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The intended use of the device is to aid in the detection of pulmonary nodules (2-30 mm in diameter) in adults (22 years of age and older) on chest radiographs. The device is intended to be used as a concurrent reader. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

The device is a software device that uses artificial intelligence to analyze chest radiographs. The device is intended to be used as a concurrent reader to aid in the detection of pulmonary nodules. The device is not intended to be used for diagnosis. The device is intended to be used in the radiology department.

Please provide the input text you are referring to as "{0}", "{1}", and "{2}". I need this information to describe the acceptance criteria and the study that proves the device meets them.

Once you provide the input, I will be able to construct a comprehensive response including:

1. A table comparing acceptance criteria with reported device performance.
2. Details on sample size, data provenance, and study design (retrospective/prospective).
3. Information on the number and qualifications of experts used for ground truth establishment.
4. Description of the adjudication method employed for the test set.
5. Whether an MRMC study was conducted and its findings regarding AI assistance.
6. Confirmation of standalone algorithm performance evaluation.
7. The type of ground truth utilized (e.g., expert consensus, pathology, outcomes).
8. The sample size of the training set.
9. The methodology for establishing ground truth within the training set.

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Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim 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. It is for over-the-counter use.

In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentanyl test claim

The subject device in this 510(k) Notification is Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim. The subject device is a patient examination glove made from nitrile compound, pink color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document is a 510(k) premarket notification for a medical device: "Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl Test Claim." Since this is a glove, the criteria are focused on physical and chemical properties and safety, not on diagnostic accuracy of an AI model. Therefore, many of the requested categories related to AI performance, such as MRMC studies, expert adjudication, training sets, and data provenance in a diagnostic sense, are not applicable.

Below is the information derived from the provided document, tailored to the context of a medical glove.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against ASTM standards and specific chemical resistance criteria.

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

• Sample Size for Physical/Chemical Testing:
  • For Freedom from Pin holes (AQL 2.5): ISO 2859-1/ G1 inspection level. The specific numerical sample size is not explicitly stated but is determined by the AQL and inspection level, which is a standard sampling plan for quality control in manufacturing.
  • For Dimensions (AQL 4.0): ISO 2859-1/ S2 inspection level.
  • For Physical properties (AQL 4.0): ISO 2859-1/ S2 inspection level.
  • For Powder-free residue: N=5 gloves tested.
  • For Biocompatibility: The exact number of samples (animals or cell cultures) used for biocompatibility testing is not specified in this summary but generally follows ISO 10993 guidelines.
  • For Chemotherapy Drugs and Fentanyl Permeation: The specific sample size for each drug test is not explicitly stated in this document but these tests typically involve multiple glove samples.
• Data Provenance: The tests were conducted by Riverstone Resources Sdn Bhd, a Malaysian company. The data is retrospective (i.e., tests were completed before the 510(k) submission).

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 medical glove, and "ground truth" as it relates to expert clinical assessments for diagnostic algorithms is not relevant here. The "ground truth" for the performance criteria is established by adherence to recognized international standards (ASTM, ISO) for physical, chemical, and biological properties.

4. Adjudication method for the test set

Not applicable. The testing involves standardized laboratory methods and measurements, not subjective interpretation requiring adjudication among experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are used for evaluating the diagnostic performance of imaging devices or AI algorithms by comparing multiple human readers' interpretations of cases. This is a physical device (glove), not a diagnostic tool.

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

Not applicable. This is not an AI algorithm. The performance tests are for the physical and chemical properties of the glove itself.

7. The type of ground truth used

The "ground truth" is based on:

• Standardized Test Methods: Adherence to established international standards such as ASTM D6319-10 (Standard specification for Nitrile Examination Gloves), ASTM D5151-06 (Freedom from Pinholes), ASTM D6124-06 (Powder-free residue), ASTM D6978-05 (Chemotherapy drug permeation), and ISO 10993 series (Biocompatibility).
• Predicate Device Performance: For chemotherapy drug permeation, the performance of the predicate device (K192954) also serves as a benchmark for comparison.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

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

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The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner.

The subject device in this 510(k) Notification is Powder Free Nitrile Examination Glove (Aqua Green). The subject device is a patient examination glove made from nitrile compound, Aqua Green color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Examination Glove (Aqua Green):

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides details about the testing performed according to various ASTM and ISO standards for properties like dimensions, physical properties, pinholes, residual powder, and biocompatibility. However, it does not explicitly state the specific sample sizes used for each of these tests. The standards themselves would dictate the sample sizes (e.g., ISO 28590:2017 is cited for "Sampling Procedure for Inspection by Attributes").

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted for the purpose of this 510(k) submission, performed by the manufacturer or a contracted lab. The submitter's address is Malaysia, suggesting the testing likely occurred there or at a laboratory serving that region.

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 type of device and study. The "ground truth" for medical examination gloves is established through objective physical and chemical testing against defined industrial standards (ASTM, ISO). It does not involve expert interpretation or consensus in the same way an imaging or diagnostic AI device would.

4. Adjudication Method for the Test Set

This is not applicable. As in point 3, the assessment is based on objective measurements against established standards, not on subjective interpretations requiring adjudication.

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

This is not applicable. The device is a medical examination glove, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.

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

This is not applicable. The device is a physical product (glove) and does not involve any algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for this device is based on established industry standards and objective measurements. Specifically:

• Physical and Mechanical Properties: Defined by ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves), ASTM D412-16 (Tensile strength and elongation).
• Freedom from Pinholes: Defined by ASTM D5151-06.
• Residual Powder: Defined by ASTM D6124-06.
• Biocompatibility: Defined by ISO 10993-10 (Irritation and Sensitization), ISO 10993-11 (Systemic Toxicity), and 16 CFR:1500.41 (Primary Irritant Substance).
• Sampling: Guided by ISO 28590:2017.

These standards provide the quantitative and qualitative acceptance criteria against which the device's performance is measured.

8. The Sample Size for the Training Set

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

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

This is not applicable. As explained in point 8, there is no training set for this type of device.

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The Nitrile Examination gloves,is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards : Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs.

The subject device in this 510(k) Notification is Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, white colour, powder free and sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-5, 10993-10, 10993-11 and permeability to chemotherapy drugs per ASTM D6978-05.

This document describes the acceptance criteria and performance of the Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White device (K190725) by Riverstone Resources SDN BHD.

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested against several standards, and the results are summarized below. The "Acceptance Criteria" column refers to the specified requirements in relevant ASTM and ISO standards, while "Reported Device Performance" indicates whether the device met these criteria. "N/A" indicates that specific numerical acceptance criteria were not explicitly stated in the provided text for certain categories, but compliance with the standard itself serves as the acceptance.

Explanation of the Study and Device Performance:

The study conducted to prove the device meets the acceptance criteria is a series of non-clinical tests performed in accordance with recognized international and national standards. The results demonstrate that the subject device (Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White) meets all the specified performance requirements for patient examination gloves, including dimensions, physical properties, freedom from holes, residual powder, and biocompatibility.

Crucially, the gloves were specifically tested for use with chemotherapy drugs according to ASTM D6978-05: Practice for assessment of medical Glove to Permeation by Chemotherapy Drugs. The results show that for most tested chemotherapy drugs, the gloves provided a breakthrough detection time of greater than 240 minutes (4 hours), indicating good resistance. For Carmustine and Thiotepa, specific breakthrough times of 39 minutes and 97.6 minutes, respectively, were reported. These specific times serve as important cautions for users.

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 (e.g., number of gloves tested for dimensions, physical properties, or chemotherapy drug permeation). However, it references established standards such as ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05, as well as ISO 10993-10 and ISO 10993-11. These standards typically define appropriate sampling plans and methodologies for testing, implying that the sample sizes used conform to these guidelines.

The data provenance is from Malaysia, as Riverstone Resources SDN BHD is located in Malaysia (Lot 55, No 13, Jalan Jasmin 2, Kawasan Perindustrian Bukit Beruntung, 48300, Bukit Beruntung Selangor, Malaysia). The studies were non-clinical, likely laboratory-based, and retrospective in the sense that the test results are reported from completed experiments to demonstrate compliance for premarket notification.

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

This information is not provided in the document. The "ground truth" for this type of device (a medical glove) is established by adherence to recognized performance standards and laboratory test methods, rather than by expert consensus in a clinical diagnostic sense. The standards themselves (e.g., ASTM, ISO) represent a consensus of expert knowledge in materials science, manufacturing, and medical device testing. The personnel conducting the tests would be qualified laboratory technicians or engineers, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set:

An adjudication method (like 2+1 or 3+1) is typically used in clinical studies involving interpretation of medical images or patient outcomes, especially when there's subjective assessment involved. This document describes non-clinical, laboratory-based performance testing of a physical device against objective criteria defined by standards. Therefore, an adjudication method for determining "ground truth" as described (e.g., by multiple clinical experts) is not applicable to this type of study. The "ground truth" is the objective measurement against the specified standard.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted medical imaging devices where human readers interpret cases, and the AI's impact on their performance is being evaluated. This document is for a medical glove, which is a physical protective barrier, not a diagnostic tool requiring human interpretation of clinical cases.

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

No, a standalone (algorithm only) performance study was not done. This concept is applicable to AI or software medical devices. The device in question is a physical medical glove, and its performance is evaluated through laboratory tests, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used for this device's evaluation is primarily based on established performance standards and objective laboratory measurements. This includes:

• Standard Specifications: Adherence to defined physical and chemical properties as outlined in standards like ASTM D6319-10 (dimensions, physical properties), ASTM D5151-06 (freedom from pinholes), ASTM D6124-06 (residual powder).
• Biocompatibility Test Results: Objective scientific assessment of biological responses in accordance with ISO 10993-10 (irritation, sensitization) and ISO 10993-11 (acute systemic toxicity).
• Permeation Resistance Measurements: Objective laboratory determination of breakthrough times for chemotherapy drugs using a standardized method (ASTM D6978-05).

8. Sample Size for the Training Set:

This information is not applicable. The device is a physical medical glove, not an artificial intelligence (AI) or machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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

This information is not applicable as there is no training set for this device.

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The White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examiner Is hand or finger to prevent contamination between patient and examiner. In addition these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs

The subject device in this 510(k) Notification is White Nitrile Examination Gloves Sterile with tested for use with Chemotherapy drugs claims. The subject device is a patient examination glove made from nitrile latex compound, White color, powder free and sterile (Per 21 CFR 880.6250, class I). The White Nitrile Examination Glove ,Sterile, 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 (product Code LZA) and is used with chemotherapy drugs (Product code LZC).

The provided document is a 510(k) Premarket Notification for a medical device: "White Nitrile Examination Glove, Sterile Tested for use with Chemotherapy Drugs Claim." It outlines the acceptance criteria for the glove's performance, particularly its resistance to chemotherapy drugs, and summarizes the non-clinical testing performed.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the chemotherapy drug resistance claim are defined by ASTM D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs. The device's performance is reported as the "Minimum Breakthrough detection time in minutes." The acceptance criteria are implicit in the comparison to the predicate device and the standard, aiming for breakthrough times that prevent drug permeation for a reasonable duration of use. The reported "Minimum Breakthrough detection time" for most drugs is "> 240 Minutes", indicating that no permeation was detected within the maximum test duration.

Other acceptance criteria and performance related to the general glove properties (ASTM D6319-10 Standard specification for Nitrile Examination Gloves) and Biological Evaluation on medical device:

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

The document does not explicitly state the specific sample size used for the chemotherapy drug permeation test set. However, it indicates that the testing was performed "in accordance with ASTM D6978-05 standards." This standard would dictate the sampling methodology and number of replicate tests required.

The data provenance is not explicitly mentioned (e.g., country of origin of the testing lab), but it is a premarket notification from Riverstone Resources SDN BHD in Selangor, Malaysia. The testing would have been conducted by a laboratory to generate data for this submission. The nature of the studies (material property and drug permeation) implies prospective testing specifically for this device submission, not retrospective data.

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

This information is not applicable as the tests described are objective, laboratory-based analyses (material properties, drug permeation, biological evaluations) governed by established ASTM and ISO standards, rather than subjective evaluations requiring expert consensus or interpretation of images. The "ground truth" is determined by the results of these standardized physical and chemical tests.

4. Adjudication method for the test set

This information is not applicable for the reasons stated in point 3. The results are quantitative measurements against predefined thresholds in 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 is not applicable. The device is a physical examination glove, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical examination glove, not an algorithm.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily based on:

• Standardized Physical and Chemical Measurements: Adherence to ASTM D6319-10 (for general glove properties) and ASTM D6978-05 (for chemotherapy drug permeation), which involve objective measurements of tensile strength, elongation, dimensions, pinhole levels, residual powder, and breakthrough times.
• Biological Evaluation Standards: Adherence to ISO 10993-10 for primary skin irritation and dermal sensitization, which are also standardized laboratory tests with objective endpoints.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical medical device testing for properties like drug permeation and material strength. The device is not an AI model requiring a training phase.

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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The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
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 .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document outlines the acceptance criteria and supporting studies for the "Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs" (K152542).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document details testing for various attributes, with specific sample sizes and testing methods mentioned.

• Mechanical Properties (Dimensions, Physical Properties, Freedom from Pin-holes, Residual Powder): The testing was conducted according to ASTM D6319-10, ASTM D5151-06, and ASTM D6124-06. These standards typically specify sampling plans (e.g., AQL levels for pinholes) which define the sample sizes. The document states "Gloves meet all the specification listed in ASTM D 6319-10" and "Meets ASTM D5151-06" and "Meets ASTM D6124-06", indicating adherence to these sampling requirements. Specific numerical sample sizes for each test are not explicitly provided in the summary, but are implied by reference to the ASTM standards.

• Resistance Against Chemotherapy Drugs: Tested in accordance with ASTM D6978-05. The specific sample size used for this test is not explicitly stated in the provided text.

• Low Dermatitis Potential Claim (Skin Sensitization):

  • Sample Size: Initial stage with 30 human subjects, followed by an additional number of subjects to reach a total of a minimum of 205 individuals.
  • Data Provenance: The study was conducted on "non sensitized adult human subjects, who reasonably reflect the general user population in the US." This implies the data is prospective and representative of the US population, although the study itself was likely conducted by the manufacturer (Riverstone Resources Sdn. Bhd. in Malaysia) or a contract research organization.

• Primary Skin Irritation: The specific sample size for this test is not explicitly stated but is also an in-vivo biological evaluation performed under ISO 10993-10:2010.

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

• For physical and chemical properties (e.g., dimensions, tensile strength, chemotherapy drug permeation, pinholes, residual powder): The ground truth is established by objective, standardized laboratory tests according to recognized ASTM and ISO standards. These do not typically involve human "experts" in the way clinical studies do. The "ground truth" is the quantitative measurement or qualitative assessment (e.g., pass/fail) determined by the test method.
• For Low Dermatitis Potential Claim (Modified Draize 95 test): This is a human subject study. The nature of the "ground truth" is the observed skin reaction (or lack thereof) in the human subjects. The qualification of individuals assessing these reactions (e.g., dermatologists) is not specified in the document but would typically involve trained medical professionals or researchers.

4. Adjudication Method for the Test Set

• For physical and chemical properties: Adjudication is not applicable in the traditional sense. The results are objective measurements against predefined criteria.
• For Low Dermatitis Potential Claim (Modified Draize 95 test): The document states that "The study completed on 205 non sensitized adult human subjects...gave all negative results. There was no clinical evidence of the presence of residual chemical additives..." This implies a direct observation and interpretation by the study's clinical staff. No specific adjudication method like "2+1" or "3+1" is mentioned for conflicting expert opinions, as the result was consistently negative for all subjects.

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

• No, an MRMC comparative effectiveness study was not done. This device is a medical glove, and the studies described are performance and biocompatibility assessments, not diagnostic imaging or clinical decision support tools that would typically involve human readers or AI assistance in the way an MRMC study is designed.

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

• Not applicable. This device is a physical product (a glove), not an algorithm or a software device. The concept of "standalone performance" for an algorithm without human involvement does not apply here. The performance is the inherent performance of the glove itself.

7. The Type of Ground Truth Used

• Physical/Chemical Properties: Standardized measurements and assessments from laboratory testing against established specifications (e.g., ASTM standards). This is objective laboratory data.
• Chemotherapy Drug Permeation: Breakthrough detection time measured in accordance with ASTM D6978-05. This is objective laboratory data.
• Primary Skin Irritation and Dermal Sensitization: In-vivo biological response observed in animal studies (for general biocompatibility, although human studies were done for sensitization). For the Low Dermatitis Potential Claim, the ground truth is the clinical outcome (presence or absence of irritation/sensitization) observed in human subjects.

8. The Sample Size for the Training Set

• Not applicable. This document describes the performance of a manufactured medical device (glove), not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The "training" for such a product would involve manufacturing process controls and quality assurance, which are not detailed as a "training set" in this context.

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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