Search Results

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential Tested For Use With Chemotherapy Drugs.

The provided text describes a 510(k) premarket notification for a medical device: "Powder Free Nitrile Examination Glove (Blue), This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential, Tested for Use With Chemotherapy Drugs."

This document is a regulatory clearance letter and does not contain the acceptance criteria or a study description in the format of a typical scientific or clinical study. It refers to the device's substantial equivalence to legally marketed predicate devices and mentions that the glove "has been tested for use with specific chemotherapy drugs."

However, based on the information provided, we can infer some details related to acceptance criteria and performance for the chemotherapy drug permeation testing, which is a specific claim for this device.

Here's an attempt to structure the available information per your request, recognizing the limitations of the source document:

1. Table of Acceptance Criteria and Reported Device Performance (Chemotherapy Drug Permeation)

The "Indications for Use" section lists specific chemotherapy drugs and their "Average Breakthrough Detection Time in Minutes." While not explicitly stated as "acceptance criteria," the listed times for each drug represent the performance achieved, and for most, a ">240 minute" breakthrough time is implied as a desirable (and likely passed) threshold for safe use. The specific values obtained for each drug would be the "reported device performance."

Note: The document explicitly states "Warning: Do Not Use With Thiotepa or Carmustine," indicating that the device did not meet acceptance criteria for these specific drugs or was not tested for them in a way that would deem it safe.

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

• Sample Size: Not specified in this regulatory letter. For permeation testing, this typically involves multiple glove samples tested per drug.
• Data Provenance: Not explicitly stated (e.g., country of origin). The applicant, Smart Glove Corporation Sdn. Bhd., is based in MALAYSIA. It's common for testing to be conducted in a laboratory setting, which could be in various locations. The data is retrospective relative to the submission date of the 510(k).

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 device performance test (chemotherapy drug permeation), not a diagnostic or interpretative study requiring human experts for ground truth establishment. The "ground truth" is determined by laboratory testing methods (e.g., spectrophotometry or chromatography to detect drug breakthrough).

4. Adjudication method for the test set

• Not Applicable. As this is a laboratory performance test, there isn't a need for expert adjudication in the same way there would be for a clinical diagnostic study. Measurements are typically objective based on standardized test methods.

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 physical device (glove) and not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not Applicable. This is a physical device. Standalone algorithm performance refers to AI systems without human intervention, which is not relevant here.

7. The type of ground truth used

• Laboratory Testing / Standardized Test Methods: The "ground truth" for the chemotherapy drug permeation testing would be the objective measurement of drug breakthrough time through the glove material. This is established by specific, standardized laboratory protocols, likely following methods like ASTM D6978 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this physical device performance testing. Training sets are relevant for machine learning or AI models.

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

• Not Applicable. As there is no training set, this question is not applicable.

Ask a specific question about this device

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs.

Powder Free Nitrile Examination Glove (Blue). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Tested For Use With Chemotherapy Drugs.

This document is a 510(k) premarket notification letter for "Powder Free Nitrile Examination Gloves (Blue)". It describes the device and its intended use, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm perspective.

The device in question is a medical glove, which is a physical product, not an AI or algorithm. Therefore, the questions posed regarding AI performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets are not applicable to the content of this document.

The letter states that the FDA found the device "substantially equivalent" to legally marketed predicate devices, meaning it met the requirements for this type of medical device at the time of review (October 2008), but it doesn't detail performance studies in the way an AI/algorithm development report would.

Ask a specific question about this device

This 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 Gloves, Blue

I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Sterile, Powder Free Nitrile Examination Gloves, Blue." It does not contain information about acceptance criteria or a study that proves a device meets such criteria. Therefore, I cannot fulfill your request for that specific information based on the input given.

Ask a specific question about this device

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

Powder Free Nitrile Examination Gloves, Magenta and White Color, Coated with AlloGel and Powder free Nitrile Examination Gloves, Magenta And White Color

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for "Powder Free Nitrile Examination Gloves, Magenta and White Color, Coated with AlloGel" and "Powder Free Nitrile Examination Gloves, Magenta And White Color".

This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device. It is a regulatory clearance for physical examination gloves, focusing on their substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance from this document.

Ask a specific question about this device

This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy (Blue)

This document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy (Blue)". It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.

Therefore, I cannot answer the question based on the provided text. The document is about medical gloves, not an AI/ML device, and thus doesn't discuss performance metrics like sensitivity, specificity, or typical study designs for AI systems.

Ask a specific question about this device

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

Powder Free Nitrile Examination Gloves, Grape Scented, Blue and White color

The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Nitrile Examination Gloves, Grape Scented, Blue And White Color". It primarily focuses on the regulatory approval and substantial equivalence determination for this medical device.

This document does NOT contain information about acceptance criteria, device performance studies, ground truth establishment, sample sizes for training or testing, or expert qualifications for AI/ML device evaluation.

Therefore, I cannot provide the requested information from the given text. The request is based on the assumption that the document describes an AI/ML medical device, which is not the case here. This document pertains to a physical medical device (gloves) and its regulatory clearance process, not a software algorithm that would have the study components listed in your request.

Ask a specific question about this device

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Coated With Cucumber With Glycerine, Blue Color

This is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. The information provided in the letter and the associated "Indication for Use" statement does not contain the details required to answer the prompt.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts for ground truth, or adjudication methods in a study.
• Information about multi-reader, multi-case comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used, training set sample size, or how ground truth for the training set was established.

This document is a regulatory approval based on "substantial equivalence" to a predicate device, not a detailed technical report of a device performance study with specific acceptance criteria and study results. Therefore, I cannot provide the requested information from the given text.

Ask a specific question about this device

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

Powder Free Nitrile Examination Gloves, Black and Gray Color

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves, Black and Gray Color". This type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, or ground truth for AI/device performance.

The letter confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to legally marketed predicate devices. It lists regulations and requirements that the manufacturer must comply with, but it does not detail the technical performance criteria or the studies used to demonstrate that performance.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document is a regulatory approval letter, not a performance report.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. This type of study is not relevant for basic examination gloves.
6. If a standalone performance study was done: Not present in this document.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

This document serves as an FDA clearance for a medical device (examination gloves) based on substantial equivalence, and it does not delve into the detailed performance metrics or study methodologies typically associated with software as a medical device (SaMD) or AI-based devices.

Ask a specific question about this device

The glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Glove (Blue) (This product does not contain Thiuram, and/or Carbamate and/or Thiazole)

This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Powder Free Nitrile Examination Glove (Blue)". It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types for training and test sets) is typical for AI/ML device submissions to the FDA. However, this document pertains to a physical medical device (examination gloves) and therefore, the content does not align with the questions you've asked about AI/ML device performance.

Therefore, I cannot extract the requested information from the provided text. The document is about regulatory clearance for a traditional medical product based on substantial equivalence to existing products, not about the performance evaluation of a software algorithm.

Ask a specific question about this device

Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This davice also provides protection against exposure to certain chemotherapy drugs.

Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue)

The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (Blue)". It does not contain information about acceptance criteria or a study proving the device meets said criteria.

Instead, the letter establishes that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed, subject to general controls. It also outlines regulatory requirements, but it does not detail any specific performance acceptance criteria or a study report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample sized used for the test set and the data provenance: This information is not present in the document because no specific study results are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
4. Adjudication method: This information is not present in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present in the document.
6. If a standalone performance (algorithm only) study was done: This information is not present in the document, as it pertains to a physical medical device (gloves), not an algorithm.
7. The type of ground truth used: This information is not present in the document.
8. The sample size for the training set: This information is not present in the document.
9. How the ground truth for the training set was established: This information is not present in the document.

The document primarily focuses on the regulatory clearance process for a medical device (nitrile examination gloves) and its "Indications for Use," which states: "Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs."

Ask a specific question about this device