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Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.

The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation.

Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner's hands to prevent contamination between patent and examiner.

Here's a breakdown of the acceptance criteria and the study information for the Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves, based on the provided FDA 510(k) clearance document:

1. Table of Acceptance Criteria and Reported Device Performance

The device meets the acceptance criteria for all listed chemotherapy drugs by demonstrating a breakthrough detection time of greater than 240 minutes, with the explicit exception of Carmustine and Thiotepa, for which a warning is issued.

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

The document states that the proposed device was "tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

• Sample Size: The document does not explicitly state the number of gloves (samples) tested for each chemotherapy drug. However, ASTM D6978-05 generally specifies a minimum of three individual test specimens per drug for permeation testing.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It implies the data was collected specifically for this submission through testing.

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

This section is not applicable to this type of device and study. The "ground truth" here is objective scientific measurement (chemical breakthrough time) performed by laboratory testing according to a recognized standard (ASTM D6978-05), not expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

This section is not applicable. As mentioned above, the "truth" is determined by objective laboratory measurements and standardized methodology, not through human adjudication of differing opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and the impact of AI on their performance. This device is an examination glove, and its performance is measured through physical and chemical interaction, not human interpretation.

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

This concept is not applicable to this device. A "standalone" study (algorithm only) refers to the performance of an AI algorithm independent of human input. This device is a physical product (gloves) whose performance is evaluated through material testing against chemical permeation, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used is objective laboratory measurement of chemical permeation. Specifically, it is the "Breakthrough Detection Time" as measured according to the ASTM D6978-05 standard. This is a direct physical measurement of the glove's resistance to different chemotherapy drugs.

8. The Sample Size for the Training Set

This section is not applicable. This device is a physical product and its performance is evaluated through direct physical/chemical testing, not by training an algorithm on a dataset. Therefore, there is no "training set" in the context of machine learning.

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

This section is not applicable for the same reason as point 8.

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mCare® Powder Free Nitrile Orange Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

mCare® Powder Free Nitrile Orange Examination Gloves

This document is a 510(k) clearance letter from the FDA for a medical device: "mCare® Powder Free Nitrile Orange Examination Gloves."

This document does not contain information regarding acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/ML medical device. It is a regulatory clearance for a physical product (gloves).

Therefore, I cannot extract the requested information as it is not present in the provided text.

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mCare® Powder Free Nitrile Black Examination Gloves are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

mCare® Powder Free Nitrile Black Examination Glove

The provided text is a U.S. FDA 510(k) clearance letter for the mCare® Powder Free Nitrile Black Examination Glove. It is a regulatory document affirming substantial equivalence to a predicate device and discussing compliance requirements for marketing this Class I medical device. It is not a study report for a medical device that uses AI or complex algorithms, nor does it contain information about acceptance criteria or performance studies of such a device.

Therefore, I cannot provide the requested information because the document does not contain details about:

• Acceptance criteria table and reported device performance for an AI/algorithmic device.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for ground truth establishment.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set sample size or ground truth establishment for a training set.

The document discusses the regulatory classification of a glove and its intended use, which is a simple barrier device.

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mCare® Powder Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05, The following drugs had no breakthrough detected up to 240 minutes

• 1. Cisplatin, 1.0 mg/ml
• 2. Cyclophosphamide (Cytoxan), 20 mg/ml
• 3. Dacarbazine (DTIC), 10.0 mg/ml
• 4. Doxorubicin Hydrochloride, 2.0 mg/ml
• 5. Etoposide (Toposar), 20.0 mg/ml
• 6. Fluorouracil, 50.0 mg/ml
• 7. Methotrexate, 25 mg/ml
• 8. Mitomycin C,0.5 mg/ml
• 9. Paclitaxel (Taxol), 6.0 mg/ml
• 10. Vincristine 1.0 mg/ml

The following drugs showed breakthrough detected in less than 240 minutes:

• 1. Carmustine (BCNU), 3.3 mg/ml: 24.6 minutes

2. Thiotepa (THT) 10.0 mg/ml: 68.9 minutes

Warning-Not for Use with Carmustine and Thiotepa

mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

The provided text is a 510(k) premarket notification letter from the FDA to Mercator Medical (Thailand) LTD regarding their mCare® Powder-Free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed.

This document primarily focuses on the regulatory clearance of a physical medical device (examination gloves) and not an AI/ML-driven software device. Therefore, the information required to describe the acceptance criteria and study proving an AI/ML device meets those criteria (questions related to test sets, experts, MRMC studies, ground truth, etc.) is not present in this document.

The document discusses:

• The device's classification and regulation.
• General controls provisions.
• The device's intended use and specific chemotherapy drugs it was tested against for breakthrough time, as per ASTM D6978-05.
• Breakthrough times for tested chemotherapy drugs, explicitly stating that two drugs (Carmustine and Thiotepa) showed breakthrough in less than 240 minutes, leading to a warning.

In summary, this document does not contain the information requested about AI/ML device performance and validation studies.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device validation based on the provided text.

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mCare® Powder Free Nitrile Blue Examination Glove are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

mCare® Powder-free Nitrile Blue Examination Gloves are substantially equivalent to the Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

This document describes the premarket notification (510(k)) for the mCare® Powder-free Nitrile Blue Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, as clinical performance data is not required for this type of device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:

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

The provided text includes a table (on page 4 and 5) that compares the characteristics, standards, and device performance of the mCare® Powder-free Nitrile Blue Examination Gloves ("Current") against a predicate device ("Predicate") and relevant ASTM standards.

After Aging
Tensile Strength min 14 MPa
Ultimate Elongation Min 400 % |
| Thickness | ASTM D6319-10 | Finger min 0.05 mm.
Palm min 0.05 mm. |
| Powder Free | ASTM D6319-06 | ≤ 2 mg/glove |
| Biocompatibility | Primary Skin Irritation - ISO 10993-10:2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 | Under the conditions of the study, not an irritant |
| | Dermal Sensitization - ISO 10993-10:2010 (E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c) (4) | Under the conditions of the study, not a sensitizer |
| Watertight (1000 ml.) | ASTM D6319-06 | AQL 2.5 |
| Intended use | - | 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. |
| Material | ASTM D6319-10 | Nitrile |
| Color | - | Blue |
| Texture | - | Finger texture |
| Size | Medical Glove Guidance Manual - Labeling | Extra Small, Small, Medium, Large, Extra Large |
| Single Use | Medical Glove Guidance Manual - Labeling | Single Use |

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 specific sample sizes used for each test (e.g., for physical properties, watertightness, biocompatibility). It references ASTM standards, which would dictate the sampling plans. The data provenance is associated with Mercator Medical (Thailand) LTD., located in Thailand, suggesting the tests were conducted or overseen by them. The studies are for a new device seeking clearance, so they are inherently prospective from the device's perspective given the timeframe of the 510(k) submission.

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)

This type of information (number and qualifications of experts) is not relevant or typically included for the testing of examination gloves. The "ground truth" for these tests are objective measurements against established engineering standards (ASTM and ISO).

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where there's subjective interpretation by multiple human readers (e.g., radiologists reviewing images). For the performance testing of examination gloves, the tests involve objective measurements against predefined standards. Therefore, an adjudication method is not applicable and not mentioned.

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

An MRMC study is completely irrelevant for this device. This device is an examination glove, not an AI-powered diagnostic tool, and it does not involve human readers interpreting data.

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

This question is also not applicable. The device is a physical examination glove, not an algorithm.

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

The "ground truth" for the performance criteria listed in the table is based on established engineering and material science standards, specifically:

• ASTM D6319-10 (for dimensions, physical properties, thickness, material)
• ASTM D6319-06 (for powder-free and watertightness)
• ISO 10993-10:2010 (E) and Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (for biocompatibility - primary skin irritation and dermal sensitization)
• Medical Glove Guidance Manual - Labeling (for size and single use)

These standards define the acceptable range or threshold for each characteristic based on scientific and industry consensus regarding what constitutes a safe and effective examination glove.

8. The sample size for the training set

There is no "training set" in the context of an examination glove's performance testing for 510(k) clearance. Training sets are relevant for machine learning algorithms.

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

Not applicable, as there is no training set for this device.

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The mCare Powder Free Latex Examination Blue 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.

mCare Powder Free Latex Examination Blue Glove

This document is a 510(k) premarket notification decision letter from the FDA for a patient examination glove. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The document confirms that Mercator Medical (Thailand) Ltd.'s "mCare Powder Free Latex Examination Blue Glove" is substantially equivalent to legally marketed predicate devices. It discusses general regulatory requirements for medical devices but provides no performance data or study details for this specific product.

Therefore, I cannot provide the requested information based on the provided text.

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