Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.

A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water. The products are designed for transient use only and are available in male and female lengths. The products are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH14, CH16, CH18. An increasing Charrière corresponds to a larger external diameter. The male catheter range also consists of variants with a bent (Tiemann) catheter tip shape.

The provided document is a 510(k) summary for the ConvaTec GentleCath™ Glide Intermittent Urinary Catheter. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on performance testing and comparison of characteristics.

Here's an analysis of the acceptance criteria and study in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a medical device's clinical performance (e.g., sensitivity, specificity for diagnostic devices). Instead, it demonstrates "substantial equivalence" to predicate devices through a series of bench tests and comparison of device characteristics. The acceptance criteria are implicitly that the subject device's performance in these tests is "similar or superior" to the predicate devices.

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

The document does not specify the sample size used for the bench tests (flow rate, tensile properties, coefficient of friction, angle of Coudé tip).
The data provenance is from laboratory testing performed by ConvaTec Limited (UK-based company). It is implicitly retrospective as it compares the new device to existing predicate devices.

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

This information is not provided in the document. Given that the testing consisted of bench tests, the "ground truth" would likely be established by validated test methods and instrumentation, rather than expert review of clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the document describes bench testing, not a clinical study involving human judgment that would require an adjudication method.

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 document describes a 510(k) submission for a physical medical device (intermittent urinary catheter), not an AI-assisted diagnostic tool. Therefore, effects on human readers or AI assistance are not relevant.

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

This is not applicable as the device is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation mostly relies on bench test measurements against established engineering and material science standards (e.g., ISO and EN standards) and comparative performance against legally marketed predicate devices. For biocompatibility, the ground truth is established by the results of specific ISO-standardized biological evaluations (e.g., cytotoxicity, sensitization, irritation reports).

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device (catheter); there is no "training set" in the context of machine learning or AI models. The design and manufacturing process are based on engineering principles and materials science.

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

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

Ask a specific question about this device

For Over-the-Counter Use: AQUACELTM Ag+ EXTRA Enhanced Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: Abrasions, Lacerations, Minor cuts, Minor scalds and burns. Under the supervision of a healthcare professional: AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection; Partial thickness (second degree) burns; Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness); Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular); Traumatic wounds; Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites; Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma; Management of painful wounds; Infected wounds.

AQUACEL™ Ag+ EXTRA™ Enhanced Hydrofiber™ dressing with Silver and Strengthening Fiber is a soft, sterile dressing made from two layers of 1.2% ionic silver impregnated sodium carboxymethylcellulose fiber with added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride and stitched together with strengthening fibers. The two Hydrofiber™ layers are nominally 77gsm (grams per square meter) weight each. Aquacel Ag+ also includes added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride (BECL).

The provided text describes a 510(k) premarket notification for the AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (Device Name: K173675). The notification aims to establish substantial equivalence to a predicate device, AQUACEL Ag EXTRA Hydrofiber Dressing (K121275).

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:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML device performance (e.g., target specificity, sensitivity, or AUC values). Instead, it focuses on demonstrating equivalence to a predicate device through various tests.

The core "acceptance criteria" for this 510(k) submission appear to be:

• Biocompatibility: The device must be safe for its intended use, as demonstrated by standard biocompatibility testing.
• Performance (Bench): The device must exhibit physical properties and preservative action comparable to or improved upon the predicate device, especially regarding antimicrobial efficacy and wound management characteristics.
• Performance (Animal Study): The device must not hinder the wound healing process and should perform comparably to the predicate device in a relevant in vivo model.
• Substantial Equivalence: Overall, the device must be shown to be as safe and effective as the predicate device, despite the addition of new components (EDTA and BECL).

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

• Test Set (Animal Study): The text mentions a "porcine model" but does not specify the exact number of animals or wounds used in the study.
• Data Provenance: The animal study was conducted using a porcine model, which is a common pre-clinical model for wound healing. The location of the study is not specified, but it's a prospective experimental study.
• Test Set (In vitro studies): No specific sample sizes (e.g., number of bacterial cultures or dressing samples) are given for the in vitro tests. These are laboratory-derived data.

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. For non-AI/ML medical devices like wound dressings, "ground truth" is typically established through objective measurements (e.g., bacterial count reduction in vitro, histological analysis in animal models) rather than expert consensus on images or clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. As noted above, the "ground truth" for this type of device study is based on objective laboratory and animal model measurements, not on human interpretation requiring adjudication.

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

• No, this was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document describes a wound dressing, not an AI/ML diagnostic tool.

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

• Not applicable. This device is a medical product (wound dressing), not an algorithm or AI system. Its performance is inherent in the physical and chemical properties of the dressing itself.

7. The Type of Ground Truth Used:

• In vitro studies: Objective laboratory measurements of bacterial growth reduction, bacterial penetration, moisture retention, gelling, absorption, tensile strength, and dry fabric properties.
• Animal study: Objective measurements of biological outcomes in a porcine model, such as rate of epithelialization, white cell infiltrate, and granulation tissue formation, likely derived from histological analysis or direct observation/measurement.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical wound dressing, not an AI/ML device that requires a training set. The "training" in this context would be the research and development phase involving materials science and biological testing to optimize the dressing's composition and manufacturing.

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

• Not applicable. See point 8.

Ask a specific question about this device

Intermittent Catheters are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.

The GentleCath™ Intermittent Urinary Catheter is labelled as a single use, sterile device and is sterilized by Ethylene Oxide to a Sterility Assurance Level of 10-6 A urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. tip/distal end of the tube is inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. Both components of the device are made using Polyvinyl chloride (PVC) as base material and bonded with Cyclohexanone. The products are designed for transient use only and are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH16, CH18. An increasing Charrière corresponds to a larger external diameter.

This document is a 510(k) premarket notification for a medical device and therefore does not contain acceptance criteria for an AI/ML device. It is for a physical medical device, the GentleCath™ Intermittent Urinary Catheter.

The acceptance criteria typically found in such a document would relate to the physical and functional properties of the device, rather than performance metrics of an AI algorithm. The study details included focus on demonstrating substantial equivalence to predicate physical devices.

Based on the provided text, here's what can be extracted regarding the device performance and comparative studies:

The document describes performance testing for the GentleCath™ Intermittent Urinary Catheter to demonstrate its substantial equivalence to two predicate devices:

• Primary Predicate: GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter (K140953)
• Secondary Predicate: Self-Cath® Intermittent Urinary Catheter (K100878)

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the format of a requirement with a "pass" or "fail" threshold. Instead, it presents a comparison of various parameters between the subject device and the predicate devices to demonstrate equivalence. The "reported device performance" is given as quantitative measurements for each parameter.

The overarching "acceptance criterion" for this type of submission is to demonstrate substantial equivalence to legally marketed predicate devices, meaning that "the device performs similarly to the predicate devices" and that "all the results are similar or superior for the GentleCath™ Intermittent Urinary Catheter."

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 states, "Details relating to performance testing of the subject device and the two predicate devices can be found in section 18 of this submission." However, Section 18 is not included in the provided text. Therefore, the specific sample sizes for the test sets are not available in this extract. The data provenance is also not available from the provided text.

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 to this type of device and study. The testing described is bench testing of physical properties (flow rate, tensile strength, dimensions), not clinical evaluation requiring expert interpretation of results for ground truth.

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

This is not applicable to this type of device and study. Bench testing of physical properties does not involve human adjudication in the way clinical studies with AI/ML devices might.

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 document is for a physical medical device (urinary catheter), not an AI/ML device that assists human readers.

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

This is not applicable. This document is for a physical medical device (urinary catheter), not a standalone AI algorithm.

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

For the performance testing mentioned (Flow Rate, Catheter Tensile Properties, K Dimension), the "ground truth" would be the measurement results obtained through standardized laboratory test methods. This is not "expert consensus, pathology, or outcomes data" in the typical sense. The standard for flow rate is mentioned as ASTM F623-99.

8. The sample size for the training set

This is not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.

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

This is not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.

Ask a specific question about this device

Intermittent catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.

GentleCath Glide intermittent catheter is intended for adult use only.

A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water.

The document provided is a 510(k) premarket notification for a medical device called "GentleCath Glide Intermittent Catheter." It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain a study that establishes acceptance criteria for specific performance metrics and then reports the device's performance against those criteria in the format requested.

The "Performance Testing - Bench" section (Page 4) mentions that the following comparison tests were performed to demonstrate equivalence:

1. Flow Rate
2. Catheter Tensile properties
3. Coefficient of Friction

It states: "The laboratory testing shows no differences that would indicate the GentleCath Glide Intermittent Urinary Catheter would be any less safe or effective than the predicate devices. All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter."

However, detailed numerical acceptance criteria for these tests or specific reported performance values for the GentleCath Glide, linked to a formal study with defined sample sizes, ground truth, or expert involvement, are not provided in this document. The document focuses on demonstrating substantial equivalence through a feature-by-feature comparison with predicates rather than presenting a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted directly from this document.

Missing Information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
• Details of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document only broadly states that the device's flow rate, tensile properties, and coefficient of friction were "similar or superior" to predicate devices, without providing specific quantitative data or acceptance thresholds for these performance parameters.

Ask a specific question about this device

AQUACEL® Ag Surgical SP may be used for the management of wounds healing by primary intent (e.g., traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.

Under the supervision of a healthcare professional, AQUACEL™ Ag Surgical SP cover dressing may be used for the management of:
Wounds healing by primary intent (e.g. traumatic and elective post operative wounds/incisions) and as an effective barrier to bacterial penetration to help reduce infection.

AQUACEL™ Ag Surgical SP dressing is a sterile post-operative dressing comprising of an inner (wound contact) non-woven pad composed of Hydrofiber™ technology and ionic silver which is stitch bonded with nylon and elastane yarns. The pad is held in place between a top layer of hydrocolloid adhesive which is bound to an outer polyurethane film and a windowed skin contact layer consisting of polyurethane film sandwiched between one layer of acrylic and one layer of Hydrocolloid contacting the skin.

The outer layer of polyurethane film of AQUACEL™ Ag Surgical SP dressing provides a bacterial and viral barrier to reduce the risk of infection provided the dressing remains intact and there is no leakage.

The highly absorbent central Hydrofiber™ pad absorbs and retains serosanguinous leakage and transforms into a soft gel which maintains a moist environment to support the body's healing process.

The hydrocolloid component of the dressing provides secure, skin friendly adhesion and supports non traumatic removal of the dressing while minimizing damage to the intact surrounding skin.

AQUACEL™ Ag Surgical SP dressing is a waterproof, bacterial and viral barrier dressing which is designed to conform to changes in the wound/incision geometry during body movement and post-operative edema.

The dressing is intended for single use and is provided sterile (via a gamma irradiation process).

This Special 510(k) details the modifications of the predicate device, AQUACEL™ Ag Surgical dressing, which form the AQUACEL™ Ag Surgical SP dressing. These modifications do not alter the intended use or indications for use.

This document is a 510(k) Summary for the AQUACEL™ Ag Surgical SP Dressing, demonstrating its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the way a diagnostic AI device would. Instead, it focuses on non-clinical testing to show performance comparability and safety.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document in the typical sense for a diagnostic device. However, I will answer the questions based on the information provided, explicitly stating where the information is not available or not applicable.

Here's an interpretation of the request in the context of this document:

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

The document does not explicitly state "acceptance criteria" with numerical thresholds in the way a diagnostic AI would have for sensitivity, specificity, etc. Instead, the acceptance criterion for this submission is substantial equivalence to the predicate device based on comparable functional and structural design parameters and biological safety.

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 document refers to "non-clinical testing" but does not specify sample sizes or data provenance.

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 as this is not a diagnostic device involving expert interpretation or ground truth establishment in that manner. The evaluation is based on laboratory/bench testing and biological assessment.

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

This information 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 information is not applicable. This is not an AI/diagnostic device; no human reader studies or MRMC studies were performed.

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

This information is not applicable. This is not an algorithm or AI device.

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

The "ground truth" here is based on established testing methodologies and standards for medical device performance (e.g., fluid handling, adhesion strength, biocompatibility testing) for which the predicate device's performance already set a benchmark. It is not expert consensus, pathology, or outcomes data in the diagnostic sense.

8. The sample size for the training set

This information is not applicable. There is no training set as this is not a machine learning or AI device.

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

This information is not applicable. There is no training set.

Ask a specific question about this device