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The Cure Twist® is a pre-lubricated intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Twist® Female Catheter is a ready-to-use intermittent catheter pre-lubricated with a water based gel and includes polished eyelets for smooth insertion and easy drainage. The catheters are manufactured in CH8 to CH16 sizes. They are single use devices made from polyvinyl chloride (PVC) and sterilized by ethylene oxide.

The Cure Medical Catheter Insertion Kits components are used to aid catheter insertion. The Cure Twist® Female Catheter plus insertion kit include the Cure Twist® Female Catheter, ambidextrous gloves (PVC or nitrile), a benzalkonium chloride (BZK) wipe, an under pad and a urine collection bag with a universal connector.

The Cure Twist catheters are expected to be used in professional healthcare facilities, homes, work, public bathrooms, as well as out and about.

The provided document is an FDA 510(k) clearance letter for the Cure Twist Female Catheter. It outlines the device, its indications for use, and a comparison to a predicate device, along with a summary of performance data. However, it does not contain the specifics of a study or acceptance criteria in the format requested, particularly for AI/machine learning device evaluation.

The document indicates that the device is a urological catheter, not an AI/ML device. Therefore, a study proving an AI device meets acceptance criteria, including specifics like sample sizes for test and training sets, expert consensus, MRMC studies, or ground truth establishment, would not be found in this type of clearance letter. The performance data points listed (sterilization, biocompatibility, packaging integrity, etc.) are standard for a physical medical device, not an AI algorithm.

Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the physical and mechanical properties of a catheter, validated through standard engineering and biological testing, not AI model performance.

Explanation of why the requested information cannot be provided from this document:

• Device Type: The Cure Twist Female Catheter is a physical medical device (urological catheter), not an artificial intelligence/machine learning (AI/ML) device.
• Performance Data Scope: The "Performance Data" section lists tests relevant to physical medical devices (e.g., sterilization, biocompatibility, packaging integrity, flow rate, tensile strength). These are not metrics or studies typically associated with evaluating AI/ML algorithms.
• Absence of AI/ML Specifics: There is no mention of deep learning models, algorithms, human readers, ground truth consensus for image or data interpretation, or any other elements that would be present in a study proving an AI device's performance.

If this were an AI device, the 510(k) summary would typically include details about:

• Clinical Performance Study: Often a standalone study or a multi-reader, multi-case (MRMC) study.
• Performance Metrics: Sensitivity, specificity, AUC, F1-score, accuracy, etc.
• Test Set Description: Number of cases, demographics, data provenance, and how ground truth was established.
• Training Set Description: Size and how ground truth was established.
• Human Reader Performance: If AI assistance improves human reader performance (MRMC).

Since the provided document pertains to a traditional physical medical device, those types of studies and acceptance criteria are not applicable or detailed within this clearance letter.

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The Cure Catheter Insertion Kit is an intermittent urinary catheter kit indicated for the purpose of bladder drainage for males and females. The urinary catheter kit comes in a variety of configurations and sizes packaged sterile for single-use.

The Cure Catheter Insertion Kits (K1, K2, K2-90, K3), Cure Hydrophilic Catheter Kit (HMxxUK), Cure Pocket Catheter Kit (MxxUK), Cure Catheter Closed System Kit (CSxx)) contain sterile products used during intermittent urinary catheterization. Two types of kit are provided, one where a urinary catheter is included and one without a catheter. The components allow users to select one or more of the products to help prevent contamination of the environment and the user and to maintain a no-touch technique during the insertion of the catheter. Catheters are inserted through the urethra and indicated for the purpose of bladder drainage.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Cure Catheter Insertion Kit" and related products. It outlines the regulatory classification, intended use, and a comparison to a predicate device.

However, it does not contain information about specific acceptance criteria or a study that objectively proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for a diagnostic or screening device.

The "Performance Data" section lists various validation tests for general device characteristics, such as:

• Sterilization validation: Conforms to AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008/AMD:2019.
• Biocompatibility testing: Conforms to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1".
• Sterile packaging: Conforms to ISO 11607-1:2019 and ISO 11607-2:2019.
• Real-time aged shelf-life testing: Conforms to ISO 11607-1:2006 with justification to version 2019.
• Packaging integrity testing: Conforms to ASTM F2096-11 (2019).
• Urinary catheter testing: Conforms to ISO 20696:2018.

These are standard engineering and safety tests for medical devices, ensuring they are safe, sterile, and perform their basic mechanical function. They are not clinical performance studies to assess diagnostic accuracy or the direct clinical efficacy of a software-driven device.

Therefore, the specific information requested in the prompt, such as acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity), study design details (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment), is not available in this 510(k) clearance letter.

This document is for a urological catheter and accessories, which are physical medical devices, not an AI or software-based diagnostic tool. The performance data listed refers to the manufacturing, material, and sterility aspects, which are crucial for this type of device, but do not involve the types of criteria and studies you've asked about for AI/diagnostic devices.

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Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

The Flexi-Seal Air™ (supplied non-sterile) is comprised of a low pressure foam-filled 100% silicone rectal retention balloon fixed to the distal end of a soft collapsible silicone catheter tube with a labelled white inflation port and an auto Inflate valve, Luer lock inflation syringe, an ENFit connector for irrigation/medication port with an ENFit compatible syringe, cinch clamp, date formatted labels, a sub-assembled self-closing quick connector to the catheter end, a matching collection bag, and "Diamonds" gelling and odor control sachets (4 sachets per kit). The components are contained in a rigid thermoformed plastic clamshell.

I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Flexi-Seal AIR (with ENFit Connector). While it details the device, its intended use, technological comparisons, and the rationale for substantial equivalence to a predicate device, it does not contain information about specific "acceptance criteria" for a study that proves the device meets these criteria in the way you've outlined.

Specifically, the document states:

• "Performance testing for Flexi-Seal Air™ was conducted for functional and structural parameters. In this testing, the device's performance has been found to be substantially equivalent to the predicate device both functionally and structurally (balloon, auto inflate valve, joint strength, mechanical properties, odor barrier, etc)."
• "The device has also been evaluated for biocompatibility in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO 10993-1:2018, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process’, issued September 8, 2023, and has been found safe in such respect for its intended use."

This indicates that various performance tests (functional, structural, biocompatibility) were done to demonstrate substantial equivalence to a predicate device, which is the primary requirement for 510(k) clearance. However, it does not specify:

• A table of explicit "acceptance criteria" and "reported device performance" in a quantitative manner as you've requested.
• Sample sizes for a test set proving a specific performance goal.
• Data provenance, number of experts, adjudication methods, or ground truth establishment as would be present in a clinical performance study for an AI/ML device or a device requiring specific clinical performance metrics to be proven.
• MRMC studies or standalone algorithm performance.

The document is a regulatory submission for a medical device that appears to be a physical product (fecal management catheter), not an AI/ML software device. Thus, the questions regarding "AI vs. without AI assistance," "standalone (algorithm only) performance," and ground truth establishment for a training set are not applicable here.

Therefore, I cannot extract the information you've requested as it is not present in the provided text.

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

GentleCath Air for Women is a sterile, single use, disposable, hydrophilic, intermittent urethral catheter. A urethral catheter is a tubular device intended for being introduced into the urinary bladder through the urethra in order to provide drainage of the bladder. The catheter tube is made using Thermoplastic Elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. GentleCath Air for Women is designed for portability, ease of use and discreet disposal. Catheters are individually packed and are wetted ready for use upon removal from the case. Catheters are available in the following product sizes: CH10, 12, and 14.

This document describes the GentleCath Air for Women intermittent urinary catheters (CH10, CH12, CH14). The information provided is from a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the details about specific acceptance criteria and the study proving it are largely in reference to a comparison with established standards and the predicate device.

Here's the breakdown of the requested information based on the provided text:

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

The document does not provide a direct table of specific acceptance criteria with corresponding performance metrics like a typical medical device performance study would. Instead, it refers to performance testing conducted per applicable sections of voluntary and FDA consensus standards. The "Performance Data" section lists the types of testing performed and the standards used, indicating that the device met the requirements of these standards.

Here's a summary of the performance testing categories and the standards referenced, which imply the acceptance criteria are adherence to these standards:

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

The document does not provide specific sample sizes for any of the performance tests. It lists the types of tests performed and the standards followed, implying that the sample sizes were appropriate for those standards.

The provenance of the data is not explicitly stated as "country of origin" or "retrospective/prospective." However, the submission is from "ConvaTec, Ltd., First Avenue, Deeside Industrial Park, Deeside, Flintshire CH5 2NU, United Kingdom," suggesting the testing was likely conducted in or overseen by this entity.

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

This type of information (expert review for truth establishment) is not present in the provided document, as it pertains to device performance testing against engineering and biological standards, not diagnostic interpretation.

4. Adjudication method for the test set

Not applicable, as this is related to expert review of diagnostic cases, which is not the focus of this 510(k) submission.

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 urinary catheter and does not involve AI or human "readers" or diagnostic interpretation in the context of an MRMC study.

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

Not applicable, as this device does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by adherence to the referenced international and FDA consensus standards. For example, for biocompatibility, the ground truth is defined by the criteria within ISO-10993-1. For flow rate, the "ground truth" is meeting the specified flow rate limits of ISO 20696.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of an AI/ML medical device. It is a 510(k) premarket notification for a urological catheter, a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria, performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as these concepts apply to the evaluation of AI/ML algorithms.

The document discusses:

• Device Name: Cure Dextra® and Cure Catheter® Closed System
• Device Type: Intermittent urinary catheter
• Regulation Number: 21 CFR 876.5130 (Urological Catheter and Accessories)
• Predicate Device: Cure Catheter® Closed System (K080881)
• Non-Clinical Performance Testing: A summary of tests performed to demonstrate substantial equivalence, including sterilization validation, biocompatibility, sterile packaging, shelf-life, packaging integrity, diameter/shaft length, flow rate, tensile strength, and kink stability testing. These are standard tests for physical medical devices and not related to AI/ML performance.

The submission concludes that the subject devices are substantially equivalent to the predicate device based on these non-clinical performance tests.

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The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.

The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.

The provided text describes the 510(k) summary for the ConvaTec Cure Ultra® urinary catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a clinical study proving device performance against specific disease-related acceptance criteria for an AI/algorithm.

Therefore, the prompt's request for information such as ground truth, expert adjudication, MRMC studies, or AI assistance is not applicable to this device and submission type. The Cure Ultra® is a physical medical device (intermittent urinary catheter), not an AI/algorithm-based diagnostic or therapeutic tool.

The "acceptance criteria" discussed in this document relate to the device meeting engineering and regulatory standards rather than clinical performance metrics in a diagnostic context.

Here's a breakdown of the available information based on the prompt's request, noting where information is not applicable:

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

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 applicable as the document describes performance testing for a physical medical device (urinary catheter) against engineering and material standards, not a diagnostic algorithm evaluated on a clinical test set. The sample sizes would refer to the number of catheters tested for each performance criterion. The document does not specify the exact number of units tested for each performance test, but it states "Performance testing... was conducted per applicable sections of voluntary and FDA consensus standards," implying sufficient samples were used to meet those standards. Data provenance (country of origin, retrospective/prospective) is also not applicable in this context.

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 is not applicable. "Ground truth" in the context of clinical experts and test sets refers to diagnostic accuracy of an AI or algorithm. This document concerns a physical device tested against engineering and material safety standards.

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

This is not applicable for the reasons stated above.

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. This describes a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

This is not applicable. The "ground truth" for this device would be its adherence to established engineering specifications and biocompatibility standards, verified through laboratory testing, rather than clinical diagnostic outcomes.

8. The sample size for the training set

This is not applicable. This device doesn't involve a "training set" in the context of machine learning.

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

This is not applicable. This device doesn't involve a "training set."

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

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

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

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

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

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

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

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

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The Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector) is an indwelling fecal management catheter intended for use to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

The subject device, Flexi-Seal™ PROTECT PLUS Fecal Management System (with ENFit™ connector), has the same intended use as the predicate device (K162906). Both devices include a low-profile retention balloon, a finger pocket to allow for easy balloon insertion, a green dome to indicate the optimal fill status of the retention balloon, a red dome to indicate the over inflation status, and the ability to administer medication through the use of a cinch clamp. In addition, the subject device incorporates new features, including: add a self-closing ENFit port for irrigation/medication and provide an ENFit (1) syringe in the kit, (2) add a sub-assembled self-closing quick connector to the catheter end, and add a matching bag connector in the collection bag with an option of (3) incorporating Diamonds™ gelling and odor control sachet (4 sachets per kit) to solidify and deodorize the fecal contents in the collection bag.

Here's an analysis of the provided text, focusing on the acceptance criteria and study proving device performance, as requested.

Important Note: The provided document is an FDA 510(k) Summary for a medical device (Flexi-Seal™ PROTECT PLUS Fecal Management System). This type of submission relies heavily on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, many of the typical "acceptance criteria" and "study" details associated with AI/software devices (like sample sizes for test sets, expert adjudication, MRMC studies, and ground truth establishment methods for AI algorithms) are not applicable here.

The "studies" conducted for this device are primarily benchtop performance tests to ensure the new features do not negatively impact the device's function or safety.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Given this is a 510(k) submission for a physical medical device with modifications, the "acceptance criteria" are implied to be that the modified device performs similarly to or better than the predicate device and that the new features do not introduce new safety or efficacy concerns. The "study" involves non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device and the "acceptance criteria" are not explicitly listed as quantitative metrics in the document but rather as functional equivalence, I will infer them from the performance tests conducted and the claim of substantial equivalence.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested for each bench test, but the document confirms these tests were "performed" and "results are detailed in Section 18 of this Submission" (which is not included in the provided excerpt). For a physical device's bench testing, this typically involves a defined number of units to ensure statistical confidence, often guided by internal quality procedures or relevant standards.
• Data Provenance: The tests were non-clinical benchtop performance tests conducted to support the 510(k) submission. The location of testing is not specified, but the applicant (ConvaTec Limited) is based in the United Kingdom. The data is prospective in the sense that it was generated specifically for this premarket submission.

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

• N/A. This information is relevant for AI/software devices where human expert consensus establishes ground truth. For this physical device, ground truth is established through objective physical measurements and observations during bench testing (e.g., measuring joint strength, observing leakage). No "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for these types of engineering/material tests.

4. Adjudication Method for the Test Set:

• N/A. Adjudication (e.g., 2+1, 3+1) is a process used when multiple human readers interpret data to resolve disagreements and establish a consensus "ground truth," typically for complex medical images or diagnoses. This process is not applicable to the objective physical bench testing performed for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

• No. An MRMC study is specific to evaluating the impact of AI algorithms on human reader performance. This device is a physical fecal management system, not an AI or software product.

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

• No. This question applies to AI/software. There is no standalone algorithm for this physical device. Section 6 explicitly states "Software Verification and Validation Testing: Not Applicable."

7. The Type of Ground Truth Used:

• Objective Physical Measurements and Engineering Standards: The "ground truth" for the performance tests (joint strength, leakage, drug efficacy) are the results of controlled laboratory experiments and measurements against predefined engineering specifications (e.g., minimum strength thresholds, zero leakage, successful drug delivery simulation). These are objective, measurable outcomes, not subjective interpretations.

8. The Sample Size for the Training Set:

• N/A. This device is not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.

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

• N/A. As there is no AI training set, this question is not applicable.

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The Avelle™ NPWT System is indicated for use on patients that would benefit from a Negative Pressure Wound Therapy (NPWT) device as it may promote wound healing via removal of exudate and infectious materials from low to moderately exuding wound, such as:

• · Chronic Wounds e.g. Leg ulcers
• · Acute Wounds
• · Subacute and dehisced wounds
• Traumatic wounds
• · Flaps & Grafts
• · Surgically closed incision sites

Avelle™ NPWT System is suitable for use in a hospital, post-acute and home health environment.

The Avelle Negative Pressure Wound Therapy (NPWT) System consists of:

• a disposable battery powered pump
• absorbent wound dressing which is connected to the pump via tubing and luer-lock fittings
• adhesive fixation strips

The Avelle System is intended for single-patient use.

The Avelle pump is disposable, portable and battery-powered. The internal software of the pump limits the use to 30 days. The pump requires 3 AAA lithium batteries to operate. Testing shows that the 3 batteries will power the pump for a minimum of 15.6 days based on testing. A total of 6 AAA lithium batteries (2 sets) are provided with the pump which will power the device for its entire 30-day lifetime. The disposable battery-powered pump unit is attached to the dressing via the supplied tubing and luer-lock fittings.

The Avelle dressing is comprised of gelling fiber (Hydrofiber®) to absorb wound exudate with negative pressure applied indirectly to the dressing via the Avelle pump. The dressing is applied to the wound and secured around its periphery via its adhesive border and adhesive fixation strips are applied to ensure an adequate seal. The dressing's adhesive surface is protected by a split release liner system comprising of 2 or 3 sections of Low Density Polyethylene (LDPE) release liner (depending on dressing size), which are removed prior to dressing application.

The pump is turned on to apply and maintain a nominal negative pressure of -80mmHg to the dressing. The pump will draw excess wound exudate and infectious materials away from the wound bed and into the Hydrofiber® layers as demonstrated in a simulated use test with a moderately exuding flow of 82 mL over 3 days and a second simulated use test with a low exuding flow of 102 mL over 7 days.

The system will deliver up to 30 days' single patient use for the pump component, and up to 7 days' wear time for the dressing. Each dressing may be used for up to 7 days but may require more frequent changes due to clinical situations. After 30 days of use the pump must be discarded and treatment must be stopped.

The pump unit is provided non-sterile. The Absorbing Dressing (with adhesive fixation strips) is provided sterile via ethylene oxide (EtO) sterilization.

This document, a 510(k) summary for the AVELLE Negative Pressure Wound Therapy System, describes non-clinical performance testing rather than clinical studies with human participants. Therefore, many of the requested elements for clinical study data (such as sample size for test sets, ground truth establishment for test sets, expert qualifications, adjudication methods, and MRMC studies) are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes that "The AVELLE NPWT meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device." Specific quantitative acceptance criteria are not provided in this summary, but the successful completion of the listed tests implies that the device met their pre-defined criteria.

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

The document does not specify exact sample sizes for each non-clinical test. The tests are "bench testing" and "simulated use tests," meaning they were conducted in a laboratory setting, not on human patients. The data provenance is ConvaTec Limited (the applicant).

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

Not applicable. These were non-clinical, bench and simulated use tests, not diagnostic studies requiring expert review for ground truth.

4. Adjudication method for the test set

Not applicable for non-clinical bench testing.

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 medical device (NPWT system), not an AI-powered diagnostic tool, and no MRMC study was conducted or mentioned. The document explicitly states "Clinical Data is not included in this 510(k)."

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

The device is a physical system (pump, dressing, tubing), not an algorithm-only device. "Standalone" performance would refer to the device's functional operation, which was assessed through the various bench and simulated use tests.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods, and industry standards for material properties, sterility, performance, and safety. For example, bacterial barrier testing would have a known standard for barrier effectiveness as its "ground truth."

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable for the same reason as above.

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