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The Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentany] Citrate is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

The gloves were tested with chemotherapy drugs and fentanyl citrate as per ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

This FDA 510(k) clearance letter pertains to medical examination gloves and does not describe an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, expert qualifications, ground truth establishment methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

The document focuses on the performance of a physical medical device (gloves) against specific chemical permeation tests.

Here's the relevant information based on the provided text, focusing on the acceptance criteria and study for the gloves:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is evaluated based on its resistance to permeation by chemotherapy drugs and Fentanyl Citrate. The acceptance criterion is implied by the testing methodology using ASTM D6978-05, aiming for a long breakthrough detection time. While an explicit "acceptance criteria" value isn't stated in the table for each drug, the "Average Breakthrough Detection Time (mins)" provides the reported performance directly. For most drugs, a breakthrough time of "> 240 minutes" is presented, indicating good resistance for at least 4 hours.

Note: The cautionary statement "CAUTION: Do not use with Carmustine and ThioTepa" implies that the breakthrough times for these two drugs (13.5 and 19.0 minutes respectively) are considered insufficient for safe use, effectively setting an implicit acceptance criterion that these drugs fail it for prolonged exposure.

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

The document does not specify the exact sample size for the test set (number of gloves tested per drug). It only refers to a standard test method. The data provenance is not explicitly stated beyond being the result of testing the manufacturer's "Powder-Free Green Biodegradable Nitrile Examination Glove." The testing is prospective for the purpose of this submission. The country of origin of the data is not specified, but the manufacturer is based in Malaysia.

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)

Not applicable. This is a physical device performance test (chemical permeation), not an AI/ML diagnostic or image interpretation. "Ground truth" in this context is the objective measurement of chemical breakthrough time, typically conducted in a laboratory by trained technicians following a standardized protocol.

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

Not applicable. This is a physical device performance test, not involving human interpretation or adjudication in the sense of comparing opinions. 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 not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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

The "ground truth" for this type of device is the objective measurement of chemical permeation/breakthrough time determined by laboratory testing protocols, specifically ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

8. The sample size for the training set

Not applicable. This is not an AI/ML powered device.

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

Not applicable. This is not an AI/ML powered device.

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A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent containation between patient and examiner. Tested for use with chemotherapy drugs as listed below.

Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.

The document describes a medical device called "Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs" and its clearance for marketing. The acceptance criteria and the study proving the device meets these criteria are specifically related to the gloves' permeation resistance to various chemotherapy drugs.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The implicit acceptance criterion for gloves tested with chemotherapy drugs is to demonstrate a reasonable "Breakthrough Detection Time," meaning the time it takes for the chemotherapy drug to permeate through the glove material. While not explicitly stated as a pass/fail threshold in the provided text, the standard practice in evaluating such gloves is typically referenced against established guidelines (e.g., ASTM standards for barrier protection). The performance reported is the actual breakthrough detection time for each drug.

Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This indicates that while higher numbers are generally better, specific breakthrough times are reported and acknowledged. The "acceptance criteria" here is simply the demonstration and reporting of these values to show the glove's performance against specific drugs, allowing users to make informed decisions.

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

The document does not explicitly state the sample size used for testing each glove type with each chemotherapy drug. The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it's a 510(k) submission to the FDA, it implies that the testing was conducted in a controlled, prospective manner to meet regulatory requirements, likely in a laboratory setting adhering to recognized standards (e.g., ASTM D6978).

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

This type of information is not applicable (N/A) to the clearance of surgical gloves for chemotherapy drug permeation. The "ground truth" here is objective scientific measurement (breakthrough detection time) determined through laboratory testing, not subjective expert assessment as would be the case for image interpretation or diagnostic accuracy.

4. Adjudication Method for the Test Set:

This is N/A. Since the "ground truth" is established by objective laboratory measurements, there is no need for expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

This is N/A. Surgical gloves are not diagnostic devices that involve "readers" or "cases" in the context of comparative effectiveness studies against AI. The document focuses on the material's barrier properties.

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

This is N/A. The device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used is objective laboratory measurement of Breakthrough Detection Time obtained through standardized chemical permeation testing (e.g., following a standard like ASTM D6978), which measures the time it takes for a chemotherapy drug to permeate through the glove material.

8. The Sample Size for the Training Set:

This is N/A. The device is a physical product, not an AI model, so there is no "training set."

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

This is N/A for the same reason as point 8.

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A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contained a a aspossors and examiner. Tested for use with chemotherapy drugs as listed below.

Powder Free White , Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs.

This document is a 510(k) premarket notification decision letter from the FDA for surgical gloves, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and sample sizes for AI/ML device testing is not present in the provided text.

The document discusses the substantial equivalence of the "Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs" to legally marketed predicate devices. The primary performance data provided relates to the glove's resistance to permeation by chemotherapy drugs.

Here’s an attempt to structure the available information, keeping in mind the original request, but highlighting what is not applicable to this document:

1. Table of Acceptance Criteria and Reported Device Performance

For chemotherapy drug permeation, the implicit acceptance criterion is that the glove demonstrates a reasonable breakthrough detection time, particularly given the explicit note about Carmustine and Thio-Tepa having lower permeation times. The actual "acceptance criteria" for a 510(k) for this type of device would likely involve compliance with recognized standards (e.g., ASTM standards for medical gloves) which are not explicitly detailed in this letter but are implied by the regulatory review process.

Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This indicates that even with these lower times, the device was considered acceptable for its intended use, likely with appropriate labeling.

The following points are not applicable to this document as it pertains to the regulatory clearance of surgical gloves, not an AI/ML powered device. Therefore, there is no information in the provided text to answer these questions.

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

   • Not Applicable. This document does not pertain to AI/ML software; it is for surgical gloves. The "test set" would refer to physical glove samples and the chemicals used for permeation testing, not data for an 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)

   • Not Applicable. Ground truth, in the context of AI/ML, refers to labels or diagnoses established by experts. For surgical glove testing, "ground truth" would relate to precise chemical permeation measurements, which are typically performed by laboratory technicians using standardized instruments, not by medical experts establishing a diagnosis.

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

   • Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling for AI/ML ground truth. This is not applicable to a physical device performance 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. MRMC studies are for evaluating diagnostic performance of readers, usually in conjunction with AI. This is entirely outside the scope of surgical glove clearance.

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

   • Not Applicable. This question relates to AI algorithm performance. No algorithm is being reviewed here.

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

   • Not Applicable. As mentioned previously, "ground truth" for AI/ML does not apply here. For surgical gloves, the "truth" is based on physical measurement protocols for chemical permeation.

8. The sample size for the training set

   • Not Applicable. This refers to AI/ML model training data. No AI/ML model is involved.

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

   • Not Applicable. This refers to AI/ML training data labeling. No AI/ML model is involved.

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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.

Not Found

The provided document is an FDA 510(k) clearance letter for examination gloves. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/software as a medical device (SaMD).

The document is for "Powder Free Pink Polychloroprene Copolymer Examination Gloves" and "Powder Free Black Polychloroprene Copolymer Examination Gloves," which are Class I medical devices (physical products, not software). The FDA's review for these physical devices focuses on substantial equivalence to predicate devices based on indications for use, without requiring clinical performance studies like those for AI/SaMD.

Therefore, I cannot provide the requested information from the given text as it pertains to AI/SaMD.

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