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These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.

This document is a 510(k) premarket notification for a medical device: "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential" (K230079). It compares the new device to a predicate device (K190018) and provides evidence of performance through various tests.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison of the subject device (K230079) against a predicate device (K190018) and also summarizes non-clinical testing. Below is a compilation of the acceptance criteria (standards/guidance/test criteria) and the reported device performance.

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

• Chemotherapy Drug Permeation (ASTM D6978-05): The document specifies the standard used but does not provide the exact sample size for the test sets (number of gloves or replicates per drug). The data is generated from laboratory testing ("under the conditions of the study"). Data provenance is not explicitly stated but implies laboratory testing for regulatory submission.
• Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Sterility: These tests refer to ASTM and ISO standards (e.g., ASTM D3577, ASTM D5151, ASTM D6124, ISO 11137-1). These standards typically define the sampling plans (e.g., AQL 1.5 for freedom from holes), but the specific number of units tested for this submission is not directly stated. Data provenance implies manufacturer's testing for regulatory submission.
• Biocompatibility (ISO 10993 series): These are biological evaluations. The document refers to "the conditions of the study" and "animal model" for acute systemic toxicity but does not provide specific sample sizes (e.g., number of animals used). Data provenance implies laboratory testing for regulatory submission.
• Human Skin Sensitization (Modified Draize-95 Test): This test was performed on "human subject tested." The sample size (number of human subjects) is not explicitly given, it ambiguously states "the human subject tested." Data provenance is from a clinical test as per FDA guidance.
• Endotoxin Study & Material Mediated Pyrogenicity Study: The document refers to "the conditions of the study" but does not provide sample sizes. Data provenance implies laboratory testing for regulatory submission.

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

This submission is for a physical device (surgical gloves) and its material properties, not an AI/algorithm-driven device requiring expert image interpretation or similar ground truth establishment. Therefore, the concept of "experts" establishing a ground truth in that context is not applicable here. The "ground truth" for the performance tests (e.g., breakthrough time, tensile strength) is established by the validated methodologies of the referenced ASTM and ISO standards.

4. Adjudication Method for the Test Set:

Not applicable in the context of material and physical property testing of a device like surgical gloves. Test results are objective measurements based on defined standard protocols.

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

No, an MRMC comparative effectiveness study was not done. This is not an AI device or a diagnostic imaging device where human reader performance is evaluated.

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

Not applicable as this is not an AI/algorithm device. The performance tests evaluate the physical gloves without any "human-in-the-loop" interaction in the testing methodology itself beyond conducting the tests.

7. The Type of Ground Truth Used:

• Objective Measurement Standards: For most physical and chemical properties (dimensions, strength, freedom from holes, powder, sterility, chemotherapy permeation, endotoxin, pyrogenicity), the "ground truth" is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards. The results are quantitative measurements against these predefined thresholds.
• Biological Response in Models: For biocompatibility tests (cytotoxicity, skin irritation, sensitization, acute systemic toxicity), the "ground truth" is established by observing biological responses in in vitro or in vivo (animal) models as per ISO 10993 standards and the Modified Draize-95 Test for human skin sensitization.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured physical product.

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

Not applicable, as there is no training set for this type of device.

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A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.

Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs." This document outlines the device's characteristics, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a table of non-clinical tests performed on the Gammex® PI Plus Glove-in-Glove™ System.

Chemotherapy Drug Permeation Times (Detailed)

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

The document does not specify sample sizes for individual tests like dimensions, physical properties, freedom from holes, powder-free, sterility, or biocompatibility studies. The general phrasing "Meets ASTM D..." or "Passes..." suggests that the sample sizes typically required by these standards were used.

For the Chemotherapy Drug Permeation Test (ASTM D6978-05), while the results for each drug are provided (Average Breakthrough Detection Time), the document does not specify the number of samples (e.g., gloves or glove specimens) tested for each drug.

The data provenance is prospective in the sense that these are tests conducted specifically for this 510(k) submission to demonstrate the device's performance against established standards. There is no mention of country of origin for the data; it is assumed to be from a testing facility compliant with the mentioned standards.

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

This information is not provided in the document. The "ground truth" for these tests is defined by the objective measurement methods and acceptance criteria specified in the referenced ASTM, ANSI, and ISO standards. These standards themselves are developed by expert consensus, but specific independent expert adjudication for this particular test set is not mentioned or typically required for this type of device and testing.

4. Adjudication Method for the Test Set:

An explicit adjudication method (like 2+1 or 3+1) is not applicable or mentioned for the non-clinical tests described. The tests are objective measurements against predefined criteria outlined in the consensus standards. The "Pass/Fail" results are determined directly by comparing the test outcomes to these established thresholds.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject device." This type of study focuses on human reader performance, often with or without AI assistance, which is not relevant to the physical and chemical resistance properties of a surgical glove.

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

No, a standalone algorithm-only performance study was not done. This device is a physical medical device (surgical glove), not an algorithm or AI software. Therefore, studies evaluating algorithm performance are not relevant.

7. The Type of Ground Truth Used:

The ground truth used for the non-clinical tests is based on consensus standards and laboratory measurements.

• For physical properties, dimensions, freedom from holes, powder residue, and sterility: The ground truth is objective measurement against the specified ASTM and ISO standards' criteria.
• For chemotherapy drug permeation: The ground truth is the measured breakthrough time determined by the ASTM D6978-05 standard.
• For biocompatibility (skin irritation, sensitization, acute systemic toxicity, cytotoxicity): The ground truth is the biological response observed in validated in vitro and in vivo models according to the ISO 10993 series of standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product (surgical glove) and does not involve AI or machine learning algorithms that would require a "training set."

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

Not applicable, as there is no training set for this device.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drugs have extremely low permeation times: 45.4 minutes and Thiotepa: 23.5 minutes. Warning: Do not use with Carmustine or Thiotepa.

Microflex 73-743 Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs is a non-sterile, single use only, disposable, powder free examination gloves. Characteristics: - . Ambidextrous with beaded cuff and straight fingers - Finger-textured . - . Blue colored - Five (5) sizes – extra-small, small, medium, large, and extra-large - . Tested against chemotherapy drugs High levels of ozone will degrade rubber material of the glove; therefore, the glove should be protected from ozone in particular. The glove is designed to meet the specifications of ASTM D6977-19, Standard Specification for Polychloroprene Examination Gloves for Medical Application.

This document is a 510(k) premarket notification for a medical device: "Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs".

The information provided describes the product's acceptance criteria and the non-clinical testing performed to demonstrate that the device meets some of these criteria. However, it does not describe an AI/ML-driven medical device, nor does it detail a study proving that an AI/ML device meets acceptance criteria. Therefore, I am unable to answer the questions related to AI/ML device performance, ground truth, expert opinions, or MRMC studies.

Instead, I will extract the acceptance criteria and study information related to the glove's performance as described in the document.

Acceptance Criteria and Study for the Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs

This submission is for a physical medical device (examination glove), not an AI/ML system. Therefore, the "acceptance criteria" relate to the physical and chemical performance characteristics of the glove. The "study" refers to non-clinical laboratory testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed against recognized standards, primarily ASTM D6977-19, ASTM D5151, ASTM D6124, and ASTM D6978-05 for chemotherapy drug permeation, as well as ISO 10993 series for biocompatibility.

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

The document does not specify exact sample sizes for each test beyond indicating the tests were conducted. However, standards like ASTM and ISO have prescribed sample sizes and methodologies. For instance, for chemotherapy drug permeation testing as per ASTM D6978-05, a minimum of three specimens are tested per drug (indicated by "Average Minimum Breakthrough Detection Time (Sample 1,2,3)").

The data provenance is not explicitly stated as retrospective or prospective or by country of origin, but it originates from non-clinical laboratory testing performed to meet recognized international standards. This type of testing is typically prospective, conducted under controlled laboratory conditions.

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

This is not applicable as this is a non-clinical device that relies on standardized laboratory testing rather than human expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. The testing is based on objective measurements and adherence to specified standard protocols, not expert 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/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the performance claims of this medical glove consists of measurements obtained according to established and recognized international laboratory standards (e.g., ASTM, ISO). For example:

• Physical dimensions and properties are measured directly.
• Freedom from holes is determined by a water leak test.
• Powder residual is measured gravimetrically.
• Biocompatibility is assessed through in vitro and in vivo biological tests with specific endpoints (e.g., cell viability for cytotoxicity, skin reactions for irritation/sensitization).
• Chemotherapy drug permeation is measured using highly sensitive analytical methods to detect breakthrough time.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device; there is no "training set."

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs. Please note that the following drug has an extremely low permeation time: Carmustine: 47.9 minutes (Blue), 49.6 minutes (Green), 27.6 minutes (Black). Warning: Do not use with Carmustine.

Microflex® Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex® Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable, powder free examination gloves are made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the gloves to make donning easy.

Characteristics:

• . Ambidextrous with beaded cuff and straight fingers
• . Finger-textured
• Blue, green, or black colored .
• . Four (4) sizes - small, medium, large, and extra-large
• . Tested against chemotherapy drugs and fentanyl citrate

High levels of ozone will degrade rubber material of the gloves; therefore, the gloves should be protected from ozone in particular.

The gloves are designed to meet the specifications of ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

This is an analysis of a 510(k) Premarket Notification for medical gloves, which are considered Class I devices. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing against established standards rather than clinical studies involving human patients or complex AI algorithms.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by referring to ASTM and ISO standards for examination gloves. The reported device performance indicates that the gloves meet or exceed these standards.

Microflex Nitrile Patient Examination Gloves (Blue, Green, Black)

Note: For chemotherapy drug permeation, the acceptance criterion isn't explicitly stated as a single value (e.g., ">X minutes"), but the comparison is made against the predicate device and the standard, indicating the longer the breakthrough time, the better the performance. The warning for Carmustine suggests that its specific permeation time is deemed too low for safe use with these gloves.

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

The document does not explicitly state the total sample size for each specific test. However, for the Chemotherapy Drug Permeation testing, it indicates "Average Minimum Breakthrough Detection Time (Sample 1,2,3) (Minutes)", implying that at least 3 samples were tested for each drug/glove combination.

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is generally understood that such testing is conducted in a laboratory setting for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission pertains to physical and chemical performance testing of medical gloves, not a diagnostic device that requires expert interpretation of images or patient data to establish ground truth. The "ground truth" for these tests is defined by the objective measurements according to the specified ASTM and ISO standards (e.g., direct measurement of length, tensile strength testing, chemical permeation detection).

4. Adjudication Method for the Test Set

Not applicable. As there are no human interpretations or judgments required for establishing the "ground truth" (instead, it's objective measurement against standards), no adjudication method (like 2+1 or 3+1) is mentioned or relevant.

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

No MRMC study was done. This is a Class I medical device (gloves) and not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device does not involve an algorithm. The performance studies are laboratory tests of the physical, chemical, and biological properties of the gloves.

7. Type of Ground Truth Used

The ground truth for the performance claims is based on objective measurements obtained through standardized laboratory tests according to recognized national and international standards, specifically:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions and physical properties like tensile strength, elongation, freedom from holes).
• ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D6978-05: Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
• ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
• ISO 10993-11:2006: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set" in the computational sense. The product development likely involved iterative design and testing, but not a formally defined "training set" for an algorithm.

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

Not applicable. (See point 8).

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Colored Tested for Use with Chemotherapy Drugs, Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Green Colored Tested for Use with Chemotherapy Drugs, Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy.

The provided text describes the acceptance criteria and the study that proves Ansell Healthcare Products LLC's Microflex® Nitrile Patient Examination Gloves (Blue, Green, and Pink colored) meet these criteria for use with chemotherapy drugs and, for the pink glove, Fentanyl Citrate.

Here's the breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are based on various ASTM standards and ISO standards for biocompatibility, in addition to performance against specific chemotherapy drugs. The reported device performance is directly compared against these standards and against a legally marketed predicate device (Micro-Touch NitraTex Sterile Nitrile Powder-Free Blue Examination Gloves, K082457).

Acceptance Criteria & Device Performance – Summary Table

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

• Test Set Sample Size: The document does not specify the exact sample sizes (number of gloves or test replicates) used for each physical, chemical (chemotherapy permeation), and biocompatibility test. It only provides the summarized results (e.g., minimum values, average breakthrough times, or "meets requirements").
• Data Provenance: The data comes from the testing performed by the manufacturer, Ansell Healthcare Products LLC, for their 510(k) premarket notification. The document itself does not specify the country of origin where the testing was physically conducted. The data is retrospective in the sense that it was generated for the purpose of this submission, rather than a prospective clinical trial.

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

• This submission is for medical gloves and relies on laboratory-based performance testing against established ASTM and ISO standards, not human expert interpretation of medical images or patient data. Therefore, the concept of "ground truth" established by a panel of medical experts (like radiologists for imaging devices) is not applicable here. The "ground truth" is defined by the objective measurement protocols outlined in the referenced standards (e.g., ASTM D6319-10 for physical characteristics, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility). The testing would have been conducted by trained laboratory personnel in accordance with these validated methods.

4. Adjudication Method for the Test Set

• As the "ground truth" is based on objective laboratory measurements against defined standards, there is no adjudication method by multiple human reviewers in the context of medical image interpretation. The testing results are quantitative and directly compared to the numerical criteria specified in the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This device is a medical glove, not an AI-assisted diagnostic tool. Therefore, the concept of assessing human reader improvement with or without AI assistance is not relevant to this submission. The device's performance is measured by its physical properties, barrier protection, and biocompatibility.

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

• No standalone algorithm performance study was done. This device is a physical product (a glove), not a software algorithm. Its performance is assessed through laboratory tests as described above.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for this device is based on objective, standardized laboratory test methods and their defined acceptance criteria. This includes:
  • Physical Properties: Measurements (dimensions, tensile strength, elongation) compared against ASTM D6319-10.
  • Barrier Integrity: Freedom from holes assessed against ASTM D6319-10 and ASTM D5151-06 (AQL 2.5).
  • Chemical Permeation: Breakthrough detection times for chemotherapy drugs and Fentanyl Citrate determined per ASTM D6978-05.
  • Biocompatibility: In vitro and in vivo testing for cytotoxicity, skin irritation, sensitization, and acute systemic toxicity evaluated against ISO 10993 series.

8. The Sample Size for the Training Set

• This submission describes a medical device (gloves), not an AI/ML algorithm. Therefore, the concept of a "training set" for model development is not applicable. The gloves were manufactured and then tested according to established quality control and regulatory requirements.

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

• As there is no training set for an AI/ML model, there is no ground truth established for a training set. The device's performance is demonstrated through direct testing against predefined physical, chemical, and biological standards.

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Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents

This document is a 510(k) Premarket Notification from the FDA for a medical device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs. The document details the substantial equivalence determination for the device.

Based on the provided text, the device in question is surgical gloves, not an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested elements of the prompt (ground truth establishment for training/test sets, expert adjudication, MRMC studies, AI effect size, etc.) are not applicable to this type of medical device submission.

The "acceptance criteria" for a physical device like a glove are typically performance specifications based on established standards (e.g., ASTM standards for dimensions, physical properties, lack of holes, chemical permeation). The "study that proves the device meets the acceptance criteria" refers to non-clinical laboratory testing.

Here's an attempt to answer the prompt using the available information, noting where AI-specific questions are not relevant:

Device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs

Type of Study: Non-clinical laboratory testing to assess the physical properties, chemical permeation resistance, and biocompatibility of the surgical gloves, demonstrating substantial equivalence to a predicate device.

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

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

• Sample Size for Testing: The document does not explicitly state the total number of gloves or samples tested for each criterion. It mentions "Minimum Breakthrough Detection Time (Sample 1,2,3)" in one table (page 5), implying at least 3 samples were used for chemotherapy permeation testing for each chemical. Standard testing protocols (like ASTM) would dictate specific sample sizes for each test.
• Data Provenance: The testing was "independent laboratory testing" performed by Ansell. The country of origin of the data is not specified, but the submission is to the U.S. FDA by an LLC based in Reno, Nevada, USA. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.

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

• Not Applicable. For a physical device like surgical gloves, "ground truth" is established by adherence to recognized national and international testing standards (e.g., ASTM, ISO). These standards define the methodologies and acceptance limits for physical, chemical, and biological performance. Experts involved would be laboratory technicians and engineers specializing in materials testing and biocompatibility, but not in the sense of clinical "expert readers" for diagnostic images.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus "ground truth" in subjective assessments, such as radiology interpretations or clinical diagnoses. For physical device testing, results are typically quantitative measurementsagainst predefined criteria.

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

• Not Applicable. This is a physical medical device (surgical gloves), not an AI-based diagnostic or assistive technology for human readers.

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

• Not Applicable. This is a physical device, not an algorithm. Standalone performance is assessed through the non-clinical laboratory tests showing the glove's inherent properties and resistance.

7. The type of ground truth used:

• Standard-based performance metrics and established laboratory methods. The "ground truth" for this device is based on meeting the performance requirements outlined in:
  • ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
  • ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
  • ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
  • ANSI/AAMI/ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
  • ISO 10993 (Biological evaluation of medical devices), specifically Parts 5 (cytotoxicity), 10 (irritation and sensitization), and 11 (systemic toxicity).
  • ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI algorithm for this type of device submission. The device itself is manufactured; it does not "learn" from data.

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

• Not Applicable. See point 8.

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Gammex PI Hybrid Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Gammex Pl Hybrid Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic rubber blend of polyisoprene and polychoroprene. A polyurethane polymer coating is applied to the inner surface of the glove to make donning eay. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and effective for handling chemotherapy agents.

The provided text describes the acceptance criteria and performance of the Gammex PI Hybrid Surgical Gloves, specifically regarding their resistance to chemotherapy drug permeation.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for chemotherapy drug permeation are implicitly defined by the reported "Minimum Breakthrough Detection Time" for each drug when tested according to ASTM D6978-05. A longer breakthrough time indicates better performance. For most drugs, the performance (>240 minutes) suggests that the gloves resist permeation for at least 4 hours, which is likely the desired acceptance criterion for practical use. The specific acceptance criteria for most physical/biological aspects are meeting the referenced ASTM and ISO standards.

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

• Chemotherapy Permeation: For the permation testing, the table in section {5} (and {2}) indicates that the "Minimum Breakthrough Detection Time" is based on 3 samples (Sample 1, 2, 3), specifically shown for Carmustine and ThioTEPA. For other drugs, only the aggregate ">240" is given, implying consistent results across samples.
• Freedom from holes: For the specific ASTM D3577-09 test mentioned in section {6}, the sample size for this attribute was 100 pieces for a lot size of 35,001 to 150,000 pieces.
• Powder-Free: The average residual powder content (0.48mg per glove) was determined "during process validation," but the specific sample size for this validation is not detailed.
• Other tests (Dimensions, Physical Properties, Biocompatibility, Sterility): The sample sizes for these tests are not explicitly stated in the provided documents, but they would have been conducted according to the requirements of the respective ASTM/ISO standards.
• Data Provenance: The studies were conducted by Ansell Healthcare Products LLC, presumably at an independent laboratory, to support a labeling modification. The data is retrospective in the sense that it was performed on an already cleared device (K151694) to add a new claim (chemotherapy drug handling), rather than being part of the initial device development for the base glove. The country of origin of the data is not specified, but the applicant is based in the USA.

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

This information is not applicable as the tests performed are objective, laboratory-based chemical and physical property tests, not interpretive studies requiring human expert assessment (like image analysis or clinical diagnosis). The "ground truth" is established by direct measurement of permeation time or other physical/chemical properties according to standardized methods.

4. Adjudication Method for the Test Set

This information is not applicable. As these are laboratory measurements, there is no adjudication method in the sense of reconciling different expert opinions. The results are quantitative measurements against a predefined standard. For instance, breakthrough time is measured directly using analytical techniques.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices." The evaluation focuses on the physical and chemical resistance properties of the gloves, not on human reader performance.

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

No, a standalone algorithm performance study was not done. This device (surgical gloves) is a physical product and does not involve any artificial intelligence algorithms or software. The evaluation is solely on the physical and chemical properties of the gloves themselves.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Direct Physical and Chemical Measurements: For chemotherapy permeation, dimensions, physical properties, freedom from holes, powder residue, and sterility.
• Standardized Biological Assay Results: For biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
  These are objective, quantitative results obtained through testing methods specified in internationally recognized standards (ASTM, ISO).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product (surgical gloves) and does not involve any machine learning algorithms that require a "training set."

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

This information is not applicable for the same reason as point 8. No training set or associated ground truth was required for the evaluation of this physical medical device.

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Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. When used as an underglove, the glove is intended to promote visibility of a fluid that breaches/enters the glove via an increased spreading rate.

Gammex Pl Breach Detect Powder Free Surgical Glove is a sterile, green in color, single use disposable powder free surgical glove. The glove is made of synthetic polyisoprene rubber. A polymer is applied to the inner surface of the glove to make donning easy. The glove's outer surface is coated with a surface-active agent and when used as an under-glove, this coating and the glove's green color can improve visibility of a glove breach by promoting wetting of the glove surface and spreading of bodily fluid penetrating the breach.

This document describes a 510(k) premarket notification for a medical device called "Gammex PI Breach Detect Powder Free Surgical Glove" (K171375). However, the document does not contain the kind of detailed information about acceptance criteria and performance study results that would typically be found for an AI/ML-driven medical device, such as a diagnostic algorithm.

The device in question is a surgical glove, which is a Class I device. The FDA's review for Class I devices generally focuses on demonstrating substantial equivalence to a predicate device based on defined physical, material, and biocompatibility characteristics, rather than extensive clinical performance studies or AI model validation.

Therefore, many of the specific questions you've asked (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, ground truth for training sets) are not applicable to this device and the information provided in this 510(k) summary.

Here's a breakdown based on the provided text, addressing what is available and explaining why other aspects are absent:

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

The document provides a table outlining "Technological Characteristics" compared to ASTM or equivalent standards. These function as the acceptance criteria for a surgical glove.

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The performance data refers to standard compliance tests (e.g., ASTM standards for glove characteristics). These tests involve sampling plans as defined within the respective standards, but the specific number of gloves tested for each characteristic is not provided in this summary.
• Data Provenance: Not applicable. These are laboratory test results based on manufactured glove samples. The data is not patient-derived from specific countries or retrospective/prospective studies.

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

• Not Applicable. This device is a physical product (surgical glove), not an AI/ML diagnostic device requiring expert interpretation of medical images or data for ground truth.

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-assisted diagnostic device. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices."

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

• Not Applicable. There is no algorithm.

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

• Ground truth for this device is based on established engineering standards and material science properties (e.g., ASTM standards for dimensions, tensile strength, freedom from holes, powder residue; ISO standards for biocompatibility and sterility). The "truth" is whether the glove meets the specified physical and biological performance characteristics.

8. The sample size for the training set:

• Not Applicable. There is no AI/ML model for which to define a training set.

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

• Not Applicable.

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Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.

The MICRO-TOUCH® DENTA-GLOVE® Nitrile HydraSoft™ are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. A polyacrylic polymer is applied to the inner surface of the glove to make donning easy. Hydrasoft coating (containing glycerine) is applied on top of the polymer coating on the glove inner surface..

Characteristic:

• Ambidextrous with beaded cuff and straight fingers
• Finger-textured,
• White colored
• Featuring inner coating of polyacrylic polymer coating and HydraSoft™ coating.
• . Five (5) sizes – extra-small, small, medium, large, and extra-large.

The provided text describes the acceptance criteria and performance data for a medical device, the "Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves."

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document focuses on non-clinical performance data and refers to established ASTM and ISO standards for testing. Specific sample sizes for each test are not explicitly stated in this summary but would be defined within the referenced ASTM and ISO standards. The data provenance is derived from these standard-compliant tests conducted on the device. No information on country of origin of the data is provided, nor whether it is retrospective or prospective, as these terms typically apply to clinical studies.

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

This information is not applicable to this document. The "ground truth" for evaluating this device's performance is based on established engineering and biocompatibility standards (ASTM and ISO), not expert consensus in a clinical context.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically used in clinical studies involving human readers/interpreters, not for performance testing against established engineering standards like those for examination gloves.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices." This type of study would involve human readers (e.g., medical professionals) evaluating cases, which is not relevant for this device.

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

This information is not applicable given the device is a patient examination glove, not an AI algorithm. The performance evaluation is based on direct physical and chemical testing of the glove itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are established international and national standards for medical devices, specifically:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
• ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
• ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2010: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
• ISO 10993-11:2006: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity.

8. The Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in that context.

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

This information is not applicable for the reasons stated in point 8.

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Skyn Original Polyisoprene Lubricated Male Condom - Flavored is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).

The Skyn Original Polyisoprene Lubricated Male Condom – Flavored is a male contraceptive and prophylactic device made from synthetic rubber Polyisoprene latex with a lubricant coating containing silicone gel with flavor oil provides a pleasant aroma/flavor for the end user. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3 year shelf-life.

The provided text describes a 510(k) premarket notification for a medical device, specifically a flavored male condom. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets acceptance criteria in the typical sense of diagnostic or AI-driven medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., test sets, ground truth, expert adjudication, MRMC studies) is not applicable or cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the performance data as presented for this specific device based on the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for the mechanical property, biocompatibility, or shelf-life tests. It mentions that performance testing was conducted according to ISO 23409:2011 and FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)." The provenance of the data is that these were tests conducted by the manufacturer, Ansell Healthcare Products LLC, for their K171172 submission. The tests were likely prospective in nature, specifically designed to support this submission.

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 and not provided. The "ground truth" for condom performance is established through standardized physical, chemical, and biological testing as per international standards (ISO) and FDA guidance, not through expert consensus or interpretation of medical images/diagnoses.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation or uncertain clinical outcomes. Condom performance tests rely on objective measurements and pass/fail criteria.

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

This is not applicable. The device is a physical medical device (condom), not an AI-driven diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This is not applicable as there is no algorithm involved.

7. The type of ground truth used

The "ground truth" for this device's performance is based on objective measurements against established engineering and biological standards (ISO 23409:2011) and regulatory guidance documents from the FDA for condom testing. This includes:

• Physical properties (e.g., dimensions, strength, integrity) confirmed through laboratory testing.
• Chemical properties (e.g., lubricant composition, flavor oil compatibility).
• Biocompatibility assessments based on recognized biological evaluation standards.
• Shelf-life stability data.

8. The sample size for the training set

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

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

This is not applicable as there is no training set for an AI algorithm.

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