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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 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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The Gammex(R) Cut Resistant Glove Liner is a single use glove liner intended to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.

Cut resistant under glove liner is a white color liner knitted from an ultrahigh molecular weight polyethylene fiber (UHMWPE) that offers ANSI/ISEA 105 Cut Level Protection against cuts. The liner is knitted using the UHMWPE as the main strengthening component along with nylon and spandex for comfort. The device is a single use device.

The provided text does not describe an AI/ML powered medical device. Instead, it is an FDA 510(k) premarket notification for a medical device called "Gammex® Cut Resistant Glove Liner."

Therefore, it is not possible to answer the request based on the provided document as the questions are specific to the acceptance criteria and study design for an AI/ML powered device.

The document focuses on demonstrating that a cut-resistant glove liner is "substantially equivalent" to a legally marketed predicate device, primarily through performance data against standards (e.g., ANSI/ISEA 105 for cut level, ISO 10993 for biocompatibility) rather than clinical studies or AI model performance.

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LifeStyles® Warm Lovin'™ Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

LifeStyles® Warm Lovin'™ Personal Lubricant is a non-sterile, personal lubricant designed to moisturize and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a clear, nonstaining, long-lasting, warming and biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.

The provided text describes the 510(k) summary for the LifeStyles® Warm Lovin'™ Personal Lubricant, detailing its non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not describe a study involving a device that uses a machine learning algorithm or AI.

Therefore, many of the requested categories related to AI/ML device studies are not applicable to this document.

Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing performed:

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

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

The document describes non-clinical bench testing and biocompatibility studies. Specific sample sizes for these tests are not provided in the summary. The studies are described as "non-clinical testing" and are likely performed in a laboratory setting, not on human subjects where data provenance (country, retrospective/prospective) would typically apply.

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

This is not applicable. The tests performed are laboratory-based and follow established standards (e.g., ASTM, ISO, USP). "Ground truth" in the context of expert consensus is not relevant for this type of device and testing.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert review processes for medical image interpretation or similar tasks, which is not relevant to the described non-clinical testing.

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

This is not applicable. This document describes a personal lubricant and its non-clinical performance; it does not involve AI or human readers for diagnostic tasks.

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

This is not applicable. The device is a personal lubricant, not an algorithm.

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

For the non-clinical testing:

• Condom compatibility: Established by adherence to ASTM D 7661 standards.
• Biocompatibility: Established by adherence to ISO 10993 standards.
• Physical/Chemical properties (viscosity, pH, specific gravity, appearance, color, odor, non-staining): Established through bench testing against internal specifications and comparison to the predicate device.
• Microbial Quality: Established by adherence to USP testing standards.
• Shelf-life: Established by real-time and accelerated aging tests against pre-defined stability criteria.

These are objective, quantifiable measures against established scientific and regulatory standards, rather than subjective "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This is not applicable. There is no training set mentioned as this is not an AI/ML device.

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

This is not applicable. There is no ground truth for a training set as this is not an AI/ML device.

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LifeStyles® Luxe™ Premium Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

LifeStyles® Luxe™ Premium Personal Lubricant is a non-sterile, silicone-based personal lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a biocompatible gel-like liquid that lasts longer than hydrous lubricants, without drying out or becoming sticky, and is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.

The provided text describes a 510(k) submission for a personal lubricant, not an AI-powered medical device or diagnostic tool. Therefore, many of the requested categories related to AI performance, ground truth, expert review, and sample sizes for training/test sets are not applicable to this document.

However, I can extract the acceptance criteria and the "device performance" as reported for this personal lubricant, even though they are for a different type of product than typically discussed in AI contexts.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "sample size" in the context of a test set for an AI model. The testing described (ASTM D7661, ISO 10993, USP <61>/<62>, bench testing, aging tests) would have involved specific sample sizes of the lubricant and test materials (e.g., condom samples, biological samples for biocompatibility), but these quantities are not detailed in this summary.
• Data Provenance: Not applicable in the AI sense. The testing was conducted for regulatory purposes to demonstrate safety and effectiveness for a medical device (personal lubricant) in the USA (submission by Ansell Healthcare Products, LLC in Dothan, AL).

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

Not applicable. This is a physical and chemical product, not one requiring expert human interpretation for "ground truth" as in medical imaging or diagnostics. The "ground truth" here is derived from standardized laboratory tests and measurements.

4. Adjudication method

Not applicable. There was no need for adjudication as the "ground truth" was established through objective tests, not human interpretation.

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-powered device or a diagnostic tool involving human readers.

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

Not applicable. This is a personal lubricant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance was established through:

• Standardized laboratory testing: ASTM D7661 for condom compatibility, ISO 10993 for biocompatibility, USP <61> and USP <62> for microbial quality.
• Bench testing: For aspects like lubrication duration, viscosity, specific gravity, appearance, color, and odor.
• Realtime and accelerated aging tests: For shelf-life.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this product as it is not an AI algorithm.

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

Not applicable, as there is no training set.

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This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment, and tested for use with chemotherapy drugs.

Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs meet all of the current specifications of ASTM D6319-00a(2005)e1, Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance of "Micro-Touch® Nitrile Powder-Free Blue Examination Gloves, Tested for Use with Chemotherapy Drugs" as part of a 510(k) submission (K093523).

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Chemotherapy Drug Permeation Acceptance Criteria: While specific minimum breakthrough times are not explicitly listed as "acceptance criteria" in the table within the document, the "Indications for Use" section presents these values as the performance data for which the device was "tested for use." The underlying acceptance criterion for these drugs would be defined by the ASTM D6978-05 standard for acceptable permeation, likely implying a desired "resistant" or "protective" duration, which the ">240 minutes" results aim to demonstrate. The WARNING regarding Carmustine and ThioTEPA with their lower breakthrough times indicates that these specific drugs do not meet an acceptable level of protection, hence the cautionary instruction.

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

The document does not specify the exact sample sizes (e.g., number of gloves tested) for each of the performance tests (Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Biocompatibility, and Chemotherapy Drug Permeation). It only reports the performance results based on standard test methods.

The data provenance is not explicitly stated in terms of country of origin, nor is it classified as retrospective or prospective. However, given that this is a 510(k) submission for a new device, the testing would generally be considered prospective in nature, performed specifically for regulatory submission.

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

There is no mention of experts being used to establish a "ground truth" in the context of interpretation or diagnosis for this device. This product is a physical device (examination gloves), and its performance is evaluated through standardized laboratory tests, not through expert review of clinical images or data. Therefore, the concept of qualified experts establishing ground truth for a test set is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the performance of the gloves is based on objective laboratory measurements and adherence to ASTM standards, not on subjective assessment requiring adjudication among experts.

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

No. This is not an imaging or diagnostic device that would typically involve human readers or MRMC studies. The device is a medical glove, and its effectiveness is determined by its physical and chemical barrier properties.

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

Yes, in a sense. The testing performed for the gloves is entirely "standalone" in that it evaluates the intrinsic properties of the device itself (e.g., integrity, dimensions, chemical resistance) without human interaction or a "human-in-the-loop" component for its functional assessment. There is no algorithm involved.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Standardized Test Methods and Specifications: Adherence to defined ASTM standards (e.g., ASTM D 6319-00a(2005)e1 for dimensions and physical properties, ASTM D 5151-06 for freedom from holes, ASTM D 6124-06 for powder residue, and ASTM D6978-05 for chemotherapy drug permeation).
• Established Biological Safety Standards: Demonstrated biocompatibility through "Animal Study" results (Primary Skin Irritation and Dermal Sensitization Assay).

These standards and test results serve as the objective "truth" against which the device's performance is measured.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm or a diagnostic system that learns from data.

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

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

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