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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs. The subject devices are identical in design and formulation to the predicate gloves of K230121.

The provided FDA 510(k) clearance letter pertains to Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), a medical device. This type of device is classified as a Class I medical device and does not involve AI/ML technology. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods, effect sizes) are not applicable.

The acceptance criteria and device performance are primarily evaluated based on material properties, chemical permeation resistance, and biocompatibility, using established ASTM and ISO standards for examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device, "NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)", was tested against various physical, chemical, and biological criteria.

Detailed Chemotherapy Drug and Fentanyl Citrate Permeation Performance:

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

The document does not explicitly state the exact sample sizes for each test (e.g., number of gloves tested for permeation, holes, dimensions, etc.) but refers to adherence to the methodologies outlined in the specified ASTM and ISO standards. These standards typically define minimum sample sizes for material testing.

• Data Provenance: The document states the applicant is from Malaysia (Careglove Global Sdn. Bhd.). The testing was conducted according to international standards (ASTM, ISO), implying the tests were performed in a controlled laboratory environment, likely by the manufacturer or a contracted lab. The data is non-clinical and derived from prospective testing of manufactured glove samples.

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

Not applicable. This device is not an AI/ML device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" for material properties is established by the physical and chemical measurements themselves, according to standardized protocols and certified laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML device that requires adjudication for interpretations. Test results are objective measurements against predefined criteria.

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

Not applicable. MRMC studies are relevant for diagnostic or interpretive AI/ML devices where human readers' performance is evaluated with and without AI assistance. This is a physical and chemical barrier device.

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

Not applicable. This device is a passive physical barrier and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements of physical properties (e.g., length, thickness, tensile strength, elongation), chemical resistance (breakthrough detection time), and biological reactivity (biocompatibility tests), as defined by internationally recognized standards (ASTM, ISO). There is no subjective human "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes "training."

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

Not applicable. This is not an AI/ML device. The manufacturing process of the gloves is designed to meet the specified standards, and quality control ensures consistency, but this is not "training" in the context of AI/ML.

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NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.

Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes

Warning: Not for Use with: Carmustine, ThioTEPA

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the watertightness test (ASTM D5151/ASTM D6319), it reports "0/125/Pass" which indicates a sample size of 125 gloves were tested for holes, and none failed.

The non-clinical tests were conducted to verify that the proposed device met all design specifications according to recognized standards. The identity of the testing laboratories or the origin of the samples is not specified in this document.

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

This document describes non-clinical performance testing of a physical device (gloves). Therefore, there is no "ground truth" derived from expert interpretation of medical images or data in the typical sense. The ground truth for these tests is established by the specified standards (ASTM and ISO standards) themselves, which outline quantitative metrics and methodologies for evaluation. No human experts are explicitly mentioned as establishing ground truth for these specific tests.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against established standards, not subjective assessments requiring adjudication or consensus among experts.

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

No. An MRMC comparative effectiveness study is not applicable to the non-clinical performance testing of medical gloves. This type of study is typically used for evaluating the effectiveness of diagnostic or prognostic medical devices that rely on human interpretation, often with AI assistance, in comparison to human interpretation alone.

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

Not applicable. This document pertains to the physical performance of medical gloves, not a software algorithm that would operate in a standalone mode.

7. Type of Ground Truth Used

The ground truth for all tests is based on established testing standards and their quantitative acceptance criteria. For example:

• Physical dimensions are compared against numerical ranges specified in ASTM D6319-19.
• Watertightness is assessed by the absence of holes per ASTM D5151-19, with an acceptable quality level (AQL).
• Powder content is measured against a maximum limit per ASTM D6124-06.
• Tensile strength and ultimate elongation are measured against minimum requirements per ASTM D6319-19.
• Chemotherapy drug permeation is determined by breakthrough detection times as per ASTM D6978-05(2023).
• Biocompatibility tests (cytotoxicity, irritation, sensitization, acute systemic toxicity) are evaluated according to ISO 10993 series standards.

8. Sample Size for the Training Set

Not applicable. This document is about a physical medical device (gloves) and its non-clinical performance testing, not an AI/ML-based device that requires a training set.

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

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

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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves, Dual Color Black-Blue are Class I Patient Examination Gloves. The glove is made dual color by double dipping. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19. The gloves are single use, disposable, and provided non-sterile.

This document describes the non-clinical performance data for the "Nitrile Examination Gloves, Dual Color Black-Blue" (K232550) and compares it to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test in the "Summary of Non-Clinical Performance Data" section. It refers to various ASTM and ISO standards, which typically specify sample sizes for their respective test methodologies. The data provenance is not specified, but it can be inferred that these are laboratory tests performed on samples of the device.

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

Not applicable. These are laboratory-based performance tests for a medical device (examination gloves), not studies requiring expert interpretation of medical images or patient data. The "ground truth" is established by the standardized test methodologies themselves.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication. The results are based on objective measurements and observations according to standardized test protocols.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases. This document pertains to the performance of examination gloves.

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

Not applicable. This document is for a physical medical device (examination gloves), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria is established by the specifications defined within the referenced ASTM and ISO standards (e.g., minimum length, maximum powder residue, specified AQL for water leak test, biological response classifications).

8. The Sample Size for the Training Set

Not applicable. This document pertains to the performance of a physical medical device (examination gloves) through non-clinical testing, not a machine learning or AI model that requires a training set.

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

Not applicable (as explained in point 8).

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powderfree variation of the class I Nitrile Patient Examination Gloves which is coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs and Fentanyl Citrate.

This document describes the testing for Nitrile Examination Gloves, focusing on their resistance to chemotherapy drugs and Fentanyl Citrate. The study assesses the gloves' physical properties, biocompatibility, and chemical permeation alongside the reported device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy and Fentanyl Citrate Permeation (Minimum Breakthrough Detection Time)

Physical Properties, Dimensional, and Biocompatibility Testing

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

The document does not explicitly state the sample size (number of gloves) used for the permeation, physical property, or biocompatibility tests.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, the tests were conducted according to international standards (e.g., ASTM, ISO), which implies a standardized, prospective testing approach in a laboratory setting. The applicant is based in Malaysia.

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

Not applicable. This is not a study involving expert readers or ground truth established by medical professionals. The "ground truth" for this device is determined by objective, standardized laboratory measurements (e.g., chemical permeation time, physical properties, biological reactions) as defined by the referenced ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There was no human adjudication process involved as the "ground truth" is determined by objective laboratory measurements and adherence to specified test standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is examination gloves, and its performance is evaluated through physical, chemical, and biological testing, not by human readers interpreting cases.

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

Not applicable. This is a medical device (examination gloves), not an AI algorithm. Therefore, the concept of "standalone" performance for an algorithm does not apply. All listed tests are "standalone" in the sense that they assess the intrinsic properties of the glove without human intervention in the measurement process itself, though human technicians conduct and analyze the tests.

7. The Type of Ground Truth Used

The ground truth used for this study is based on:

• Performance Standards: Defined by international standards such as ASTM D6978-05 (for chemotherapy drug permeation), ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (for physical properties and hole freedom), and ISO 10993-10, ISO 10993-5:2009, ISO 10993-11 (for biocompatibility).
• Objective Laboratory Measurements: Direct measurements of breakthrough time, dimensional properties, tensile strength, elongation, residual powder, and biological response to the glove materials.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned or implied in this submission, as the device is not an AI/ML algorithm that requires training data.

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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Nitrile Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319 -19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color have Finger Texture, Ambidextrous, single-use, and are powderfree. The product is non-sterile.

The provided document K222813 describes the acceptance criteria and the study that proves the Ecoglove Nitrile Examination Gloves meet these criteria.

Here's the detailed breakdown:

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

Note: For the "In Vitro Cytotoxicity" test, the proposed device failed the initial acceptance criteria of being "Non-cytotoxic". However, the document includes a note (Note1 in Table 1) stating: "Additional testing was performed to determine if this was a systemic toxicity concern." This implies that while the initial in vitro result was
considered "Fail" against the direct "Non-cytotoxic" criterion, further investigation might have clarified that it does not pose a systemic toxicity concern.

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

The document does not explicitly state the specific sample sizes used for each performance test (dimension, physical properties, hole detection, powder residue, and biocompatibility). However, it implies that the tests were conducted according to established ASTM standards (D6319-19, D5151-19, D6124-06) and ISO standards (10993-5:2009, 10993-10:2021, 10993-23:2021, 10993-11:2017). These standards typically specify sampling plans and test methodologies.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are non-clinical performance and biocompatibility tests, which are typically conducted in a controlled laboratory setting.

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. The device is a "Nitrile Examination Glove," which is a physical product subject to objective performance testing against established standards, not a diagnostic or AI-driven device requiring expert interpretation for ground truth.

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

This information is not applicable. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, like medical imaging or clinical trials. The tests performed for this device are objective laboratory tests.

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

This information is not applicable. This device is a medical glove, not an AI-assisted diagnostic tool.

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

This information is not applicable. This is not an algorithm-based device.

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

The "ground truth" for the performance tests relies on industry standards (ASTM and ISO) which define acceptable limits for physical properties, barrier integrity, and chemical residue. For biocompatibility, the ground truth is defined by the criteria established in the ISO 10993 series of standards.

8. The sample size for the training set:

This information is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

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

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Single use disposable device intended for medical purposes that is worn on the hands of examiners to prevent contamination between the examiner and the patient.

Nitrile Examination Gloves

The provided text is an FDA 510(k) clearance letter for Nitrile Examination Gloves. It does not contain any information about acceptance criteria, device performance, or studies related to AI/algorithm performance.

The letter focuses on regulatory approval, stating that the device is substantially equivalent to legally marketed predicate devices. It lists the regulation number, product code, and indications for use of the gloves. It also outlines the regulatory obligations of the manufacturer.

Therefore, I cannot provide the requested information based on this document. The questions you've asked are typically relevant to the performance evaluation of a software-as-a-medical-device (SaMD) or AI-powered medical device, which is not what this document describes.

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Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.

Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only. Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for "Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)":

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

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

The document does not explicitly state the specific sample sizes used for each test. For many of the physical and chemical property tests (e.g., dimensions, tensile strength, freedom from holes, residual powder, chemotherapy drug permeation), the relevant ASTM standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05) would specify the required statistical sampling plans, but the summary document only provides the results.

Similarly, for biocompatibility tests (ISO 10993 series), the number of animals or cell cultures used is not detailed in this summary, but the standards themselves outline the required protocols.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that these are bench and lab tests for a premarket notification, it's highly probable that the tests were conducted prospectively by the manufacturer or a contracted testing laboratory to demonstrate compliance with the referenced standards.

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 since the studies performed are bench testing and biocompatibility testing against established international standards (ASTM and ISO). These types of tests do not typically involve human experts establishing a "ground truth" through interpretation, as would be the case for an AI diagnostic device. Instead, the "ground truth" is defined by the objective measurement parameters and criteria specified in the standard test methods themselves.

4. Adjudication method for the test set

Not applicable. As noted above, these are objective bench and lab tests against predefined specifications in standards. There is no subjective interpretation requiring an adjudication method like 2+1 or 3+1. The results are quantitative measurements or direct observations (e.g., passes/fails AQL).

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

Not applicable. This device is a medical glove, not an AI diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or would be relevant.

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

Not applicable. This device is a medical glove, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the performance evaluation of these nitrile examination gloves are the acceptance criteria defined by the relevant ASTM and ISO standards. These standards provide:

• Specific measurable thresholds (e.g., minimum length, minimum tensile strength, maximum residual powder).
• Defined test methods and methodologies (e.g., how to measure breakthrough time for chemotherapy drugs, how to assess irritation or sensitization).
• Statistical sampling plans (e.g., AQL for freedom from holes).

Compliance with these pre-defined, objective criteria from the standards constitutes the "ground truth" for the device's performance.

8. The sample size for the training set

Not applicable. This is a physical device (medical glove), not an AI model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The device is powder free nitrile examination gloves. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.

The provided text is for a 510(k) premarket notification for Nitrile Examination Gloves, a Class I medical device. This type of device is a physical product, not an AI/ML algorithm or software. Therefore, the "acceptance criteria and the study that proves the device meets the acceptance criteria" requested in the prompt refers to physical and biological performance testing for the gloves, not to a study about the performance of an AI model.

Here's the breakdown of the information based on the provided text, adapted for a physical device:

Acceptance Criteria and Device Performance for Nitrile Examination Gloves

The study to prove the device meets acceptance criteria involved non-clinical tests based on recognized standards for medical gloves.

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 explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for dimensions, holes, etc.) or the provenance of the materials/specimens (e.g., country of origin, retrospective or prospective). It indicates that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the "ground truth" for a physical device like medical gloves is established through direct physical, chemical, and biological testing according to predefined standards and objective measurements, not by expert consensus on interpretations. The tests are performed by trained personnel in laboratories.

4. Adjudication method for the test set
Not applicable. The tests involve objective measurements against pass/fail criteria from recognized standards, not expert adjudication of subjective assessments.

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 (nitrile examination gloves), not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used
The ground truth is established by objective measurements and observations in accordance with standardized test methods (ASTM and ISO standards). For example:

• Physical Dimensions: Measured length and width of gloves.
• Thickness: Measured thickness at finger and palm.
• Physical Properties (Tensile Strength, Elongation): Mechanically tested to quantify material strength and stretch.
• Watertightness: Direct testing for leaks/holes.
• Powder Content: Quantified residue weight.
• Biocompatibility (Systemic Toxicity, Irritation, Sensitization): In vivo animal testing or in vitro assays as defined by ISO 10993 standards to observe biological reactions.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The manufacturing process is validated, not trained.

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 or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.

The proposed Nitrile Examination Gloves are ambidextrous, non-sterile, powder-free, Not made with natural rubber latex and is made of nitrile (Butyronitrile latex) . It has a finger textured surface and is colored blue. This is a single use, disposable device(s), provided non-sterile. The device is provided in 4 sizes, from small to extra-large.

The provided text is a 510(k) Summary for Nitrile Examination Gloves (K212929). It does not describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

The document discusses the following for the Nitrile Examination Gloves:

• Acceptance Criteria and Reported Device Performance (Table I and II): These tables detail physical properties (dimensions, tensile strength, elongation), freedom from holes, residual powder, and biocompatibility tests (irritation, sensitization, systemic toxicity, cytotoxicity). The "Reported Device Performance" is the "Proposed Device Nitrile Examination Gloves" column in Table I and the "Results" column in Table II, showing that the product meets or exceeds the specified acceptance criteria for each test.
• Study Proving Device Meets Acceptance Criteria: The study proving the device meets the acceptance criteria consists of adherence to established ASTM and ISO standards for examination gloves. These are non-clinical (laboratory) tests.
• Sample Size: For the physical dimensions and properties, the sample sizes are not explicitly stated, but the ASTM standards followed would specify these. For "Watertightness Test for Detection of Holes," the result is "0/200/Pass," implying a sample size of 200 gloves tested.
• Data Provenance: The data provenance is from laboratory testing performed on the "Proposed Device Nitrile Examination Gloves." The country of origin of the data is not specified, but the manufacturer is WATCHTOWER PPE SUPPLIES, INC. located in Hicksville, New York, USA. The tests are non-clinical, so the concepts of retrospective/prospective clinical data do not apply.
• Experts/Ground Truth/Adjudication/MRMC/Standalone: These concepts are relevant to AI/ML device studies where human expert input is used to establish ground truth or evaluate AI performance. They are not applicable to the non-clinical, physical, and biological testing of examination gloves.
• Training Set: There is no training set mentioned because this is not an AI/ML device.

In summary, the provided document describes the regulatory clearance for a physical medical device (nitrile examination gloves) based on non-clinical performance and biocompatibility testing against established standards, not an AI/ML device.

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The NITRILE EXAMINATION GLOVES is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is white, cobalt blue, black, blue. It can be available in six specifications: S, M, L, XL. The subject device is non-sterile.

This document is a 510(k) Premarket Notification for Nitrile Examination Gloves, a Class I medical device. The information provided is specifically for proving the substantial equivalence of these gloves to a legally marketed predicate device.

Therefore, the request for acceptance criteria and study details related to AI/ML-based medical devices using concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," "number of experts," "adjudication method," and "training set size and ground truth" are not applicable to this document.

This document describes the performance of the physical glove itself, not a software algorithm.

Here's a breakdown of the requested information based on the provided document, highlighting why most of the AI/ML-related questions are irrelevant:

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

The document provides this information clearly in "Table 2 - Summary of non-clinical performance testing" on pages 6-9.

Regarding the AI/ML-specific questions (2-9):

These questions are designed for evaluating AI/ML-based medical devices or diagnostic software. This 510(k) submission is for a physical device (nitrile examination gloves) and does not involve AI/ML technology, image analysis, computer vision, or diagnostic algorithms. Therefore, the concepts of "test set," "training set," "experts creating ground truth," "adjudication," or "human-in-the-loop performance" are not applicable.

The "study" referenced in this document refers to non-clinical performance testing of the physical glove's properties and biocompatibility, as outlined in the tables above.

Here's why each specific AI/ML question is not applicable:

2. Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model. The "samples" are physical gloves subjected to laboratory tests. The provenance is likely from the manufacturing facility (Vietnam, as per submitter info).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for physical properties (e.g., tensile strength, dimensions) is established by standardized testing methods (e.g., ASTM, ISO) and laboratory equipment, not by human experts interpreting data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to human consensus on complex interpretations, not objective physical measurements.
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 for AI-assisted diagnostic tools.
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): Not applicable in the AI/ML sense. The "ground truth" for glove performance is defined by the acceptance criteria of the relevant ASTM and ISO standards for physical properties and biocompatibility (e.g., a specific tensile strength value, AQL for holes, non-cytotoxicity as per ISO 10993-5).
8. The sample size for the training set: Not applicable. There is no "training set" as this is not a learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, this 510(k) submission successfully demonstrates that the Nitrile Examination Gloves meet the required performance standards for their intended use through standard physical and biocompatibility testing, proving substantial equivalence to the predicate device. The framework of questions provided is not suitable for this type of medical device submission.

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