., country of origin, retrospective/prospective nature). The tests appear to be laboratory or bench-top tests of the device components and functionality.

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. The device is an electrosurgical tool, and its performance is evaluated against engineering specifications and functional requirements, not through expert-labeled diagnostic data. Therefore, there's no "ground truth" in the clinical imaging or diagnostic sense being established by experts for a test set in this context.

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

This is not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data (e.g., medical images). This document describes device performance and safety testing, not diagnostic performance.

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 is not applicable. The VAPR® ARCTIC™ Suction Electrode is an electrosurgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant to this submission.

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

This is not applicable. As stated above, this device is a surgical instrument, not an algorithm, and the concept of "standalone" performance for an algorithm is not relevant here.

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

The "ground truth" for this device's performance is established by engineering specifications, industry standards (listed in Table 2), and functional requirements for surgical tools. This includes measurements of physical properties (e.g., articulation angle, tensile strength), electrical properties, biological compatibility, and demonstration of proper function (e.g., activation, suction flow, non-clogging). It does not involve clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

This is not applicable. This device is not an AI algorithm that requires a training set.

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

This is not applicable. This device is not an AI algorithm that requires a training set or ground truth establishment for a training set.

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The DePuy Mitek VAPR Electrodes for use with the VAPR System are intended for resection, , ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscpic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

The VAPR system is electrosurgical system that utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the joint space, and accessories such as a footswitch and electrodes.

The provided document is a 510(k) Premarket Notification for the DePuy Mitek VAPR Electrodes, specifically seeking to add hip arthroscopy to the indications for use. This document outlines the safety and performance testing conducted to support this change.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set (number of electrodes tested for each criterion). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). However, given that this is a 510(k) submission for an electrosurgical device, the testing would typically be conducted in a laboratory setting.

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

The provided text does not mention the use of experts to establish a ground truth for the mechanical and physical tests performed (Device Insertion, Shaft Bending, Active Tip Engagement). These are objective engineering tests with pass/fail criteria.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests performed are objective and do not require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance."

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

This question is not applicable to this device. The VAPR Electrode is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

For the safety and performance testing described (Device Insertion, Shaft Bending, Active Tip Engagement), the "ground truth" is based on objective engineering and material science pass/fail criteria. For example, "no visible cracks" or "no breakage at the active tip" are directly observable and measurable outcomes against predefined standards. There is no concept of "expert consensus," "pathology," or "outcomes data" for these specific engineering tests.

8. The Sample Size for the Training Set

This question is not applicable. The VAPR Electrode is a physical medical device, not an AI or machine learning system that requires a "training set."

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

This question is not applicable for the same reason as point 8.

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The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The Mitek VAPR II Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The DePuy Mitek VAPR Electrodes for use with the VAPR VUE Radiofrequency System are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

The VAPR system is electrosurgical system that utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the joint space. and accessories such as a footswitch and electrodes.

The provided document describes a 510(k) premarket notification for the DePuy Mitek VAPR® VUE™ Radiofrequency System, VAPR III Electrode Surgical System, VAPR II Electrode Surgical System, and various VAPR electrodes (P90, CP90, CP90 with Handcontrol, LDS, LPS Electrode). The purpose of the submission is to add hip arthroscopy to the existing indications for use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Description:

The document states: "Safety and Performance Verification and Validation of the VAPR Electrodes included performance testing to demonstrate that the device is appropriate for hip arthroscopy. A summary of testing is provided in Table 1."

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

• Sample Size: The document does not specify the exact number of devices tested for each performance test (Device Insertion, Shaft Bending, Active Tip Engagement). It only states "performance testing."
• Data Provenance: The data provenance is not explicitly stated. However, given that this is a premarket notification to the FDA, the testing was presumably conducted by the manufacturer, DePuy Mitek, a Johnson & Johnson company, in a controlled laboratory environment. It is not clinical data; it's device performance testing.

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

• This type of information is not applicable to the provided study. The study involves engineering performance tests (e.g., physical integrity of the electrodes) rather than assessments requiring expert medical interpretation of images or patient outcomes. The "ground truth" for these tests is based on objective pass/fail criteria for physical characteristics.

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

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiographic readings). The disclosed study involves objective engineering performance tests with clear pass/fail criteria, not subjective interpretations.

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

• An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The current submission is for electrosurgical devices and does not involve AI or human reading tasks.

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

• A standalone performance study of an algorithm was not done. The VAPR system and electrodes are electrosurgical devices, not AI algorithms.

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

• The ground truth for this performance testing is based on objective engineering and physical integrity criteria. For example, for "Device Insertion," "Pass" means "No visible cracks or missing portions at the distal tip of the electrodes." This is a directly observable and measurable physical attribute, not requiring expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• This information is not applicable. This is not an AI/machine learning study, so there is no training set mentioned or implied.

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

• This information is not applicable for the same reason as point 8. There is no training set in this context.

In summary, the provided document describes a premarket notification for electrosurgical devices, specifically seeking to add hip arthroscopy to their indications. The "study" described involves engineering-based performance verification and validation of the device's physical integrity and functionality, rather than clinical trials or AI performance evaluations.

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