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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 to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate: Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.

This document is a 510(k) premarket notification decision letter from the FDA for several types of nitrile examination gloves. It acknowledges the substantial equivalence of the gloves to legally marketed predicate devices.

The acceptance criteria and device performance are related to the gloves' resistance to permeation by chemotherapy drugs and opioid drugs, specifically Fentanyl Citrate and Xylazine HCl. The study conducted appears to be ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it reports the "Minimum Breakthrough Detection Time in Minutes" for various drugs. For the purpose of this analysis, we can infer that a higher breakthrough time (ideally ">240 minutes") is the desired performance. The document explicitly highlights cases where performance is lower than presumably desired.

Note: For Carmustine (BCNU) and Thiotepa, the warning "Do Not Use with Carmustine (BCNU) and Thiotepa" implies that the reported breakthrough times are considered insufficient for safe use, despite meeting some base level of detection. Thus, the implicit acceptance criterion for these specific drugs is to not use the gloves. For all other drugs where ">240" is reported, this indicates the gloves met or exceeded the 4-hour test duration without breakthrough.

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 (number of gloves or trials) used for the permeation tests. It indicates the testing was "as per ASTM D6978-05 (Reapproved 2019) Standard Practice." This ASTM standard would specify the required sample size and methodology.
The data provenance is not explicitly stated in terms of country of origin but is presented as results from a technical study. This would be a prospective test, as the gloves were submitted for testing to demonstrate compliance.

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

This type of testing (chemical permeation) does not typically involve human experts establishing ground truth in the way medical imaging or clinical diagnoses do. The "ground truth" is established by the specified ASTM D6978-05 standard methodology, which is an objective chemical permeation test using analytical equipment.

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

Not applicable. Chemical permeation testing is a laboratory-based, objective measurement, not subject to subjective adjudication by human readers/experts.

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 technical performance test for medical gloves, not a study involving human readers or AI in diagnostic interpretation.

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

Not applicable. This is not an algorithm or AI product.

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

The ground truth is based on objective chemical permeation measurements performed according to ASTM D6978-05 (Reapproved 2019) Standard Practice. This standard defines the method for detecting the breakthrough of specific chemicals through a material.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable for the same reason as point 8.

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

Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim; Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim

The provided text is an FDA 510(k) clearance letter for a medical device: "Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim" and "Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim."

This document grants substantial equivalence based on the device's intended use as a patient examination glove, which is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner."

The FDA letter does not include information about AI/ML device performance, acceptance criteria, test set details, expert ground truth establishment, MRMC studies, or any of the other specific questions related to AI/ML device validation. These are standard requirements for AI/ML-driven medical devices, but this document pertains to a Class I medical device (gloves), which typically undergo different types of evaluation (e.g., biocompatibility, physical properties, sterility, and non-pyrogenicity) rather than AI/ML performance studies.

Therefore, it is not possible to extract the requested information from the provided text, as it describes the regulatory clearance for examination gloves, not an AI/ML powered device.

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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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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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