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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 hand to prevent contamination between patient and examiner.

In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.

KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.

The provided text describes the acceptance criteria and study results for "KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid." This is a medical device, specifically examination gloves, and the acceptance criteria and studies are related to its physical properties, biocompatibility, and resistance to permeation by certain chemicals.

Here's an analysis based on your request:

1. Table of acceptance criteria and the reported device performance:

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

The document does not explicitly state the exact sample sizes used for each specific test (e.g., how many gloves were tested for pinholes, or how many individual permeation tests were conducted for each chemical). However, it references recognized standards like ASTM D6319 (for dimensions and physical properties, which dictates sampling plans), ASTM D5151 (for holes, which specifies AQLs), and ISO 2859-1:1999 (Sampling Procedures and Tables for Inspection by Attributes). Meeting these AQLs (Acceptable Quality Levels) implies specific sample sizes would have been drawn and tested in accordance with the standards.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given it's an FDA 510(k) submission, the studies would have been conducted by the manufacturer (Kimberly-Clark Corporation) or their designated testing facilities, likely in a controlled, prospective manner to generate data for the submission. The testing standards are international (ASTM, ISO), suggesting globally recognized methods.

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

This information is not applicable to this type of device and study. The testing described involves objective, quantitative measurements of physical and chemical resistance properties according to established engineering and material science standards (ASTM, ISO). "Ground truth" in this context is defined by the objective measurement procedures and acceptance criteria outlined in these standards, not by expert consensus or interpretation of images/clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers in diagnostic imaging or clinical studies. The studies presented here are laboratory-based, objective material property tests.

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:

This is not applicable. This submission is for a physical medical device (examination gloves), not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant.

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

This is not applicable. As stated above, this is not an AI algorithm. The performance described is inherent to the physical glove material and construction.

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

The "ground truth" for this device's performance is established by objective, quantitative measurements conducted in a laboratory setting according to internationally recognized standards and test methods. For example:

• Dimensions: Measured directly using calibrated instruments.
• Tensile Strength & Elongation: Measured using universal testing machines as per ASTM standards.
• Freedom from Pinholes: Determined by water leak tests following ASTM D5151.
• Powder Content: Measured gravimetrically as per ASTM D6124.
• Biocompatibility: Determined by laboratory animal studies (e.g., skin irritation, sensitization, systemic toxicity) following ISO 10993 guidelines, which define the biological response.
• Permeation Resistance: Measured by quantifying breakthrough time of specific chemicals using analytical techniques (e.g., chromatography) as per ASTM D6978-05.

8. The sample size for the training set:

This is not applicable. These studies are for a physical product validation, not for training an AI or machine learning model. There is no "training set" in this context.

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 validation.

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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 hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.

KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.

The provided document describes the safety and performance testing of KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves. However, this is a 510(k) premarket notification for a medical glove, not an AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, or clinical study design (MRMC), is not present in this document.

The document focuses on non-clinical performance tests of the physical and chemical properties of the gloves.

Here's an attempt to extract relevant "acceptance criteria" and "reported performance" based on the provided document, framed as close as possible to the request, while highlighting the limitations for an AI/ML context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is for a physical medical device (gloves), the "acceptance criteria" are defined by recognized standards (e.g., ASTM, ISO) for physical properties, chemical resistance, and biocompatibility.

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U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.

The U by Kotex® Click® Unscented Menstrual Tampon is a conventional unscented menstrual tampon consisting of an absorbent pledget and a telescoping three-piece plastic applicator. The device will be manufactured in Regular, Super, and Super Plus absorbencies. The absorbent pledget consists of an absorbent core of radially wound rayon ribbon compressed into a grooved cylinder with a rounded, bullet-like tip, a non-woven overwrap cover, and a rayon-polyester blend withdrawal string. The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.

The document describes a 510(k) submission for a medical device, which generally means comparing a new device to a legally marketed predicate device to demonstrate substantial equivalence. For this type of submission, extensive acceptance criteria and detailed clinical studies as might be found for novel technologies are often not present in the same format. Instead, the focus is on showing that the modified device performs as safely and effectively as the predicate.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance for a test set. Instead, it states that the device was assessed against various standards and guidance documents. The "Performance" column in Table 05-02 indicates the outcome of the tests, rather than specific numerical acceptance criteria. Similarly, for other performance characteristics, the document states they "were assessed in accordance with the 2005 FDA guidance document," implying compliance with the requirements within that guidance, but without listing specific numerical targets.

However, we can infer some "performance" outcomes from the biocompatibility tests:

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 states, "No clinical tests were performed as part of this device modification." Therefore, there is no clinical test set, sample size, or specific data provenance (country, retrospective/prospective) for clinical performance in the traditional sense. The performance data discussed relates to non-clinical laboratory testing. The document does not specify sample sizes for these non-clinical tests (e.g., how many tampons were tested for absorbency, string strength, etc.).

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

Not applicable. Since no clinical tests were performed and no human interpretation of data for diagnostic purposes is relevant to this device, no "experts" in the context of establishing ground truth for a test set are mentioned. The testing was conducted against regulatory standards and guidelines by presumably qualified laboratory personnel.

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

Not applicable. This device is a menstrual tampon, and the performance assessment is based on physical and chemical properties and biocompatibility, not on a diagnostic interpretation requiring adjudication of results from multiple readers.

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 device is a menstrual tampon and does not involve AI or human readers for diagnostic purposes.

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

Not applicable. This device is a physical medical device (menstrual tampon), not an algorithm or software.

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

For the non-clinical tests, the "ground truth" is defined by the established regulatory standards and guidance documents (e.g., ISO 10993 series for biocompatibility, 2005 FDA guidance for tampons for performance characteristics). Compliance with these standards indicates acceptable performance. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense applied to diagnostic devices.

8. The sample size for the training set

Not applicable. This is a 510(k) submission for a physical medical device, not an AI or machine learning device requiring a training set.

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

Not applicable for the reason mentioned above.

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The 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.

The device is a disposable examination glove. The subject gloves are made of Synthetic: Nitrile & Polychloroprene. They are non-sterile and intended for Over-The-Counter use.

The provided document is a 510(k) Premarket Notification for medical examination gloves. It details the safety and performance characteristics of "KIMTECH™ PRIZM™ Multi-Layered Exam Glove" and "KIMTECH™ PRIZM™ Xtra Multi-Layered Exam Glove," particularly regarding their resistance to chemotherapy drugs, opioid Fentanyl Citrate, and simulated gastric acid.

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided text:

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

The acceptance criteria are generally established standards from ASTM and ISO. The reported device performance is indicated as "Pass" for all tested attributes. Chemical permeation times are specific performance metrics for the glove's resistance to various substances.

Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of gloves or test replicates) used for each specific test. It indicates that "Non-Clinical Testing was conducted to demonstrate that the two proposed devices met all required design specifications." The testing appears to follow relevant ASTM and ISO standards, which would typically specify sample sizes.

The data provenance is from non-clinical testing conducted by Kimberly Clark Corporation, based in the United States. The testing is performed for premarket notification, indicating it's prospective data for the purpose of demonstrating substantial equivalence to a legally marketed predicate device.

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

This information is not applicable. The device is a medical examination glove, and the performance evaluation is based on objective, quantifiable physical and chemical tests (e.g., tensile strength, resistance to chemical permeation, and biocompatibility) against established standards. There is no qualitative assessment or "ground truth" to be established by human experts in the context of diagnostic interpretation.

4. Adjudication method for the test set

This information is not applicable. As stated above, the evaluation relies on objective measurements against engineering and chemical standards, not on human interpretation that would require adjudication.

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

This information is not applicable. This is a 510(k) submission for exam gloves, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable, as this is not an AI-powered device.

7. The type of ground truth used

The "ground truth" for evaluating these examination gloves is provided by established international and national standards for medical device performance. Specifically:

• ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D412-2006a: Standard Test Method for Vulcanized Rubber and Thermoplastic Elastomers-Tension
• ASTM D573-2004: Standard Test Method for Rubber-Deterioration in an Air Oven
• ASTM D3767-03: Standard Practice for Rubber Measurement of Dimensions
• ASTM D5151-2006: Standard Test Method for Detection of holes in Medical Gloves
• ASTM D6124-2006: Standard Tested Method for Residual Powder on Medical Gloves
• ASTM D6978-05 (Reapproved 2013): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
• ISO 2859: Sampling Procedures and Tables for Inspection by Attributes
• ISO 10993-10: Biological Evaluation of medical Devices-Part 10: Tests for Irritation and Sensitization
• ISO 10993-11: Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity

These standards define the methodologies and acceptable limits for various physical, chemical, and biological properties of the gloves.

8. The sample size for the training set

This information is not applicable. The device is a physical product (exam glove), not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for this type of device.

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The Nitrile Powder Free patient examination glove is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.

KIMTECH™ Purple Nitrile™ Examination Gloves, Powder Free, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric acid and Fentanyl in Simulated Gastric acid are single use only, non-sterile, disposable gloves. The powder-free gloves are made of a synthetic copolymer of acrylonitrile and butadiene with a purple color additive. The gloves are available in extra small, medium, large, and extra-large sizes.

This document is a 510(k) Premarket Notification for KIMTECH™ Purple Nitrile™ Powder Free Examination Gloves. It focuses on demonstrating that the proposed device is substantially equivalent to legally marketed predicate devices, particularly concerning its resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and fentanyl in simulated gastric acid.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the permeation resistance of the gloves are defined by the "Minimum Breakthrough Detection Time" for each substance. For other characteristics, the acceptance criteria are generally "Complies with" or "Pass" based on recognized ASTM and ISO standards.

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