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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. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

Nitrile Blue Powder-Free Examination Gloves

This document is a 510(k) Premarket Notification from the FDA regarding "Nitrile Blue Powder-free Examination Gloves." It is a clearance letter, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies of a device related to AI, image analysis, or similar technologies.

The document only provides information about the chemical permeation resistance of the gloves to various chemotherapy drugs.

Thus, I cannot fulfill your request for the following reasons:

• No AI/ML Device: The device described (nitrile examination gloves) is a physical medical device, not a software or AI/ML-based device.
• No Performance Study Data of the Type Requested: The document details the results of ASTM D6978, which is a chemical permeation test, not a performance study involving test sets, expert readers, ground truth, or MRMC analysis for an AI algorithm.
• No Acceptance Criteria for AI/ML Performance: The "acceptance criteria" presented are minimum breakthrough times for chemotherapy drugs, not metrics like sensitivity, specificity, AUC, or other measures common for AI/ML diagnostic tools.

Therefore, I cannot extract the information asked for in points 1-9 of your prompt from the provided text.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powder Free Examination Glove

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

This document is a 510(k) clearance letter for a medical device (Nitrile Blue Powder Free Examination Glove). It does not contain the acceptance criteria or results of a study designed to prove the device meets specific performance criteria, especially not in the context of an AI/ML powered device.

Instead, this document is a regulatory approval letter stating that the device is "substantially equivalent" to a legally marketed predicate device. This means the manufacturer demonstrated that their device performs similarly to an existing device for its intended use, rather than conducting a de novo study against a set of predefined acceptance criteria for novel performance claims.

Therefore, I cannot provide the requested information from the provided text. The questions you've asked are typically relevant for AI/ML device submissions, which involve rigorous testing against performance metrics. This document pertains to a Class I medical device for which the primary regulatory pathway is demonstrating substantial equivalence.

However, to illustrate what specific elements are missing and why the provided document does not fulfill the request, let's address each point as if this were an AI/ML device submission, explaining why the information is absent:

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

• Missing: This document does not specify any quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1 score, AUC) or corresponding acceptance criteria needed for an AI/ML device. For a glove, the "performance" would relate to barrier integrity, tensile strength, and freedom from holes, but these types of metrics are not detailed here.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Missing: No test set is described, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.

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)

• Missing: Not applicable for this type of device and submission.

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

• Missing: Not applicable.

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

• Missing: Not applicable. This device is not an AI algorithm intended to assist human readers.

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

• Missing: Not applicable. This is a physical product, not an algorithm.

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

• Missing: Not applicable. For a glove, "ground truth" might relate to physical properties meeting standards, but this is not detailed.

8. The sample size for the training set

• Missing: Not applicable. There is no training set for a physical device like a glove.

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

• Missing: Not applicable.

Conclusion:

The provided FDA letter (K071208) is a clearance for a Nitrile Blue Powder Free Examination Glove based on substantial equivalence. It does not contain the detailed performance metrics, study designs, or data provenance information that would be requested for an AI/ML device's acceptance criteria and validation study. The letter confirms market clearance, but not specific test results or acceptance criteria in the manner you've outlined for software/algorithm performance.

Ask a specific question about this device

A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

NITRILE BLUE POWDER FREE EXAMINATION GLOVE

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Nitrile Blue Powder Free Examination Glove. It is a regulatory document and does not contain information about the acceptance criteria, study details, or performance of a device in the context of AI/ML or medical imaging analysis as implied by your detailed request.

The document discusses:

• The FDA's review of a premarket notification for a medical glove.
• The determination of substantial equivalence to a legally marketed predicate device.
• General controls and regulations applicable to the device.
• The intended use of the glove as a disposable device to prevent contamination between patient and examiner.

Therefore, I cannot extract the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

Ask a specific question about this device

A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powder Free Examination Glove

The provided document is a 510(k) clearance letter from the FDA for a Nitrile Blue Powder Free Examination Glove. This document does not contain information about acceptance criteria or a study proving that an AI device meets these criteria. The approval is for a physical medical device (examination glove), not an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, expert qualifications, or AI-related metrics like MRMC studies or standalone AI performance.

Ask a specific question about this device