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The DISPOSABLE FACE MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

The DISPOSABLE FACE MASK is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided document describes the safety and effectiveness of a DISPOSABLE FACE MASK (Models: TX-005, TX-006) by Jiujiang Taixin Technology Co., Ltd. It is a 510(k) premarket notification, indicating a comparison to a legally marketed predicate device (K202424) rather than a de novo approval requiring extensive clinical trials. Therefore, the "study" referred to is a series of non-clinical performance and biocompatibility tests conducted according to established international standards.

Here's a breakdown of the requested information:

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

2. Sample sized 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 sample sizes used for each performance test. The tests were performed according to specified ASTM and ISO standards, which would dictate the appropriate sample sizes for each test in a prospective manner. The provenance of the data is from Jiujiang Taixin Technology Co., Ltd. in China. The tests are non-clinical, meaning they are laboratory tests, not human subject studies.

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 is a non-clinical device (face mask). "Ground truth" in the context of expert review for medical imaging or clinical diagnosis is not applicable here. The performance criteria are objective measurements defined by international standards (ASTM, EN, ISO). The "ground truth" is the specified performance criteria for each test.

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

Adjudication methods like 2+1 or 3+1 are used for human expert review, typically in clinical studies or for establishing ground truth in image analysis. This is a non-clinical device, so such adjudication is not applicable. The device performance is determined by objective laboratory testing.

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

No MRMC comparative effectiveness study was done. This is a basic medical device (face mask) and does not involve AI or human reader interpretation.

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

Not applicable. This device does not incorporate an algorithm.

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

The "ground truth" for the performance tests are the established international standards (ASTM F2101, EN 14683, ASTM F2299, ASTM F1862, 16 CFR Part 1610, ISO 10993). These standards define the acceptable range or threshold for each performance characteristic (e.g., BFE ≥ 98%, Flammability Class 1, non-cytotoxic).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable, as this device does not use an AI/ML algorithm or a 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.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large. The subject device is non-sterile.

Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves

This document outlines the acceptance criteria and details the studies conducted to demonstrate that the "Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For Carmustine (BCNU) and ThioTepa, the device performance did not meet the implicitly accepted longer breakthrough times of the predicate device for safe use, and as such, a warning was issued for non-use with these specific drugs. For other drugs, the device demonstrated comparable or superior performance to the predicate.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test. However, for the Watertightness Test (ASTM D5151), the result "0/125/Pass" indicates a sample size of 125 gloves were tested, and none failed.

The data provenance is implied to be prospective bench testing conducted specifically for the submission of this device, presumably within China, given the manufacturer's and correspondent's addresses. There is no information provided regarding country of origin of data beyond the manufacturer's location.

3. Number of Experts and Qualifications for Ground Truth

This section is not applicable as the studies are primarily bench testing of physical and chemical properties of a medical device (gloves). The "ground truth" for these tests is established by published ASTM and ISO standards and their specified methodologies, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable as the studies involve objective physical and chemical testing against established standards, not interpretation of data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a medical glove, and the evaluation does not involve diagnostic imaging or human-in-the-loop performance with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a medical glove, not an algorithm, and its performance is assessed directly through physical and chemical testing.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards: These standards define the test methodologies, performance criteria (e.g., minimum tensile strength, maximum powder content, minimum breakthrough times for chemotherapy drugs, irritation/sensitization levels), and acceptable limits.
• Objective laboratory measurements: Physical dimensions, tensile strength, elongation, watertightness, powder content, and chemical permeation breakthrough times were measured directly according to the specified standard test methods.

8. Sample Size for the Training Set

This is not applicable. The device is a physical product (medical gloves), not an AI algorithm that requires a training set. The performance is based on direct testing of the product itself.

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

This is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation is established by the relevant ASTM and ISO standards as mentioned in point 7.

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