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The Nitrile Powder Free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

"Disposable Powder Free Nitrile Examination Glove, Pink Color" and "Disposable Powder Free Nitrile Examination Glove, Black Color" are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document is a 510(k) summary for a disposable powder-free nitrile examination glove, and as such, it focuses on demonstrating substantial equivalence to a predicate device based on bench testing. It does not describe an AI medical device, and therefore, many of the requested elements for AI/ML evaluation (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance of an algorithm) are not applicable.

However, I can extract the acceptance criteria and reported device performance from the provided text for the physical characteristics of the glove.

1. Table of acceptance criteria and the reported device performance

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White Color and Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange Color are a patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

The provided document describes a 510(k) premarket notification for disposable powder-free nitrile examination gloves, tested for use with chemotherapy drugs. This type of filing is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria and studies for an AI-powered device, including details like sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.

The document focuses on the physical and chemical properties of the gloves and their resistance to chemotherapy drug permeation, comparing them to established standards and a predicate glove. The "device" in this context is a physical medical glove, not an AI/ML diagnostic or assistive tool.

However, I can extract the acceptance criteria and reported performance for the glove from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the medical gloves are primarily based on ASTM standards (ASTM D6319-10 updated 2015 for Nitrile Examination Gloves and ASTM D6978-05 for chemotherapy drug permeation) and 21 CFR 800.20 for freedom from pinholes.

Table: Acceptance Criteria and Reported Device Performance for Disposable Powder Free Nitrile Examination Gloves

Note: For chemotherapy drugs like Carmustine and Thiotepa, the document explicitly states warnings due to "extremely low permeation time," indicating these drugs do not meet a desired high breakthrough time, hence the warning not to use them with these gloves for prolonged periods. The "acceptance criteria" for these specific drugs seem to be met by simply reporting the actual breakthrough time, coupled with a warning. For the other drugs, >240 minutes indicates they exceeded the maximum testing time, which is generally desired for chemotherapy-resistant gloves.

Non-Applicable Information for AI/ML Devices:

The following points are tailored for AI/ML device evaluations and are not relevant to the provided document about medical gloves:

2. Sample size used for the test set and the data provenance: Not applicable. Tests were bench-top physical/chemical tests on glove samples, not a data-driven AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth was established by laboratory measurements against ASTM standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Lab testing results are objective 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-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 algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for the glove was defined by internationally recognized standards (ASTM, ISO) for physical properties and chemical resistance.
8. The sample size for the training set: Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI model or training set.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs is a patient examination glove made from nitrile compound. non-sterile (as per 21 CFR 880.6250. Class I). The patient examination glove made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This document is a 510(k) Premarket Notification from the FDA, evaluating a medical device for substantial equivalence to a legally marketed predicate device. The information provided heavily focuses on bench testing and comparison to standards, rather than clinical studies with human participants or AI-driven performance metrics typically found in software as a medical device (SaMD) clearances.

Therefore, many of the requested details, such as the use of a test set with ground truth established by experts, MRMC studies, or training set details for an AI model, are not applicable to this document. The "device" in this context is a physical product (nitrile examination gloves) and not an AI/ML software.

The acceptance criteria and performance are related to the physical and chemical properties of the gloves, not AI performance.

Here's an attempt to answer the questions based only on the provided text, noting where information is not applicable (N/A) or not present.

Acceptance Criteria and Device Performance for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by adherence to various ASTM standards and 21 CFR regulations for physical and chemical properties, and specifically ASTM D6978-05 for chemotherapy drug permeation. The reported performance is the device's measured characteristics against these standards.

Note: For Carmustine and Thiotepa, the "acceptance criteria" is not explicitly defined as a threshold, but rather it is noted that these drugs have "extremely low permeation time," and the observed times are reported. The comparison is against the predicate device's performance for these specific drugs, which the proposed device improved upon (59.4 vs 12.4 for Carmustine, 118.5 vs 24.4 for Thiotepa).

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

• Sample Size for Test Set: The document does not specify the exact sample sizes for each specific test (e.g., how many gloves were tested for pinholes, or how many samples for each chemotherapy drug). It references adherence to ASTM standards, which would dictate appropriate sample sizes for these types of bench tests.
• Data Provenance: The tests were conducted to evaluate the qualities of the "Disposable Powder Free Nitrile Examination Glove, Blue Color" manufactured by Ever Growth (Vietnam) Co. Ltd. (Vietnam). These are bench tests on manufactured products, not data from human subjects or collected retrospectively/prospectively in a clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A. The "ground truth" for the performance of these gloves is established by objective, standardized bench testing methods (e.g., ASTM standards for material properties, chemical permeation tests). There is no "expert consensus" or human adjudication involved in determining these physical and chemical properties.

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

• N/A. No adjudication method is applicable as these are objective bench test measurements, not subjective human interpretations that require reconciliation.

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

• N/A. This device is a physical medical glove, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant.

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

• N/A. This device is a physical medical glove. "Standalone performance" in the context of an algorithm is not applicable.

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

• The "ground truth" for the device's performance is determined by objective measurements obtained through standardized bench testing methods (e.g., ASTM International standards for physical properties, chemical permeation analysis). For example, a "pinhole" is objectively detected using a water leak test, and "tensile strength" is measured mechanically.

8. The sample size for the training set

• N/A. This is a physical device, not an AI/ML model for which a "training set" would be used.

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

• N/A. Not applicable, as there is no training set for a physical product.

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

Disposable Powder Free Vinyl Exam Glove, Clear/ Yellow

The provided text is an FDA 510(k) clearance letter for a medical device: "Disposable Powder Free Vinyl Exam Glove, Clear/Yellow." This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software validation.

Instead, this document is a regulatory approval for a physical medical glove. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a device already on the market, or that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document because it pertains to a different type of device and regulatory review process.

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