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

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

Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany) are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners as a barrier protection to prevent contamination between a patient and an examiner. The qloves are powder free, ambidextrous, blue color, and beaded cuff.

The gloves are designed and manufactured in accordance with the ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

The gloves are also complied with requirements for Standard Practice for Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs and Fentanyl as per ASTM D6978-05 (Reapproved 2019).

The document describes the acceptance criteria and performance of "Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)".

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Detailed Permeation Testing Results:

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

• Sample Size: Not explicitly stated in terms of number of gloves tested for each permeation or biocompatibility test. The document refers to compliance with standards like ASTM D6978-05(2019) and ISO 10993, which typically specify sample sizes for such tests.
• Data Provenance: The testing was performed for the submitter, PT. Shamrock Manufacturing Corpora, based in North Sumatera, Indonesia. The tests are "non-clinical tests," implying laboratory-based testing rather than clinical data from human subjects.

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

• This information is not applicable as the document describes non-clinical testing of a medical device (gloves) for physical properties and chemical resistance. There is no "ground truth" established by human experts in the context of diagnostic performance or interpretation. The ground truth for these tests is defined by the standardized methodologies of ASTM and ISO.

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

• This information is not applicable as the document describes non-clinical testing of a medical device (gloves). Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments, which are not relevant here.

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

• This information is not applicable. The device is medical examination gloves, not an AI-powered diagnostic tool. Therefore, MRMC studies 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 information is not applicable. The device is medical examination gloves, not an algorithm or software. The tests performed are laboratory-based assessments of material properties and chemical resistance.

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

• The "ground truth" for this device's performance is established by standardized test methods and material science principles. For biocompatibility, it's defined by the pass/fail criteria of ISO 10993 standards. For permeation, it's the measured breakthrough time according to ASTM D6978-05(2019). These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of device testing for medical gloves. This refers to a dataset used to train AI/machine learning models, which is irrelevant for this device.

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

• This information is not applicable for the same reasons as #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 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 of Permeation by Chemotherapy Drugs

The Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) – Regular Cuff and the Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentany)) - Extended Cuff are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The proposed device is offered in two versions: Regular cuff (VS311) and Extended cuff (VS711).

The provided document is a 510(k) Premarket Notification from Medline Industries, Inc. for their Powder-Free Blue Nitrile Examination Gloves. This document focuses on demonstrating the substantial equivalence of their new device to a legally marketed predicate device.

It is NOT a study about a device employing an Artificial Intelligence (AI) algorithm. Therefore, the requested information regarding acceptance criteria and study proving device meets acceptance criteria for an AI device cannot be extracted directly from this document. The document describes traditional performance testing for physical attributes and chemical permeation resistance of medical gloves, not AI algorithm performance.

However, I can extract and present analogous information from the document as if it were a "device" in a general sense, focusing on the acceptance criteria and performance data for the gloves as described. I will make a note where the requested information is not applicable (N/A) due to the nature of the device (medical gloves vs. AI algorithm).

Acceptance Criteria and Device Performance for Medline Powder-Free Blue Nitrile Examination Gloves

This document pertains to the performance testing of Medline Powder-Free Blue Nitrile Examination Gloves (Regular Cuff and Extended Cuff versions) for medical uses, specifically their resistance to chemotherapy drugs and Fentanyl permeation, as well as general physical characteristics. This is not an AI-powered device, so typical AI/ML study components like training/test sets, expert adjudication, or MRMC studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are based on various ASTM standards.

Regular Cuff (VS311) - Summarized Performance

*Note: The cytotoxicity testing failed, indicating the device is cytotoxic under the conditions of the study. However, the FDA has still cleared the device. This implies that the cytotoxicity is either not considered clinically significant for the intended use (external, short-term contact) or that the benefits outweigh this particular risk, likely due to a robust biocompatibility assessment involving multiple tests. This document itself doesn't elaborate further on the implications of the "Failed" cytotoxicity result beyond reporting it.

Extended Cuff (VS711) - Summarized Performance (Only differences from Regular Cuff noted, otherwise assumed to be the same)

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

• Sample Size for Physical Dimensions and Powder Content: 13 glove samples of each size (extra-small, small, medium, large, and extra-large) were tested for physical dimensions. For powder content, the average results across all five sizes are summarized, implying individual testing for each size.
• Sample Size for Freedom from Holes: Varies based on total number inspected:
  • Regular Cuff: XS/Small/Medium – 200 gloves each; Large – 400 gloves; X-Large -200 gloves.
  • Extended Cuff: XS/Small/Medium, Large, X-Large - 200 gloves each.
• Sample Size for Permeation Testing: The document does not specify the exact number of samples tested for each chemotherapy drug or Fentanyl. The test method cited is ASTM D6978, which typically involves multiple replicates per drug.
• Data Provenance: The tests were conducted to support a 510(k) premarket notification for a disposable medical device. This is regulatory testing to demonstrate compliance with recognized standards. The country of origin of the data is not explicitly stated beyond being part of an FDA submission. The nature of this engineering testing is retrospective, as it's data collected to support a product already manufactured or designed.

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

Not applicable. This is not an AI/ML device where expert human annotation typically establishes ground truth. The "ground truth" for glove performance is established by adherence to physical and chemical testing standards (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978). The qualification of personnel conducting these lab tests would typically be laboratory technicians and engineers with expertise in the relevant standards and equipment, but this is not specified in the document.

4. Adjudication method for the test set

Not applicable. There is no human interpretative "test set" requiring adjudication in the context of this device. Performance is determined by objective physical and chemical measurements against defined standards.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is objective measurement against established industry standards (ASTM standards for physical properties, hole detection, powder content, and chemical permeation). These standards define the acceptable range or threshold for each characteristic.

8. The sample size for the training set

Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.

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

Not applicable. See point 8.

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A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.

Powder Free Blue Nitrite Examination Gloves- Tested for Use with Chemotherapy Drugs.

This document describes the FDA's 510(k) clearance for "Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs" (K182089). The primary focus of the performance data in this document relates to the gloves' resistance to permeation by chemotherapy drugs.

Here's an analysis based on your request, using the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for gloves used with chemotherapy drugs are typically defined by regulatory bodies or consensus standards (like ASTM D6978, which is often referenced for chemotherapy glove testing) as a minimum breakthrough time. While explicit "acceptance criteria" values are not stated in this document as a separate column, the reported device performance clearly indicates whether the gloves meet the implied standard of extended protection (often >240 minutes for many drugs).

Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes. Do not use with Carmustine and Thio-Tepa." This indicates that for these two drugs, the gloves did not meet the standard expectation for chemotherapy glove use, and this limitation is clearly communicated.

The subsequent questions (2-9) are primarily relevant to clinical studies involving AI or diagnostics that interpret medical data. This document describes the clearance of a medical device (gloves) based on laboratory testing for chemical permeation, not a clinical study involving human patients, expert readers, or AI algorithms. Therefore, most of these questions are not applicable to the provided information.

However, I will address those that can be inferred or directly commented on:

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

• Sample Size for Test Set: Not explicitly stated in terms of number of gloves tested, but it would involve multiple samples of the glove material subjected to permeation testing according to a standard like ASTM D6978. For each chemotherapy drug listed, a sample of the glove material would be exposed, and the time until breakthrough is detected would be measured.
• Data Provenance: The document implies laboratory testing conducted by the manufacturer or a certified lab. The country of origin of the data is not specified beyond the manufacturer being "Platinum Glove Industries Sdn Bhd" from "Malaysia." This is retrospective testing of the glove material properties.

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

• Not Applicable. This is not a study involving human interpretation of medical data where "ground truth" is established by experts. The "ground truth" in this context is the physical property of the glove's resistance to chemical permeation, measured by laboratory instrumentation and protocols (e.g., using a permeation cell and analytical detection methods).

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

• Not Applicable. See point 3.

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 a clinical or AI-based diagnostic study.

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

• Not Applicable. This is not an algorithm.

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

• The "ground truth" in this context is the measured chemical permeation time of specific chemotherapy drugs through the glove material, determined through standardized laboratory testing (e.g., in accordance with ASTM D6978 or an equivalent standard).

8. The sample size for the training set:

• Not Applicable. This is not an AI or machine learning study, so there is no "training set."

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

• Not Applicable. See point 8.

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The Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device, Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes

The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, based on the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against specific ASTM standards for various properties and against a predicate device (K163146) for comparison. The key acceptance criteria and reported performance for critical aspects are as follows:

Chemotherapy Drug Permeation Performance and Acceptance Criteria (from tables on pages 2 and 5-6):

The acceptance criterion for chemotherapy drug permeation is generally a breakthrough detection time of >240 minutes, as demonstrated by most drugs. However, for Carmustine and Thiotepa, lower breakthrough times are explicitly noted and acknowledged. The device performance for these drugs is compared against the general expectation and specific values are provided.

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

The document does not explicitly state the exact sample size for each specific test. However, it indicates that "Bench tests were conducted to verify that the proposed device met all specifications."

• Sample Size: Not explicitly stated as a numerical value for each test. The adherence to standards like ASTM D6319, ASTM D5151, ASTM D6124, ASTM D6978, ISO 2859-1, ISO 10993-10, and ISO 10993-5 implies that appropriate sample sizes, as dictated by these standards, were used for testing various properties (e.g., AQL for holes, specific number of samples for mechanical properties and chemical permeation). ISO 2859-1 specifically relates to "Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," indicating a quality control sampling approach for certain attributes.
• Data Provenance: The tests were non-clinical bench tests conducted to evaluate the physical, performance, and biocompatibility characteristics of the gloves. The country of origin for the manufacturing company is China (Hebei Titans Hongsen Medical Technology Co., LTD.). The submission is for a medical device (gloves), and the testing appears to be prospective in nature, conducted specifically for this 510(k) submission to demonstrate compliance with standards.

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

This type of information is not applicable to this submission. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM and ISO). The "ground truth" here is the pass/fail criteria defined by these objective engineering and material science standards, not subjective human interpretations or expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective, standardized test methods with clear pass/fail criteria, not on subjective expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. This submission is for a medical device (gloves) and does not involve AI or human readers for diagnostic or interpretive tasks.

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

This is not applicable. This submission is not for an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific and engineering standards and their predefined pass/fail criteria. These include:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application (for dimensions, physical properties).
• 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 of Medical Gloves to Permeation by Chemotherapy Drugs (for chemical permeation).
• ISO 2859-1:1999: Sampling Procedures for Inspection by Attributes – Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
• ISO 10993-10: 2010: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
• ISO 10993-5:2009: Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.

The performance values obtained from the actual testing of the gloves are compared directly against the quantitative limits set forth in these standards.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (gloves) and does not involve a "training set" in the context of machine learning or AI models.

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

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

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A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands and finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

These patient examination gloves are formulated using nitrile, non-sterile, powder free, meet all the requirements of ASTM D6319 and tested for use with chemotherapy drugs.

The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs." This is a medical device, and the data presented relates to its physical and chemical properties, not an AI/ML powered device. Therefore, many of the requested fields are not applicable.

Here's the information extracted from the document based on the prompt:

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 does not explicitly state the sample size for the tests conducted to determine the breakthrough detection times or other physical properties. It generally refers to conducting tests "in accordance with ASTMD6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs," and other ASTM and ISO standards. These standards typically specify sample sizes for their respective tests. The provenance of the data is implied to be from the manufacturer's testing (Maxter Glove Manufacturing Sdn Bhd) in Malaysia, as they are the submitter of the 510(k). The tests are prospective in nature, as they are performed to demonstrate compliance with standards for the device being submitted.

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. This is a physical device (gloves) and the "ground truth" is established through standardized laboratory testing against chemical permeation and physical properties, not through expert consensus on medical images or diagnoses.

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

Not applicable. This is a physical device.

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

Not applicable. This is a physical device, not an AI/ML powered medical device.

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

Not applicable. This is a physical device.

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

The "ground truth" for this device is based on objective measurements conducted according to established international and national standards (e.g., ASTM D6319-10, ASTM D5151, ASTM D6124, ASTM D6978-05, ISO 10993). This involves laboratory measurements for physical dimensions, tensile strength, elongation, freedom from holes, powder residue levels, breakthrough time for chemotherapy drugs, and biocompatibility endpoints (irritation, sensitization, cytotoxicity).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML-powered device that requires a training set.

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

Not applicable. This is a physical device.

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A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.

The provided documents describe the performance of "Non-sterile, Powder-free Blue Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs" (K101822) against various acceptance criteria relevant to medical examination gloves and specifically for their resistance to chemotherapy drugs.

Here’s a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on established ASTM (American Society for Testing and Materials) standards and a comparison to a legally marketed predicate device (K082957). The key performance indicator for chemotherapy drug resistance is the "Breakthrough Detection Time" as per ASTM D6978-05.

Acceptance Criteria and Reported Device Performance for K101822

Summary of Study Proving Acceptance:

The device K101822 was shown to meet its acceptance criteria through various tests described in the "Substantial Equivalence Discussion" (Document 2, page 2 of 2) and the "CONCLUSION" (Document 4, page 1 of 1). The primary study for chemotherapy drug resistance was conducted according to ASTM D6978-05. For other characteristics like dimensions, physical properties, freedom from pinholes, and powder-free status, the device was tested against and found to meet ASTM D6319-00a-05, ISO 2859-1 (for water leak test), ASTM D5151-06 (for detection of holes), and ASTM D6124-06 respectively. Biocompatibility tests included Primary Skin Irritation in Rabbits and Guinea Pig Maximization tests.

The device's performance was directly compared to a legally marketed predicate device, Siam Sempermed Corp. Ltd.'s Non-sterile, Powder-free Nitrile Examination Glove (K082957), showing substantial equivalence in all tested parameters, except for highlighting the short permeation times for Carmustine (BCNU) and Thiotepa, for which the gloves are explicitly not approved.

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

• Sample Size for Test Set: The specific sample sizes for each test (e.g., number of gloves tested for chemotherapy permeation, number of rabbits/guinea pigs for biocompatibility, or specific counts for physical properties) are not explicitly stated in the provided documents. The documents only state that the device "Meets ASTM D6319-00a-05," "Meets ASTM D6124-06", etc., which implies that the testing was performed according to the methodologies and sample size requirements specified in those respective ASTM/ISO standards.
• Data Provenance: The data is presented as part of a 510(k) Premarket Notification submission to the FDA by SGMP Company Limited, located in Thailand (Document 0, page 1 of 2). This indicates the testing was conducted by or on behalf of the manufacturer, and generally, such data would be generated in a controlled laboratory environment. The documents do not specify the country of origin of the specific lab that conducted these tests, but the manufacturer is based in Thailand. The studies were retrospective in the sense that they were conducted to characterize the finished medical device for regulatory submission, rather than as part of a clinical trial.

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 to this type of device submission. The "ground truth" for the performance of these examination gloves is established through standardized laboratory tests (e.g., ASTM standards) measuring physical and chemical properties, not through expert human interpretation or clinical ground truth. Therefore, there are no "experts" in the sense of medical professionals establishing ground truth for diagnostic accuracy, nor are their qualifications relevant here.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human judgment (e.g., for image interpretation) to resolve disagreements among experts. The performance of these gloves is determined by objective, quantitative laboratory measurements according to published standards.

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

This question is not applicable. An MRMC study is relevant for diagnostic devices (e.g., AI algorithms for image interpretation) where human readers evaluate cases with and without AI assistance. This submission describes an examination glove, which is a physical barrier device, and does not involve human readers or AI assistance.

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

This question is not applicable. This describes a physical medical device (examination gloves), not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for performance validation is based on objective, quantitative measurements obtained through standardized laboratory testing protocols, primarily from ASTM standards (D6319-00a-05, D6124-06, D6978-05) and ISO 2859-1. For biocompatibility, the ground truth is established by the observed biological responses in animal models (rabbits and guinea pigs) according to standardized tests for skin irritation and sensitization. The device's performance is then compared against the requirements specified in these standards and against the performance of a legally marketed predicate device.

8. The sample size for the training set

This question is not applicable. This is a physical medical device, not an AI model or algorithm that requires a "training set" of data.

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

This question is not applicable as there is no training set for this type of device.

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Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) 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.

Medline Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotheraphy Drugs)

This document is a 510(k) clearance letter from the FDA for Medline Powder-Free Blue Nitrile Examination Gloves. It primarily addresses regulatory approval and does not contain information about studies proving the device meets acceptance criteria related to its performance beyond its intended medical purpose. The letter confirms the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data, study designs, or details on ground truth establishment that would typically be found in a clinical study report or technical documentation for device performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from the provided text.

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