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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.

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymer-coating and mild on-line chlorination process modifies the surface characteristics and causes it to remain tackfree without the use of any dusting or donning powder.

Based on the provided document, the device in question is Powder Free Nitrile Examination Gloves, Blue (colored). This document is a 510(k) Summary for a medical device which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, many of the requested elements for an AI device (like human reader improvement with AI assistance, standalone performance, training set details, expert qualifications for ground truth) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria and performance data for the physical and biological characteristics of the gloves as presented in the "Summary of the Technological Characteristic" section.

Here's the breakdown:

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

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

The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for length, tensile strength, or water leaks). It simply states that the subject device "Meet[s]" or "Passes" the criteria. The provenance of the data is not explicitly stated beyond being presented in a submission from Careglove Global Sdn Bhd, Malaysia, implying the testing was conducted to support their device. It's standard for these types of tests to be prospective, laboratory-based evaluations.

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

Not applicable. This device is a physical product (examination gloves), not an AI-powered diagnostic tool requiring expert interpretation for "ground truth". The performance criteria are physical and chemical measurements or biological response assessments, not based on expert consensus.

4. Adjudication method for the test set:

Not applicable for the same reasons as #3. Quality control of physical properties does not typically involve expert adjudication.

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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device. The "standalone performance" is the inherent physical and chemical properties of the glove itself.

7. The type of ground truth used:

The "ground truth" for the physical and chemical properties of the gloves is established by standardized laboratory testing methods (e.g., likely conforming to ASTM standards like D6310, as mentioned in the document). For biocompatibility, the ground truth is established by the biological response observed in appropriate in vivo or in vitro models as per standard biocompatibility testing protocols.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device.

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

POWDER FREE NITRILE EXAMINATION GLOVE, WHITE

I am sorry, but the provided document is a letter from the FDA regarding the 510(k) clearance for a "Powder Free Nitrile Examination Glove, White". It details the regulatory classification and indications for use of the device.

This document does not contain information about:

• Acceptance criteria and reported device performance (in a table or otherwise).
• Details of a study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods).
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill your request for this specific document as the information you are asking for is not present within the provided text.

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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.

It is the powder-free variation of the class I latex patient examination gloves made by online polymer-coating and on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. It is particularly suitable to users who prefer a powder-free work environment or who may be sensitive to the powdered version of the same gloves.

The provided text describes the acceptance criteria and performance of a medical device, specifically a "Powder Free Nitrile Examination Glove, Blue (Colored)". The device is being submitted for 510(k) premarket notification to establish substantial equivalence to a legally marketed predicate device.

Here's the breakdown of the information requested:

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 (e.g., how many gloves were tested for water tightness, physical properties, or powder content).
• For biocompatibility tests, it mentions "No Animal Irritation" and "No Animal Sensitization," implying animal studies were conducted, but the number of animals or the specific details of the studies are not provided.
• Data Provenance: The manufacturing company is "Careplus (M) SDN BHD" located in Malaysia. The tests were presumably conducted as part of their manufacturing and quality control process. The studies appear to be prospective as they are conducted to demonstrate the performance of the device for regulatory submission.

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

• This information is not provided in the document. The "ground truth" for these types of physical and biocompatibility tests on medical gloves is typically established by laboratory testing against defined ASTM and ISO standards, rather than expert consensus on subjective data.

4. Adjudication Method for the Test Set

• This information is not applicable for the type of tests conducted. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostics where human readers interpret data, and discrepancies need to be resolved. The tests mentioned here are objective laboratory 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

• This information is not applicable to this device. This document describes a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.

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

• This information is not applicable to this device, as it is not an algorithm or AI system.

7. The Type of Ground Truth Used

• The ground truth for this device's performance is established by objective measurements against established national and international standards. These include:
  • Physical Property Standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06
  • Biocompatibility Standards: ISO 10993-10, 16CFR Part 1500
• The results are compared directly to the quantitative requirements specified in these standards.

8. The Sample Size for the Training Set

• This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

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

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

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Please note that Carmustine and Thiotepa have extremely low permeation times of 30.9 minutes and 2.3 minutes, respectively.

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM standard D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's a breakdown of the acceptance criteria and the study information for the Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), based on the provided text:

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 the individual tests (e.g., tensile strength, pinholes, biocompatibility, resistance to permeation). However, it indicates that the device's physical and performance characteristics meet the requirements of ASTM D 6319-10 and ASTM D 6978-05, which are standards that specify testing methodologies and, implicitly, sample sizes (e.g., AQL levels for pinholes).

The data provenance is from non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The country of origin for the device manufacturer is CHINA (Hebei Province). The testing itself (e.g., ASTM standards, ISO standards) is generally applicable internationally. The document does not specify if the data is retrospective or prospective, but given it's part of a 510(k) submission, it would be considered prospective in the sense that the device was specifically tested to demonstrate compliance for this submission.

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

This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM, ISO) that yield quantitative measurements (e.g., tensile strength values, breakthrough detection times, pass/fail for pinholes, irritation/sensitization ratings). There isn't a need for expert consensus in the way there would be for image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the acceptance criteria are 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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret results, and the study aims to assess the impact of an AI tool on their performance. For a medical glove, performance is evaluated through physical, chemical, and biological testing as outlined above.

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 (a glove), not an algorithm or AI system. Its performance is inherent to the product itself, not an independent algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Standardized Test Results: Compliance with established industry standards such as ASTM D6319-10 (for physical properties like tensile strength, elongation, dimensions, freedom from holes, residual powder) and ISO 10993-10 (for biocompatibility).
• Quantitative Measurement: For chemotherapy drug permeation, the "ground truth" is the measured breakthrough detection time (BDT), determined according to ASTM D6978-05.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The manufacturing process of the glove and its materials are designed to meet the specifications, and the testing ensures these specifications are met for production batches.

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

This is not applicable for the same reasons as #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.

POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK

The provided document is a 510(k) premarket notification letter from the FDA for Powder-Free Nitrile Examination Gloves. This type of document is a regulatory approval for a medical device and therefore primarily focuses on compliance with regulations and substantial equivalence to a predicate device.

It does not contain the detailed information required to describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. The document is for a physical patient examination glove, not a software or AI-driven device.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth establishment
• Adjudication method for the test set
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size and ground truth establishment for the training set

This document pertains to the regulatory clearance of a physical medical device (gloves) and such information is not applicable or present within this text.

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

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-10.

The provided document describes the acceptance criteria and performance of Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves. However, it does not describe an AI device or a study involving AI. Therefore, I cannot provide information related to AI-specific aspects like training sets, ground truth for training sets, MRMC studies, or standalone algorithm performance.

The document details the device's adherence to established standards for medical examination gloves to demonstrate substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA.

Here's the information based on the provided text, focusing on the device's performance against its acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study described is a non-clinical performance evaluation comparing the subject device (Hongye Plastic Products Co., Ltd.'s Powder Free Nitrile Examination Gloves) to a predicate device (Hong Xin Rubber Products Co., Ltd Powder Free Nitrile Examination Gloves, Blue) and against recognized industry standards. The purpose is to demonstrate "Substantial Equivalence" as required for FDA 510(k) clearance.

The study involved testing the physical properties, dimensions, freedom from pinholes, residual powder, and biocompatibility of the subject device.

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 specify the exact sample sizes used for each test (e.g., how many gloves were tested for tensile strength, pinholes, etc.). It only states that the device "Meets" the specified ASTM standards.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, beyond the manufacturing location of Hongye Plastic Products Co., Ltd. being in Hebei, China.

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 and not provided. The "ground truth" for examination gloves is adherence to measurable physical and biological standards (e.g., tensile strength, dimensions, biocompatibility), which are typically assessed through standardized laboratory testing, not expert consensus.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments or when multiple human readers are involved in clinical studies. For physical property testing of gloves, objective measurements against a standard are performed.

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 document describes a medical device (examination gloves), not an AI system or an imaging diagnostic tool where MRMC studies would be relevant.

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

This information is not applicable. The device is a physical product (gloves) and does not involve an algorithm or AI.

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

The "ground truth" for this device is based on objective, measurable criteria established by recognized industry standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves), ISO 10993 Part 10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization), and relevant CFR regulations (e.g., 16CFR 1500.41, 16CFR 1500.3 for flammability and irritation).

8. The sample size for the training set

This information is not applicable as this is not an AI device.

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

This information is not applicable as this is not an AI device, and therefore no training set or its associated ground truth was established.

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Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove 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 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:

| | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time in
Minutes, 0.01 ug/cm2/minute |
|---|--------------------------------------------------|-----------------------------------------------------------------------|
| 1 | Cisplatin, 1.0 mg/ml (1,000ppm) | >240 |
| 2 | Cyclophosphamide (Cytoxan),20.0mg/ml (20,000ppm) | >240 |
| 3 | Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 |
| 4 | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| 5 | Etoposide (Toposar), 20.0 mg/ml (20,000)ppm | >240 |
| 6 | Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 |
| 7 | Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 |
| 8 | Carmustine (BCNU)3.3mg/ml(3,300ppm) | 0.9 |
| 9 | Thiotepa, 10.0mg/ml (10,000ppm) | 0.05 |

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes

Carmustine (BCNU)3.3mg/ml(3,300ppm) Thiotepa, 10.0mg/ml ( 10,000ppm)

Not Found

This document details the acceptance criteria and performance for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs" in the context of their ability to prevent permeation by chemotherapy drugs.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document specifies that the maximum testing time is 240 minutes. For Carmustine and Thiotepa, while specific acceptance criteria in the ">X" format are not given, the note highlights their extremely low permeation times, which can be interpreted as a disclosure rather than a failure of an acceptance criterion that requires >240 minutes.

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

• Sample Size for Test Set: Not explicitly stated in the provided document. The study refers to testing in accordance with ASTM D6978-05. The sample size would be dictated by the requirements of this standard.
• Data Provenance: Not explicitly stated. The testing was performed in accordance with ASTM D6978-05, which is an international standard.

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

This document describes a physical performance test for medical gloves against chemotherapy drugs, not a diagnostic or clinical AI study. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is the objective measurement of breakthrough time, determined by standardized laboratory procedures.

4. Adjudication method for the test set

Not applicable. This is a laboratory performance test based on a standardized methodology (ASTM D6978-05), not a situation requiring 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 document pertains to the physical performance of a medical device (gloves), not an AI-assisted diagnostic or imaging system involving human readers.

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

Not applicable. This is a physical performance test of a medical device (gloves), not an algorithm.

7. The type of ground truth used

The ground truth used is the objective measurement of chemotherapy drug permeation breakthrough time, determined by a standardized laboratory method, specifically ASTM D6978-05. This is a quantitative, empirical measurement.

8. The sample size for the training set

Not applicable. This is a physical performance test for a medical device (gloves), not an AI model that requires a training set.

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

Not applicable. As this is not an AI model, there is no training set or ground truth for a training set in this context.

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A Powder Free Nitrile Examination Glove - Blue (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05

Powder Free Nitrile Examination Glove - Blue (Chemotherapy)

The provided document outlines the FDA's substantial equivalence determination for a medical device, specifically "Powder Free Nitrile Examination Glove -- Blue (Chemotherapy)." The primary focus of the document regarding performance is the permeation resistance of these gloves to various chemotherapy drugs.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For chemotherapy gloves, the critical acceptance criterion is the Minimum Breakthrough Detection Time when exposed to specific chemotherapy drugs. The device performance is measured against this criterion. While the document doesn't explicitly state "acceptance criteria" for each drug with a numerical threshold (e.g., "must be > X minutes"), it presents the test results, implying that demonstrating adequate permeation resistance for a certain duration is the goal. For the purpose of this analysis, the reported breakthrough detection times serve as the device's performance against an implicit criterion of maintaining barrier integrity for a reasonable period.

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

• Sample Size: For each chemotherapy drug, the breakthrough detection time is reported with values for three specimens (e.g., "(60.3, 60.5, 60.6)"). Therefore, the sample size for the test set regarding permeation was 3 specimens per drug.
• Data Provenance: The document does not specify the country of origin of the data. It is a submission to the FDA from a Malaysian company (Matang Manufacturing Sdn. Bhd, Melaka, Malaysia). The study appears to be prospective testing specifically conducted for this 510(k) submission, rather than retrospective data analysis.

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 study described is a laboratory test (permeation test) conducted according to a standard (ASTM D 6978-05). It does not involve human interpretation or subjective assessment that would require "experts" to establish a ground truth in the typical sense of clinical studies (e.g., radiologists interpreting images). The "ground truth" here is the objective chemical permeation through the glove material as measured by the testing method.

4. Adjudication Method for the Test Set

• This information is not applicable as the study is a laboratory permeation test, not a study involving human interpretation or subjective assessment that would require an adjudication method among experts. The results for each specimen are reported independently.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, And What Was the Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve multiple readers (e.g., physicians) interpreting cases (e.g., medical images) with and without AI assistance. The described study is a laboratory material performance test for gloves.

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

• This question is not applicable as the device is a physical product (examination glove), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply. The performance reported is that of the physical device under laboratory conditions.

7. The Type of Ground Truth Used

• The "ground truth" used is based on objective laboratory measurements of chemical permeation through the glove material, as defined by ASTM D 6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs). This standard outlines validated methods for determining breakthrough time. It is a direct physical measurement, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• This information is not applicable. The device is a physical product (glove) whose performance is determined through physical testing, not through a machine learning algorithm that requires a training set.

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

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

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The Powder Free Nitrile Examination Gloves, Non Sterile (Blue Colored, Black Colored and White Colored) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Glove Class 1 patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.

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

The provided document is a 510(k) summary for a medical device (Powder Free Nitrile Examination Glove) and an FDA clearance letter. It details how the device meets regulatory standards rather than outlining a traditional "study" in the sense of a clinical trial for diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" and a "training set" in the context of machine learning or AI. Instead, it refers to testing conducted to meet specific ASTM standards and regulatory requirements for medical devices.

• Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the respective ASTM standards.
• Data Provenance: The origin of the data is not specified beyond indicating compliance with international ASTM standards and US regulatory bodies (FDA, Consumer Product Safety Commission). The nature of the testing is "non-clinical performance data," implying lab-based assessments of physical and biocompatibility characteristics, rather than patient data. The tests are prospective in the sense that they are performed on samples of the manufactured gloves to demonstrate compliance.

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

This is not applicable in the traditional sense for this type of device and study. The "ground truth" here is objective measurement against established physical and chemical standards (ASTM specifications, CPSC regulations). Experts would be involved in performing the tests and interpreting the results according to the standard protocols, but they are not "establishing ground truth" in the way, for example, a radiologist establishes ground truth for an image-based AI system.

4. Adjudication Method for the Test Set

Not applicable. The tests are based on objective measurements and compliance with predefined thresholds in standards, not subjective assessments requiring adjudication.

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 (e.g., AI in radiology) where human-in-the-loop performance is being assessed. This document concerns a physical medical device (examination gloves) and its compliance with material and biocompatibility standards.

• Effect Size: Not applicable.

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

No, a standalone performance assessment in the context of an "algorithm only" is not applicable here. This device is not an algorithm or an AI system. Its performance is inherent to its physical and chemical properties.

7. The Type of Ground Truth Used

The "ground truth" used is defined by:

• ASTM Standard Specifications: For dimensions, physical properties, freedom from pin-holes, and powder-free residue. These are quantitative and objective thresholds and methodologies described in the respective ASTM documents.
• Regulatory Guidelines/Standards: For biocompatibility tests (dermal sensitization, primary skin irritation), referencing ASTM F720 and Consumer Product Safety Commission regulations. These tests involve observing biological responses in animal models against predefined criteria for "irritant" or "sensitizer."

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI or machine learning model for this device. The manufacturing process and quality control ensure the device consistently meets the required specifications.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth," as described in point 7, is established by industry-wide recognized standards and regulatory requirements for medical gloves.

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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.

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:

Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

Not Found

This document describes a 510(k) premarket notification for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs (Non-Sterile)". The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices for general patient examination glove use, and additionally, to provide data on the gloves' resistance to permeation by chemotherapy drugs.

As such, the information provided focuses on the testing for chemotherapy drug permeation.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the test standard ASTM D6978-05, which is a standard practice for assessing medical gloves for permeation by chemotherapy drugs. While the document doesn't explicitly state a "pass/fail" threshold for breakthrough time (e.g., all drugs must be > X minutes), it does highlight drugs with permeation times less than 240 minutes, implying that longer breakthrough times are generally more desirable. The reported performance is the minimum breakthrough detection time for each drug.

Note on Acceptance Criteria: The document explicitly notes: "Please note that the following drugs have low permeation time of less than 240 minutes: Carmustine (BCNU), 3.3mg/ml (3,300ppm) Thiotepa, 10.0mg/ml (10,000ppm)". This indicates that while the device was tested, a breakthrough time of less than 240 minutes for these specific drugs is acknowledged and disclosed, rather than being an outright "failure". The acceptance criterion is therefore the performance according to the specified ASTM standard, with the understanding that users would be informed about the permeation characteristics.

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

The document does not explicitly state the sample size (number of gloves or individual tests) used for the chemotherapy drug permeation testing. It only lists the results for each drug.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective". However, the manufacturer is Maxter Glove Manufacturing Sdn. Bhd. in Malaysia, suggesting the testing likely occurred in or was commissioned by the manufacturer, possibly in Malaysia or a testing lab accredited to perform ASTM D6978-05. The testing itself is a prospective performance test of the device.

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

This type of device (patient examination gloves) and the specific test (chemotherapy drug permeation) do not involve "experts" establishing a ground truth in the traditional sense of clinical diagnosis or interpretation. The "ground truth" is established by the standardized laboratory test procedure itself (ASTM D6978-05), which objectively measures the breakthrough time of the chemotherapy drugs through the glove material. The "truth" is the measured time according to the standard.

4. Adjudication Method for the Test Set

Not applicable. This is a laboratory performance test, not a subjective assessment requiring adjudication. The results are quantitative 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 a performance test for a patient examination glove, not an AI-assisted diagnostic or interpretive device involving human readers.

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

Not applicable. This is a physical device (glove), not an algorithm or AI. The testing performed is an objective measurement of its physical properties.

7. The type of ground truth used

The ground truth used is objective laboratory measurement based on a standardized test method (ASTM D6978-05). This standard details how to measure the permeation of chemotherapy drugs through medical glove materials, providing a quantifiable breakthrough time.

8. The sample size for the training set

Not applicable. This is a physical device undergoing performance testing, not a machine learning model that requires a training set.

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

Not applicable. As this is not a machine learning model, there is no training set or associated ground truth for a training set.

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