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A patient examination 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.

This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim." The core of the submission revolves around demonstrating the glove's resistance to permeation by chemotherapy drugs and Fentanyl.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nitrile Powder Free Examination Glove's resistance to chemotherapy drugs and Fentanyl permeation are based on the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is the "Minimum breakthrough Detection Time (min)" for each chemical.

The Study that Proves the Device Meets the Criteria:

The study referenced is the testing performed "as per ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard is a recognized methodology for evaluating the integrity of medical gloves when exposed to hazardous chemicals. The table provided directly presents the results of this testing, showing the breakthrough detection times for each specified drug and Fentanyl Citrate.

Remaining Information Not Present in the Document:

The provided document (an FDA 510(k) clearance letter and Indications for Use statement) does not contain the detailed technical information required to answer the following questions:

2. Sample size used for the test set and the data provenance: Not mentioned. The document only presents chemical permeation test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical performance test for a glove, not an AI or diagnostic device requiring expert interpretation of results for "ground truth." The "ground truth" here is the direct measurement of chemical breakthrough time.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus building among human readers for diagnostic interpretation, which is not relevant for a glove permeation test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic devices, not protective equipment like gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by the direct measurement of chemical permeation through the glove material according to the ASTM D6978-05 standard. It is a direct physical measurement.
8. The sample size for the training set: Not applicable. This refers to the training of machine learning models, which is irrelevant for a glove permeation test.
9. How the ground truth for the training set was established: Not applicable. This refers to the training of machine learning models.

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

Not Found

This document is an FDA 510(k) clearance letter for Nitrile Examination Powder Free Gloves. It does not contain information about an AI/ML medical device, its acceptance criteria, or a study proving that such a device meets acceptance criteria.

The information provided in the prompt, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used to establish the ground truth," and "If a multi reader multi case (MRMC) comparative effectiveness study was done," are all relevant to the evaluation of AI/ML-driven medical devices. However, this document is for a physical medical device (gloves) and therefore does not include any of these details.

To answer your request, I would need a document related to an AI/ML medical device, not a physical one.

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

Nitrile Examination Powder Free Glove, Black; Nitrile Powder Free Glove, Orange

The provided text is a 510(k) premarket notification decision letter from the FDA for Nitrile Examination Powder Free Gloves. This document does not contain any information related to acceptance criteria, study details, or device performance for an AI/ML powered medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input material does not pertain to such a device or study.

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A patient examination 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. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

The provided document is a 510(k) premarket notification decision letter from the FDA regarding Nitrile Blue Powder Free Examination Gloves. This document describes the regulatory classification and general controls applicable to the device, and importantly, includes the "Indications for Use" statement and a table of chemotherapy drug permeation test results.

Therefore, the acceptance criteria and study proving the device meets the acceptance criteria are related to the performance of the gloves against permeation by chemotherapy drugs, not an AI/ML algorithm or a diagnostic device, which is what the prompt's questions are geared towards.

Given the nature of the device (examination gloves) and the content of the document, most of the questions in the prompt are not applicable. The information provided is for a physical medical device, not a software or AI-based diagnostic tool.

However, I can extract information relevant to the performance claims and their supporting study as presented in the document, reinterpreting the prompt's questions for this context.

Here's an attempt to answer the questions based only on the provided document, acknowledging that most questions are designed for AI/ML or diagnostic devices and do not fit:

Device Under Evaluation: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

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

For the specific claim "Tested for Use with Chemotherapy Drugs," the acceptance criterion is implied by the standard referenced (ASTM D6978-05) and the reported "Breakthrough Detection Time." While an explicit "acceptance criterion" value (e.g., must be > X minutes) is not stated in this document, the demonstration of high breakthrough times for most drugs indicates meeting a performance expectation set by the standard for protective gloves.

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

The document references "ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard would specify the sample size requirements (e.g., number of gloves tested per drug). This specific document does not state the sample size used for the permeation tests.

• Data Provenance: The tests were conducted according to a recognized ASTM standard, implying a controlled laboratory setting. The country of origin of the data is not specified, but the applicant (GMP MEDICARE SDN.BHD.) is based in Malaysia ("MY"). The testing would typically be done in a lab, which could be internal or external.
• Retrospective or Prospective: Not applicable in the context of physical product testing. These are laboratory characterization tests on manufactured samples.

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 and study. The "ground truth" for chemical permeation is established by the standardized test method (ASTM D6978-05) itself, which involves specialized laboratory equipment and procedures, not human expert interpretation.

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

Not applicable. Adjudication methods are used to resolve disagreements in expert interpretations (e.g., in medical image reading). This study involves objective chemical permeation 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 document is about a physical product (gloves) and their chemical resistance, not an AI or diagnostic tool.

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

Not applicable. This refers to the standalone performance of an algorithm. The "device" here is a pair of gloves. The performance (breakthrough time) is inherently "standalone" in the sense that it's a direct measurement of the glove material properties, not an assisted human process.

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

The "ground truth" for the performance claims would be the objective measurements obtained according to ASTM D6978-05. This standard defines how permeation is measured and what constitutes a "breakthrough detection time." It's a direct physical measurement/test outcome, not an interpretation from experts, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of physical medical device performance testing like chemical permeation. This concept applies to machine learning models.

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

Not applicable, for the same reason as point 8.

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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.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

Chemotherapy Drug Permeation

• The following chemicals have been tested with these gloves

• Please note that the following drugs have extremely low permeation times:

Carmustine (BCNU): 10.1 minutes and Thiotepa: 20.2 minutes

Nitrile Blue Powder Free 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.

This document describes the FDA's substantial equivalence determination for Nitrile Blue Powder Free Examination Gloves. It focuses on their safety and effectiveness, particularly when exposed to chemotherapy drugs, based on performance criteria.

Here's an analysis of the provided information, framed by your request for acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for permeation by chemotherapy drugs are not explicitly stated as numerical targets in the document. However, they are implied by the testing methodology and the presentation of "Breakthrough Detection Time in Minutes." The general acceptance would be to demonstrate a reasonable barrier against these drugs, with the specific times providing the performance metrics.

Note: The document highlights that Carmustine and Thiotepa had "extremely low permeation times" compared to others, indicating these might be areas of concern if specific minimum times were regulatory requirements.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the sample size (number of gloves or tests) used for the chemotherapy drug permeation study. The table presents drug-specific results, but not the number of replicates or individual tests contributing to those results.
• Data Provenance: The study was conducted "as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard is a highly detailed, globally recognized protocol for testing these products, ensuring reproducibility and reliability of the data. The country of origin of the data is not specified beyond the Malaysian company (GMP Medicare SDN. BHD.) submitting the device. It is a prospective study as tests were conducted to specific ASTM standard.

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

This information is not applicable and therefore not provided in the document. The "ground truth" for this device's performance is established by the results of physical and chemical testing (specifically, permeation testing against a standardized protocol), not by expert consensus or interpretation of images/data. The ASTM D6978-05 standard itself defines the methodology for determining this ground truth (breakthrough time).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical or diagnostic studies where expert opinions or interpretations are being harmonized. For material performance testing, the results are derived directly from the test procedure according to the ASTM standard, not from human adjudication of results.

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

Not applicable. This device is a medical glove, and its performance for chemotherapy drug permeation is assessed through laboratory material testing, not through human reader interpretation of cases or clinical scenarios. Therefore, an MRMC study and the concept of "improving human readers with AI" are irrelevant to this submission.

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

Not applicable. This is not an AI/algorithm-based device. Its performance is purely based on the physical barrier properties of the glove material when exposed to specific chemicals.

7. Type of Ground Truth Used

The ground truth used is based on physical and chemical testing results derived from a standardized protocol: ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This standard uses instrumental analysis to detect when a chemotherapy drug permeates through the glove material.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the context of developing an algorithm. The testing described is for performance validation, not for training a model.

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

Not applicable, as there is no training set for an AI/ML algorithm. The "truth" for the product's performance is established through direct, standardized laboratory testing as outlined in point 7.

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