The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® Eclipse Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber lates, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® Surgeons Natural rubber latex surgical gloves tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Biogel® Indicator Underglove Green natural rubber latex surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of natural rubber latex, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® PI Micro Indicator Underglove Blue polyisoprene surgical indicator underglove tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® PI UltraTouch S Polyisoprene surgical gloves for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The Biogel® PI UltraTouch S Indicator Underglove Blue polyisoprene surgical indicator underglove for reduced risk of Type IV allergic contact dermatitis Tested for use with chemotherapy agents is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The document provides information on the performance of several types of surgical gloves when tested for resistance to permeation by chemotherapy drugs. The acceptance criteria and the study method are based on ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The implicit acceptance criterion for these gloves, based on the Breakthrough detection time values and the common understanding in such tests, is that the gloves should demonstrate resistance to permeation by chemotherapy drugs for a reasonable duration (e.g., as long as possible, or at least a certain minimum time). While a specific "pass/fail" threshold is not explicitly stated as an acceptance criterion in minutes, the values of ">240 minutes" indicate excellent performance for most drugs. The lower values for Carmustine and Thiotepa highlight instances where permeation occurs more quickly.

The reported device performance for each glove type and chemotherapy drug is provided in the tables across the document. Below is a summary table combining this information as an example, for "Biogel Eclipse Natural Rubber Latex Surgical Gloves tested for use with chemotherapy agents" (from page 3):

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

The document does not explicitly state the sample size for the test set (number of gloves tested per drug type). It only reports the breakthrough detection time.
The data provenance is from testing conducted in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based prospective testing methodology. The country of origin of the data is not specified, but the submission is to the U.S. FDA.

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

This type of study (chemical permeation testing of medical devices) does not typically involve human expert adjudication in the same way, for example, a diagnostic image interpretation study would. The "ground truth" is established by the objective, quantitative measurement of chemical permeation according to the specified ASTM standard. Therefore, there are no "experts" in the sense of clinical reviewers establishing a ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is a laboratory test with objective measurements, not a human interpretation task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a standalone performance test of a physical device against chemical permeation, not an AI-assisted diagnostic task involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This entire study is a standalone performance assessment of a physical device. There is no "algorithm" or "human-in-the-loop" concept involved. The performance is the intrinsic resistance of the glove material to chemical permeation.

7. The Type of Ground Truth Used:

The ground truth used is based on objective, quantitative measurements of chemical permeation using analytical methods specified or implied by the ASTM D6978 standard. The "Breakthrough detection time" is the measured outcome, indicating the time at which a quantifiable amount of the chemotherapy drug permeates through the glove material.

8. The Sample Size for the Training Set:

Not applicable. This is a direct performance test of a manufactured product, not a machine learning model. There is no "training set" in this context.

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

Not applicable. There is no training set for this type of device performance study.

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The Biogel® PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel® PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.

This document is a 510(k) summary for a medical device (surgical gloves) and not a study describing the validation of an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the subject devices (Biogel® PI UltraTouch S Surgical Glove and Indicator Underglove with a Low Dermatitis Potential Claim) to predicate devices already on the market. The low dermatitis potential claim is supported by non-clinical testing.

Here's what can be extracted, although it pertains to non-AI/ML device testing:

1. Acceptance Criteria and Reported Device Performance (for the non-AI/ML medical device):

The acceptance criteria for the surgical gloves are primarily defined by adherence to recognized standards and the demonstration of "Low Dermatitis Potential."

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

The document refers to "studies" for biocompatibility and performance, but does not specify sample sizes for these tests. The data provenance is implied to be from testing conducted by or for the manufacturer, Mölnlycke Health Care US, LLC. The testing is described as "non-clinical," meaning it does not involve human subjects in a clinical setting when assessing device performance characteristics.

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

This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring expert ground truth establishment for algorithm performance.

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

This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device requiring adjudication of expert 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:

This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device. "Clinical data was not required" for this submission.

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

This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device.

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

The "ground truth" for the surgical gloves is established by their adherence to defined physical, chemical, and biological performance characteristics measured against industry standards (e.g., ASTM, ISO) and specific test methodologies (e.g., Modified Draize-95 Test).

8. The sample size for the training set:

This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set.

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

This information is not applicable as the document describes the testing of a physical medical device (surgical gloves), not an AI/ML device that requires a training set and corresponding ground truth.

In summary, the provided FDA 510(k) summary is for a traditional Class I medical device (surgical gloves) and therefore does not contain the information typically associated with the validation of an AI/ML-driven device.

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The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The Biogel® PI UltraTouch S Indicator Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.

Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.

The provided text describes a 510(k) premarket notification for surgical gloves and does not involve AI or algorithms. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), or ground truth establishment for an AI device.

The document is a regulatory submission for medical devices (surgical gloves) which are classified as Class I. The submission is focused on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the performance of an AI model against specific acceptance criteria.

The "acceptance criteria" discussed in the document relate to the physical and biocompatibility properties of the gloves, such as:

• Physical Characteristics: Dimensions, tensile strength, elongation, freedom from holes, and powder residual. These are assessed against established ASTM (American Society for Testing and Materials) standards and FDA regulations (e.g., 21 CFR 800.20, ASTM D3577-09(2015), ASTM D5151-06(2015), ASTM D6124-06(2017)).
• Biocompatibility: Primary skin irritation, ISO closed patch sensitization, and acute systemic toxicity. These are assessed against ISO 10993 standards.
• Sterilization: Sterility Assurance Level (SAL) of 10-6.

Here's a breakdown of why your specific questions cannot be answered from the provided text, and what the text does provide regarding the device's performance:

Based on the provided text, the device is a surgical glove, not an AI or algorithm-based device. Therefore, the questions related to AI/algorithm performance, such as MRMC studies, standalone performance, training sets, and expert adjudication for ground truth of an AI model, are not applicable to this document.

The document describes the acceptance criteria and device performance for surgical gloves as part of a 510(k) submission to demonstrate substantial equivalence to predicate devices.

Here's the relevant information from the document:

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

The document presents a "Summary of Non-Clinical Testing" which effectively serves as the acceptance criteria and the reported performance against those criteria.

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

The document states "Summary of Non-Clinical Testing" but does not specify the sample sizes used for each of the tests (e.g., number of gloves tested for holes, number of animals for biocompatibility). The data provenance is implied to be from laboratory testing conducted to meet the specified ASTM and ISO standards, which are international. It's not retrospective or prospective in the clinical study sense; rather, it's laboratory testing of manufactured goods.

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

Not applicable, as this is for a physical device (surgical glove) and not an AI model. "Ground truth" here refers to established physical and biocompatibility standards, not expert interpretations of medical images or data.

4. Adjudication method for the test set

Not applicable. Testing involves conforming to predefined physical and chemical specifications, not subjective interpretation requiring adjudication.

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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

The "ground truth" for the device's performance is established by internationally recognized standards and regulations for surgical gloves, specifically:

• ASTM International standards (e.g., D3577, D5151, D6124) for physical properties.
• ISO (International Organization for Standardization) standards (e.g., 10993 series) for biocompatibility.
• FDA regulations (e.g., 21 CFR 800.20) for acceptable quality levels (AQL) for freedom from holes.

These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residual, AQL for holes, non-irritant response).

8. The sample size for the training set

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Ask a specific question about this device

The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this premarket notification is a line addition to the Avance NPWT System: the Avance Foam Dressing Kit in size XL. Prior to this submission, the product offering consisted of foam dressing kits in sizes small, medium, and large. The subject Avance Foam Dressing Kit - XL consists of the same components as the Avance Foam Dressing Kits cleared under K141847: Avance ViewPad, Avance Foam (green), Avance Transparent Film.

This document describes the FDA 510(k) clearance for the Molnlycke Health Care US, LLC Avance Foam Dressing Kit - XL. This is an add-on to an existing Negative Pressure Wound Therapy (NPWT) system. As such, the submission focuses on demonstrating that the new component (the XL foam dressing) does not negatively impact the overall system's safety and effectiveness compared to the previously cleared system.

Here's a 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 specific table with acceptance criteria values and reported device performance. It generally states that "all predefined acceptance criteria were met" for the bench tests conducted.

2. Sample sized 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 the bench tests. It only mentions that "Bench testing has been performed." The data provenance (country of origin, retrospective/prospective) is not mentioned.

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 a medical dressing and a component of a physical system, not an AI/diagnostic software. No experts were used to establish ground truth in the context of diagnostic interpretation.

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

This information is not applicable. The device is a medical dressing and a component of a physical system, not an AI/diagnostic software.

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. No MRMC study was conducted as this is not an AI/diagnostic software.

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 AI algorithm.

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

For the non-clinical testing, the "ground truth" would be established engineering and functional specifications for the NPWT system's ability to transport fluid and deliver pressure. The document implicitly states that these functional requirements were met.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device; therefore, there is no training set.

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

This information is not applicable as there is no training set.

Summary of Device Acceptance Criteria and Study:

The Avance Foam Dressing Kit - XL is an addition to an existing Negative Pressure Wound Therapy (NPWT) system. The acceptance criteria focus on demonstrating that this new, larger dressing component does not negatively affect the overall system's functional performance and biocompatibility.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

The document does not provide specific numerical acceptance criteria or performance metrics but states compliance.

Study Details:

• Type of Study: Non-clinical bench testing.
• Sample Size: Not specified for the bench tests.
• Data Provenance: Not specified.
• Ground Truth Establishment: For bench testing, the ground truth would be based on engineering specifications and validated test methods for fluid transport and pressure delivery within NPWT systems.
• Clinical Data: No clinical data was required or submitted to support substantial equivalence.
• AI/Machine Learning Specifics: Not applicable; this device is a physical medical dressing, not an AI algorithm.

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The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:

• Antimicrobial gauze dressing
• Avance Transparent Film or Avance Film with Safetac technology
• Avance ViewPad

This document is a 510(k) premarket notification for "Avance Gauze Dressing Kits," which are line additions to an existing Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the information typically associated with a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, expert involvement, and ground truth establishment) is not fully present in the document in the format you've requested for an AI model.

However, I can extract the relevant information regarding acceptance criteria and general statements about testing from the provided text:

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

The document states that "all predefined acceptance criteria were met" for the bench testing. However, the specific quantitative acceptance criteria are not detailed in this summary.

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 sizes used for the bench testing. No clinical data was required or submitted, so there is no information on data provenance relating to clinical studies. The testing described is "non-clinical bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable and not provided. The testing described is bench testing, which typically relies on established engineering and materials science principles, not expert human assessment of images or patient data to establish ground truth.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers, which this submission did not include.

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 MRMC study was done. This device is not an AI-assisted diagnostic tool; it is a medical dressing kit for Negative Pressure Wound Therapy.

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

This is not applicable as the device is not an algorithm or AI. The bench testing performed would be considered "standalone" in the sense that it evaluated the device's physical performance independently.

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

For biocompatibility, the ground truth would be established by the requirements of ISO 10993. For fluid transport and pressure delivery, the ground truth would be engineering specifications and functional parameters for NPWT systems, where "as intended" means meeting these predefined technical requirements.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dressing kits) and its non-clinical bench testing, not an AI or machine learning algorithm 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 submission.

Ask a specific question about this device

The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness bums, flaps and grafts.

The subject Avance Tubing serves as the connecting link between the Avance NPWT pump and the Avance dressings, thereby delivering negative pressure wound therapy from the pump to the wound bed and facilitating the transport of fluid and exudate from the wound site to the canister. It consists of a 1.5 m length of tubing with connectors on each end to facilitate connection to other components of the Avance NPWT System.

The subject Avance Y-Connector allows connection of multiple Avance dressings to one Avance pump in order to accommodate large or multiple wounds. It consists of y-tubing with connectors on all ends to facilitate connection to other components of the Avance NPWT System. A maximum of one Avance Y-Connector may be used to connect up to two large dressing kits to a single pump.

The subject Avance ViewPad used in conjunction with the Avance dressings; it is placed on top of the wound cover (film), connected to the wound filler via a hole cut in the wound cover, and then connected to the Avance NPWT pump tubing for delivery of NPWT and transport of fluids and exudate away from the wound. The subject Avance ViewPad is similar to the existing ViewPad component of the Avance Foam Dressing Kits (K141847), with the exception of a green colorant that has been added to the connector and a modification to the design of the slide clamp.

This document describes the premarket notification for Avance Tubing, Avance Y-Connector, and Avance ViewPad, which are components of a Negative Pressure Wound Therapy (NPWT) system.

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:

The document states that the devices were evaluated through non-clinical bench testing. The general acceptance criteria were that the devices "performed as intended in the test setups, and all predefined acceptance criteria were met." Specific quantitative acceptance criteria are not explicitly detailed in this summary, but the reported performance is that they met all such criteria.

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

• Test Set Sample Size: The document does not specify the exact sample size (number of devices or test runs) for the non-clinical bench testing. It only states that "Bench testing has been performed."
• Data Provenance: The testing was conducted as part of the premarket notification for the devices by the manufacturer, Mölnlycke Health Care. It is considered prospective data generated specifically for regulatory submission. The country of origin for the data is not explicitly stated, but the manufacturer is Mölnlycke Health Care, US LLC, located in Norcross, Georgia.

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

This information is not applicable as the studies conducted were non-clinical bench tests, not clinical studies involving expert interpretation of medical data or ground truth established by medical professionals. The "ground truth" here refers to the functional performance of the device against engineering specifications and industry standards.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies conducted were non-clinical bench tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts assess the same cases to arrive at a consensus for ground truth. In bench testing, performance is measured objectively against predefined engineering specifications.

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. The submission is for components of a Negative Pressure Wound Therapy system, which are physical medical devices, not an AI or computer-aided diagnostic (CAD) system. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this device.

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

This information is not applicable as the submitted devices are physical medical device components, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical testing was based on predefined engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and functional performance requirements. These requirements dictated that the device should:

• Not negatively affect fluid transport.
• Deliver pressure according to pump settings.
• Maintain alarm functionality.
• Meet biocompatibility criteria (non-cytotoxic, non-sensitizing, non-irritating).

8. The Sample Size for the Training Set:

This information is not applicable. The tested devices are physical components, not machine learning algorithms that require training data.

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

This information is not applicable as there is no training set for these physical devices.

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For over-the-counter use, Exufiber Ag+ may be used for:

• · Abrasions
• · Lacerations
• Minor cuts
• · Minor scalds and burns

Under the supervision of a healthcare professional, Exufiber Ag+ is intended to be used on the following medium to high exuding wounds:

• · Leg ulcers (venous stasis ulcers and ulcers and ulcers of mixed etiology) and diabetic foot ulcers
• · Pressure ulcers (partial and full thickness)
• Partial thickness burns
• · Donor sites and other wounds that are prone to bleeding, such as debrided wounds
• Traumatic wounds
• Surgical wounds that heal by primary intention, such as dermatological incisions (e.g. orthopaedic and vascular), and surgical wounds left to heal by secondary intention, such as dehisced surgical incisions
• · Oncology wounds with exudate, such as fungoides-cutaneous tumours, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma

Exufiber Ag+ may be used for management of wounds as an effective barrier to bacterial penetration of the dressing, as this may help to reduce the risk of infection.

Indicated wear time: up to seven (7) days.

Exufiber Ag+ Antimicrobial Gelling Fibre Dressing is a highly absorbent and gel-forming wound dressing that is intended to be used on medium to high exuding wound fluid, creating a soft gel and maintaining a moist wound healing environment. The dressing consists of a polyvinyl alcohol (PVA) pad or ribbon, coated on both sides with silver sulfate to act as a preservative in the dressing to inhibit or reduce microbial growth.

The provided document is a 510(k) Summary for the "Exufiber Ag+ Antimicrobial Gelling Fibre Dressing" and mainly focuses on demonstrating substantial equivalence to a predicate device ("Aquacel Ag Extra Hydrofiber Dressing with Silver and Strengthening Fiber"). It does not include detailed information about specific acceptance criteria and a study proving the device meets those criteria, as one would expect for a performance study with detailed metrics.

Instead, the document states: "In vitro and in vivo methods have been used to demonstrate the safety and effectiveness of the Exufiber Ag+ Antimicrobial Gelling Fibre Dressing with regards to the following parameters: Cytotoxicity, Irritation, Sensitization, Wound healing model, Antimicrobial efficacy against 11 strains, Silver release kinetics, Minimum effective concentration." It also explicitly states: "No clinical data was required to support substantial equivalence."

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance based on the input text. The information is not present in this regulatory submission.

However, I can extract the general categories of performance data mentioned:

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

The document does not provide a table with specific acceptance criteria (e.g., "cytotoxicity level must be below X") or detailed quantitative reported device performance for these criteria. It only lists the types of tests performed to demonstrate safety and effectiveness.

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

This information is not provided in the document. The studies mentioned are described as "in vitro and in vivo methods," which typically refer to laboratory and animal studies, not human clinical trials 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 information is not provided in the document. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant for the types of in vitro and in vivo safety/effectiveness studies mentioned in this 510(k) summary.

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

This information is not provided in the document, as it's not applicable to the types of studies described (laboratory and animal studies for safety and effectiveness).

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable to an antimicrobial gelling fibre dressing. The document explicitly states "No clinical data was required to support substantial equivalence."

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

This concept is not applicable to a medical device like a wound dressing. This device does not involve an algorithm or AI.

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

For the mentioned studies:

• Cytotoxicity, Irritation, Sensitization: Likely based on standardized biological assay results (e.g., cell viability, skin reactions) compared against established safety thresholds.
• Wound healing model: Likely based on observable physiological changes and measurements in an animal model, compared to controls.
• Antimicrobial efficacy: Likely based on laboratory measurements of bacterial count reduction (e.g., colony-forming units) after exposure to the dressing, compared to specified acceptance criteria.
• Silver release kinetics: Likely based on analytical chemistry measurements of silver concentration over time.
• Minimum effective concentration: Likely based on microbiology experiments to determine the lowest concentration of silver needed to inhibit microbial growth.

8. The sample size for the training set

This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.

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

This is not applicable as the device is a physical wound dressing and does not involve a training set or AI model.

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Mepiseal is intended to be used on periwound skin in conjunction with a wound dressing to prevent leakage and premature loosening of the dressing. It is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. When used under NPWT dressings, Mepiseal serves as a sealant to help create and maintain a seal, which enables delivery of effective negative pressure wound therapy.

When used under NPWT dressings to aid in seal formation, Mepiseal is compatible with the Avance Dressing Kits that include Avance Film with Safetac Technology and Avance Transparent Film.

The subject device is a soft silicone sealant intended to be used on periwound skin in conjunction with a wound dressing and is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. Mepiseal serves the same function as the soft silicone layer of any wound dressing, to maintain the seal of the dressing around the wound. It is considered an accessory to the wound dressing and can be used under conventional wound dressings and under Negative Pressure Wound Therapy (NPWT) dressings.

The provided text is a 510(k) summary for the Mepiseal Soft Silicone Sealant. It describes the device, its intended use, and its comparison to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of typical AI/ML device performance.

The "Performance Data" section states: "Bench testing has been performed to demonstrate that Mepiseal is capable of sealing air leaks in the Avance NPWT system and does not otherwise interfere with the system's ability to transport fluid away from the wound. Mepiseal's performance has been evaluated under both soft silicone films and acrylic films (Avance Film with Safetac Technology and Avance Transparent Film) and found to be acceptable."

This indicates functional testing of the sealing ability and compatibility with an NPWT system, not a study assessing diagnostic performance (like sensitivity, specificity, or AUC) which would be typical for an AI/ML device. Therefore, I cannot provide details for most of your requested points, as they are not applicable to the type of device described (a silicone sealant) or the type of data presented (bench testing for physical functionality).

However, I can extract the following:

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

Based on the provided text, the acceptance criteria implicitly relate to the device's ability to create and maintain a seal for negative pressure wound therapy systems and not interfere with fluid transport. The "reported device performance" is a qualitative statement of meeting these criteria.

2. Sample sized used for the test set and the data provenance: Not applicable. This was bench testing, not a clinical study or AI/ML performance evaluation test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system or diagnostic accuracy was not established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device or a diagnostic device where human reader improvement would be measured.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the physical principles of sealing and fluid transport, verified through bench test measurements.

8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.

9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI/ML algorithm.

In summary, the provided document describes a medical device (a silicone sealant) and its associated bench testing results for a 510(k) submission, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML performance studies (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies) is not present and not relevant to this specific premarket notification.

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Avance Y-connector S is intended for use in the Avance Negative Pressure Wound Therapy (NPWT) system, to connect and allow therapy of multiple wounds simultaneously by using one pump. The Avance NPWT system, with associated products are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

The subject of this submission is the Avance® Y-Connector S, which is an accessory to the Avance® Negative Pressure Wound Therapy (NPWT) System. It allows connection of multiple dressing kits to one pump in order to accommodate large or multiple wounds. We have classified this device as Class II as it is directly indicated for use with an NPWT Pump which falls under that classification, and the Avance® Y-Connector S forms an integral part of the overall system when multiple wound sites require therapy.

The Avance® Y-connector S is a polyurethane/polypropylene based single lumen Yconnector. It is designed to function with existing Avance® NPWT pumps and dressing kits by connecting the Avance® Canister Tubing to two single lumen transfer pads which are applied to the Avance® Foam dressings. Use of the Avance® Y-Connector S allows therapy and transportation of exudate from more than one wound simultaneously using one pump. A maximum of two Avance® Y-Connector S devices may be used to connect three wounds to one pump.

The Molnlycke Health Care Avance® Y-Connector S is an accessory to a Negative Pressure Wound Therapy (NPWT) system, allowing connection of multiple dressing kits to one pump for simultaneous treatment of large or multiple wounds. The provided documentation primarily focuses on demonstrating substantial equivalence to predicate devices and presents performance data from internal testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices or test units. The "NPWT Functionality" test involved a "test setup included the use of the Avance® Y-Connector S to connect multiple wound models," suggesting a laboratory-based, non-clinical evaluation.
• Data Provenance: The testing was conducted internally by Molnlycke Health Care ("internal Mölnlycke test method"). This indicates the data is from the manufacturer's own product development and validation processes. No country of origin is specified for the data itself, but the applicant is Molnlycke Health Care US, LLC. The studies are by nature retrospective as they were conducted to support a 510(k) submission for an already developed device.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. The studies described are primarily benchtop (biocompatibility and functional performance) and do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way, for example, a diagnostic AI device would.

4. Adjudication Method for Test Set

• Not applicable. There was no human interpretation or subjective assessment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging AI or diagnostic AI tools where human readers’ diagnostic accuracy or efficiency is being evaluated with and without AI assistance. The Avance® Y-Connector S is a physical accessory for a medical device and its performance is evaluated through material and functional testing, not through human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

• Yes, a standalone study was performed in the context of device functionality. The "NPWT Functionality" test and biocompatibility tests assess the device's inherent physical and functional properties without human intervention being part of its core performance mechanism. The device itself (the Y-connector) does not have an "algorithm" in the conventional sense of an AI/software device. Its performance is assessed as a standalone physical component within a system.

7. Type of Ground Truth Used

• Biocompatibility: Ground truth was established by adherence to recognized international standards (ISO 10993-5 and ISO 10993-10) for evaluating biological responses to medical devices.
• NPWT Functionality: Ground truth was based on an "internal Mölnlycke test method for fluid transport in NPWT," which likely defines objective criteria for what constitutes sufficient fluid transport. This would involve measurable parameters such as flow rate, pressure maintenance, and absence of leaks, against predefined thresholds.

8. Sample Size for the Training Set

• Not applicable. This device is a physical accessory, not a software or AI algorithm that requires a training set.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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The Biogel® PI Micro Surgical Glove is a disposable device made of Poly-Isoprene material that is intended to be worn on the hands, usually in surgical setting, to provide a barrier against potentially infectious material and other contaminants.

The subiect device is a single-use disposable powder-free surgical glove that is supplied sterile and made from synthetic Poly-Isoprene material (not made from natural rubber latex). The gloves are manufactured using hand-specific molds (right and left hand). Each glove contains a beaded cuff to help reduce cuff roll-down during use.

The document describes the Biogel® PI Micro Surgical Glove, a disposable, powder-free surgical glove made from synthetic Poly-Isoprene material. This device is a modification of the previously cleared Biogel® PI Surgical Glove (K050184), with changes in material thickness and the removal of a donning coating.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies standards and tests (e.g., ISO 10993-10, ASTM D3577, ASTM D5151, ASTM D6124) were used to demonstrate performance. However, the specific sample sizes used for each test are not explicitly stated within this document. The data provenance is also not specified (e.g., country of origin, retrospective or prospective).

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

This section is not applicable as the document describes performance testing based on engineering and material science standards (e.g., biocompatibility testing, physical properties, freedom from holes, powder residual), not on subjective expert assessment of an AI's output.

4. Adjudication method for the test set

This section is not applicable for the same reasons as #3. The performance is objectively measured against established standards.

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

This section is not applicable. This document describes a medical device (surgical glove) that functions as a physical barrier. It is not an AI-powered diagnostic or assistive tool, therefore, MRMC studies involving human readers or AI assistance are irrelevant.

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

This section is not applicable. This is a physical device, not an algorithm. The performance tests evaluate the glove itself.

7. The type of ground truth used

The ground truth for the performance evaluations are established by widely accepted international and national standards for medical devices and surgical gloves. Specifically:

• Biocompatibility: ISO 10993-10
• Dimensions & Physical Properties: ASTM D3577
• Freedom from holes: 21 CFR 800.20 and ASTM D3577, tested according to ASTM D5151
• Powder residual: ASTM D3577, tested using ASTM standard D6124

These standards define the acceptable range or threshold for each characteristic.

8. The sample size for the training set

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

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

This section is not applicable for the same reasons as #8.

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